Oculus EASYFIELD-MANUAL
Oculus EASYFIELD-MANUAL
Oculus EASYFIELD-MANUAL
EASYFIELD®
INSTRUCTION MANUAL
Fast and Precise Testing of the Central Visual Field
Notes on this instruction manual
Thank you for your purchase and the trust you have placed in this OCULUS product. The
Easyfield - Perimeter has been manufactured and tested according to strict quality crite-
ria. You have selected a modern and well-engineered product.
To ensure safe operation, it is essential that you use the device correctly. For this reason
you should familiarise yourself thoroughly with the contents of this instruction manual
before operating the device. In particular, pay attention to the safety instructions.
This instruction manual describes how to manage patient data, the default settings
of the Easyfield program and the measuring process.
The Easyfield User Guide contains information supplementing the description of the
operating concept.
Due to ongoing development, the diagrams shown may depict minor changes to the
actual device delivered.
If you have any queries or would like additional information about your device, do not
hesitate to call or send us a fax. Our service team will gladly assist.
OCULUS is certified according to DIN EN ISO 9001:2000 and 13485:2003, setting high
standards of quality where development, manufacture, quality assurance and service re-
garding the entire range of products are concerned.
Table of contents
1 Scope of Delivery...................................................................................................................................... 1
2 Safety instructions................................................................................................................................... 2
2.1 Safety instructions concerning organisation ................................................................. 2
2.2 Pictogram definitions ............................................................................................................... 3
2.3 Safety Instructions for Use of the Easyfield Perimeter .............................................. 3
3 Proper Usage.............................................................................................................................................. 4
4 Transportation and Disposal................................................................................................................ 5
4.1 Transport and storage instructions .................................................................................... 5
4.2 Disposal of used devices ......................................................................................................... 5
5 Electromagnetic Compatibility (EMC) / Cables............................................................................. 5
6 Device Description ................................................................................................................................... 6
6.1 Overview of device components.......................................................................................... 6
6.2 How the Easyfield - Perimeter works................................................................................. 6
7 Operation..................................................................................................................................................... 7
8 Conducting Examinations using the Easyfield Control Pad ................................................... 8
8.1 Functions of the Control Pad ................................................................................................ 8
9 Patient Data Management ................................................................................................................... 9
9.1 Enter a new patient.................................................................................................................10
9.2 Select patient .............................................................................................................................10
9.3 Start the Easyfield program.................................................................................................10
10 Easyfield - Program (Control pad) ..................................................................................................11
10.1 Examination Parameters .......................................................................................................11
10.2 Quick-Start Programs.............................................................................................................13
11 Measuring Procedure............................................................................................................................14
11.1 Start the Easyfield Program.................................................................................................16
12 Conducting an Examination with the PC-Software "Easyfield"..........................................17
12.1 Enter a new patient.................................................................................................................17
12.2 Selecting existing patients ...................................................................................................18
12.3 Start the Easyfield Program on the PC............................................................................18
13 Easyfield Program (PC).........................................................................................................................19
13.1 Starting the Evaluation (PC) ................................................................................................20
13.2 Saving the Examination (PC) ...............................................................................................20
14 Troubleshooting......................................................................................................................................21
15 Care and maintenance .........................................................................................................................22
15.1 Care, Cleaning and Desinfection........................................................................................22
15.2 Inserting a New Roll of Printer Paper..............................................................................23
16 Warranty and Service ...........................................................................................................................23
16.1 Warranty ......................................................................................................................................23
16.2 Liability for Malfunctions or Damage..............................................................................24
1 Scope of Delivery
Note!
☞
We reserve the right to change the scope of delivery in line with ongoing technical devel-
opment.
2 Safety instructions
The law requires that the manufacturer expressly informs the user about safety aspects
concerning the handling of the Easyfield. This chapter contains a summary of the most
important points regarding these safety matters.
Attention
Do not use the device if you have not understood the instruction manual.
Î Make sure to keep this instruction manual in a safe place and available to operating
personnel at all times.
Î Observe the legal regulations with regard to accident prevention.
