Zeiss CIRRUS photo 600 User manual

CIRRUS photo
(CIRRUS photo 600 and CIRRUS photo 800)
Documentation set

© 2016, Carl Zeiss Meditec AG, Jena
All rights reserved in the event of granting of patents or registration as a utility
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no liability for the performance or use of such products.
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CIRRUS photo®is a trademark of Carl Zeiss Meditec AG.
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000000-2121-813-Inhalt0-GB-050416
Contents
User manual
(CIRRUS photo 600 and CIRRUS photo 800)
[000000-2121-813-GA-GB-050416]
Addendum to the documentation set
Remote maintenance tool
[000000-2121-813-AddGA01-GB-210915]
MICROSOFT SOFTWARE LICENSE TERMS
WINDOWS EMBEDDED STANDARD 7
[WINDOWS EMBEDDED STANDARD 7 GB, 21.06.2012]
Appendix
CIRRUS photo 600/CIRRUS photo 800 - Settings
[000000-2121-813-AddGA02-GB-280815]
CIRRUS photo 600/800 - Internal fixation targets
[000000-2121-813-AddGA03-GB-030915]
CIRRUS photo scan acquisition - Quick instructions Models 600 and 800
[000000-2121-813-KurzGA01-GB-280815]
CIRRUS photo 600/800 quick instructions - User-defined workflow
[000000-2121-813-KurzGA02-GB-040915]
Fundus Photography - Advice and Tips
[000000-2133-713-KurzGA02-GB-190815]
2
1
3

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Contents
User manual
(CIRRUS photo 600 and CIRRUS photo 800)
[000000-2121-813-GA-GB-050416]
1

CIRRUS photo
(CIRRUS photo 600 and CIRRUS photo 800)
User manual

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Contents
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1
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.......................................................................................9
Disposal of the product ................................................................................10
External labels...............................................................................................11
Performance specifications ......................................................15
Functional description...................................................................................15
Service life.....................................................................................................16
Description of the device..........................................................17
Connection panel of main unit......................................................................21
Connection panel of OCT engine ..................................................................22
Power module...............................................................................................23
Installation ...............................................................................25
Notes on installation and use .......................................................................25
Daily use...................................................................................27
Switching on .................................................................................................28
Operation of the device............................................................29
General..........................................................................................................30
Operation using the control panel on the instrument base..........................31
Coaxial overlap check ...................................................................................33
Test tool ................................................................................................................................ 33
Installation of the test tool..................................................................................................... 33
Shutting down..........................................................................35
Switching off the device ...............................................................................35

Contents
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2
Notes on angiography ............................................................. 36
Angiography using the CIRRUS photo 800 .................................................. 36
Maintenance and care ............................................................. 37
Fault remedy ................................................................................................ 37
Replacing the flashing diode of the external fixation lamp ......................... 38
Maintenance................................................................................................. 39
Care and cleaning ..................................................................................................................39
Data backup ................................................................................................. 45
Data backup using FORUM Archive........................................................................................45
Data backup via DICOM export/import ..................................................................................45
CIRRUS photo backup function ..............................................................................................45
Further notes on data backup ................................................................................................46
Inspection of electrical safety....................................................................... 46
Optional accessories ................................................................ 48
Demonstration eye ....................................................................................... 49
USB flash drive ............................................................................................. 49
Printer .......................................................................................................... 50
Installation of a network printer.............................................................................................51
Technical data.......................................................................... 54
Electromagnetic compatibility ................................................. 56
Abbreviations/Glossary ............................................................ 61
Figures ..................................................................................... 62
Index........................................................................................ 63

Notes on the user manual
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Notes on the user manual
Purpose and availability of documentation
This user manual and software description of this instrument explain the
safety precautions, functions, usage, performance parameters and measures
for care and maintenance of the CIRRUS photo.
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 CIRRUS photo the first
time. Please also observe the operating instructions for other device
components.
The user manuals and other documentation enclosed with the CIRRUS photo
should be kept accessible to users at all times to ensure that the information
required for use of the CIRRUS photo is readily available.
Questions and comments
If you have any questions or comments concerning this user manual or the
CIRRUS photo, please contact ZEISS service or your local dealer. (Contact
details see reverse.)

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 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 death or serious injury if
the appropriate safety precautions are not heeded.
CAUTION
Indicates a hazardous situation which may 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.

