plusoptiX SO8 Instruction Manual Ver 4.6.18

Table of contents 1. Safety Instructions...3 1.1 Warning and symbols... 3 1.2 Handling of the plusoptiX S08 ...4 1.3 Exclusive use of the plusoptiX S08 ...4 1.4 Operation of the plusoptiX S08 ...4 1.5 Customer obligations...4

2. Delivery...5 2.1 Storage... 6 2.2 Unpacking...6

3. System Installation ... 6 3.2 How to install the software on the notebook... 7 3.3 Switching "on" the system...8

4. Binocular Measurement (License C)... 9 4.1 Measurement procedure step 1 to 5...9 4.2 Settings... 13 4.3 Documentation... 14 4.4 Reviewing the video of the last measurement... 15 4.5 Switching "off" the system... 16

5. Monocular Measurement (License M, optional)...18 6. Screening Mode (License A, optional)... 19 6.1 Entering "pass/refer" criteria... 20 6.2 Making of the "pass/refer" criteria... 21 6.3 Screening results...22

7. Patient Database (License D, optional)...23 7.1 Adding a new and selecting an existing patient... 24 7.2 Reviewing a measurement...25 7.3 Edit patient data...26

8. Printing Certificate (License Z, optional)... 27 8.1 Creating new certificates... 28 8.2 Printing certificates...29 8.3 Modifying and deleting existing certificates...31

9. Warranty... 32 10. Service and Maintenance... 32 10.1 Service... 32 10.2 Maintenance... 33

11. Operating Tips... 33 12. Specifications... 35

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1.

Safety Instructions Please read all of the instructions in this manual by all means in order to avoid any danger to life and health.

1.1

Warning and symbols ATTENTION:

Refer to the operating instructions. This symbol is intended to advise the user of the presence of important operating or maintenance instructions in the documents accompanying the instrument.

Service or repair to be performed by qualified, authorized personnel only. There are no user serviceable parts inside the instrument. Opening this device can expose the user to harmful invisible electrical shock. Note:

Disassembly of plusoptiX S08 device will void the warranty. Refer all servicing to Plusoptix authorized service representatives listed in the section Service and Maintenance (page 33).

Do not sterilize the plusoptiX S08 device or any of the components.

CAUTION:

Use of controls or adjustments or performance of procedures other than those specified herein may result in wrong measurements.

Use only with IEC 60601-1 approved printers or keep printer out of patient vicinity.

Double insulated power supply.

0123

The CE mark on this device indicates that it has been tested and conforms to the provisions noted within the 93/42/EEC Medical Device Directive. At the end of life, electronic waste. Note: This product contains no hazardous materials. Its disposal will not contaminate or harm the environment, or present any risk to individuals disposing of the product. As a precaution, it is recommended to contact the local disposal and / or recycling authority for information regarding the disposal of the equipment.

ESD sensitive device: Discharge human body by touching a grounded plane or use ground strips before installation or touching the connectors.

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1.2

Handling of the plusoptiX S08 The plusoptiX S08 is an optical electronic measuring device. The construction and functionality of the plusoptiX S08 is very similar of a video camera / camcorder. So, please handle the device as carefully as you would use your own camcorder. If you follow this advice the plusoptiX S08 will last you for many years without any trouble.

1.3

Exclusive use of the plusoptiX S08 The exclusive use of the plusoptiX S08 device is to measure refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) from one meter (3.3 ft) away from the patient. Note: Detecting anisometropia in miosis is only possible with a binocular measurement in real time, like with the plusoptiX S08. And in this case it is not important whether the children are accommodating during the measurement, because the refractive difference between both eyes is always the same. The measurement is from one meter distance to the patient and so 1.00 dpt accommodation is included into the measurement result. CAUTION: The measurement results can only be translated into a prescription for glasses/ contacts by a licensed eye care professional and are not to be taken directly for a prescription.

