SL 130 Slit Lamp User Manual

© 2018, 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 SL 120 Slit lamp [000000-1490-499-GA-GB-090118]

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SL 120 Slit lamp

User manual

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Contents

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Contents Contents ...1 Notes on the user manual ...3 Purpose and availability of documentation ... 3 Questions and comments... 3 Explanation of symbols used ... 4

Package check list ...5 Country-specific information and labels ...6 Classification/Manufacturer's declaration ... 6 Intended Use ... 7 Intended user profile... 8 Disposal of the product ... 9 External labels ... 10

Performance specifications ...14 Functional description... 14 Service life ... 15

Description of the instrument ...16 Installation ...20 Notes on installation and use ... 20 Unpacking ... 21 Assembly of the SL 120 Slit Lamp ... 22 Electrical connection ... 24 Power supply unit ... 24

Daily use ...25 Switching on ... 25

Operation of the instrument ...26 Preparations ... 28 Slit lamp ... 28 Setting the slit brightness ... 29 Positioning the patient... 29 General notes on instrument operation ... 29 Adjusting the illumination ... 31 Tonometry ... 31 Gonioscopy ... 32

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Contents

Shutting down ... 33 Switching off the instrument ... 33

Maintenance and care ... 34 Replacing the lamp ... 35 Maintenance ... 36 Care and cleaning ...36 Safety inspections ... 37

Optional accessories ... 38 Mounting the beam splitter ... 39 Mounting a filter changer with barrier filter (yellow) ... 40 Mounting the ACCENTO Ergotube ... 41 DigiCam Adapter ... 42 DigiCam Illuminator ... 43 Focusing rod ... 44 Fixation lamp... 45 AT 020/AT 030 applanation tonometer ... 45 Special eyepieces ... 46 10x micrometer eyepiece with linear and angular scales ...46 Angular measurement ...47 Length measurement ...47 Breathing shield ... 48 Paper pads ... 48 Fender plate ... 48

Technical data ... 49 Electromagnetic compatibility ... 51 Ambient conditions for intended use ... 51 Restrictions on essential performance ... 51

Abbreviations/Glossary ... 55 Figures ... 56 Index ... 57

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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 SL 120 Slit Lamp. Correct operation of the system is imperative for its safe and successful functioning. You should therefore ensure that you are thoroughly familiar with this user manual before setting up and using the SL 120 Slit Lamp for the first time. The user manuals and other documentation enclosed with the SL 120 Slit Lamp should be kept accessible to users at all times to ensure that the information required for the use of the SL 120 Slit Lamp is readily available.

Questions and comments If you have any questions or comments concerning this user manual or the SL 120 Slit Lamp, please contact ZEISS Service or your local dealer (Contact details see reverse).

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Notes on the user manual

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 instrument labels.

WARNING Indicates a hazardous situation which could result in death or serious 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.



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Information, hints and advice for better understanding of the instructions to be observed in the operation of the device.

Package check list

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Package check list The following components are included in the delivery scope: • SL 120 Slit Lamp • Halogen bulb • Eyepieces • Dust cover • Power supply unit • Power cable • Documentation set

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Country-specific information and labels

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, applicable industry standards and occupational safety and accident prevention regulations. Further notes on classification are to be found in section Technical data, page 49 and following.

This device complies with EU Medical Device Directive 93/42/EEC. Device class according to MPG:

I

Device group:

2 pursuant to ISO 15004-2:2007

EMC:

See chapter Electromagnetic compatibility, page 51 and following.

N° UMDNS:

12-281

The product is RoHS-compliant according to directive 2011/65/EU. This declaration shall be rendered invalid if changes are made to the product without the manufacturer’s authorization.

