Zeiss VISULAS YAG III User manual

VISULAS YAG III
Documentation set

© 2013, Carl Zeiss Meditec AG, Jena
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Contents
User manual
VISULAS YAG III
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Appendix
VISULAS YAG III stand-alone operation - Quick instructions
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VISULAS YAG III combination mode - Quick instructions
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Laser sign
[390000-3229-000]

VISULAS YA G III
User manual

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Contents
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Contents
Contents.....................................................................................1
Notes on the user manual ..........................................................4
Purpose and availability of documentation ....................................................4
Questions and comments................................................................................ 4
Explanation of symbols used ..........................................................................5
Package check list......................................................................6
Country-specific information and labels.....................................7
Classification/Manufacturer's declaration ...................................................... 7
Indication for use ............................................................................................8
Side effects/contraindications.........................................................................8
Intended user profile....................................................................................... 9
Disposal of the product ................................................................................10
Disposal of the product within the EU......................................................................10
Labels ............................................................................................................11
General warning and safety instructions..................................16
General notes................................................................................................16
Safety officer.................................................................................................17
Laser safety goggles .....................................................................................18
Patient safety ................................................................................................19
Explosion and fire hazards............................................................................19
Dangers caused by direct irradiation and reflection.....................................20
Performance specifications ......................................................22
Functional description...................................................................................22
Principle of Nd:YAG laser treatment .........................................................................22
Useful life ......................................................................................................23
Description of the device..........................................................24
Instrument base with head rest for VISULAS YAG III/
VISULAS YAG III Combi/VISULAS Trion Combi .............................................24
Design of the VISULAS YAG III......................................................................26
Design of the LSL YAG III laser slit lamp ...................................................................27
Beam delivery in the LSL YAG III laser slit lamp.........................................................28
VISULAS YAG III laser console ..................................................................................30
Design of VISULAS YAG III Combi/ VISULAS Trion Combi ............................32
VISULAS YAG III Combi.............................................................................................32

Contents
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VISULAS Trion Combi................................................................................................34
Design of the LSL YAG III Combi/LSL Trion Combi laser slit lamp .............................36
Beam delivery in the LSL YAG III Combi/LSL Trion Combi laser slit lamp...................37
VISULAS 532s/VISULAS Trion control panel for
VISULAS YAG III Combi/VISULAS Trion Combi..........................................................39
Installation ............................................................................... 40
Notes for installation and use ...................................................................... 40
Installation and transport of the VISULAS YAG III ....................................... 43
Installation of VISULAS YAG III Combi ......................................................... 45
Installation of VISULAS Trion Combi............................................................ 48
Installation of additional components ......................................................... 51
Moving the instrument table with the instrument....................................... 52
Installation of ACCENTO eyepiece to VISULAS YAG III/ VISULAS YAG III
Combi and VISULAS Trion Combi................................................................. 53
Data display in the ACCENTO eyepiece.....................................................................54
ACCENTO foot switch .................................................................................. 55
Daily use .................................................................................. 56
Switching on ................................................................................................ 56
Function test ................................................................................................ 57
Operation of the device ........................................................... 58
Laser treatment using VISULAS YAG III/
VISULAS YAG III Combi/VISULAS Trion Combi............................................. 59
Adjusting the slit lamp and eyepieces.......................................................................59
Start-up and laser treatment.....................................................................................60
VISULAS YAG III menu description............................................................... 61
Menu navigation.......................................................................................................61
Power-up mode ........................................................................................................62
Diagnosis mode ........................................................................................................63
Treatment STANDBY mode.......................................................................................64
Information mode.....................................................................................................66
Setting the system time ............................................................................................68
Treatment READY mode ...........................................................................................69
Menu description for VISULAS YAG III Combi.............................................. 70
Menu navigation.......................................................................................................70
VISULAS 532s power-up mode.................................................................................71
Diagnosis mode ........................................................................................................72
VISULAS YAG III power-up mode .............................................................................73
YAG III treatment mode............................................................................................74
STANDBY ..................................................................................................................75
READY ......................................................................................................................77
VISULAS Trion Combi menu description ...................................................... 78
Menu navigation.......................................................................................................78
VISULAS Trion power-up mode ................................................................................79
Diagnosis mode ........................................................................................................80
VISULAS YAG III power-up mode .............................................................................81