Î The Easyfield Perimeter is a high-quality, technical product. To ensure that it func-
tions correctly and safely we recommend the following: Have the unit checked every
two years by our service department or an authorized dealer. If an error occurs
which you are unable to correct, label the device as "out of order" and contact our
service department or an authorised dealer.
Attention
Identifies a potentially dangerous situation which may cause minor injury or damage to
property.
Note
Instructions for use, and useful or important information.
Note
☞
Identifies important information about the product or on how to use it, which requires
special attention.
Attention
No modifications may be made to this device without the permission of the manufactur-
er.
Î Only operate the Easyfield using original accessory parts supplied by us, and when
the device is in technically correct working order.
Î Never put a damaged Easyfield into operation. Should such a situation arise, contact
the supplier.
Î Do not operate the devices included in the delivery in areas where explosions may
occur, where there are inflammable anaesthetics, volatile substances such as alcohol
or petrol nearby.
Î Do not use or store the Easyfield in damp rooms.
Î Keep the Easyfield away from water that may drip, surge or splash and make sure
that no liquids can enter the device. Do not place any containers with liquid either
close to or on the device.
Î When cleaning, use a damp cloth and make sure that no liquid enters the device.
Î Only operate the device in rooms used for medical purposes if VDE 0100 installation
procedures have been observed.
Caution!
Any additional equipment that is to be connected to either analogue or digital interfaces
must verifiably fulfil appropriate EN or IC specifications. Furthermore, all configurations
must comply with the IEC 601 - 1 system norm.
Caution!
ll
If you connect the Easyfield-Perimeter with non-medical equipment (e.g. data processing
equipment) to a medical electrical system, doing so must not cause patient-relevant safe-
ty levels to fall below IEC 601 - 1. If making this connection leads to the leakage current
threshold being exceeded, protective measures including a circuit breaker must be in
place.
3 Proper Usage
This unit is intended for the use described in this operating manual. It is designed for test-
ing the visual field of the human eye.
The unit must only be operated by people with adequate knowledge and practical expe-
rience to guarantee proper handling.
Only operate the device using original accessory parts supplied by us, and when the de-
vice is in technically correct working order.
No other software programs (screen saver, applications, etc.) must run simultaneously
with the examination program in the foreground on the computer that controls the Easy-
field Perimeter.
Power-save modes (BIOS or Windows) must be deactivated.
When transporting the control pad, do not hold it by the blue cover. The cover is not se-
curely attached as it must be detached for reloading the printer paper. If the control pad
is held by the blue cover, it could come loose and the control pad could fall.
Only connect the unit to a power supply whose voltage lies within the voltage range spec-
ified on the rating plate.
Please also heed to safety instructions listed above
Great care must be taken when transporting the Pentacam from one location to another.
Î Avoid operating or storing the device next to heaters/radiators or in damp areas.
Î Check the Easyfield for damage every time it has been transported.
The requirements for transporting and storing the device according to IEC 601 - 1 are as
follows:
These levels apply in conjunction with the use of appropriate packaging and for a maxi-
mum period of 15 weeks.
After that, the values for the operating conditions apply:
In accordance with Directive 2002/96/EC of the European Parliament and the Council of
27 January 2003, and in accordance with German law governing the circulation, return
and environmentally friendly disposal of used electrical and electronic devices, such ap-
pliances must be recycled and may not be discarded as household waste.
5 Electromagnetic Compatibility
(EMC) / Cables
Special precautionary measures in respect of EMC apply to electrically operated medical
devices.
No special measures need be observed in respect of OCULUS devices and systems.
Attention
Portable and mobile HF sets can interfere with electrically operated medical devices.
Cables
6 Device Description
The Oculus - Easyfield has been designed for combined use as a screening unit with all
perimetrical options for immediate follow-up examination of suspicious findings. The
most common examination grids and strategies for the central visual field range up to
30° can be accessed.
The Easyfield offers pre-programmed combinations for often needed examination rou-
tines. For example: Glaucoma, macular degeneration, screening Custom routines can also
be combined and saved as programs.
The Easyfield’s integrated perimeter bowl with its 30 cm radius and a distance-correcting
lens meets the Goldmann standard. The unit complies with the ISO Norm 12866 for pe-
rimeters.