1.4

Operation of the plusoptiX S08 Check all cable connections from the mains and between the plusoptiX S08 device and the notebook that they are in good conditions every time before switching on the system. Make sure that any cables or connectors which show any damage are replaced before tuning on the plusoptiX S08 system. Use only the delivered medical power adapter MES30B-3P1J and the delivered cables. If a cable is damaged please contact Plusoptix GmbH. The plusoptiX S08 device combined with a notebook with a power consumption of maximum 1.7 A and the medical isolation transformer IMED 300 complies with the medical device directive 93/42/EEC. The medical isolation transformer has also been tested to the IEC 60601-1. In case the customer uses his own PC the medical device directive 93/42/EEC applies only when the PC is approved as a medical device. Otherwise use a medical isolation transformer which is tested to the IEC 60601-1 and make sure that the power consumption of the PC does not exceed the maximum rating of the medical isolation transformer.

1.5

Customer obligations The customer is responsible to allow only qualified and trained staff to operate the plusoptiX S08 system. All operators must read this manual and use the system in accordance with instructions. Note: Training courses for vision screening are regularly available. Page 4 of 36

If the customer plugs in devices which are not released by Plusoptix or deviate from the instruction manual, he is responsible that the Standard EN 60601-1 and En 60601-1-1 applies.

2.

Delivery The plusoptiX S08 device is delivered in a paper carton. The following information is printed on the carton:

Only 5 cartons on each other

This side up

Fragile

Keep dry

Carton manufacturer

CE conform

Recycleable

Inside the paper carton the measuring device is placed in a preformed inset to avoid damages to the plusoptiX S08 device during transportation. Cradle

CD-Rom Camera Medical Power Adapter Cables

Cover

Paper carton size:

51cm x 41cm x 20cm (20 inches x 16 inches x 8 inches)

Preformed inset:

Polyurethane foam (volume weight 28 kg / CBM)

Weight:

3.1 kg (6.3 LB) Carton including plusoptiX S08 device

In case the paper carton shows any damages which may be caused by external force during transportation, e.g. careless loading or unloading, please do not accept the delivery and inform Plusoptix GmbH or our sales partner immediately. Page 5 of 36

2.1

Storage The plusoptiX S08 device can be stored in the original package for one year when the storage room full fills the following requirements: Temperature: Humidity:

0°C to +50°C (32°F to 122°F) 10% to 85% (no condensation)

Protect the plusoptiX S08 device from direct sunlight and keep it away from any heat source.

2.2

Unpacking Open the carton only in position “This side up”. After unpacking the plusoptiX S08 device please check that all items are delivered which are listed on the delivery note. Missing items can only be replaced when a claim has been forwarded to Plusoptix GmbH within one week after accepting the delivery. Note: Please keep the original packing material in case later transportation may be required. Do not store the packing material in a room with an open fire.

3.

System Installation The plusoptiX S08 system operation requires a notebook with the following minimum requirements: Processor:

Intel Pentium 4/2,5Ghz or Intel Pentium M/1.6Ghz or Intel Pentium Centrino/1,6Ghz

Memory:

2GB RAM (Windows Vista)

Hard disc:

20GB

Operating System:

Windows XP or Vista

Resolution:

1024 x 768 Pixel

Interfaces:

Firewire and USB

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3.1

Cable connections plusoptiX S08 Connect the USB-, Firewire- and 12VDC cable as shown in picture 1. The corresponding sockets on the plusoptiX S08 device are shown in picture 2. For the corresponding sockets on the notebook please refer to the user manual of the notebook.

Picture 2

Picture 1

plusoptiX S08

notebook

Audio cable Firewire cable medical power adapter MES 30B-3P1J

12VDC cable Firewire cable

On/Off Switch

USB cable

3.2

How to install the software on the notebook

Step 1:

Switch on the plusoptiX S08 device and thereafter the notebook.

Step 2:

Click on

to terminate the “InstallShield Wizard”.

Step 3:

Click on

to terminate the “InstallShield Wizard”.

Step 4:

Insert the Plusoptix CD-ROM. The installation process starts automatically.

Step 5:

Do you want to install the software? (y/n)

Step 6:

Click on

Step 7:

Click on

Step 8:

Click on

of the “Microsoft(R) Direct X(R) Installation”.