Package check list
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Package check list
The following components are included in the CIRRUS photo delivery
package:
•Documentation set
•Basic device, consisting of:
–Main unit
–OCT engine
•Power module with power isolation transformer
•Instrument table
•Table mounting for power module and OCT engine
•External fixation lamp
•TFT display
•Monitor holder
•Keyboard
•Mouse
•Test equipment (coalignment tool)
•LensPen cleaning pen
•Power cable

Country-specific information and labels
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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 54 and following.
This device complies with EC Directive 93/42/EEC (MDD).
Device group (overall system): 2 in accordance with
ISO 15004-2:2007
Device class according to the MDD: IIa
Light emitting diodes: Class 1 according to IEC 60825-1
EMC: See section Electromagnetic
compatibility, page 56 and following.
UMDNS No.: 12-815 (fundus camera),
18-191 (optical tomography)
This declaration shall be rendered invalid if changes are made to the product
without the manufacturer’s authorization.
The product is RoHS-compliant according to Directive 2011/65/EU.

Country-specific information and labels
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Intended use
The CIRRUS photo is a non-contact, high-resolution tomographic and
biomicroscopic imaging device that incorporates a digital camera which is
suitable for photographing, displaying and storing the data of the retina and
surrounding parts of the eye to be examined under mydriatic and non-
mydriatic conditions.
These photographs support the diagnosis and subsequent observation of eye
diseases which can be visually monitored and photographically documented.
The CIRRUS photo is indicated for in-vivo viewing, axial cross sectional, and
three-dimensional imaging and measurement of anterior and posterior
ocular structures, including cornea, retina, retinal nerve fiber layer, macula,
and optic disc.
It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH),
and Macular Normative Database which is a quantitative tool for the
comparison of retinal nerve fiber layer, optic nerve head, and the macula in
the human retina to a database of known normal subjects. The CIRRUS
photo is intended for use as a diagnostic device to aid in the detection and
management of ocular diseases including, but not limited to, macular holes,
cystoid macular edema, diabetic retinopathy, age-related macular
degeneration, and glaucoma.
CAUTION - HAZARDS DUE TO SIDE EFFECTS
When using mydriatics observe the respective information of the
manufacturer on contraindications and side effects!
CAUTION – GENERAL HAZARDS
This device works with visual stimuli, including lights and patterns flashing
and flickering between 5 and 65 Hz. It is the responsibility of the physician
to decide whether this device is suitable for use with patients who may be
light-sensitive. This group includes epileptics.

Country-specific information and labels
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CAUTION - RISKS ARISING FROM OPERATING ERRORS
Do not use the instrument in patients who:
•are unable to follow the instructions of the user
•are unable to sit upright in front of the instrument
•have 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 instrument for patient groups:
•Patients with complete or partial coverage of the cornea caused by
palpebral fissure which is closed or too small
•Patients unable to steadily fixate 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

Country-specific information and labels
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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 CIRRUS photo must have a basic knowledge of
ophthalmic examination and diagnosis methods. It is recommended that the
CIRRUS photo operator has the following skills:
Ophthalmic photographer, optometrist, MTA and staff who prepare
images using the CIRRUS photo
•Completed training as optician, optometrist, ophthalmo-photographer or
medical-technical assistant
•Knowledge of current ophthalmic diagnostic procedures and their
examination results
•Knowledge of the effects of incorrect or inaccurate readings on the
therapy
•Possible consistency checks against other measurement results
•Practical experience in handling ophthalmic diagnostic devices
•Experience in calming and explaining to patients, in particular older
population.
•Experience with the Microsoft Windows operating system and
applications based on it
Physicians who review images and analyze data for diagnostic
purposes with the CIRRUS photo
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
•Diagnostically relevant findings in macula and optic disc scans as well as
scans of the anterior eye segment

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
device and its internal 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.

Country-specific information and labels
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External labels
Fig. 1 Warning and information labels on the device

Country-specific information and labels
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Item Label
Explanation
1
CIRRUS photo 800
CIRRUS photo 600
CIRRUS photo type label
IP20
Manufacturer
Date of manufacture
Appli
ed part type B
Housing protection class
(protected against
solid
foreign bodies of 12.5 mm in
diameter and larger, no
protection against
penetration of water)
2
CIRRUS photo 800 identification label
REF Catalogue number/part number
SN Serial number
CIRRUS photo 600 identification label
3
Sign with date of manufacture
4
CE marking label and disposal advise for
EU
EU conformity symbol with
Identification number of
notified body
Disposal advise for EU
5 Not applicable
Not applicable
6
Computer identification label
CIRRUS photo