VISCUAM 200 and 500 User Manual July 2010

User manual VISUCAM Digital Fundus Camera 000000-1781-493_GA_GB_230710 23.07.2010

© 2010, 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 manual may be trademarks or registered trademarks. Third party products are cited for information purposes only. This does not represent approval or recommendation of these products. Carl Zeiss Meditec AG accepts no liability for the performance or use of such products.

Microsoft Windows® is a registered trademark of Microsoft Corporation, Inc.

VISUCAM® and VISUPAC® are trademarks of Carl Zeiss Meditec AG.

Other brand names, software and hardware names used in this user manual are generally subject to trademark or patent protection. The quoting of products is for informational purposes only and does not represent a trademark misuse. This user manual 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 manual is not subject to the revision service. Please contact the manufacturer or authorized dealer to request the latest edition of the manual.

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Contents

`çåíÉåíë= 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 DICOM Conformance Statement ...6 Indication for use ...7 Intended user profile...8 Disposal of the product ...9 Labels...10

Performance specifications ... 12 Functional description...12 Service life...13

Description of the device... 14 Installation ... 17 Notes on installation and use...17 Unpacking...18 VISUCAM installation ... 18 Electrical connection ... 19 Power isolation transformer for external devices...21

Daily use ... 23 Switching on ...24

Operation... 25 General...26 Operation using the control panel on the instrument base ...27 Operation via keyboard and mouse ...28 Screen layout ...29 Overview of menus and buttons ...31

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Contents

Shutting down ...34 Switching off the instrument ... 34

Notes on angiography...36 Angiography using the VISUCAM 500... 36

Maintenance and care...37 Fault remedy ... 37 Replacing the blinking diode of the fixation lamp... 38 Replacing the fuses ... 39 Replacing the power isolation transformer fuse ...39 Replacing the basic unit fuse ... 40 Maintenance ... 41 Operating the online remote maintenance module...41 Operating the offline remote maintenance module ...42 Care and cleaning...44 Data backup... 49 Safety inspections ... 49

Optional accessories...50 Mounting the monitor holder on an instrument table... 50 Demonstration eye... 51 USB flash drive... 51 Stereo viewer ... 52 Printer... 52 Installation of a network printer...52

Technical data...54 Electromagnetic compatibility ...56 Abbreviations/Glossary...60 Figures/Tables ...61 Index...62

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Notes on the user manual

kçíÉë=çå=íÜÉ=ìëÉê=ã~åì~ä= Purpose and availability of documentation This user manual explains the safety precautions, functions, usage, performance parameters and measures for care and maintenance of the VISUCAM. 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 VISUCAM the first time. Please also observe the operating instructions for other equipment used with this instrument. The user manuals and other documentation enclosed with the VISUCAM should be kept accessible to users at all times to ensure that the information required for use of the VISUCAM is readily available.

Questions and comments If you have any questions or comments concerning this user manual or the VISUCAM, please contact Carl Zeiss Meditec customer service or your local dealer.

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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 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.

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

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Package check list

m~Åâ~ÖÉ=ÅÜÉÅâ=äáëí= The following accessories are supplied with the VISUCAM: • Document set • 19" TFT monitor • Keyboard • Mouse • Power isolation transformer • VISUPAC 4.4 installation CD with license for one PC • Power cable • LensPen cleaning pen • Fixation lamp (only for VISUCAM 500)

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Country-specific information and labels

`çìåíêóJëéÉÅáÑáÅ=áåÑçêã~íáçå=~åÇ= ä~ÄÉäë= 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 54 and following. 1

0297

1

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

2 pursuant to ISO 15004-2:2007

Device class according to the Medical Products Act:

IIa

Light emitting diodes:

Class 1 pursuant to DIN EN 60825-1:2003

EMC:

See section Electromagnetic compatibility, page 56 and following. 1

UMDNS No.:

12-815

This declaration shall be rendered invalid if changes are made to the product without the manufacturer’s authorization.

DICOM Conformance Statement The manufacturer supports the export of images in a file format which conforms with the DICOM 3.0 Standard (Ophthalmic Photography (OP)).

