oculus easyfield...oculus optikgeräte gmbh shall not be liable in any form for further use of the...

OCULUSEASYFIELD®

INSTRUCTION MANUALFast and Precise Testing of the Central Visual Field

i / iii Instruction Manual Easyfield (G/56930/0409/en)

Notes on this instruction manual

Thank you for your purchase and the trust you have placed in this OCULUS product. TheEasyfield - 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 reasonyou should familiarise yourself thoroughly with the contents of this instruction manualbefore operating the device. In particular, pay attention to the safety instructions.

This instruction manual describes how to manage patient data, the default settingsof the Easyfield program and the measuring process.

The Easyfield User Guide contains information supplementing the description of theoperating 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 nothesitate to call or send us a fax. Our service team will gladly assist.

OCULUS Optikgeräte GmbH

OCULUS is certified according to DIN EN ISO 9001:2000 and 13485:2003, setting highstandards of quality where development, manufacture, quality assurance and service re-garding the entire range of products are concerned.

Table of contents

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

Instruction Manual Easyfield (G/56930/0409/en) ii / iii

Table of contents

16.3 Manufacturer’s and Service Addresses ...........................................................................24

17 Declaration of Conformity .................................................................................................................25

18 Technical Specifications / Minimum PC Requirements..........................................................26

iii / iii Instruction Manual Easyfield (G/56930/0409/en)

1 Scope of Delivery

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

Instruction Manual Easyfield (G/56930/0409/en) 1 / 27

2 Safety instructions

☞

Note!

We reserve the right to change the scope of delivery in line with ongoing technical devel-opment.


2.1 Safety instructions concerning organisation

The law requires that the manufacturer expressly informs the user about safety aspectsconcerning the handling of the Easyfield. This chapter contains a summary of the mostimportant points regarding these safety matters.

Attention

Do not use the device if you have not understood the instruction manual.

Make sure to keep this instruction manual in a safe place and available to operatingpersonnel 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 func-tions correctly and safely we recommend the following: Have the unit checked everytwo years by our service department or an authorized dealer. If an error occurswhich you are unable to correct, label the device as "out of order" and contact ourservice department or an authorised dealer.

Optional accessories Order number

Thermal print paper for control pad (length 25m, width 57mm, Plastic tubing, ∅ 12mm)

65311

Carrying case 56936

Corrective lenses, small set with 12 lenses. (±6D / ±4D / ±3D / ±2D / ±1D / ±0.5D)

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 toproperty.

Note

Instructions for use, and useful or important information.

☞

Note

Identifies important information about the product or on how to use it, which requiresspecial 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 manufactur-er.

Only operate the Easyfield using original accessory parts supplied by us, and whenthe device is in technically correct working order.

Never put a damaged Easyfield into operation. Should such a situation arise, contactthe supplier.

Do not operate the devices included in the delivery in areas where explosions mayoccur, where there are inflammable anaesthetics, volatile substances such as alcoholor 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 surethat no liquids can enter the device. Do not place any containers with liquid eitherclose 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 installationprocedures have been observed.


3 Proper Usage

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 repairthe damage.

When disconnecting electrical connections, pull on the respective plug instead ofthe cable itself.

Caution!

Any additional equipment that is to be connected to either analogue or digital interfacesmust verifiably fulfil appropriate EN or IC specifications. Furthermore, all configurationsmust comply with the IEC 601 - 1 system norm.

ll Caution!

If you connect the Easyfield-Perimeter with non-medical equipment (e.g. data processingequipment) 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 currentthreshold being exceeded, protective measures including a circuit breaker must be inplace.

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 simultaneouslywith 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 padis 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


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.

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 asfollows:

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:

4.2 Disposal of used devices

In accordance with Directive 2002/96/EC of the European Parliament and the Council of27 January 2003, and in accordance with German law governing the circulation, returnand 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 medicaldevices.

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.

Ambient temperature: -25 °C to +70 °CRelative humidity 10% to 75%Air pressure: 500hPa to 1060hPa

Ambient temperature: +10 °C to +40 °CRelative humidity: 30% to 75%Air pressure: 700hPa to 1060hPa


6 Device Description

Cables

To minimise emitted interference and to increase interference resistance, the followingtypes of cables must be used:

6 Device Description

6.1 Overview of device components

Fig. 6-1: Device components

6.2 How the Easyfield - Perimeter works

The Oculus - Easyfield has been designed for combined use as a screening unit with allperimetrical options for immediate follow-up examination of suspicious findings. Themost common examination grids and strategies for the central visual field range up to30° can be accessed.

