Professional Documents
Culture Documents
MASTER lase
EXPERT lase
Draft
English
GA_MASTERlase+EXPERTlase_1.010.0274_E_en
MASTER lase / EXPERT lase
Trademarks
Registered trademarks, trade names and names are used in these
instructions for use. The relevant protective provisions are applicable even if
they are not designated as such.
Service Support
KaVo Dental GmbH
Bahnhofstraße 20
88447 Warthausen
Phone: +49 7351 56-2800
Mail: Service.Laser@kavo.com
GA_MASTERlase+EXPERTlase_1.010.0274_E_en
MASTER lase / EXPERT lase
Table of contents
Important instructions .................................................................................. 5
Design of safety instructions ................................................................... 5
Legend ..................................................................................................... 6
Description of product .................................................................... 9
Intended medical use - application field ...................................................... 9
Indications, indication areas ........................................................................ 9
Combination with accessories................................................................... 10
Contraindications ...................................................................................... 10
Requirements for laser application ........................................................... 10
Education and declaration of consent of patient ....................................... 10
Safety ............................................................................................. 11
Medical Device Law (MPG) / EU – Medical products - guideline ............. 11
Possible complications, risks and hazards ............................................... 12
Installation and initial commissioning ........................................................ 13
Laser Safety .............................................................................................. 14
Application of laser radiation ..................................................................... 16
Laser safety office ..................................................................................... 16
Eye protection ........................................................................................... 17
Safety of the patients, user and third parties ............................................ 18
Training and responsibility of the user ...................................................... 18
Training and75Bdue dilligence of the operating personnel ....................... 19
Responsibility of Kaltenbach & Voigt GmbH ............................................. 19
Warning and safety instructions concerning electromagnetic compatibility in
accordance with EMC - Norm DIN EN 60601-1-2:2007 ........................... 20
Guidelines and manufacturer's declaration - electromagnetic emission:20
Guidelines and manufacturer's statement - Electromagnetic immunity: 21
Safety measures and safety systems ....................................................... 25
Electrical installation .............................................................................. 25
Disconnection from the supply network................................................. 25
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MASTER lase / EXPERT lase
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MASTER lase / EXPERT lase
Assemble wireless foot switch and log into the device ......................... 55
Commissioning .......................................................................................... 57
Commissioning of the transmission fibre optic conductor ..................... 59
Mounting the sapphire tip handpiece and commissioning .................... 62
Mounting the bare fibre handpiece and commissioning ........................ 66
Blacken the sapphire tip / bare fibre tip ................................................. 70
Dismounting the sapphire tip handpiece ............................................... 72
Dismantling the bare fibre handpiece .................................................... 73
Therapy settings ........................................................................................ 74
Select the indication .............................................................................. 74
Setting the performance ........................................................................ 75
Setting the performance with the wireless foot switch .......................... 76
Setting the pulse form............................................................................ 77
Setting the pulse duration ...................................................................... 78
Setting the pulse pause ......................................................................... 79
Setting the duration of application ......................................................... 80
Compilation and use of list of Favorites ................................................ 81
Saving the default settings of the indication parameters .................. 81
Saving individual indication parameter settings ............................... 82
Calling up indication parameters from the list of Favorites ............... 83
Deleting indication parameters from the list of Favorites ................. 84
Setting the brightness of the pilot laser ................................................. 85
Changing the display mode of the protocol button ................................ 86
Resetting the protocol or timer .............................................................. 87
Menu settings ............................................................................................ 88
Setting the volume for laser warning signal tones and input feedback . 88
Setting the shutdown time ..................................................................... 89
Setting transitional period Ready Standby........................................ 90
Selecting option „Pilot during therapy“ .................................................. 91
Selecting operation ................................................................................ 92
Setting the language.............................................................................. 94
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MASTER lase / EXPERT lase
4 GA_MASTERlase+EXPERTlase_1.010.0274_E_en 20.03.2015
Design of safety instructions
Important instructions
Design of safety instructions
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Design of safety instructions
Legend
Caution
Article number
Serial number
~ Alternating current
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Design of safety instructions
Manufacturer
Date of manufacture
1
Specification laser beam
1
Plate for the specification of the laser beam is only an example.
