FF 450 Plus Fundus Camera User Manual Sept 2014

© 2014, 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 only 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 documentation set 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 FF450plus Fundus camera [000000-1087-183-GA-GB-240914]

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Appendices FF450plus Fundus camera quick instructions [000000-1087-183-KurzGA01-GB-110612]

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FF 450 Fundus camera plus

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 Labels ... 10

Performance specifications ...13 Functional description... 13

Description of the instrument ...14 Controls of the fundus camera ... 16 NAG 450plus ... 20

Installation ...22 Unpacking ... 23 Installation of fundus camera ... 25 Installation of fixation lamps... 27 Mounting the NAG 450plus on the IT 1060... 28 Electrical connection ... 29 Checking the voltage setting ... 29 Establishing electric connections ... 30

Daily use ...32 Switching on ... 32

Operation of the instrument ...33 General notes on use of fundus camera ... 34 Preparing the eyepieces ... 34 Preparing the NAG 450plus ... 34 Preparing the fundus camera... 34 Adjustments to the patient ... 35 Capture modes ... 37 Fluorescein angiography (FA) ... 37 Injection ... 38

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Contents

Procedure for fluorescence series ...39 Incidents after fluorescein injections ...39 Fundus autofluorescence images ...41

Shutting down ... 42 Switching off the instrument ... 42

Maintenance and care ... 43 Fault remedy ... 43 Replacing the halogen lamp ... 45 Replacing the flashing diode of the fixation lamp ... 46 Replacing the fuses on the NAG 450plus ... 47 Maintenance ... 48 Care and cleaning ...48 Safety inspections ... 49

Optional accessories ... 50 VISUPAC software ... 51 VISUPAC computer ... 51 VISUPAC 481 ...51 VISUPAC 500 ...51 IT 1060 instrument table ... 52 FF 450plus video adapter ... 53 Digital sensors ... 54 ZK-5 color camera...54 Canon 5D Mark III color camera ...54 Pike 145 monochromatic camera ...54 Pike 421 monochromatic camera ...54 JC-12 observation camera...55 Observation monitor ... 55 Autofluorescence filter set ... 56 Mounting the autofluorescence filter set ...56 Internal fixation device... 56 Astigmatism compensator ... 57 Demonstration eye with holder ... 57

Technical data ... 58 Electromagnetic compatibility ... 61 Abbreviations/Glossary ... 66 Figures ... 67 Index ... 68

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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 care and maintenance measures for the FF 450plus. 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 FF 450plus the first time. The user manuals and other documentation enclosed with the FF 450plus should be kept accessible to users at all times to ensure that the information required for use of the FF 450plus is readily available. Please also observe the user manual of the other device equipment, in particular the user manual of the IT 1060 instrument table.

Questions and comments If you have any questions or comments concerning this user manual or the FF 450plus, please contact Carl Zeiss Meditec customer 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 device 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 parts are supplied with the FF 450plus: • FF 450plus basic instrument • NAG 450plus • Power cable • 2 fixation lamps • Dust cover • 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, 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.

This device complies with EC Medical Device Directive 93/42/EEC and its national implementation in the form of the German Medical Products Act (MPG). Device class according to MPG:

I

EMC:

See section Electromagnetic compatibility, page 61 ff.

UMDNS No.:

12-815

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 FF 450plus is a monocular retina camera for routine use. It is designed to capture images of the eye, especially the retina area, as well as surrounding areas, to aid diagnosing or monitoring diseases of the eye that may be observed and photographed. If used in combination with dedicated optional equipment (electronic image sensors, digital archiving system) the system allows images to be displayed, stored, manipulated and archived digitally. CAUTION - GENERAL HAZARDS Use of mydriatics may occasionally result in side effects which may include life or sight-threatening reactions such as acute glaucoma, cardiac arrhythmias, increased intraocular pressure, and sudden high blood pressure. The lowest possible dose for dilation of the pupil should be used. Please observe manufacturer's specifications.

