Zeiss VISUREF 150 User manual

ZEISS VISUREF 150
Autorefractor/Keratometer
Documentation set

© 2021, Carl Zeiss Meditec AG, Jena
All rights reserved in the event of granting of patents or registration as a utility
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This does not represent approval or recommendation of these products.
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Contents
User manual
ZEISS VISUREF 150 Autorefractor/Keratometer
[000000-2227-967-GA-GB-281021]

ZEISS VISUREF 150
Autorefractor/Keratometer
User manual

000000-2227-967-GA-GB-281021

Contents
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Contents
Contents.....................................................................................1
Notes on the user manual ..........................................................4
Purpose and availability of the documentation ..............................................4
Questions and comments................................................................................ 4
Explanation of symbols used ..........................................................................5
Package check list......................................................................6
Country-specific information and labels.....................................7
Classification/Manufacturer's declaration ......................................................7
Intended use ...................................................................................................8
Intended user profile.......................................................................................9
Disposal of the product ................................................................................10
External labels...............................................................................................11
Performance specifications ......................................................14
Functional description...................................................................................14
Service life.....................................................................................................15
Description of the device..........................................................16
Installation ...............................................................................19
Notes on installation and use .......................................................................19
Unpacking the device....................................................................................19
Installing the device ......................................................................................20
Connecting the device...................................................................................21
Connecting the device with other devices ....................................................22
Patient environment .............................................................................................24
Network configuration .........................................................................................25
Data exchange .....................................................................................................26
Initial start-up...........................................................................27
Switching on .................................................................................................27
Device initialization.......................................................................................28
Connection to the EMR/PMS system ............................................................29
Using the serial interface ......................................................................................29
File-based data exchange .....................................................................................30
Direct data transmission via network ....................................................................30

Contents
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Connection to ZEISS FORUM................................................................................ 31
Connection to ZEISS VISUCONSULT/i.Com mobile................................................. 33
Provision of data to be collected via the network (web service)............................. 34
Daily startup ............................................................................ 35
Switching on ................................................................................................ 36
Operation of the device ........................................................... 37
Warning and information messages ............................................................ 38
Operating concept........................................................................................ 38
Screen layout................................................................................................ 39
Measurement screens .......................................................................................... 40
Review screens .................................................................................................... 41
Device settings ............................................................................................. 42
On-screen keyboard ............................................................................................. 44
Full measurement procedure........................................................................ 46
Patient selection........................................................................................... 47
Patient selection prior to measurement procedure ................................................ 47
Subsequent patient allocation .............................................................................. 49
Measurement of refraction and keratometry .............................................. 51
Preparation of the device for measurement .......................................................... 51
Positioning the patient and explaining the procedure to the patient...................... 57
Performing a measurement.................................................................................. 58
Data display in the review screen ......................................................................... 61
Measurement of pupil and corneal diameters ............................................. 64
Preparation of the device for measurement .......................................................... 64
Review screen displays......................................................................................... 70
Image captures............................................................................................. 71
Preparation of the device for measurement .......................................................... 71
Capturing images ................................................................................................ 73
Image display in review screen ............................................................................. 75
Measurement of contact lenses ................................................................... 77
Preparation of measurement................................................................................ 77
Performing contact lens measurement ................................................................. 78
Data display in the review screen ......................................................................... 81
Delete measurement data ............................................................................ 82
Review of completed measurements ........................................................... 84
Output of measurement results ................................................................... 84
Device settings ............................................................................................. 87
General submenu ................................................................................................ 88
Measurement submenu ....................................................................................... 91
Output submenu ................................................................................................. 92
Interface submenu............................................................................................... 95
Web server interface.......................................................................................... 101