Take the data from the plate on the device.
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Design of safety instructions
Type of instrument,
For current manufacturing date,
serial number and
performance / supply data see nameplate on
instrument
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Description of product
Description of product
Intended medical use - application field
The device is a portable diode laser for multidisciplinary application in
dental surgeries and practices.
The power transmitted to the tissue by the device amounts to up to 10
Watt.
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Description of product
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Safety
Safety
Prior to the startup of the MASTER/EXPERT lase, every user must have
read the complete instructions for use and understand them.
The adherence to the safety guidelines when handling the laser is the
responsibility of the laser safety officer.
All safety aspects defined in the section "Safety" of these instructions
for use must be adhered to.
The instructions for use must always be available in the vicinity of the
device.
The instructions for use must be passed on to all subsequent users.
Medical Device Law (MPG) / EU – Medical products - guideline
The laser device is an active medical device in accordance with Class
IIb pursuant to Directive 93/42/ECC concerning medical devices.
In accordance with the Medical Product Law, medical devices may
only be set up, used and operated in accordance with their intended
purpose, according to the guidelines of this law and the pursuant
approved legislation, the acknowledged rule of technology and the
occupational safety and accident prevention regulations. They may not
be used or operated if they exhibit defects or could endanger patients,
staff or other persons. They may only be used and operated by
persons who can ensure proper handling based on their training or
knowledge and practical experience.
Class IIb medical devices may only be used by persons who have been
familiarised with the device and trained in appropriate handling in
consideration of the instructions for use.
Only such persons who can ensure proper handling based on their
training or knowledge and practical experience in handling the device
may be trained.
In addition, the user must keep a medical device log.
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Safety
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Safety
Laser Safety
All valid guidelines concerning radiation protection for laser devices
must be adhered to when operating the device. In case of ambiguity of
the guidelines, the laser safety officer must be consulted.
The laser area is defined as the area in which the values for the
maximum permissible radiation dose (MRD) for eyes (IEC/EN 60825-
1:2007) could be achieved or exceeded.
The entire operating room is regarded as laser area if hand applicators
are used for open work.
An unintentional distraction of the laser beam must be taken into
consideration.
Adequate laser safety goggles must be worn inside the laser area.
The laser area must be marked with door signs and warning lights,
must be kept as small as possible and secured against unauthorised
entrance.
The number of persons within the laser area must be as low as
possible.
Reflecting, shining materials must be removed form the laser area or
packed in flame-retardant cloths. Combustible materials must be
removed.
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Safety
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Safety
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Safety
Eye protection
The eye is especially endangered due to the high energy density. The eye
can be damaged even by weak laser radiation.
Laser area according to IEC EN 60825 (version 03-2007; section
3.61).
The safe distance from the eye to the laser beam egress point is
defined as „Nominal Ocular Hazard Distance“ (NOHD). Laser safety
goggles need not be worn outside this area if the fibre optic conductor
is not operated in combination with the focussing optics. The beam
divergence (a) is 10° (full angle).
The safety distance NOHD for the MASTER/EXPERT lase is defined as 3.2
m to the distal end of the fibre optic conductor or handpiece used.
Laser safety goggles for the laser system must fulfil the following
conditions at least:
Wavelength of the Protection class Manufacturer
Laser type
filtered beam EN 207:2002 abbreviation
in accordance
D 980 nm LB3 with
EN 207:2009
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Safety
Prior to every treatment, the user must have verified the proper
functioning of the device in order to exclude any danger to patients,
third parties or himself. If the device is used with accessories, the
instructions for use of the accessories must have been read completely
and understood.
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Safety
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Safety
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Safety
Compliance Electromagnetic
IEC 60601 test
Immunity tests environment -
levels level Guidelines
Floors should be
± 6 kV contact ± 6 kV contact made of wood or
discharge discharge concrete or be fitted
Electrostatic
with ceramic tiles. If
discharge (ESD)
the floor is made of
according to IEC
synthetic material,
61000-4-2 ± 8 kV atmospheric ± 8 kV atmospheric the relative humidity
discharge discharge must be at least
30%.