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For currently available DICOM Conformance Statements please go to our website: http://www.meditec.zeiss.com/dcs.

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Country-specific information and labels

Indication for use The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye being examined under mydriatic and non-mydriatic conditions. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographically documented.

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 also observe manufacturer's specifications. CAUTION - RISK OF OPERATING ERRORS Do not use the VISUCAM 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 VISUCAM 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 lights 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

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Country-specific information and labels

Intended user profile CAUTION - RISK OF OPERATING ERRORS The 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 additional national qualification guidelines applicable in your country. Persons who operate the VISUCAM must have a basic knowledge of ophthalmic examination and diagnosis methods. It is recommended that the VISUCAM operator has the following essential skills: Ophthalmo photographer, optometrist, MTA and staff who prepare images using the VISUCAM • 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 VISUCAM 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 angiograms

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Country-specific information and labels

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 also 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 is to 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 VISUCAM

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Country-specific information and labels

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VISUCAM type plate Carl Zeiss Meditec AG

Manufacturer

07740 Jena, GERMANY VISUCAM

XXXX

Date of manufacture

100 - 240 V 50/60 Hz

EU conformity symbol

340 VA IP20 000000-1769-898-01-DE-Vs01

MW IB

Identification number of notified body

0297

Application part type B

CSA approval for USA and Canada AC voltage Housing protection class (protected against solid foreign bodies of 12.5 mm in diameter and larger, no protection against penetration of water)

IP20

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REF SN

1781-493 XXXXXXX

VISUCAM 500 identification label REF Catalogue number/part number SN Serial number

REF SN

1769-898 XXXXXXX

VISUCAM 200 identification label REF Catalogue number/part number SN Serial number

REF SN

1789-392 XXXXXXX

1-2

T 3.15 A/H

VISUCAM computer identification label

Fuse label

Fuse F1/F2

5

Disconnect device from the power supply before opening

6

Observe user manual

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Performance specifications

mÉêÑçêã~åÅÉ=ëéÉÅáÑáÅ~íáçåë= Functional description The VISUCAM allows the fundus of the eye to be viewed and documented with the pupil in a naturally or medicinally-induced dilated state. Easy-to-use camera operation ensures quick results. It is particularly suitable for routine use and screening. The fundus is evaluated on the basis of a flash photograph. Image capture and display is fully digital. The VISUCAM employs the ophthalmoscope principle of the modern fundus camera and images the fundus of the eye at a field angle of 45° or 30°. The instrument operates in non-contact mode. Non-mydriatic operation is based on positioning and focusing of the camera using infrared light. This means that the use of pupil-dilating drops is not necessarily required. This does, however, require a naturally dilated pupil, such as is achieved in a darkened room. The non-mydriatic technique is not suitable for fluorescein angiography (VISUCAM 500 only); in this case medicinally-induced dilation is required. Infrared diodes are used as a light source for setting up the camera. The working distance is set up using two working distance dots and the fundus brought into focus using a pair of coincident lines. A flashbulb is used to record images. The VISUCAM 200 supports capture modes Color, G (green), R (red) and B (blue). VISUCAM 500 additionally supports capture modes FA (fluorescein angiography) and optionally AutoFluo (auto-fluorescence) and ICGA (indocyanine green angiography). The settings are controlled via the live setup image displayed on the monitor. After image capture has been triggered, the image is displayed on the monitor in place of the live set-up image and saved automatically. The digital image sensor has a resolution of five megapixels. The VISUCAM includes an intuitive software interface for databasesupported patient and image data administration. Images can be displayed, printed and exported and patient data created and adapted simply at any time. The software also includes a basic image optimization feature for printouts.

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Performance specifications

As for standard commercial digital cameras, the VISUCAM is only able to store images for a limited time period, depending on the limited hard disk capacity. Images can be stored long term using an external archiving system (e.g. VISUPAC or FORUM systems) or by retaining the printouts. Image data can be exported in BMP, JPEG, TIFF or DICOM formats. The DICOM format additionally permits the transfer of patient-relevant information. To export and copy data to another computer system, a network connection is recommended. The integrated DVD/CD burner allows data to be transferred to DVD or CD. A USB flash drive is also available.

