VISULAS YAG III User Manual

© 2022, Carl Zeiss Meditec AG, Jena All rights reserved in the event of granting of patents or registration as a utility patent. All names of companies and products cited in this documentation set may be trademarks or registered trademarks. References to products of other manufacturers are for information purposes only. Such references are intended neither as an approval nor a recommendation of these products. Carl Zeiss Meditec AG accepts no liability for the performance or use of such products. Other brand names, software and hardware names used in this documentation set are generally subject to trademark or patent protection. The quoting of products is for informational purposes only and does not represent a trademark misuse. The weblinks are dynamic hyperlinks. Before incorporating any links, Carl Zeiss Meditec AG checks their content to ensure that it is not likely to result in civil or criminal liability. It does not, however, continuously check for any changes which could form the basis for liability. If Carl Zeiss Meditec AG determines that a link which it has incorporated could result in civil or criminal liability, or is alerted to the fact by a third party, the link will be removed. This documentation set is protected by copyright. Unless expressly authorized in writing, dissemination, duplication or other commercial exploitation of this document or communication of its contents or parts of it is not permitted. In case of infringement, the violator may be liable to pay compensation for damages. Specifications due to technical developments are subject to change. This documentation set is not subject to the revision service. Please contact the manufacturer or authorized dealer to request the latest edition of the documentation set.

Contents

User manual VISULAS YAG III [000000-1272-175-GA-en-GB-210122]

Appendix VISULAS YAG III stand-alone operation - Quick instructions [000000-1272-175-KurzGA01-GB-090620] VISULAS YAG III combination mode - Quick instructions [000000-1272-175-KurzGA02-GB-090620]

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VISULAS YAG 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 the 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 Intended use ... 8 Side effects/contraindications ... 8 Intended user profile ... 9 Disposal of the product ... 10 Disposal of the device within the EU ... 10 External labels ... 11

General warning and safety instructions ...16 General information ... 16 Laser safety goggles... 17 Patient safety ... 18 Explosion and fire hazards ... 18 Dangers caused by direct irradiation and reflection ... 19

Performance specifications ...21 Functional description ... 21 Principle of Nd:YAG laser treatment ... 21 Service life ... 22

Description of the device...23 Instrument base with head rest for VISULAS YAG III/ VISULAS YAG III Combi/VISULAS Trion Combi ... 23 Design of the VISULAS YAG III ... 25 Foot switch (optional) ... 26 Design of the LSL YAG III laser slit lamp ... 28 Beam delivery in the LSL YAG III laser slit lamp ... 29 VISULAS YAG III laser console ... 31 Design of VISULAS YAG III Combi/ VISULAS Trion Combi... 33 VISULAS YAG III Combi ... 33 VISULAS Trion Combi ... 35 Design of the LSL YAG III Combi/LSL Trion Combi laser slit lamp ... 37

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Contents

Beam delivery in the LSL YAG III Combi/LSL Trion Combi laser slit lamp ... 38 VISULAS 532s/VISULAS Trion control panel for VISULAS YAG III Combi/VISULAS Trion Combi ... 40

Installation ...41 Notes on installation and use ... 41 Installation and transport of the VISULAS YAG III ... 44 Installation of VISULAS YAG III Combi ... 46 Installation of VISULAS Trion Combi ... 49 Installation of additional components ... 52 Moving the instrument table with the device... 53 Installation of ACCENTO eyepiece to VISULAS YAG III/VISULAS YAG III Combi and VISULAS Trion Combi ... 54 Data display in the ACCENTO eyepiece ... 55 ACCENTO foot switch ... 56

Daily startup...57 Switching on ... 57 Functional test ... 58

Operation of the device ...59 Laser treatment using VISULAS YAG III/ VISULAS YAG III Combi/VISULAS Trion Combi ... 60 Adjusting the slit lamp and eyepieces... 60 Start-up and laser treatment ... 61 VISULAS YAG III menu description ... 62 Menu navigation... 62 Power-up mode ... 63 Diagnosis mode ... 64 Treatment STANDBY mode ... 65 Information mode ... 67 Setting the system time ... 69 Treatment READY mode ... 70 Menu description for VISULAS YAG III Combi ... 71 Menu navigation... 71 VISULAS 532s power-up mode ... 72 Diagnosis mode ... 73 VISULAS YAG III power-up mode ... 74 YAG III treatment mode ... 75 STANDBY ... 76 READY ... 78 VISULAS Trion Combi menu description... 79 Menu navigation... 79 VISULAS Trion power-up mode ... 80 Diagnosis mode ... 81 VISULAS YAG III power-up mode ... 82 YAG III treatment mode ... 83 STANDBY ... 84 READY ... 86

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Using the aiming beam system with the VISULAS YAG III/VISULAS YAG III Combi/VISULAS Trion Combi ... 87 Focus shift and defocusing ... 89

Shutting down ...91 Switching off the device ... 91

Maintenance and care ...92 Troubleshooting ... 92 Troubleshooting tables... 92 Error messages on YAG III ... 93 Error messages on VISULAS YAG III Combi/VISULAS Trion Combi... 93 Replacing the fuses ... 95 Replacing the fuse on the VISULAS YAG III laser console ... 95 Replacing the halogen bulb in the laser slit lamp ... 96 Maintenance ... 98 Care and cleaning ... 98 Cleaning of optical components ... 99 Cleaning and disinfection of painted surfaces... 99 Safety inspections ... 100

Optional accessories...101 Contact lenses ... 103

Essential performance ...104 Technical data ...105 VISULAS YAG III laser system ... 105 LSL YAG III laser slit lamp ... 106 LSL YAG III Combi/LSL Trion Combi laser slit lamp ... 106

Electromagnetic compatibility ...108 Ambient conditions for intended use ... 108 Emission ... 110 Immunity ... 111 Restriction regarding clinical functions ... 112

Abbreviations/Glossary...113 Figures ...114 Index ...116

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Notes on the user manual

Notes on the user manual Purpose and availability of the 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. The user manual describes all functions with a maximum device configuration of VISULAS YAG III. Certain features may not be available due to your order or local approvals.