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Safety
Compliance Electromagnetic
IEC 60601 test
Immunity tests environment -
levels level Guidelines
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Safety
Compliance Electromagnetic
IEC 60601 test
Immunity tests environment -
levels level Guidelines
Handheld and mobile wireless devices should not be used at a shorter distance from the
including cables than the recommended safe clearance calculated with the appropriate
equation for the emission frequency.
Recommended safe
distance:
d = 2.3. P 800
MHz to 2.5 GHz
With P as the rated power of the transmitter in Watts (W) according to the transmitter
manufacturer, and d as the recommended safe distance in meters (m).
The field strength of stationary wireless radio transmitters as measured locally:
b
should be lower than the conformance level of all frequencies.
c
interference is possible in the vicinity of devices that bear the following symbol.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2:These guidelines may not be applicable in all situations. The spread of
electromagnetic waves is absorbed and reflected by buildings, objects and people.
a
The ISM bands between 150 kHZ and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to
13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz.
b
The field strength of stationary transmitters such as base stations of mobile telephones and
land radio devices, amateur radio stations, AM and FM, radio and television broadcasters
cannot be theoretically predetermined accurately. A site study should be considered to
determine the electromagnetic environment in terms of stationary transmitters. The device
should be observed to verify the functioning as intended. Should unusual performance
features be observed, additional measures may be required, such as e.g. a different alignment
or another location for the device.
c
The field strength is less than 3 V/m over the frequency range of 150 kHz to 80
MHz.
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Safety
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Safety
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Safety
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Technical specifications
Technical specifications
Technical specifications EXPERT lase
Model designation
Maximum L ≤ 60 dB
in standby L < 50 dB
Fibres
Wavelengths 980 15 nm
Laser power 0.2 - 8 Watt (see also Setting ranges, page 43)
Pilot laser
Wavelengths 640 ± 10 nm
Laser power 0 to 1 mW
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Technical specifications
Maximum L ≤ 60 dB
in standby L < 50 dB
Fibres
Wavelengths 980 15 nm
Laser power 0.2 - 10 Watt (see also Setting ranges, page 43)
Pilot laser
Wavelengths 640 ± 10 nm
Laser power 0 to 1 mW
Accuracy of the defined values is compliant with EN 60601-2-22.
Further technical details can be found in the current service manual for
MASTER/EXPERT lase.
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Description
Description
Scope of delivery and accessories
Different device variants can be selected. The accessories specified
for the device are dependent on the model (see „Combination with
accessories, page 10).
No. in Figure 3
Instructions for use
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Description
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Description
Device variants
Scope of delivery
MASTER lase
EXPERT lase
Standard Wireless
with internal power supply 1x - -
with internal battery - 1x 1x
Charger adaptor - 1x 1x
Wired foot switch 1x 1x -
Wireless foot switch - - 1x
Tool for the wireless foot switch - - 1x
Bare fibre tip 300 m 3x 3x 3x
Bare fibre tip 240 m 2x 2x 2x
Sapphire tip - 2x 2x
Cleaning cap for sapphire tip - 1x 1x
Tool for sapphire tip - 2x 2x
Handpiece for bare fibre tip 1x 1x 1x
Handpiece for sapphire tip - 1x 1x
Transmission fibre optic conductor 1x 1x 1x
Safety goggles (patient) 1x 1x 1x
Safety goggles (operator) 2x 2x 2x
Device case 1x 1x 1x
Laser warning label 1x 1x 1x
The charging adaptor charges the battery (version with battery) and charges
the battery of the wireless foot switch.
The tool is required for the assembly of the wireless foot switch for the initial commissioning
(see Assemble wireless foot switch, page 55).
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Description
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Description
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Description
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Description
Setup
The device is enclosed in portable housing.
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Description
Terminals
Electrical terminals
Electrical terminals are located on the rear side of the device.