Contents
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Shutting down........................................................................103
Switching off the device .............................................................................103
Maintenance and care............................................................104
Troubleshooting..........................................................................................104
Update device software ..............................................................................105
Replacing the fuses .....................................................................................106
Maintenance ...............................................................................................107
Replacing the printer paper roll...........................................................................107
Care and cleaning...............................................................................................108
Cleaning and disinfection of painted surfaces......................................................109
Safety inspections .......................................................................................110
Transport................................................................................111
Transport without packaging .....................................................................111
Transport with packaging...........................................................................111
Technical data ........................................................................113
Electromagnetic compatibility................................................115
Ambient conditions for intended use .........................................................115
Limitations on essential performance features...........................................115
Electromagnetic emission ...........................................................................117
Electromagnetic immunity ..........................................................................117
Abbreviations/Glossary...........................................................119
Figures....................................................................................120
Tables.....................................................................................122
Index ......................................................................................123

Notes on the user manual
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Notes on the user manual
Purpose and availability of the documentation
This user manual describes the safety precautions, functions, usage and
performance parameters, as well as care and maintenance measures for the
ZEISS VISUREF® 150 Autorefractor/Keratometer.
Correct operation of the device is imperative for safe and effective functioning.
You should therefore ensure that you are thoroughly familiar with this user
manual before setting up and using the device for the first time.
The user manuals and other documentation enclosed with the device should
be kept accessible to users at all times, to ensure that the information
required for using the device is readily available.
Questions and comments
If you have any questions or comments concerning this user manual or the
device, 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 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 death or serious bodily
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 ZEISS VISUREF 150 basic device is supplied with the parts shown in the
following figure.
1
Power supply cable
2
Test eye (also used as contact lens holder)
3
Printer paper (1 roll installed when delivered)
4
Documentation set
5
Dust cover
6
2 fuses (see Section Technical data, page 113)
7
Data carrier with source data of free software components (optional)
8
Network cable
9
USB storage device
10
Se rial Interface cable (optional)
Fig. 1 Package check list

This device contains free software. The data carrier (7, Fig. 1) is
provided as an option for licensing reasons, but does not include
any installation-ready software necessary for the operation of the
device.

Country-specific information and labels
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Country-specific information and labels
Classification/Manufacturer's declaration
WARNING - GENERAL HAZARD
This device may be set up, operated and used only for the intended use and
in accordance with local country-
specific regulations, generally accepted
engineering standards and occupational safety and accident prevention
regulations. Further notes on classif
ication are to be found in Section
Technical data, page 113 and following.
Device group:
1 in accordance with ISO 15004-2
(max. radiation intensity < 117.1
µW/cm²)
UMDNS No.
13-313 (Refractometer, ophthalmic)
12-811 (Ophthalmometer)
This declaration shall be rendered invalid if changes are made to the product
without the manufacturer's authorization.
Further notes on electromagnetic compatibility are to be found in Section
Electromagnetic compatibility, page 115 and following.
The product is RoHS-compliant according to Directive 2011/65/EU.

Country-specific information and labels
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Intended use
The ZEISS VISUREF 150 Autorefractor/Keratometer is a diagnostic device
used to determine the objective refractive values and keratometric
characteristics of the human eye. The results are used to assist the process of
prescribing optical aids such as eyeglasses and contact lenses.

Measurement errors may occur when using the device on patients
in the following categories:
•Patients who are unable to steadily fixate the fixation image with
the eye under
examination (e.g. in the case of nystagmus,
extremely poor visual acuity, lack of concentration).
•Patients who are unable to follow the instructions of the user.
•Patients who are unable to sit upright in front of the device.
•Patients who have forehead or c
hin injuries that prevent the
head from being supported on the forehead/chin rest
•Patients whose eyes exhibit an optical media transparency that
is too low for refraction measurements (such as cataract with
dense lens clouding).
•Patients whose eyes have an insufficient corneal reflection for
keratometry or refraction measurements (e.g. due to distortion
of the tear film, corneal scarring or caustic burns of the cornea).
•Patients with significantly changed cornea (e.g. keratoconus).
•Patients whose pupil opening is too small (< 2 mm) for refraction
measurements.
•Patients whose closed or partially closed palpebral fissure causes
complete or partial obstruction of the pupil.
•Patients with morphological changes of the retinal anatomy in
the region of the fovea for refraction measurements (e.g. retinal
detachment, edema, ulcer).

