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OCULUS
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 criteria. 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 Optikgeräte GmbH i / iii
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 regarding the entire range of products are concerned.
Instruction Manual Easyfield (G/56930/0409/en)
Table of contents
Instruction Manual Easyfield (G/56930/0409/en)
Table of contents
ii / iii
Table of contents
iii / iii Instruction Manual Easyfield (G/56930/0409/en)
1 Scope of Delivery
Components (Scope of delivery with control pad) Order number
56930
OCULUS-Easyfield-Perimeter
Easyfield control pad
Download cable
Backup software
Dust protection cover
Table-top power pack (Model SW172)
Mains cable
Eye patch
Hand-held button
Lens holder for inserting trial lenses
Instruction Manual
Electrical safety test certificate
Serial cable
Components (Scope of delivery for use of the PC software) Order number
56932
OCULUS-Easyfield-Perimeter
Dust protection cover
Table-top power pack (Model SW172)
Mains cable
Eye patch
Hand-held button
Lens holder for inserting trial lenses
Instruction Manual
Electrical safety test certificate
Serial cable
Data medium with software
1 Scope of Delivery
Instruction Manual Easyfield (G/56930/0409/en) 1 / 27
2 Safety instructions
Optional accessories
Thermal print paper for control pad (length 25m, width 57mm, Plastic tubing,
∅
12mm)
Carrying case
(
Corrective lenses, small set with 12 lenses.
±6
D /
±4
D
/ ±3
D /
±
2D /
±
1D /
±
0.5D)
Order number
65311
56936
Note!
We reserve the right to change the scope of delivery in line with ongoing technical development.
2 Safety instructions
2.1
Safety instructions concerning organisation
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.
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Make sure to keep this instruction manual in a safe place and available to operating personnel at all times.
Observe the legal regulations with regard to accident prevention.
The Easyfield Perimeter is a high-quality, technical product. To ensure that it functions 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.
2 / 27 Instruction Manual Easyfield (G/56930/0409/en)
2.2
Pictogram definitions
Attention
Identifies a potentially dangerous situation which may cause minor injury or damage to property.
Note
Instructions for use, and useful or important information.
2 Safety instructions
Note
Identifies important information about the product or on how to use it, which requires special attention.
2.3
Safety Instructions for Use of the Easyfield
Perimeter
Attention
No modifications may be made to this device without the permission of the manufacturer.
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Only operate the Easyfield using original accessory parts supplied by us, and when the device is in technically correct working order.
Never put a damaged Easyfield into operation. Should such a situation arise, contact the supplier.
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.
Do not use or store the Easyfield in damp rooms.
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.
When cleaning, use a damp cloth and make sure that no liquid enters the device.
Only operate the device in rooms used for medical purposes if VDE 0100 installation procedures have been observed.
Instruction Manual Easyfield (G/56930/0409/en) 3 / 27
ll
3 Proper Usage
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Do not force any plug connections.
If you are unable to make a plug connection, check whether the plug fits the socket.
If you detect damage to the connection, you should let our service personnel repair the damage.
When disconnecting electrical connections, pull on the respective plug instead of the cable itself.
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!
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 safety 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 testing the visual field of the human eye.
The unit must only be operated by people with adequate knowledge and practical experience to guarantee proper handling.
Only operate the device using original accessory parts supplied by us, and when the device 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 Easyfield 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 securely 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 specified on the rating plate.
Please also heed to safety instructions listed above
4 / 27 Instruction Manual Easyfield (G/56930/0409/en)
4 Transportation and Disposal
4 Transportation and Disposal
4.1
Transport and storage instructions
Great care must be taken when transporting the Pentacam from one location to another.
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Avoid operating or storing the device next to heaters/radiators or in damp areas.
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:
Ambient temperature:
Relative humidity
Air pressure:
-25 °C to +70 °C
10% to 75%
500hPa to 1060hPa
These levels apply in conjunction with the use of appropriate packaging and for a maximum period of 15 weeks.
After that, the values for the operating conditions apply:
Ambient temperature:
Relative humidity:
Air pressure:
+10 °C to +40 °C
30% to 75%
700hPa to 1060hPa
4.2
Disposal of used devices
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 appliances 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.