Figure 8. Connections (rear side)
Interlock
Power cable
Connection charger
(battery model)
The fibre optic conductor terminal is located on the side of the device
and is for the connection of the transmission of the transmission fibre
optic conductor.
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Description
Right button Switches the performance of the device one level higher
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Description
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Description
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Description
Control panel
The control panel serves the input and display of the device functions
(operating modes, setting parameters etc.) and consists of the display
and the touch keys.
The display is equipped with a touch-sensitive surface (touchscreen). the
touchscreen is divided into three areas which are emphasised by different
background colours.
The input is made by pressing the keys and touching a displayed element or
value.
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Description
No. in
Name Function
Figure 10
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Description
Therapy mode
Setting parameters
Table 1. Adjustable pulse forms
Pulse forms Description
Pulse Setting the inactive phase between two pulses of the therapy laser
pause beam.
Duration Setting the application time for the therapy laser beam.
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Description
Device
Parameters
variants
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Description
Selection of indication
The treatment parameters are specified by selection of the desired
indication (recommendations).
Treatment instructions compiled by experienced specialists and
reference physicians are given with the indications. Special cautionary
measures are prefixed with CAVE and displayed in orange.
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Description
Abscess Abscess
Adenoma Adenoma
Biopsy Biopsy
Drainage Drainage
Epulis Epulis
Fibroma Fibroma
Fistula duct Fistula duct
Labial frenectomy Labial frenectomy
Lingual frenect. Lingual frenect.
Gingivectomy Gingivectomy
Gingivoplasty Gingivoplasty
Hemangioma Hemangioma
8W Hemostasis Hemostasis
Hyperplasias Hyperplasias
Leukoplakias Leukoplakias
Operculectomy Operculectomy
Papilloma Papilloma
Vestibuloplasty Vestibuloplasty
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Description
Indication
Maximum
Specialised Display on the
adjustable Display on indication
areas indication element Full text
performance selection
button
Endo / Paro
Endodontics
Endodontics Endodontics
adjuvant
Endo adjuvant
Endo periapical Endo periapical in periapical
defect
Exstirpation Exstirpation
4W Periodontology
Periodontology Periodontology
adjuvant
Peri-implantitis
Periimplantitis Periimplantitis decontamination
of the implant
Pulpotomy Pulpotomy
Pulp capping Pulp capping
Others
Aphthea, herpes Aphthea, herpes
Activation of
bleaching
Bleaching Bleaching material by
means of laser
light
8W Desensitisation Desensitisation
Mycoses Mycoses
Sulcus dilation Sulcus dilation
Low Level
LLLT LLLT
Laser Therapy
Blacken the fiber Blacken the fiber
Customized 1 to 5 Call indications
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Description
Pilot
The pilot laser simulates an invisible therapy laser beam by means of
visible light. The brightness of the pilot laser can be set from 0 to 5 in
single increments.
The pilot laser is a laser of the laser class 2 according to IEC EN
60825:2007-03.
If the pilot is switched off and invisible, the device may only be used
for contact applications.
Protocol
The device logs and displays automatically:
the sum of the applied energy and application times
the duration of the inactive phase of the laser beam
the duration of the inactive phase and the duration of the active
phase of the laser beam
Peak performance and average performance
You will find information concerning the selection of the
on page 86.
The protocol data can be reset to 0 via the protocol element.
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Description
Menu
The menu enables the individual definition and saving of basic settings
for the user.
Table 5. Adjustable parameters in the menu
Function / setting Description
- Settings Tab
Volume Volume setting
Laser audible Volume of the audible warning
warning the volume of the audible warning can be set at 5 levels.
volume of the feedback tone on button activation
Input feedback
the volume of the audible warning can be set at 5 levels.
Tool Option
Set the time for the automatic switch off. Devices with
mains power supply:
3, 5, 10, 15, 30 minutes or Off.
Devices with battery supply:
Switch-off time (min.) 3, 5, 10, 15 minutes.
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Description
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Operation
Operation
This chapter assumes that you are familiar with the operating elements
of the device.
Observe safety
Carry out a visual inspection prior to every startup:
You may not start the device if the safety checks give reason
for concern.