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Country-specific information and labels

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Intended Use The SL 120 Slit Lamp is a powerful universal instrument for observation, diagnosis, measurement and documentation of the anterior eye segment. Responsibility for using the device other than as intended lies with the user. CAUTION - RISKS ARISING FROM OPERATING ERRORS Do not use the SL 120 Slit Lamp in patients with the following conditions: • Unable to follow the instructions of the user • Unable to sit upright in front of the instrument • Forehead or chin injuries that prevent the head from being supported on the head/chin rest

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Country-specific information and labels

Intended user profile CAUTION - RISKS 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. Persons who operate the SL 120 Slit Lamp must have completed the following training: • Ophthalmologist • Optician • Optometrist

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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 decide to dispose of the packaging material, submit it to a recognized collection system for recycling. The device contains electronic components. At the end of its lifetime, the product 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 disposing of this product please contact your local dealer or the manufacturer or its legal successor company. Please read the latest information provided on the manufacturer's website. If 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

External labels

Fig. 1

Labeling of the SL 120 Slit Lamp

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Country-specific information and labels

Fig. 2

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Labeling of the power supply unit

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Country-specific information and labels

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Item

Label

Explanation SL 120 Slit Lamp type label

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Manufacturer Date of manufacture Application part type B conforming to IEC 60601-1 DC voltage IP20

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

SL 120 identification label for instrument tables (000000-2014-901) and SL 120 for ophthalmic units (000000-2014-902)

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SN

Serial number

3

Sign with date of manufacture

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CE approval label and disposal advise for EU (for device with 2006-387 NAG SL 6V) EU conformity symbol Disposal advise for EU

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Not applicable

Not applicable

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Identification sign for the focusing rod as accessory of SL 120 Slit Lamp

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Power supply unit type label EU conformity symbol NRTL approval for USA and Canada

IP20

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Application part type B conforming to IEC 60601-1 Ingress protection rating for housing (protected against solid foreign bodies of 12.5 mm in diameter and larger, no protection against penetration of water)

Country-specific information and labels

Item

Label

13

Explanation

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

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Information label "Observe user manual"

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Performance specifications

Performance specifications Functional description The SL 120 Slit Lamp allows observation, diagnosis, measurement and documentation of the anterior eye segment, including the lens and vitreous body. Additional optical elements such as contact or correction lenses also render the deeper regions of the eye and the chamber angle visible. The SL 120 Slit Lamp is designed for the complete application area of a typical slit lamp. It is used by ophthalmologists, optometrists and opticians. The slit lamp consists of an instrument base (with joystick) onto which an illumination system (slit projector) and an observation unit (stereomicroscope with binocular tube and eyepieces) are mounted. The illumination system and the observation unit can be swiveled independently of each other around the same vertical axis. The head of the patient lies on the head rest. Using a fixation lamp, the user can direct the patient's eye as desired. The illumination system generates a slit image which can be modified in length, width, position and brightness and which has a specified distance from the slit lamp. The user can adjust each of the modifiable parameters of the slit image using the controls. The observation unit allows the user to observe the eye segment to be examined in five selectable magnification steps. The magnification changer is a Galilean system with telecentric beam path. The user can position the slit lamp in relation to the examined object in all three axes using the joystick of the instrument base so that the desired observation area of the eye is in focus. Using different illumination methods, variable slit images and filters, it is possible to view almost all eye segments. The SL 120 Slit Lamp can be enhanced by optional accessories. With the AT 020 and AT 030 Goldmann applanation tonometer the user can precisely measure the intraocular pressure. The micrometer eyepiece enables the user to measure angles and lengths in a simple process. Various documentation accessories help the user capture images of the diagnosis.

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Performance specifications

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Service life WARNING - GENERAL HAZARDS The development, production and maintenance of this device, together with associated risks, are based on an expected service life of eight years, assuming that the device is serviced at the specified intervals. Modifications to the product or failure to follow the manufacturer’s instructions may substantially reduce the expected service life and significantly increase the risks associated with the use of this device. It is the responsibility of the institution operating this product to follow the manufacturer’s instructions and to decide on the risk/benefit ratio upon expiration of the expected service life or maintenance and inspection intervals specified by the manufacturer.

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