Zeiss VISUSCOUT 100 User manual

VISUSCOUT 100
Mobile Retinal Camera
User Manual

VISUSCOUT 100-GA-GB-031219

VISUSCOUT 100-GA-GB-031219
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Contents
Notes on the user manual........................................................................3
Purpose and availability of documentation..................................................................3
Questions and suggestions .............................................................................................3
Explanation of the symbols used...................................................................................4
Package check list....................................................................................6
Country-specific information and labels...............................................7
Classification/Manufacturer’s declaration...................................................................7
Intended use....................................................................................................................8
Side effects/contraindications........................................................................................8
Disposal of the product ................................................................................................10
External labels ..............................................................................................................11
Performance specifications...................................................................13
Functional description..................................................................................................13
Service life.....................................................................................................................13
Description of the device..............................................................................................14
User interface................................................................................................................15
Quick start guide ...................................................................................16
Operation................................................................................................17
Preparations..................................................................................................................17
Connection to a PC.......................................................................................................17
Basic use –starting up, shutting down and taking an image....................................18
Image quality analysis..................................................................................................19
Device Menu..................................................................................................................20
Adjusting focus and automatic focus..........................................................................24
Resetting the device......................................................................................................24
Installation..............................................................................................30
Notes on installation and use .......................................................................................30
Unpacking and installing the device ...........................................................................31
Daily use .................................................................................................32
Usage environment requirements ........................................................33
Maintenance and care...........................................................................34
Cleaning instructions ...................................................................................................35

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Fault remedy.................................................................................................................37
Optional accessories.............................................................................. 38
Technical description of VISUSCOUT 100........................................ 39
Camera..........................................................................................................................39
Optics.............................................................................................................................39
Charging Station ..........................................................................................................40
Power supply.................................................................................................................40
Battery...........................................................................................................................40
USB cable......................................................................................................................40
Environmental Conditions for Use, Storage, Transportation .......... 41
Warranty ............................................................................................... 43
Electromagnetic compatibility............................................................. 44
Appendix A –Electromagnetic compatibility .................................... 45
Appendix B - Replacing the battery.................................................... 49
Appendix C –WIFI functionality........................................................ 50
VISUSCOUT 100 Client..............................................................................................50
Installing / Uninstalling................................................................................................50
Operation ......................................................................................................................50
WIFI SD card firmware update..................................................................................54
Index....................................................................................................... 56

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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 VISUSCOUT 100
mobile retinal camera.
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 VISUSCOUT 100 the first time.
The user manuals and other documentation enclosed with the VISUSCOUT 100
should be kept accessible to users at all times to ensure that the information
required for use of the VISUSCOUT 100 is readily available.
Questions and suggestions
If you have any questions or comments concerning this user manual or the
VISUSCOUT 100, please contact Carl Zeiss customer service or your local
dealer. (Contact details see the reverse side.)

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

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Symbol
Description
0598
The CE mark with notified body identification
number on this product indicates it has been
tested and conforms to the provisions noted
within the 93/42/EEC Medical Device Directive.
Read accompanying user documentation
indicates that important operating instructions
are included in this User’s and Maintenance
Manual. Failure to follow these instructions
could place the patient or operator at risk.
Type BF applied parts.
Applied part is a part of the VISUSCOUT 100
that in normal use necessarily comes into
physical contact with the patient.
9V, 1.1 A
Charger polarity symbol, voltage and power
Interference may occur in the vicinity of
equipment.
Prepare the device for reuse or separate
collection as specified by Directive 2002/96/EC
of the European Parliament and Council of the
European Union on Waste Electronic and
Electrical Equipment (WEEE). If this product is
contaminated, this directive does not apply.
Caution: Federal law restricts this device to sale
by or on the order of a physician or licensed
practitioner.

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Package check list
The VISUSCOUT 100 basic device is supplied with the parts shown below.
Carl Zeiss VISUSCOUT 100 retinal camera and accessories:
In addition, the sales case includes:
-Batteries (2 pcs)
-Spare Eye cup
-Cleaning cloth
-User manual
-USB memory stick (includes VISUSCOUT 100 Client, VISUSCOUT
100 SYNC Software and User Manual)
Fig. 1 VISUSCOUT 100 package check list

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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.
Federal law restricts this device to sale by or on the order of a physician.
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 class according to the
German Medical Products Act: IIa
EMC: See section Electromagnetic
compatibility, page 44 and following.
UMDNS No.: 10551
This declaration shall be rendered invalid if changes are made to the product
without the manufacturer’s authorization.
VISUSCOUT 100 supports Toshiba FlashAir W04 WIFI card with 32 GB Flash. For
more information: www.Toshiba-memory.com.
0598

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Intended use
The ZEISS VISUSCOUT 100 is a medical digital camera that is used to take
digital images and video of the fundus of the human eye.

The ZEISS VISUSCOUT 100 is designed to be used in medical
environment.
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 (medical professionals
and trained staff). Please also adhere to the national qualification
guidelines applicable in your country.

Image data is intended for medical documentation and
consultation.
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.
Side effects/contraindications
Because prolonged intense light exposure can damage the retina, the use of the
device for ocular examination should not be unnecessarily prolonged, and the
brightness setting should not exceed what is needed to provide clear visualization
of the target structures.
The retinal exposure dose for a photochemical hazard is a product of the radiance
and the exposure time. If the value of radiance were reduced in half, twice the
time would be needed to reach the maximum exposure limit.
While no acute optical radiation hazards have been identified for direct or indirect
ophthalmoscopes, it is recommended that the intensity of light directed into the
patient's eye to be limited to the minimum level which is necessary for diagnosis.
Infants and persons with aphakia or diseased eyes will be at greater risk. The risk
may also be increased if the person being examined has had any exposure with
the same instrument or any other ophthalmic instrument using a visible light
source during the previous 24 hours. This will apply particularly if the eye has
been exposed to retinal photography.
The ZEISS VISUSCOUT 100 classified as Group 2 based on standard ISO
15004-2:2007. The daily usage time and maximum allowed number of pulses is
calculated based on optical classification results according to standard ISO
15004-2:2007.