In this case, notify your responsible after sales service.
1. Check the control panel and the housing of the device for
mechanical damage.
2. Check the existing cable for mechanical damage.
3. Check the existing connections for mechanical damage.
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Operation
If the laser beam hits inner parts of the device, this could
damage the eyes of the user and damage the device.
The fibre optic conductor must protrude distally on laser
activation from the device canal.
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Operation
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Operation
2. Clearly define and mark the laser area, see section „Laser
protection officer“.
3. Only for models with mains power supply:
Connect the power cable to the power supply.
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Operation
Assemble wireless foot switch and log into the device, page 55.
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Operation
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Operation
The wireless foot switch may not be connected to the device and
the device must be switched on. When switching on the device,
observe chapter „Commissioning“, page 57.
if you possess several KaVo devices with wireless foot switches, you
have to log the foot switch into the device each time you switch on.
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Operation
Commissioning
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Operation
if you have forgotten your personal PIN, you can start up the device with a
Super PIN. You can obtain the Super PIN from Kaltenbach & Voigt GmbH
Service Support. After the start with the Super PIN, change the PIN on your
personal PIN again.
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Operation
Danger of contamination!
Carry out the wipe disinfection of the transmission fibre optic
conductor both just before application as well as directly after
application including the initial commissioning.
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Operation
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Operation
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Operation
Contamination hazard!
If sterile packaging is damaged, previously sterilised handpieces
and sapphire tips must be sterilised again before use.
Contamination hazard!
If possible, keep the handpiece in your hand and do not lay it
down on an unsterile surface. Avoid contact with the
sapphire tip.
Use only a sterile holder throughout the entire process!
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Operation
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Operation
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Operation
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Operation
Contamination hazard!
If possible, keep the handpiece in your hand and do not lay it
down on an unsterile surface. Avoid contact with the bare
fibre tip.
Use only a sterile holder throughout the entire process!
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Operation
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Operation
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Operation
In case of a technically faultless bare fibre tip, an even circular light spot is generated
with intensity rapidly decreasing to the outside.
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Operation
4. Confirm with
OK to proceed
to therapy mode.
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Operation
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Operation
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Operation
At the end of the service life cycle, dispose of the optic fibres and
handpieces in accordance with the local regulations for
contaminated products. In this way you will minimise hazards for
the environment and personnel that could be caused by
contamination and residues of the fibres and handpieces
employed.
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Operation
Therapy settings
To be able to monitor the set parameters during therapy, secure a clear view of
the display of the device.
Select the indication
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Operation
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Operation
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Operation
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Operation
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Operation
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Operation
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Operation
4. Activate
Save as Favorites.
The Favorites display changes colour to green and
moves to the left. The desired indication is included in
the list of Favorites.
5. Confirm with
OK to proceed to
therapy mode.
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Operation
4. Activate
Save as Favorites.
5. Confirm with
OK to proceed to
therapy mode.
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Operation
2. Activate Favorites.
The Favorites display changes colour to
green and moves to the left.
4. Confirm with
OK to proceed to
therapy mode.
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Operation
3. Activate Delete.
4. Confirm with
OK to proceed to
therapy mode.
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Operation
Risk of injury!
If the pilot is switched off and invisible, the device may only be used for
contact applications.
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Operation
Display , :
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Menu settings
Setting the volume for laser warning signal tones and input feedback
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Operation
Selecting operation
The Demo operation is only for demonstration purposes. Treatment is not possible.
the Service operation is only accessible to the customer service. Treatment is not possible.
In this screen, you can also switch off the device, Shutdown.
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1. Activate Therapy.
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Operation
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4. Activate OK to return to
therapy mode.
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Operation
Warn all persons in the laser area before triggering the laser
beam.
All persons present in the laser area must wear safety goggles.
Risk of injury!
Activate the laser bar or the switch-on button of the device
and switch the device to „Standby“ - mode if you want to
interrupt the laser operation or treatment.
Risk of injury!
Activate the left button on the wireless foot switch and
switch the device to „Standby“ - mode if you want to
interrupt the laser operation or treatment.