05200320 or 05200210 (110 volt) Mains cable 2.5 m in length

1 Printout slot 7 Key (2)2 Rotary knob 8 Key (1)3 "Back" button 9 Base4 "Enter" button 10 Eyepiece5 Key (4) 11 Perimeter viewer6 Key (3) 12 Forehead rest


7 Operation

The Easyfield offers pre-programmed combinations for often needed examination rou-tines. For example: Glaucoma, macular degeneration, screening Custom routines can alsobe combined and saved as programs.

The Easyfield’s integrated perimeter bowl with its 30 cm radius and a distance-correctinglens 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 testpoints 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

Fig. 7-1: Operation

Place the Easyfield Perimeter on a level surface and connect the unit to the powersupply with the supplied power cable.

Make sure that the mains voltage is the same as the voltage specified on the ratingplate.

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.

1 Serial interface port 3 Port for external power pack2 On/Off switch 4 Port for the hand-held button


8 Conducting Examinations using the Easyfield Control Pad

8 Conducting Examinations using the Easyfield Control Pad

8.1 Functions of the Control Pad

Fig. 8-1: Control Pad

The Easyfield control pad is equipped with six pushbuttons and a rotary knob.

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 re-spectively.

The rotary knob is used to switch back and forth among the parameters of the pro-gram.

An active parameter is either highlighted in blue or has a blue frame around it.

1 Rotary knob 5 Key 32 "Back" button 6 Key 23 "Enter" button 7 Key 14 Key 4


9 Patient Data Management

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 toit. The "Delete" function is then assigned to one of the buttons 1-4.


After the control pad is turned on, the Patient Data Management menu is opened.

The following screen appears:

Fig. 9-1: Patient Data Management

To enter the Easyfield program, you must either enter a new patient or select an ex-isting patient from the list.



9.1 Enter a new patient

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 confirmeach selected letter by pressing the "Enter" button.

Fig. 9-2: Entering patients

You can correct an incorrect entry by activating the "←" symbol or by pressing the"Delete" button.

After you have entered the full last name, press [Enter ↓]

Alternatively, you scroll up to the previous line or down to the next line by activatingthe 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.

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.

In the Patient Data Management menu, press the button [List].

Turn the rotary knob to get to the desired entry in the list.

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:

Press the [Start] button.

The Easyfield program starts.


10 Easyfield - Program (Control pad)


Fig. 10-1: Easyfield program menu

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. Fordetailed information about the functions of the Easyfield program and the examinationparameter settings, please refer to the User Guide.

10.1 Examination Parameters

Change the parameters for the respective examination.

Select the required parameters by turning the rotary knob.

Press the Enter button

The following parameters can be changed:

Eye

Select which eye is to be examined.



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)

Enter the correction value that is to be used during the examination (in the "CurrentDistance 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.

The calculation is done based on age and taking into account the spherical equivalent (forcylinder values up to 1.25, the spherical equivalent is used).

Field (Fld)

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)

Select the applicable strategy from the following options:

Supra-Threshold StrategiesAfter 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 andsmall scotomas can be detected.

Exact Threshold Determination 4/2The full threshold staircase strategy, as it is also known, is used to determine as ac-curate a threshold value as possible at each grid point.

This method provides very useable starting values for the examination.

Fast Threshold DeterminationThe threshold is also determined at each grid point with this strategy.

The fast threshold strategy is more susceptible to error than the threshold strategyif the patient gives incorrect answers, but achieves the same results when the pa-tient 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 pre-programmed combinations for often needed examination routines. Four programs arepre-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.

Activate the [Program] tab in the Easyfield program.

Select the desired program.

Program Field Strategy Fixation Speed Fluct.

Screening 24-2 Supra-thr. 2 Central Adaptive Test deact.

Standard 30-2 Supra-thr. Q. Central Adaptive Test deact.

Macular 10-2 Fast Thrsh. H. Krakau Adaptive Test deact.