Instruction Manual Easyfield (G/56930/0409/en) 5 / 27
6 Device Description
Cables
To minimise emitted interference and to increase interference resistance, the following types of cables must be used:
05200320 or 05200210 (110 volt) Mains cable 2.5 m in length
6 Device Description
6.1
Overview of device components
6 / 27
Fig. 6-1: Device components
1 Printout slot
2 Rotary knob
3 "Back" button
4 "Enter" button
5 Key (4)
6 Key (3)
7 Key (2)
8 Key (1)
9 Base
10 Eyepiece
11 Perimeter viewer
12 Forehead rest
6.2
How the Easyfield - Perimeter works
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.
Instruction Manual Easyfield (G/56930/0409/en)
The Easyfield offers pre-programmed combinations for often needed examination routines. 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 perimeters.
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 recorded by a Easyfield-Perimeter and for the evaluations it has calculated.
7 Operation
7 Operation
1 Serial interface port
2 On/Off switch
Fig. 7-1: Operation
3 Port for external power pack
4 Port for the hand-held button
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Place the Easyfield Perimeter on a level surface and connect the unit to the power supply with the supplied power cable.
Make sure that the mains voltage is the same as the voltage specified on the rating plate.
Plug the cable of the Easyfield control pad (serial interface) and that of the handheld button into the respective ports at the back of the Easyfield Perimeter.
Instruction Manual Easyfield (G/56930/0409/en) 7 / 27
8 Conducting Examinations using the Easyfield Control Pad
8 Conducting Examinations using the Easyfield Control Pad
8.1
Functions of the Control Pad
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1 Rotary knob
2 "Back" button
3 "Enter" button
4 Key 4
Fig. 8-1: Control Pad
5 Key 3
6 Key 2
7 Key 1
The Easyfield control pad is equipped with six pushbuttons and a rotary knob.
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The functions assigned to buttons 1-4 depends on the respective screen.
The adjacent button field on the screen is activated by pressing the buttons 1-4 respectively.
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The rotary knob is used to switch back and forth among the parameters of the program.
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An active parameter is either highlighted in blue or has a blue frame around it.
Instruction Manual Easyfield (G/56930/0409/en)
9 Patient Data Management
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Press the "Back" button (2) to exit the activated parameter.
In the Patient Data Management menu, this button is assigned the "Delete" function.
Confirm the selected parameter by pressing the "Enter" button (3).
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.
9 Patient Data Management
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After the control pad is turned on, the Patient Data Management menu is opened.
The following screen appears:
Fig. 9-1: Patient Data Management
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To enter the Easyfield program, you must either enter a new patient or select an existing patient from the list.
Instruction Manual Easyfield (G/56930/0409/en) 9 / 27
9 Patient Data Management
9.1
Enter a new patient
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To enter a new patient, press the button [New Patient].
Enter the patient’s last name.
Select each individual letter by turning the rotary knob accordingly and confirm each selected letter by pressing the "Enter" button.
10 / 27
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Fig. 9-2: Entering patients
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You can correct an incorrect entry by activating the "
←
" symbol or by pressing the
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"Delete" button.
After you have entered the full last name, press [Enter
↓
]
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Alternatively, you scroll up to the previous line or down to the next line by activating the symbols "
↑
" and "
↓
" accordingly.
Enter the patient’s first name and date of birth in the same manner.
After you have entered the date of birth, confirm by pressing [Enter
↓
].
You will now be asked whether you want to save the new patient data.
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Select the option "Yes". The name of the patient appears in the list.
Press the [Start] button to load the examination program.
9.2
Select patient
Select patients whose data have already been saved.
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In the Patient Data Management menu, press the button [List].
Turn the rotary knob to get to the desired entry in the list.
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The patient’s name simultaneously appears in the Patient window.
Press the [Start] button to load the examination program.
9.3
Start the Easyfield program
After you have entered a new patient or have selected one from the list of patients:
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Press the [Start] button.
The Easyfield program starts.
Instruction Manual Easyfield (G/56930/0409/en)
10 Easyfield - Program
(Control pad)
10 Easyfield - Program (Control pad)
Fig. 10-1: Easyfield program menu
After the Easyfield program has started, the patient data and the pre-selected examination 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.
10.1 Examination Parameters
Change the parameters for the respective examination.
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Select the required parameters by turning the rotary knob.
Press the Enter button
The following parameters can be changed:
Eye
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Select which eye is to be examined.