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 device

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Cap for fixation lamp Fixation lamp, freely (3D) movable (not supplied with VISUCAM 200) Headrest with vertically adjustable chin rest, forehead support and mount for fixation lamp Monitor for observation of the patient’s eye and display of instrument information Keyboard and mouse for the entry of patient data and operation of the device Instrument base Computer base unit with head rest Camera head containing illumination and viewing system with image sensors

Fig. 2

Basic instrument design

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Description of the device

Monitor Mouse Keyboard Connector panel (see Fig. 5) Rotary knob for adjusting the brightness of the observation light Knurled knob for locking the instrument base Joystick for 3D adjustment of instrument base (X/Y-axis: tilting; Z-axis: rotating), when carrying out coarse adjustment in the X/Y axes, the instrument base is pushed in the desired direction 8 Release button for taking photographs 9 Operating panel with quick-select buttons (see Fig. 10) 10 Focusing control 1 2 3 4 5 6 7

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Fig. 3

VISUCAM controls, right hand view

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Description of the device

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Sleeve nut for fixation lamp Patient forehead support Red marks (suitable patient eye level for optimum photography) Front lens (exit aperture for LED illumination; with protective front lens cap) Patient chin rest Fastening pins for paper pads Knurled knob for vertical adjustment of chin rest DVD burner

Fig. 4

VISUCAM controls, left hand view

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Installation

fåëí~ää~íáçå= Notes on installation and use WARNING - GENERAL HAZARDS The device may not be stored or operated in ambient conditions other than those prescribed (see section Technical data on page 54). 1

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The device should be set up so that the power cable can be disconnected from the power supply quickly and easily without any tools. WARNING - RISK OF ELECTRIC SHOCK Additional extension cables or portable multiple sockets may not be used. The electrical installation must conform to IEC 60364-7-710 or the applicable national regulations. This includes the existence of a ground fault circuit interrupter (GFCI). To avert the risk of an electric shock this device may only be connected to a power supply with a protective earth conductor. Ensure that the power supply plug is suitable and certified for the local connection. If the supplied power cable must be replaced, at least the following specifications must be adhered to: • Protective earth conductor resistance maximum 0.2 Ohm • Local certification of the power cable for connection to medical devices • Device plug C19 conforming to IEC 60320 • Cross-section at least 0.75 mm²/AWG 18 Hospital Grade design for specific countries (e.g. USA, Canada) (For cables > 2.5 m the cross-section must be increased to 1.5 mm²) WARNING - FIRE HAZARD The device is not suitable for operation in explosion risk areas (e.g. combustible mixture of anaesthetic, cleaning or disinfecting agents with air, oxygen or nitrous oxide). The electrical installation must conform to IEC 60364-7-710. The data concerning power consumption on the type plate must be taken into account in the selection of overcurrent protection. The device should be switched off and unplugged from the power supply before replacing the fuse.

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Installation

CAUTION - PROPERTY DAMAGE Do not store or use this device in damp rooms. Do not expose the device to water splashes, dripping or sprayed water. CAUTION - PROPERTY DAMAGE Handle with care; the instrument should not be lifted or carried by the instrument head!

Unpacking The user will usually carry out the following procedures: • Unpack the accessories cardboard box (keyboard, mouse, etc.). • Remove plastic compression straps from the instrument box lift box straight up. • Remove the compression strap and foam. • Place the device on the table. • Remove the red transportation locking device. • If used, insert the fixation lamp into the mount and secure it in place using the sleeve nut (1, Fig. 4). 1

VISUCAM installation CAUTION - DANGER FROM FALLING PARTS When selecting a suitable table, ensure that the combination of table and instrument is stable up to an angle of tilt of 10°. Furthermore, the table must be designed for 4 times the weight of the device configuration. If the table is on castors, these must have a locking device. The VISUCAM must be set on the instrument table so that all four rubber feet sit securely on the surface at a sufficient distance from the table edge.

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