Glaucoma 30-2 Fast Thrsh. Central Adaptive Test deact.


11 Measuring Procedure

A dialog box appears asking you which eye is to be examined:

The evaluation starts after you confirm the eye that is to be tested.


Required presettings for the evaluation process described here:

The data for the patient on whom the test is being performed has been entered orand 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 ap-erture lenses instead of the patient’s own glasses or contact lenses.

For this purpose, insert the supplied lens holder into the viewer of the Easyfield Pe-rimeter.

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

Check the Examination Conditions

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.



Prepare the Patient for the Examination

Ask the patient to sit in a comfortable position in front of the unit. He should sit asupright 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, slideit the right. Ask the patient to place his forehead on the headrest.

Fig. 11-2: Fixation of the Patient

To check that the patient is seated in the correct position, ask him to look into theunit. He should fixate on the center of the four red dots.

The patient is sitting in the correct position when the patient’s pupil lies within thered rectangle in the grey box at the bottom left corner of the position window onthe control pad.

Fig. 11-3: Position Window at the Control Pad

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 onehand.

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."



11.1 Start the Easyfield Program

Individual Evaluation:

Select the [Examination] tab and press [Start]

Confirm your selection by pressing the "Enter" button.

The following dialog box appears:

Select [Start] to begin the examination.

Evaluation Using a Quick-Start Program:

Activate the [Program] tab in the Easyfield program.

Select the desired program.

A dialog box appears asking you which eye is to be examined:

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

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:

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.

Select the [Examination] tab and confirm with [Print].


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

To enter the examination program, you must either enter a new patient or select anexisting patient from the list.

12.1 Enter a new patient

Enter the patient’s full last name, first name and date of birth in the patient window.

Fig. 12-2: Entering patients

Optionally you can enter an ID number for the patient.

To accept the entries you have made, click [Save]. The patient you have just enterednow appears in the patient list.



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 pa-tients in alphabetical order.

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.

Optionally you can search for the patient by entering his or her ID number, assumingthat patient was assigned one when first entered.

Click the appropriate entry in the list to transfer that patient’s name to the patientwindow. This also brings up a list of any previous examinations for that patient inthe examination window (bottom right-hand side).

Extended patient search: [Extended] checkbox

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.

Fig. 12-3: Extended search

12.3 Start the Easyfield Program on the PC

After you have selected a patient start the Easyfield program by clicking [Easyfield].

Alternatively, start the Easyfield program by double-clicking on the selected pa-tient’s name.


13 Easyfield Program (PC)


Fig. 13-1: Easyfield Program (PC)

In the same way as for conducting an examination with the Easyfield control pad:

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 Easy-field control pad.

Insert the lens holder, if necessary.

Check the examination conditions

Prepare the patient for the examination.



13.1 Starting the Evaluation (PC)

Select the [Examination] tab and click [Start].

Fig. 13-2: Start of the Examination

The following dialog box appears:

Fig. 13-3: Starting the Evaluation

Click on [Start].

The evaluation begins.

13.2 Saving the Examination (PC)

After the evaluation has been completed, the following dialog box appears:

Fig. 13-4: Saving the Examination

To save the examination, click on the [Save] button.

Print Examination Results

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

14 Troubleshooting

Attention

Do not plug in or pull out any cables while the PC or the Easyfield Perimeter is switchedon.

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 authoriseddealer.

Fault Possible Cause HelpNothing happens when the powerswitch is turned on

The Easyfield Perimeter is not con-nected to the power supply.

Plug the power cable into the pow-er outlet, or into the port at theEasyfield Perimeter.

Power failure or power outlet isnot active.

Plug the power cable into the pow-er outlet, or into the port at theEasyfield Perimeter.

The control pad or the serial cableof the PC is not connected proper-ly.

Check that the connector isplugged in properly.

When the control pad is switchedon, the message "Perimeter notconnected !" appears.

TheEasyfield control pad connectoris not properly plugged in andscrewed tight in the port at theunit.

Check the connnection, Plug theconnector in again and screw ittight. Switch off the unit and thenswitch it back on again.

The unit has been switched off andback on again too quickly.

Leave the unit switched off for atleast five seconds before putting itback into operation.

The printer is not printing. No paper. Insert a new roll of paper into thecontrol pad.