Instruction Manual Easyfield (G/56930/0409/en) 11 / 27
10 Easyfield - Program (Control pad)
Pupil size (Pup)
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 .
Correction lens (Cor)
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Enter the correction value that is to be used during the examination (in the "Current
Distance Rx" box).
You can also have the unit calculate the necessary correction value.
Activate the checkbox [Calc. from Distance Rx]
Enter the distance correction values in the top part of the screen.
12 / 27
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)
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With the selected field grid, determine the exact points at which individual evaluations are to be taken (refer to the User Guide for more information).
Instruction Manual Easyfield (G/56930/0409/en)
10 Easyfield - Program (Control pad)
Strategy (Str)
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Select the applicable strategy from the following options:
Supra-Threshold Strategies
After an initial examination run, these strategies determine deviations from the individual norm. Defects are thus localized.
With these strategies, many locations can be examined in a relatively short time and small scotomas can be detected.
Exact Threshold Determination 4/2
The full threshold staircase strategy, as it is also known, is used to determine as accurate a threshold value as possible at each grid point.
This method provides very useable starting values for the examination.
Fast Threshold Determination
The threshold is also determined at each grid point with this strategy.
The fast threshold strategy is more susceptible to error than the threshold strategy if the patient gives incorrect answers, but achieves the same results when the patient cooperates well and is much faster.
[more information about the strategies and other examination parameters can be found in the
User Guide]
10.2 Quick-Start Programs
Optional, for individual selection of the examination parameters: The Easyfield offers preprogrammed 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.
Program
Screening
Standard
Macular
Glaucoma
Field
24-2
30-2
10-2
30-2
Strategy
Supra-thr. 2
Supra-thr. Q.
Fast Thrsh.
Fast Thrsh.
Fixation
Central
Central
H. Krakau
Central
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Activate the [Program] tab in the Easyfield program.
Select the desired program.
Speed
Adaptive
Adaptive
Adaptive
Fluct.
Test deact.
Test deact.
Test deact.
Adaptive Test deact.
Instruction Manual Easyfield (G/56930/0409/en) 13 / 27
11 Measuring Procedure
A dialog box appears asking you which eye is to be examined:
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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.
Inserting the Lens Holder
If the patient requires corrective lenses, the visual acuity can be corrected with full aperture lenses instead of the patient’s own glasses or contact lenses.
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For this purpose, insert the supplied lens holder into the viewer of the Easyfield Perimeter.
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Make sure that the locating pin of the unit sits in the notch (1) of the lens holder.
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Fig. 11-1: left: Lens holder with notch; right: Viewer of the Easyfield Perimeter
Check the Examination Conditions
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Make sure that no interfering light is getting into the viewer of the perimeter.
To achieve an optimal test result, slightly dim the room lighting.
Also ensure that the examination takes place in a quiet atmosphere.
Instruction Manual Easyfield (G/56930/0409/en)
11 Measuring Procedure
Prepare the Patient for the Examination
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Ask the patient to sit in a comfortable position in front of the unit. He should sit as upright as possible.
Cover the eye that is not being tested with the eyepatch.
The perimeter viewer can be adjusted in height by gently pushing it up or down
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.
Fig. 11-2: Fixation of the Patient
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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.
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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.
Fig. 11-3: Position Window at the Control Pad
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Before you start the examination, explain to the patient how the test will proceed.
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:
"Please look into the center of the four red dots during the whole examination."
"Press the button every time you see a spot of light."
Instruction Manual Easyfield (G/56930/0409/en) 15 / 27
11 Measuring Procedure
11.1 Start the Easyfield Program
Individual Evaluation:
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Select the [Examination] tab and press [Start]
Confirm your selection by pressing the "Enter" button.
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The following dialog box appears:
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Select [Start] to begin the examination.
Evaluation Using a Quick-Start Program:
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Activate the [Program] tab in the Easyfield program.
Select the desired program.
A dialog box appears asking you which eye is to be examined:
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The evaluation starts after you confirm the eye that is to be tested.
Just before starting the evaluation procedure tell the patient:
"Please look into the center of the four dots."
After completing the examination:
Ask the patient to lean back and to put down the hand-held pushbutton.
Save the Examination Results
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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:
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Press the "Enter" button to confirm that you want to [Save] the examination.
Print Examination Results
The examination results can be printed out immediately on the integrated printer.
