User Manual
66 Pages
Preview
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SL 220 Slit lamp
Documentation set
© 2020, 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 220 Slit lamp [000000-2115-784-GA-GB-190320]
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SL 220 Slit lamp
User manual
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Contents
Contents Contents ... 1 Notes on the user manual ... 3 Purpose and availability of documentation ... 3 Questions and comments... 3 Explanation of the 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 device ... 16 Installation ... 20 Notes on installation and use ... 20 Unpacking ... 21 Assembly of the SL 220 ... 22 Electrical connection ... 24 Power supply unit ...24
Daily use ... 26 Switching on ... 26
Operation of the device ... 27 Preparations ... 28 Slit lamp ...28 Setting brightness ...30 Positioning the patient...30 General notes on device operation ...30 Adjusting the illumination ...31 Tonometry ...31
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Contents
Gonioscopy ...32
Shutting down ... 33 Switching off ... 33
Maintenance and care ... 34 Maintenance... 35 Troubleshooting...35 Care, cleaning and disinfection ...36 Safety inspections ... 38
Optional accessories ... 39 Mounting the beam splitter 50 ... 41 Wide-field illumination ... 42 AT 030 applanation tonometer ... 43 Fixation lamp... 44 Focusing rod ... 45 Breathing shield ... 46 Paper pads... 46
Technical data ... 47 Electromagnetic compatibility ... 49 Ambient conditions for intended use ... 49 Restrictions on essential performance ... 49
Abbreviations/Glossary ... 53 Figures ... 54 Index ... 55
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Notes on the user manual
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 220 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 220 for the first time. The user manuals and other documentation enclosed with the SL 220 should be kept accessible to users at all times to ensure that the information required for the use of the SL 220 is readily available.
Questions and comments If you have any questions or comments concerning this user manual or the SL 220, please contact ZEISS service or your local dealer. (Contact details see reverse.)
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Notes on the user manual
Explanation of the 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.
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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
Package check list The scope of supply of the SL 220 contains the following components: SL 220
Binocular tube
Eyepieces
Dust cover
Power supply unit
Power cable
Documentation set
Mounting accessories
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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, 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 47 and following.
Device group:
2 pursuant to ISO 15004-2:2007
EMC:
See chapter Electromagnetic compatibility, page 49 and following.
UMDNS No.:
12-281
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
Intended use An AC-powered slit lamp is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties 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 this device in patients with the following conditions:
Unable to follow the instructions of the user
Unable to sit upright in front of the device
Forehead or chin injuries that prevent the head from being supported on the head or 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. SL 220 is intended to be used by persons from the following professions or their national equivalences:
Ophthalmologist
Optician
Optometrist
Notification to manufacturers and authorities In member states of the European Union, the responsible organization or person must report serious incidents to his competent authority. In all other countries, comparable rules apply where national legislation so requires.
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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 0000-033-DE-Vs01 waste disposal system or communal waste disposal facilities.
MWIB
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
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Labeling of the SL 220
Country-specific information and labels
Fig. 2
Item 1
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Labeling of the power supply unit
Label
Explanation SL 220 type label Manufacturer Date of manufacture Applied part type B conforming to IEC 60601-1 SN
Serial number
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) Unique device identification code (data matrix and plain text) EU conformity symbol "Observe user manual" sign
Disposal advise for EU 2109-201
Microscope 5x parallel
2109-206
Microscope 5x convergent
2109-211
Microscope 3x parallel
2109-216
Microscope 3x convergent
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Country-specific information and labels
Item
Label
Explanation Identification sign for the stereomicroscope as part of SL 220
2
SN
Serial number
3
Prescription use only
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MET approval for USA and Canada
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Not applicable
Not applicable
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Not applicable
Not applicable
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Power supply unit type label Manufacturer Date of manufacture REF
Catalogue number/part number
SN
Serial number Connection data for illumination cable Connection data for fixation lamp and wide-field illumination
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) EU conformity symbol Disposal advise for EU Applied part type B con-forming to IEC 60601-1 "Observe user manual" sign Protective insulation, protection class 2
8
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"Disconnect device from the power supply before opening" sign
Country-specific information and labels
Item
Label
9
Not applicable
13
Explanation
Not applicable MET approval for USA and Canada
10
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Label for marking the device as a medical device
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Performance specifications
Performance specifications Functional description The SL 220 allows observation, diagnosis, measurement and documentation of the anterior eye segment, including the lens and vitreous body. The SL 220 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 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 220 can be enhanced by optional accessories. With the AT 030 applanation tonometer the user can measure the intraocular pressure. The SL cam 5.0 imaging accessory for slit lamps enables images and videos of the anterior segment of the eye to be acquired for documentation purposes.
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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 device 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 device 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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