The printer is printing red stripes. End of the paper roll. Insert a new paper roll into thecontrol pad

The Easyfield control pad is not re-acting.

The connector of the Easyfieldcontrol pad is not properly pluggedin and screwed tight in the port atthe unit.

Check the connnection, Plug theconnector in again and screw ittight.


15 Care and maintenance

15 Care and maintenance

15.1 Care, Cleaning and Desinfection

Attention

Always disconnect the power supply before cleaning!

Do not use aggressive cleaning agents that contain chlorine or solvents, nor abrasiveor sharp-edged cleaning products to clean the unit.

Always heed the product descriptions and directions for use of products you use tocare for, clean, snd desinfect the unit and/or its accessories.

Cleaning the HeadrestClean these parts with soapy water (or with alcohol, if they are very dirty). Use a lint-free, damp cloth.

Desinfection of all Surfaces, Except the PlexiglassOCULUS 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


Camera image is too dark. The camera brightness settings areincorrect.

Re-adjust the brightness

Fault Possible Cause Help


16 Warranty and Service

15.2 Inserting a New Roll of Printer Paper

Switch off the unit and open the cover above the display.

Fig. 15-1: left: Paper infeed; right: adjustable lever

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.

Move the dark grey lever (1) at the printer to the vertical position and slide the paperfrom 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 thecover 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 instructionmanual 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 claimsare rendered null and void, because improper modifications, maintenance and repairscan lead to considerable harzards for the User and the Patient.

Any entitlement to a warranty shall also be void if unauthorised persons interfere withthe 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 properclaims settlement procedure.

Overall, the general terms and conditions of business and delivery apply as per the dateof purchase.



16.2 Liability for Malfunctions or Damage

OCULUS will only accept responsibility for the safety, reliability and serviceability of theunit if the unit is used in compliance with the instructions contained in this instructionmanual.

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 isserviced or handled improperly.

If the above-mentioned jobs are done by duly authorized personnel, they must issueproper certification stating the type and extent of the repair, with specification of anychanges made to the characteristics or performance ranges, if applicable. This certificatemust bear a date, a signature, specify who carried out the work, and contain companyinformation.

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 computersthat were not supplied by OCULUS.

16.3 Manufacturer’s and Service Addresses

Our service department or authorised representatives will furnish you with additional in-formation.

Manufacturer - Service Addresses:

Germany:OCULUS Optikgeräte GmbH

Münchholzhaeuser Str. 29

D - 35582 Wetzlar, Germany

Tel.: ++49 641/2005-0

Fax: ++49 641/2005-255



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


Austria:OCULUS Vertriebsgesellschaft mbH

A-7501 Spitzzicken 77

Tel.: ++43 33 52 22 8 –67

Fax: ++43 33 52 33 8 – 68


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

In accordance with the provisions of Directive 93 / 42 /EEC for medical devices

Rainer Kirchhübel, certified engineer

Management Executive of,

OCULUS Optikgeräte GmbH


18 Technical Specifications / Minimum PC Requirements


Classification according to IEC 60601 - 1

Ambient operating requirements

Transport and storage requirements (according to IEC 601 - 1)

Control pad

Power supply

Type of protection against electrical shock Protection class 1

Level of protection against electrical shock Type B

Housing protection class IP40

Temperature +10 °C to +40 °C

Humidity 30% to 75%

Air pressure 700 hPa to 1060 hPa

Ambient temperature -25 °C to +70 °C

Relative humidity, including condensation 10% to 75%

Air pressure 500 hPa to 1060 hPa

Screen Colour LCD

Storage 4000 Patients (also data transfer to thePC)

Printer Thermal printer

Weight 1.1 kg

Dimensions 162x228.4x113.5 mm

Input 100 or 240 V AC50 / 60 Hz

110 VA0.75 A - 0.35 A

Output 12 V DC2.75 A



Perimeter

Other information

Minimum PC requirements

Mains connection 100 - 240 V AC, 50 - 60 Hz

Power input 60 W

Power output 24 V, 2.1 A

Fuses Integrated overcurrent shut-off

CE marking CE 0123

Contraindications None noted

Lifecycle expectancy Up to 10 years

CPU Pentium 500 MHz

Operating system Windows 98 SE or higher

RAM 128 MB

Graphics card 1 MB


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