Step 9:

Click on

of the “Microsoft(R) Direct X(R) Installation”.

Step 10:

Click on

of the “Microsoft(R) Direct X(R) Installation”.

Step 11:

Click on and thereafter remove the Plusoptix CD-ROM. The notebook automatically reboots. After a little while the “Main Menu” of the Plusoptix program and the “System ID” appears on the monitor.

Enter “y” and press “Return”.

in the “Hardware Installation”. of the “Microsoft(R) Direct X(R) Installation”.

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Note:

In order to activate the software licence on your notebook, please disclose the “System ID” by phone, fax or e-mail to Plusoptix.

Click here to write in the activation code you got from Plusoptix and click OK below to confirm the activation of your licences.

3.3

Switching "on" the system Switch on the plusoptiX S08 device (picture 2, page 8) and thereafter the notebook. Note: Always switch on the plusoptiX S08 device first. Otherwise the Windows operation system can not detect the plusoptiX S08 device and the error message "Communication errors with S08 device" appears on the monitor. After you have switched on the plusoptiX S08 device and the notebook the licensed program automatically appears on the monitor. If not please send the "System ID" to Plusoptix for activating the program. Start screen

Click here to start the program. or Click here to read the instruction manual.

Hardware configuration and software version.

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4.

Binocular Measurement (License C)

4.1

Measurement procedure step 1 to 5 Step 1:

The plusoptiX S08 system is now ready for use. Please fill in patient data if required and follow the instructions as shown on the monitor. Fill in patient data. Click here to select language. The measurement setup and procedure is displayed once after opening the program.

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Step 2: Place the child 1m (3.3 feet) away from the camera. Arrange the notebook so that the child can not look at the monitor. The attention span of young infants is very short and therefore attracting the attention at the appropriate time is crucial to perform the examination.

1m

Step 3:

Hold the camera at the same height as child´s eyes. Press the trigger on the handle to activate the camera. A warble sound is emitted from the loudspeakers to attract the child´s attention towards the camera.

Camera

Loudspeakers Trigger Handle

Note:

During the measurement process you can press the trigger again at any time to regain attention of the child. Page 10 of 36

Step 4:

Bring the eyes of the child in focus of the white rectangle on the monitor.

Move the camera slowly toward or backward until a green circle appears around each pupil. At that moment the measurement starts automatically and once more a warble sound is emitted to keep the child´s attention. The measurement is completed with a "ping tone". Note:

In case the measurement result is "Measurement aborted" please check the following conditions: 1. A white square around the pupil is an indication that the measuring distance is not within 1m ± 5cm (approx. 3.3 feet) of the subject. 2. A red circle around the pupil is in most cases an indication that the pupil size is too small. Reduce room light level to enlarge pupils. 3. If the camera does not find the pupils within 20sec, the measurement process is switched off automatically and "Measurement aborted" appears on the monitor. One of the following situations may exist: - One or both pupils are not on focus by the camera, e.g. an eyelid or eyelashes may be partly covering the pupil. - One of the two eyes is off axis (more than 10°). The center of the pupil appears in red on the gaze chart. In this case you have the option to measure monocular (License M). - In all other cases repeat the measurement in accordance with step 1 to 5 of this section. If after two or three attempts the result is still "Measurement aborted" a complete eye examination is necessary. Page 11 of 36

Step 5:

Measuring results

Readings

Gaze chart (for OD; right eye)

Gaze chart (for OS; left eye)

Refraction

=

Sphere, cylinder and axis

Pupil size

=

Diameter in mm

Gaze Charts

=

Visualization of the fixation line of each eye during the measurement (Hirschberg: 1mm = 11,82°, 1° ≈ 1,75 pdpt).

Pupil distance =

The distance between both eyes measured from the middle of the pupil.

Attack angle

Angle between the virtual connection line of the pupils and the horizontal. This angle can be caused by the posture of the head or the alignment of the camera. This angle is calculated in the axis of the cylinder by the program.