Country-specific information and labels
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Intended user profile
CAUTION - RISK 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 using the device must belong to the following occupational
groups or their national equivalents:
•Ophthalmologists or assistants
•Opticians or assistants
•Optometrists or assistants

Country-specific information and labels
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Disposal of the product
CAUTION - RISK OF ENVIRONMENTAL POLLUTION
The packing material should be kept to be used for a future move or for
repairs.
If you want to dispose of the packing material, please use a recognized
collection system for recycling.
The device contains electronic components. At the end of the service life,
the device and the batteries installed in it have to be disposed of properly
according to the national laws.
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 detailed information on the disposal of the product, please contact your
local dealer or the device manufacturer or its legal successor company.
Please read 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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11
External labels
Fig.
2 External labels
7 218 14 4 1 6517
8
910
16
15
11 12 13
193
20
21

Country-specific information and labels
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12
Pos.
Label
Explanation
1
ZEISS VISUREF 150 type label
Manufacturer
Date of manufacture
Applied part type B
2
Identification label with unique device
identification code VISUREF 150
Catalogue number/part number
Serial number
UDI: Unique device identification code
(data matrix and plain text)
3
Device identification code (data matrix,
serial number, and device name)
4
Label with manufacturing date
5
CE approval label and disposal advice for
EU
6
Sign with UL approval for USA and Canada
7
Information label
“Observe user manual”
8
Warning label "Risk of pinching fingers"
9
Warning label "Avoid contact with the
hand"

Country-specific information and labels
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13
Pos.
Label
Explanation
10
Warning label "Avoid contact with the
hand"
11
Country of origin label
12
Label with fuse specifications
13
Information label "Disconnect device from
the power supply before opening"
14
Not applicable
Not applicable
15
Applied part type B
16
Applied part type B
17
Not applicable
Not applicable
18
Approval label for Brazil
19
Not applicable
Not applicable
20
Not applicable
Not applicable
21
Not applicable
Not applicable
Registro ANVISA n°:
10332030123

Performance specifications
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Performance specifications
Functional description
ZEISS VISUREF 150 is an autorefractor/keratometer. It allows the
measurement of objective refraction including sphere, cylinder, axis. The
VISUREF 150 covers the refractive measurement range from -25 D to +22 D
so that even patients with severe refractive errors can be measured.
Furthermore, the device determines the central keratometry values of the
eye, consisting of corneal radii and the axis. Data on pupil distance and pupil
diameter is also recorded. In contact lens mode, the device can measure the
base curve of contact lenses.
The user can take up to seven measurements per eye, either manually or
automatically. The device calculates the average value from these
measurements. Results of intermediate measurements can also be retrieved.
Various illumination parameters can be adapted for the purpose of
enhancing the visual inspection of the measured object and optimizing the
measurement. These include the intensity of the ambient light on the
measured object, reference illumination and illumination of the optical
fixation target. Special illumination parameters in IOL mode can be
preselected when measuring patients with implanted intraocular lenses (IOL).
By adapting the illumination parameters, it is also possible to measures eyes
with a slight cataract.
The device can capture, save and output images of the eye to be measured.
Space is provided for up to two images per eye. Abnormalities or
pathological details of the eye can be enlarged using the zoom function.
Furthermore, the device can be used to manually measure any distance in
these captured images, e.g. corneal or pupil diameters.
The device has a motorized chin rest for comfortable positioning of the
patient's eye at the level of the Canthus mark. The device is operated via an
adjustable touchscreen display with an intuitive user interface, control
buttons for the chin rest and a joystick for alignment of the measuring head.