The Easyfield has a test point grid with 79 test points, including 30-2 and additional test
points in the 10° range.
Caution!
OCULUS Optikgeräte GmbH shall not be liable in any form for further use of the data re-
corded by a Easyfield-Perimeter and for the evaluations it has calculated.
7 Operation
Î Place the Easyfield Perimeter on a level surface and connect the unit to the power
supply with the supplied power cable.
Î Make sure that the mains voltage is the same as the voltage specified on the rating
plate.
Î Plug the cable of the Easyfield control pad (serial interface) and that of the hand-
held button into the respective ports at the back of the Easyfield Perimeter.
The Easyfield control pad is equipped with six pushbuttons and a rotary knob.
Î The functions assigned to buttons 1-4 depends on the respective screen.
Î The adjacent button field on the screen is activated by pressing the buttons 1-4 re-
spectively.
Î The rotary knob is used to switch back and forth among the parameters of the pro-
gram.
Î An active parameter is either highlighted in blue or has a blue frame around it.
Note!
☞
To avoid accidental deletion of data, the "Back" button often has no function assigned to
it. The "Delete" function is then assigned to one of the buttons 1-4.
Î To enter the Easyfield program, you must either enter a new patient or select an ex-
isting patient from the list.
Î You can correct an incorrect entry by activating the "←" symbol or by pressing the
"Delete" button.
Î After you have entered the full last name, press [Enter ↓]
Î Alternatively, you scroll up to the previous line or down to the next line by activating
the symbols "↑" and "↓" accordingly.
Î Enter the patient’s first name and date of birth in the same manner.
Î After you have entered the date of birth, confirm by pressing [Enter↓].
Î You will now be asked whether you want to save the new patient data.
Select the option "Yes". The name of the patient appears in the list.
Î Press the [Start] button to load the examination program.
After you have entered a new patient or have selected one from the list of patients:
Î Press the [Start] button.
Î The Easyfield program starts.
10 Easyfield - Program
(Control pad)
After the Easyfield program has started, the patient data and the pre-selected exam-
ination parameters are displayed.
Note!
☞
This instruction manual is limited to information about how to operate the Easyfield. For
detailed information about the functions of the Easyfield program and the examination
parameter settings, please refer to the User Guide.
Eye
Set the pupil diameter individually my hand or measure it with the camera image.
To improve the image quality, change the camera brightness, if necessary .
Î Enter the correction value that is to be used during the examination (in the "Current
Distance Rx" box).
Î You can also have the unit calculate the necessary correction value.
Î Activate the checkbox [Calc. from Distance Rx]
Î Enter the distance correction values in the top part of the screen.
The calculation is done based on age and taking into account the spherical equivalent (for
cylinder values up to 1.25, the spherical equivalent is used).
Field (Fld)
Î With the selected field grid, determine the exact points at which individual evalua-
tions are to be taken (refer to the User Guide for more information).
Strategy (Str)
Supra-Threshold Strategies
After an initial examination run, these strategies determine deviations from the in-
dividual norm. Defects are thus localized.
With these strategies, many locations can be examined in a relatively short time and
small scotomas can be detected.
[more information about the strategies and other examination parameters can be found in the
User Guide]
Optional, for individual selection of the examination parameters: The Easyfield offers pre-
programmed combinations for often needed examination routines. Four programs are
pre-installed: Screening, Standard, Macular and Glaucoma.
These programs are made up of various examination parameter combinations such as,
field, strategy, fixation method, speed and fluctuation test.
Î The evaluation starts after you confirm the eye that is to be tested.
11 Measuring Procedure
Required presettings for the evaluation process described here:
The data for the patient on whom the test is being performed has been entered or
and exisiting patient has been selected from the list of patients (sect. 9.1, page 10).
You are sure about the individual settings of the examination parameters (sect. 10.1,
page 11).
Optional: A quick-start program has been selected.
If the patient requires corrective lenses, the visual acuity can be corrected with full ap-
erture lenses instead of the patient’s own glasses or contact lenses.