=

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4.2

Settings

Click here to change the measurement result from minus- to plus- cylinder or back. Right click here to change the color mode from black and white into false color. This is useful to see the brightness differences of both eyes (Brückner test). Click here to turn on/off the loudspeakers or regulate the loudness of the warble sound.

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4.3

Documentation

Click here to print a self adhesive label with measurement results for patients file.

Note: The plusoptiX S08 system can also be connected to your local network in order to transfer the measurement results directly into the patient database. Please contact Plusoptix to supply the data exchange protocol for your network administration.

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4.4

Reviewing the video of the last measurement Each measurement can be reviewed as a video or in single measurement steps to analyze the result.

Click here to play the video in single measurement steps. The measurement results of each screen shot are shown on the monitor. Click here to play the entire video in real time. - Refraction data: sphere, cylinder and axis from the last video - Pupil size in mm: average of the complete measurement - Gaze deviation in °: average of the complete measurement Click here to rewind the video for a replay.

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4.5

Switching "off" the system Switch off the notebook first and afterwards the plusoptiX S08 device. Otherwise the program may malfunction.

Click here to go back to the start screen (page 9).

Start screen

Click here to switch off1) Check box exit mode

1)

Check the box marked "Close program" if you want to go back to Windows. Check the box marked "Switch off notebook" if you want to close the program and to turn off the notebook at the same time.

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Note: If you have switched off the plusoptiX S08 device by accident first, the following message occurs:

Click here to close the screening program.

Now turn off your notebook as follows: Step 1:

Click

Step 2:

Click

Step 3:

Click

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5.

Monocular Measurement (License M, optional) Children with a gaze deviation of more than 10° can not be measured in the binocular mode (license C). The monocular mode (license M) allows the user to measure each eye separately. Click here to measure the right eye. Click here to measure the left eye.

Measurement of e.g the left eye.

In case the camera finds two pupils the measurement result is "Measurement aborted". A status report will remind you to cover the eye which you do not intend to measure.

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6.

Screening Mode (License A, optional) Using the screening mode option (license A) enables the plusoptiX S08 to be used as a screening device. In this case the plusoptiX S08 system automatically compares the measured values with present "pass/refer" criteria. See section 6.1 how to set "pass/refer" criteria for different age groups. When all measured values are within the limits of the pass criteria, the screening result "Test passed" appears on the monitor. If one or more values exceed the limit, the screening result "Refer child to doctor" appears on the monitor. The measured values are displayed on the monitor in either case. If the M and A license are used together it is not possible to print the A certificate on monocular measurements only. Fill in patient data (at least the date of birth (YYYY-MM-DD; e.g. 2005-10-21)). Click here to enter the "Pass/Refer Criteria". Click here to enter data for certificate. Click here to select language. The measurement setup and procedure is displayed once after opening the program.

Click here to print a self adhesive label with the measured values. Click here to print a certificate with the screening result.

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6.1

Entering "pass/refer" criteria "Pass/Refer" criteria are threshold values to distinguish a pass from a refer vision screening result. You may define up to 20 different sets of "pass/refer" criteria for distinct age groups. You need to define all "pass/refer" criteria for a particular age group otherwise the age group is not defined and will not be considered in the automated evaluation. The "pass/refer" criteria are the maximum measured values that lead to a pass vision screening result.

Age group in months

Value for anisocoria in mm. Value for the spherical equivalent of hyperopia in dpt Value for the spherical equivalent of myopia in dpt. Value for astigmatism in dpt.

Value for anisometropia of the spherical equivalent of both eyes in dpt.

To modify "pass/refer" criteria click on the value you want to change. Fill in the new value and acknowledge the change by pressing "Enter". To delete a complete age group click on one of the values in this line and thereafter click "Delete!". For specification whether a patient has passed or not, the effectively measured data is used. Therefore it is possible that the written, rounded measurement result does not agree with the written screening result, e.g. “Pass”. To check the result replay the video again and press the “Ctrl” key during the whole replay. You will see the effectively measured data when the video has finished. So you can evaluate the spherical equivalent (= sphere + ½ cylinder) and reproduce the result.

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