3. Select Shutdown.
Pull the power plug to disconnect the device from the power
supply.
before/after
Please check and clean the outer surfaces
use
before/after
Check the accessories
use
before/after
Check the foot switch and the connection to the device
use
before/after
Check the laser warning light on the OP door
use
before/after
Check the electric cable (power cable and accessory cables)
use
Check the battery charging status of the device and wireless foot switch
before use
(MASTER lase)
Cleaning
The device may only be wiped down with a moist cloth on the
outside with conventional clinical cleaning agents.
The control panel (touchscreen) must be cleaned especially
carefully and gently using a dry, soft cloth. If the control panel
(touchscreen) is really dirty, it can be cleaned with a slightly
moistened cloth.
Safety checks
Safety checks are understood as maintenance conducted at regular
intervals.
The interval for the device is determined at every 500 operating hours or
every 12 months, at the latest. A note appears in the device display if the
interval is exceeded.
After every change of location outside the clinic or dental practice
- in case of appropriate transportation without detectable transport
damage - a function check is sufficient (National German Guidelines /
BGV A3, MPBetreibV).
Function check comprises commissioning with device self test (see page
57), fibre optic conductor with pilot laser (see page 65) and subsequent
check of laser performance at fibre end at 5 Watt setting.
Messages
Messages are indicated in the display. Some messages are
accompanied by an acoustic alarm.
Table 7. Messages
Message Meaning Action, reference
the device has switched off Wait until the device is ready for operation
Over-
because the housing again (do not switch off). Please contact
temperature
temperature or therapy KaVo Service if the message is still
housing
laser beam is too high displayed after 2/5 minutes.
The device has switched off Wait until the device is ready for operation
Over-
the therapy laser beam again (do not switch off). Please contact
temperature
because the laser diode KaVo Service if the message is still
laser
temperature too high displayed after 2/5 minutes.
The device has switched off Wait until the device is ready for operation
Over-
the therapy laser beam again (do not switch off). Please contact
temperature
because the cooling unit is KaVo Service if the message is still
heatsink
overloaded displayed after 2/5 minutes.
High
temperature, The battery temperature is The current therapy can be continued
switch-off too high. for 3 - 5 minutes.
possible
Update
Invalid date and time set Set the correct date and time.
date/time
Exchange RTC Notify service, have the battery for the
Index
battery real/time clock changed.
Battery health The battery has reached the Notify service, have the battery
weak end of its life changed.
Index
A R
Accessories · 29 Reading the logbook · 99
Assemble wireless foot switch · 55 Resetting the protocol · 87
B S
Blacken the sapphire tip / bare fibre tip · 70 Safety checks · 108
Select the indication · 74
C Selecting operation · 92
Changing the PIN · 96
Selecting option „Pilot during therapy“ · 91
Cleaning · 106
Selection of indication · 44
Commissioning · 56, 57
Setting parameters · 42
Commissioning of the transmission fibre
optic conductor · 59 Setting ranges · 43
Compilation and use of list of Favorites · 81 Setting the date and time · 95
Setting the duration of application · 80
D Setting the frequency of the PIN - request ·
Dismantling the bare fibre handpiece · 73 98
Dismounting the sapphire handpiece · 72 Setting the language · 94
Disposal · 111 Setting the performance · 75
I Setting the pulse duration · 78
Intended medical use · 9 Setting the pulse form · 77
Setting the pulse pause · 79
L Setting the shutdown time · 89
Laser safety glasses · 14
Setting the volume for laser warning signal
Laserschutzbrille · 17 tones and input feedback · 88
M Setting transition period · 90
Maintenance · 105 Shutdown the device · 103
Messages · 109 Super PIN · 58
Mounting the bare fibre handpiece and Switch on the device · 56
commissioning · 66 Switch the device on · 57
Mounting the sapphire tip handpiece and
commissioning · 62 T
Technical specifications · 27
O Trademarks · 3
Operation – demo change to therapy Transportation of the device · 104
operation · 93
Triggering the therapy beam · 100
P
Protocol button · 86