Î For this purpose, insert the supplied lens holder into the viewer of the Easyfield Pe-
rimeter.
Î Make sure that the locating pin of the unit sits in the notch (1) of the lens holder.
Fig. 11-1: left: Lens holder with notch; right: Viewer of the Easyfield Perimeter
Î Make sure that no interfering light is getting into the viewer of the perimeter.
Î To achieve an optimal test result, slightly dim the room lighting.
Î Also ensure that the examination takes place in a quiet atmosphere.
Î Ask the patient to sit in a comfortable position in front of the unit. He should sit as
upright as possible.
Î Cover the eye that is not being tested with the eyepatch.
Î The perimeter viewer can be adjusted in height by gently pushing it up or down
Î To examine the right eye, slide the headrest to the left. To examine the left eye, slide
it the right. Ask the patient to place his forehead on the headrest.
Î To check that the patient is seated in the correct position, ask him to look into the
unit. He should fixate on the center of the four red dots.
Î The patient is sitting in the correct position when the patient’s pupil lies within the
red rectangle in the grey box at the bottom left corner of the position window on
the control pad.
Î Before you start the examination, explain to the patient how the test will proceed.
Î Give the patient the hand-held pushbutton for the unit and ask him to hold it in one
hand.
What to say to the patient:
Î "Please look into the center of the four red dots during the whole examination."
Î "Press the button every time you see a spot of light."
Individual Evaluation:
Î The evaluation starts after you confirm the eye that is to be tested.
Just before starting the evaluation procedure tell the patient:
Î "Please look into the center of the four dots."
After completing the examination:
Î Ask the patient to lean back and to put down the hand-held pushbutton.
Î Ask the patient to lean back and to put down the hand-held pushbutton.
After the evaluation has been completed, the following dialog box appears:
Î Press the "Enter" button to confirm that you want to [Save] the examination.
The examination results can be printed out immediately on the integrated printer.
Î Select the [Examination] tab and confirm with [Print].
Î To enter the examination program, you must either enter a new patient or select an
existing patient from the list.
Î Enter the patient’s full last name, first name and date of birth in the patient window.
Î Select this new patient from the patient list and start the Easyfield program.
The patient list on the left-hand side of the screen displays all previously examined pa-
tients in alphabetical order.
Î Click [Search] to quickly find the patient you require from the list.
Î Enter the patient’s name or the first letter of the name in the "Last name" field.
Î Optionally you can search for the patient by entering his or her ID number, assuming
that patient was assigned one when first entered.
Î Click the appropriate entry in the list to transfer that patient’s name to the patient
window. This also brings up a list of any previous examinations for that patient in
the examination window (bottom right-hand side).
Î After you have selected a patient start the Easyfield program by clicking [Easyfield].
Î Alternatively, start the Easyfield program by double-clicking on the selected pa-
tient’s name.
Î Click on [Start].
Î The evaluation begins.
Î After the evaluation has been completed, the following dialog box appears:
Î Activate the [Examination] tab in the Easyfield program and then click on [Print].
The printout contains all examination data along with the respective statistical char-
acteristics.
14 Troubleshooting
Attention
Do not plug in or pull out any cables while the PC or the Easyfield Perimeter is switched
on.
Attention
If an error occurs which you are unable to correct by following the instructions below,
label the device as "out of order" and contact our service department or an authorised
dealer.
Power failure or power outlet is Plug the power cable into the pow-
not active. er outlet, or into the port at the
Easyfield Perimeter.
The control pad or the serial cable Check that the connector is
of the PC is not connected proper- plugged in properly.
ly.
When the control pad is switched TheEasyfield control pad connector Check the connnection, Plug the
on, the message "Perimeter not is not properly plugged in and connector in again and screw it
connected !" appears. screwed tight in the port at the tight. Switch off the unit and then
unit. switch it back on again.
The unit has been switched off and Leave the unit switched off for at
back on again too quickly. least five seconds before putting it
back into operation.
The printer is not printing. No paper. Insert a new roll of paper into the
control pad.