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Select the [Examination] tab and confirm with [Print].
Instruction Manual Easyfield (G/56930/0409/en)
12 Conducting an Examination with the PC-Software "Easyfield"
12 Conducting an Examination with the PC-Software "Easyfield"
Conduct the examination with the Easyfield Perimeter in the usual manner via your PC.
After you have switched on the PC, it first loads the operating system.
Open / start the Easyfield software.
The Patient Data Management menu then appears:
Fig. 12-1: Patient Data Management
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To enter the examination program, you must either enter a new patient or select an existing patient from the list.
12.1 Enter a new patient
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Enter the patient’s full last name, first name and date of birth in the patient window.
Fig. 12-2: Entering patients
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Optionally you can enter an ID number for the patient.
To accept the entries you have made, click [Save]. The patient you have just entered now appears in the patient list.
Instruction Manual Easyfield (G/56930/0409/en) 17 / 27
12 Conducting an Examination with the PC-Software "Easyfield"
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Select this new patient from the patient list and start the Easyfield program.
12.2 Selecting existing patients
The patient list on the left-hand side of the screen displays all previously examined patients in alphabetical order.
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Click [Search] to quickly find the patient you require from the list.
Enter the patient’s name or the first letter of the name in the "Last name" field.
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Optionally you can search for the patient by entering his or her ID number, assuming that patient was assigned one when first entered.
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).
Extended patient search: [Extended] checkbox
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Activate the [Extended] checkbox.
The screen displays additional search parameters which reference previous examinations, for example. The procedure is similar to entering a new patient name.
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Fig. 12-3: Extended search
12.3 Start the Easyfield Program on the PC
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After you have selected a patient start the Easyfield program by clicking [Easyfield].
Alternatively, start the Easyfield program by double-clicking on the selected patient’s name.
Instruction Manual Easyfield (G/56930/0409/en)
13 Easyfield Program (PC)
13 Easyfield Program (PC)
Fig. 13-1: Easyfield Program (PC)
In the same way as for conducting an examination with the Easyfield control pad:
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Set your individual examination parameters.
Optional: Select a quick-start program.
Prepare the evaluation process in the same way as you would when using the Easyfield control pad.
Insert the lens holder, if necessary.
Check the examination conditions
Prepare the patient for the examination.
Instruction Manual Easyfield (G/56930/0409/en) 19 / 27
13 Easyfield Program (PC)
13.1 Starting the Evaluation (PC)
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Select the [Examination] tab and click [Start].
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Fig. 13-2: Start of the Examination
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The following dialog box appears:
Fig. 13-3: Starting the Evaluation
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Click on [Start].
The evaluation begins.
13.2 Saving the Examination (PC)
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After the evaluation has been completed, the following dialog box appears:
Fig. 13-4: Saving the Examination
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To save the examination, click on the [Save] button.
Print Examination Results
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Activate the [Examination] tab in the Easyfield program and then click on [Print].
The printout contains all examination data along with the respective statistical characteristics.
Instruction Manual Easyfield (G/56930/0409/en)
14 Troubleshooting
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.
Fault
Nothing happens when the power switch is turned on
Possible Cause
The Easyfield Perimeter is not connected to the power supply.
Help
Plug the power cable into the power outlet, or into the port at the
Easyfield Perimeter.
Power failure or power outlet is not active.
Plug the power cable into the power outlet, or into the port at the
Easyfield Perimeter.
The control pad or the serial cable of the PC is not connected properly.
Check that the connector is plugged in properly.
When the control pad is switched on, the message "Perimeter not connected !" appears.
TheEasyfield control pad connector is not properly plugged in and screwed tight in the port at the unit.
Check the connnection, Plug the connector in again and screw it tight. Switch off the unit and then switch it back on again.
The printer is not printing.
The printer is printing red stripes.
The unit has been switched off and back on again too quickly.
Leave the unit switched off for at least five seconds before putting it back into operation.
No paper.
End of the paper roll.
Insert a new roll of paper into the control pad.
Insert a new paper roll into the control pad
The Easyfield control pad is not reacting.
The connector of the Easyfield control pad is not properly plugged in and screwed tight in the port at the unit.
Check the connnection, Plug the connector in again and screw it tight.
Instruction Manual Easyfield (G/56930/0409/en) 21 / 27
15 Care and maintenance
Fault
Camera image is too dark.