Contents
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YAG III treatment mode............................................................................................82
STANDBY ..................................................................................................................83
READY ......................................................................................................................85
Using the aiming beam system with the
VISULAS YAG III/VISULAS YAG III Combi/ VISULAS Trion Combi .................86
Focus shift and defocusing ...........................................................................88
Shutting down..........................................................................90
Switching off the instrument ....................................................................................90
Maintenance and care..............................................................91
Fault remedy .................................................................................................91
Troubleshooting tables .............................................................................................91
Error messages on YAG III ........................................................................................92
Error messages on VISULAS YAG III Combi/VISULAS Trion Combi............................92
Replacing the fuses .......................................................................................94
Replacing the fuse on the VISULAS YAG III laser console .........................................94
Replacing the halogen bulb in the laser slit lamp.........................................95
Maintenance and care ..................................................................................97
Care and cleaning.....................................................................................................97
Cleaning of optical components...............................................................................97
Cleaning and disinfection of painted surfaces ..........................................................98
Safety inspections .........................................................................................99
Optional accessories...............................................................100
Contact lenses.............................................................................................102
Essential performance............................................................103
VISULAS YAG III laser system .....................................................................104
Technical data ........................................................................104
LSL YAG III laser slit lamp ...........................................................................105
LSL YAG III Combi/LSL Trion Combi laser slit lamp.....................................105
Electromagnetic compatibility................................................107
Abbreviations/Glossary...........................................................112
Figures....................................................................................113
Index ......................................................................................115

Notes on the user manual
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Notes on the user manual
Purpose and availability of documentation
This user manual explains the safety precautions, functions, usage,
performance parameters and measures for care and maintenance of the
VISULAS YAG III.
Correct operation of the system is imperative for its safe and successful
function. You should therefore ensure that you are thoroughly familiar with
this user manual before setting up and using the VISULAS YAG III the first
time.
The user manuals and other documentation enclosed with the
VISULAS YAG III should be kept accessible to users at all times to ensure that
the information required for use of the VISULAS YAG III is readily available.
Questions and comments
If you have any questions or comments concerning this user manual or the
VISULAS YAG III, please contact Carl Zeiss Meditec customer service or your
local dealer (Contact details see reverse.).

Notes on the user manual
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Explanation of symbols used
The symbols used in this user manual refer to important safety information
which warn against possible health risks or fatal injuries and contain useful
notes. Whenever you see these symbols, read the accompanying information
carefully and observe all safety notes and information in this user manual
and on instrument labels.
WARNING
Indicates a hazardous situation which may result in fatal or serious bodily
injury if the appropriate safety precautions are not heeded.
CAUTION
Indicates a hazardous situation which may result in minor injury if the
appropriate safety precautions are not heeded.
CAUTION - PROPERTY DAMAGE
Indicates possible device damage if the appropriate safety precautions are
not heeded.

Information, hints and advice for a better understanding of the
instructions to be observed in the operation of the instrument.

Package check list
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Package check list
The delivery package contains the following components:
•VISULAS YAG III laser console
•LSL YAG III laser slit lamp
•Straight binocular tube f = 140 mm
•2 eyepieces 10x
•Head restrainer for VISULAS laser
•Armrest (height-adjustable)
•Dust cover
•Fixation lamp
•Cover plate for fixation lamp
•Flashing diode, red, for fixation lamp
•Power supply cable 2.5 m
•Documentation set

Country-specific information and labels
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Country-specific information and
labels
Classification/Manufacturer's declaration
WARNING - GENERAL HAZARDS
This device may only be set up, operated and used for the specified purpose
and according to national regulations, consistent with the applicable
industry standards and occupational safety and accident prevention
regulations. Further notes on classification are to be found in section
Technical data, page 104.
The device VISULAS YAG III complies with EU Medical Device Directive
93/42/EEC and its national implementation in the form of the German
Medical Products Act (MPG).
Device class:
2 pursuant to ISO 15004-2:2007
Device class according to the Medical
Products Act:
IIb
Laser class in accordance with
DIN EN 60825-1-2003:
4 (VISULAS YAG III)
EMC:
See section Electromagnetic
compatibility, page 107 and
following.
UMDNS No.:
16-947 (VISULAS YAG III)
UMDNS No.:
12-281 (laser slit lamp)
This declaration shall be rendered invalid if changes are made to the product
without the manufacturer’s authorization.
0297

Country-specific information and labels
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Indication for use
The VISULAS YAG III is designed for ophthalmologic use including posterior
capsulotomy and peripheral iridotomy.

Note for VISULAS YAG III Combi:
The VISULAS YAG III Combi instrument system consists of the
VISULAS 532s laser system, the VISULAS YAG III laser system and
the LSL YAG III Combi laser slit lamp as a general applicator for the
two laser systems.
For correct operation of the VISULAS 532s, the VISULAS 532s user
manual must be observed.