The printer is printing red stripes. End of the paper roll. Insert a new paper roll into the
control pad
The Easyfield control pad is not re- The connector of the Easyfield Check the connnection, Plug the
acting. control pad is not properly plugged connector in again and screw it
in and screwed tight in the port at tight.
the unit.
Attention
Always disconnect the power supply before cleaning!
Î Do not use aggressive cleaning agents that contain chlorine or solvents, nor abrasive
or sharp-edged cleaning products to clean the unit.
Î Always heed the product descriptions and directions for use of products you use to
care for, clean, snd desinfect the unit and/or its accessories.
Cleaning the Headrest
Clean these parts with soapy water (or with alcohol, if they are very dirty). Use a lint-
free, damp cloth.
Î Switch off the unit and open the cover above the display.
Î Take the shaft of the paper roll out of its holder and insert a new roll.
The paper must unroll towards the interior of the unit.
Î Move the dark grey lever (1) at the printer to the vertical position and slide the paper
from underneath through the paper guide.
Î Let the paper stick approx. 10 cm out of the mechanism.
Î Return the lever to its original position.
Î Slide the end of the paper through the slot in the blue unit housing and close the
cover again.
16.1 Warranty
The device you have purchased is a high-quality OCULUS product. This device was care-
fully manufactured using quality materials and modern production methods. Any soft-
ware included in the delivery was tested by us and complies with technical standards.
Prior to and while operating the device it is important that you observe the instruction
manual and safety instructions.
The device carries a warranty to which you are entitled in accordance with the legal pro-
visions.
If the unit is tampered with in any way by non-authorized persons, all warranty claims
are rendered null and void, because improper modifications, maintenance and repairs
can lead to considerable harzards for the User and the Patient.
Any entitlement to a warranty shall also be void if unauthorised persons interfere with
the PC hardware and software supplied.
In the event of transport damage, we request that you notify the shipping company im-
mediately and have the damage confirmed on the consignment note, to enable a proper
claims settlement procedure.
Overall, the general terms and conditions of business and delivery apply as per the date
of purchase.
OCULUS will only accept responsibility for the safety, reliability and serviceability of the
unit if the unit is used in compliance with the instructions contained in this instruction
manual.
There are no user-serviceable parts either on or inside the device.
OCULUS accepts no liability whatsoever if assembly jobs, add-ons, adjustments, mainte-
nance jobs, modifications or repairs are done by non-authorized persons, or if the unit is
serviced or handled improperly.
If the above-mentioned jobs are done by duly authorized personnel, they must issue
proper certification stating the type and extent of the repair, with specification of any
changes made to the characteristics or performance ranges, if applicable. This certificate
must bear a date, a signature, specify who carried out the work, and contain company
information.
On request, and for this purpose, OCULUS will supply authorised persons with circuit di-
agrams, spare parts lists, additional descriptions and instructions on how to make set-
tings.
OCULUS accepts no liability for the integrity of the examination software on computers
that were not supplied by OCULUS.
Our service department or authorised representatives will furnish you with additional in-
formation.
Germany:
OCULUS Optikgeräte GmbH
Münchholzhaeuser Str. 29
D - 35582 Wetzlar, Germany
Tel.: ++49 641/2005-0
Fax: ++49 641/2005-255
E-mail: [email protected]
USA:
OCULUS Inc.
P.O. Box 1007
18902 NE 150th St.
Woodinville, WA 98072-1007
Tel.: 425-867-1800
Fax: 425-867-1881
E-mail: [email protected]
Austria:
OCULUS Vertriebsgesellschaft mbH
A-7501 Spitzzicken 77
Tel.: ++43 33 52 22 8 –67
Fax: ++43 33 52 33 8 – 68
E-mail: [email protected]
17 Declaration of Conformity
We hereby declare with sole responsibility that this product is in compliance with the fol-
lowing norms or normative documents:
DIN EN 60601-1
DIN EN 60601-1-2
DIN EN ISO 12866
18 Technical Specifications /
Minimum PC Requirements
Classification according to IEC 60601 - 1
Control pad
Power supply
Perimeter
Other information
CE marking CE 0123
Contraindications None noted
Lifecycle expectancy Up to 10 years
Minimum PC requirements