CAUTION - RISK OF OPERATING ERRORS Do not use the FF 450plus 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 Allow for serious restrictions in the use of the FF 450plus for the following patient groups: • Complete or partial coverage of the cornea caused by palpebral fissure which is closed or too small • Unable to steadily fixate the fixation lamps with the eye under examination (e.g. in the case of nystagmus, tremor, Parkinson's disease, extremely poor visual acuity, lack of concentration) • Non-foreseeable influence of wearing contact lenses (remove contact lenses before exposure) • Patients with a small pupil • Patients with a dense cataract

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Country-specific information and labels

Intended user profile CAUTION - RISK OF 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. Persons who operate the FF 450plus must have a basic knowledge of ophthalmic examination and diagnosis methods. It is recommended that the FF 450plus operator has the following essential skills: Ophthalmic photographer, optometrist, MTA and staff who prepare images using the FF 450plus • Completed training as optician, optometrist, ophthalmo-photographer or medical-technical assistant • Experience with the Microsoft Windows operating system and applications based on it • Knowledge of current ophthalmic diagnostic procedures and their examination results • Knowledge of the effects of incorrect or inaccurate examination results on the therapy • Possible consistency checks against other examination results • Practical experience in handling ophthalmic diagnostic devices • Experience in calming and explaining to patients, in particular older population Physicians who prepare images and diagnoses with the FF 450plus In addition to the above skills, the operator should have completed training as an eye specialist in order to recognize and evaluate the different findings, in particular: • Diagnostically relevant findings in fundus color images or red-free photographs • Diagnostically relevant findings in the early, medium and late phase of fluorescein angiograms • Skills in the evaluation of fundus autofluorescence images and indocyanine green angiograms

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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 wish to dispose of the packaging material, hand it over to a recognized collection system for recycling. The device 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.

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Country-specific information and labels

Labels

Fig. 1

Labeling of FF 450plus

Fig. 2

Labeling of NAG 450plus

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Country-specific information and labels

Item

Label

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Explanation FF 450plus type plate

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Manufacturer Date of manufacture Application part type B IP20 Ingress protection rating (protected against solid foreign bodies of 12.5 mm in diameter and larger, no protection against penetration of water) 2

REF 1087-183 SN XXXXXXX

FF 450plus identification label REF Order number SN Serial number Bottom: Serial number as barcode

REF 1087-184 SN XXXXXXX

FF 450plus IRu identification label

REF 1087-185 SN XXXXXXX

FF 450plus IR identification label

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Sign with date of manufacture

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CE approval label and disposal advise for EU EU conformity symbol Disposal instructions for EU

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Information label "Disconnect device from the power supply before opening" Not applicable

Not applicable Information label "Observe user manual"

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Country-specific information and labels

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NAG 450plus type label Manufacturer Date of manufacture Application part type B IP20

Ingress protection rating (protected against solid foreign bodies of 12.5 mm in diameter and larger, no protection against penetration of water) EU conformity symbol CSA approval for USA and Canada

REF

Order number

SN

Serial number AC voltage

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Warning label "Danger zone"

10

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

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Performance specifications

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Performance specifications Functional description The FF 450plus is a universal fundus camera with an image field of 50°, 30° and 20°, an eyepiece for direct observation, two external fixation lamps and a high-performance flash light unit. It can be swiveled in vertical and horizontal direction. In combination with accessories for digital photography, it is possible to capture color and red-free images, fluorescein and ICG angiography, monochromatic images with blue and red filters and fundus autofluorescence images. It is also possible to produce documentation images of the iris, the sclera or the eyelid without additional switching.

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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Description of the instrument

Description of the instrument

Fig. 3

Structure of the FF 450plus

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Description of the instrument

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The major subassemblies of the FF 450plus (Fig. 3) include: 1 Fundus camera with illuminating and viewing system with filters as well as ports for documentation systems. 2 Fixation lamp 3 Head rest with vertically adjustable chin rest, forehead rest and mounts for fixation lamps. 4 Motorized IT 1060 instrument table (optional) with motorized adjustment of table height. 5 NAG 450plus power supply unit for power supply of fundus camera, fixation lamps and observation monitor. Besides, it allows connection of an additional lamp. 6 Instrument base with 3D joystick positioning of fundus camera, controls for halogen lamp brightness and head rest. The halogen lamp switches to sleep mode, if you leave the fundus camera without any operating command for more than 4 minutes.

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