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.)

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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 may 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 device labels. WARNING Indicates a hazardous situation which could result in death or serious bodily injury if the appropriate safety precautions are not heeded. CAUTION Indicates a hazardous situation which could result in minor or moderate 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 better understanding of the instructions to be observed in the operation of the device.

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Package check list

Package check list The delivery package contains the following components: •

VISULAS YAG III laser console

•

LSL YAG III laser slit lamp

•

Parallel tube f = 140 mm

•

2 eyepieces 10x

•

Headband for VISULAS laser

•

Armrest (height-adjustable)

•

Dust cover

•

Fixation light

•

Occulting sleeve for fixation light

•

Flashing diode, red, for fixation light

•

Power supply cable 2.5 m

•

Documentation set

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Country-specific information and labels

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Country-specific information and labels Classification/Manufacturer's declaration WARNING - GENERAL HAZARDS This device may be set up, operated and used only for the intended use and in accordance with local country-specific regulations, generally accepted engineering standards and occupational safety and accident prevention regulations. This device complies with EC Medical Device Directive 93/42/EEC (MDD). Device class according to MDD:

IIb

UMDNS No.

16-947 (VISULAS YAG III)

The product is compliant to RoHS according to Directive 2011/65/EU. This declaration shall be rendered invalid if changes are made to the product without the manufacturer's authorization. Further notes on classification are to be found in section Technical data, page 105 and following.

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Country-specific information and labels

Intended 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 device 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 intended use of the VISULAS 532s, the VISULAS 532s user manual must be observed.



Note for VISULAS Trion Combi: The VISULAS Trion Combi device 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 intended use 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: Complication Cystoid macular edema Retinal detachment* Endophthalmitis Increased intraocular pressure Rubeosis iridis (associated with diabetes)

Incidence Estimated: Total population: After capsulotomy: : Estimated: Estimated: Estimated:

<1% 1.4 % 2.8 % <1% <1% <1%

* 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. Contraindications, side-effects and complications are not limited to this list. For a complete list of contraindications, please consult medical literature and professional associations.

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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 also 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 device, 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 device at least once a year. Keep a written record of these instructions listing the participants.

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Country-specific information and labels

Disposal of the product CAUTION - RISK OF ENVIRONMENTAL POLLUTION If you want to dispose of the packing material, please use a recognized collection system for recycling. The device contains electronic components. At the end of the service life, the device and the batteries installed in it have to be disposed of properly according to the national laws.



The packing material should be kept to be used for a future move or for repairs.

Disposal of the device 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 detailed information on the disposal of the product, please contact your local dealer or the device manufacturer or its legal successor company. Please read 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.

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Country-specific information and labels

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External labels

Fig. 1

Warning and information labels on the VISULAS YAG III

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Country-specific information and labels

Item 1

Label

Explanation VISULAS YAG III type label Manufacturer Date of manufacture Applied part type B IP20

2

Ingress protection rating of casing (protected against solid foreign bodies of 12.5mm in diameter and larger, no protection against penetration of water)

Identification label with unique device identification code (Unique device identification label) VISULAS YAG III REF SN

Catalogue number/ part number Serial number Unique device identification code (Data matrix and plain text)

3

Device Identification code (Data matrix, serial number and device name)

4

Label with manufacturing date

5

CE marking label and disposal advice for EU EU conformity symbol with identification number of notified body Disposal advice for EU

6

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"Disconnect device from the power supply before opening" information label

Country-specific information and labels

Item

Label

7

10

11

Explanation "Observe user manual" information label

8

9

13

Laser class 4 1064/660-680 nm warning label

Not applicable

Not applicable Label with fuse specifications VISULAS YAG III

LSL YAG III type label LSL YAG III Combi type label LSL Trion Combi type label Manufacturer Date of manufacture Applied part type B conforming to IEC 60601-1 EU conformity symbol with identification number of notified body Disposal advice for EU

IP20

Ingress protection rating of casing (protected against solid foreign bodies of 12.5 mm in diameter and larger, no protection against penetration of water)

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Country-specific information and labels

Item 12

13 14

15

16

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Label

Explanation Identification label LSL YAG III/ LSL YAG III Combi/ LSL Trion Combi REF

Catalogue number/ part number

SN

Serial number

Label with manufacturing date Laser Class 4 warning sign

"Laser aperture" warning label LSL YAG III LSL YAG III Combi LSL TRION Combi "Laser aperture" warning label LSL YAG III Combi LSL TRION Combi

Country-specific information and labels

Item

Label

17

15

Explanation Type label Foot switch, complete, cable 5m/ Foot switch, complete Manufacturer Date of manufacture Applied part type B conforming to IEC 60601-1 REF

Catalogue number/part number

SN

Serial number EU conformity symbol with identification number of notified body

IPX8

18

Ingress protection rating of casing (protected against continuous immersion in water)

ACCENTO foot switch (1.2 m)/ ACCENTO foot switch (5 m) Manufacturer Date of manufacture REF

Catalogue number/part number

SN

Serial number EU conformity symbol with identification number of notified body

IPX8

19

20

Ingress protection rating of casing (protected against continuous immersion in water)

Identification label ACCENTO eyepiece

Not applicable

Not applicable

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