Possible Cause
The camera brightness settings are incorrect.
Help
Re-adjust the brightness
15 Care and maintenance
15.1 Care, Cleaning and Desinfection
Attention
Always disconnect the power supply before cleaning!
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Do not use aggressive cleaning agents that contain chlorine or solvents, nor abrasive or sharp-edged cleaning products to clean the unit.
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 lintfree, damp cloth.
Desinfection of all Surfaces, Except the Plexiglass
OCULUS recommends:
PURSEPT
®
- a desinfecting wipe from Merz+Co
D-60318 Frankfurt:
Tel.: +49 69 1503 1
Fax: +49 69 596 21 50
E-mail: [email protected]
USA: Merz Pharmaceuticals
Tel.: 336 8 56 20 03
Fax: 336 8 56 01 07
E-mail: [email protected]
22 / 27 Instruction Manual Easyfield (G/56930/0409/en)
15.2 Inserting a New Roll of Printer Paper
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Switch off the unit and open the cover above the display.
16 Warranty and Service
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Fig. 15-1: left: Paper infeed; right: adjustable lever
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Take the shaft of the paper roll out of its holder and insert a new roll.
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The paper must unroll towards the interior of the unit.
Move the dark grey lever (1) at the printer to the vertical position and slide the paper from underneath through the paper guide.
Let the paper stick approx. 10 cm out of the mechanism.
Return the lever to its original position.
Slide the end of the paper through the slot in the blue unit housing and close the cover again.
16 Warranty and Service
16.1 Warranty
The device you have purchased is a high-quality OCULUS product. This device was carefully manufactured using quality materials and modern production methods. Any software 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 provisions.
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 immediately 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.
Instruction Manual Easyfield (G/56930/0409/en) 23 / 27
16 Warranty and Service
16.2 Liability for Malfunctions or Damage
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, maintenance 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 diagrams, spare parts lists, additional descriptions and instructions on how to make settings.
OCULUS accepts no liability for the integrity of the examination software on computers that were not supplied by OCULUS.
16.3 Manufacturer’s and Service Addresses
Our service department or authorised representatives will furnish you with additional information.
Manufacturer - Service Addresses:
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]
24 / 27 Instruction Manual Easyfield (G/56930/0409/en)
17 Declaration of Conformity
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 following norms or normative documents:
DIN EN 60601-1
DIN EN 60601-1-2
DIN EN ISO 12866
In accordance with the provisions of Directive 93 / 42 /EEC for medical devices
Rainer Kirchhübel, certified engineer
Management Executive of,
OCULUS Optikgeräte GmbH
Instruction Manual Easyfield (G/56930/0409/en) 25 / 27
18 Technical Specifications / Minimum PC Requirements
18 Technical Specifications /
Minimum PC Requirements
Classification according to IEC 60601 - 1
Type of protection against electrical shock
Level of protection against electrical shock
Housing protection class
Protection class 1
Type B
IP40
Ambient operating requirements
Temperature
Humidity
Air pressure
Control pad
Screen
Storage
Printer
Weight
Dimensions
+10 °C to +40 °C
30% to 75%
700 hPa to 1060 hPa
Transport and storage requirements (according to IEC 601 - 1)
Ambient temperature
Relative humidity, including condensation
Air pressure
-25 °C to +70 °C
10% to 75%
500 hPa to 1060 hPa
Colour LCD
4000 Patients (also data transfer to the
PC)
Thermal printer
1.1 kg
162x228.4x113.5 mm
Power supply
Input
Output
100 or 240 V AC
50 / 60 Hz
110 VA
0.75 A - 0.35 A
12 V DC
2.75 A
26 / 27 Instruction Manual Easyfield (G/56930/0409/en)
Perimeter
Mains connection
Power input
Power output
Fuses
Other information
CE marking
Contraindications
Lifecycle expectancy
Minimum PC requirements
CPU
Operating system
RAM
Graphics card
18 Technical Specifications / Minimum PC Requirements
100 - 240 V AC, 50 - 60 Hz
60 W
24 V, 2.1 A
Integrated overcurrent shut-off
CE 0123
None noted
Up to 10 years
Pentium 500 MHz
Windows 98 SE or higher
128 MB
1 MB
Instruction Manual Easyfield (G/56930/0409/en) 27 / 27
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