Note for VISULAS Trion Combi:
The VISULAS Trion Combi instrument system consists of the
VISULAS Trion laser system, the VISULAS YAG III laser system and
the LSL Trion Combi laser slit lamp as a common applicator for the
two laser systems.
For correct operation of the VISULAS Trion, the VISULAS Trion user
manual must be observed.
The user is liable for any use of the device other than intended.
Side effects/contraindications
The VISULAS YAG III should not be used in cases of retinal detachment or
cystoid macular edema, or with patients with intraocular glass lenses. Glass
lenses can be destroyed by the effect of the optical breakdown.
The following complications have been reported after Nd:YAG laser
treatment:
* Christian Ohrloff "Die Bedeutung der intakten Hinterkapsel für den Glaskörper"
Klin. Monatsbl. Augenheilkd. 1994; 205:181-186 © 1994 F. Enke Verlag Stuttgart
The frequency and severity of complications depends on the energy applied.
The lower the energy used, the lower the degree of postoperative
inflammation and increase in intraocular pressure.
Complication Incidence
Cystoid macular edema Estimated: < 1 %
Retinal detachment* Total population: 1.4 %
After capsulotomy: 2.8 %
Endophthalmitis Estimated: < 1 %
Increased intraocular pressure Estimated: < 1 %
Rubeosis iridis (associated with
diabetes)
Estimated: < 1 %

Country-specific information and labels
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Intended user profile
CAUTION - RISK ARISING FROM OPERATING ERRORS
This device may only be installed, operated, used and maintained by
persons who have been properly trained or who have the required
knowledge and experience to do so. Please adhere to the national
qualification guidelines applicable in your country.
The VISULAS YAG III may only be operated by physicians who have
adequate knowledge of the medical application of the instrument, the
effect of the laser beam on tissues and possible side effects.
People working in the laser hazard area must be given instruction
concerning safety regulations, safety precautions and operation of the
instrument at least once a year. Keep a written record of these instructions
listing the participants.

Country-specific information and labels
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Disposal of the product
CAUTION - RISK OF ENVIRONMENTAL POLLUTION
Packaging materials should be retained for future relocation or repair.
If you wish to dispose of the packaging material, hand it over to a
recognized collection system for recycling.
The instrument contains electronic components. At the end of its lifetime,
the device and its integrated batteries should be disposed of in accordance
with the relevant national regulations.
Disposal of the product within the EU
In accordance with applicable EU guidelines and national regulations at the
time at which the product was brought onto the market, the product
specified on the consignment note is not to be disposed of via the domestic
waste disposal system or communal waste disposal facilities.
For further information on disposal of this product please contact your local
dealer or the manufacturer or its legal successor company. Please read the
latest internet information provided by the manufacturer.
Where the product or its components are resold, the seller must inform the
buyer that the product must be disposed of in accordance with the currently
applicable national regulations.

Country-specific information and labels
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Labels
Fig. 1 Warning and information labels on the VISULAS YAG III

Country-specific information and labels
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Item Label Explanation
1
VISULAS YAG III type label
IP20
Manufacturer
Date of manufacture
Application part type B
Housing protection class
(protected against solid
foreign bodies of 12.5mm in
diameter and larger, no
protection against penetration
of water)
2
Identification label
VISULAS YAG III
REF Catalogue number/
part number
SN Serial number
3
Date of manufacture label
4
CE marking label and disposal advise
for EU
5
"Disconnect device from the power
supply before opening" sign
6
"Observe user manual" sign
REF 1272-175
SN XXXXXXX
XX/XXXX
0000-033-DE-Vs01 MWIB

Country-specific information and labels
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Item Label Explanation
7
Laser class 4 1064/660-680 nm
warning label
8
Not applicable
Not applicable
9
Label with fuse specifications
VISULAS YAG III
10
LSL YAG III type label
LSL YAG III Combi type label
LSL Trion Combi type label
Manufacturer
Date of manufacture
Application parts type B
conforming to IEC 60601-1
CE marking label and disposal
advise for EU
IP20 Housing protection class
(protected against solid foreign
bodies of 12.5 mm in diameter
and larger, no protection
against penetration of water)

Country-specific information and labels
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Item Label Explanation
11
Identification label
LSL YAG III
Identification label
LSL YAG III Combi
Identification label
LSL Trion Combi
12
Date of manufacture
13
Laser class 4 warning label
14
"Laser exit aperture"
warning label
LSL YAG III
LSL YAG III Combi
LSL Trion Combi
15
"Laser exit aperture"
warning label
LSL YAG III Combi
LSL Trion Combi
REF 1272-071
SN XXXXXXX
REF 1272-069
SN XXXXXXX
REF 1377-684
SN XXXXXXX
XX/XXXX