plusOptix S09 Instruction Manual Ver 5.0.11.0, PAD

Table  of  contents   1.  

Safety instructions ... 4  

1.1   1.2   1.3   1.4   1.5  

2.  

Warning and Symbols ... 4   Handling of the plusoptiX S09... 5   Exclusive use of the plusoptiX S09 ... 5   Operation of the plusoptiX S09 ... 5   Duties of the operator ... 5  

Delivery ... 6  

2.1   2.2   2.3  

3.  

Storage... 7   Unpacking ... 7   Setting up ... 7  

Connecting and switching on the system ... 8  

3.1   Connection ... 8   3.2   Switching on the system ... 9  

4.  

Settings ... 10  

4.1   General (Basic settings) ... 10   4.2   Accounting ... 11   4.2.1   Accounting ... 11   4.2.2   Logbook ... 12   4.3   Installing a printer ... 13   4.4   Practice network (GDT) ... 14   4.5   Referral criteria ... 15   4.6   My Address ... 16   4.7   System ... 17  

5.  

Binocular measurement ... 18  

5.1   5.2   5.3   5.4   5.5   5.6  

Measurement procedure ... 18   Documentation ... 22   Adding an info column... 25   Viewing the video of the last measurement ... 26   Storing a video ... 27   Loading a video ... 29  

6.

Ordering new credits ... 30  

7.

Patient database ... 31   7.1   7.2   7.3   7.4  

Entering patient data ... 31   Measurement data ... 32   Deleting or modifying patient data ... 33   Backing up measurement results... 34  

Page 2 of 44

8.

Switching off the system ... 35  

9.

Warranty ... 36  

10. Service and maintenance ... 37   10.1   Service ... 37   10.2   Maintenance ... 37  

11.

Practical tips ... 38  

11.1   Measurement results... 38   11.2 Referial criteria ... 40   11.3 Status messages ... 41   11.4   Troubleshooting ... 42  

12. Specifications ... 43  

Page 3 of 44

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, to achieve reliable measurement results and to obtain the device in good working conditions.

1.1

Warning and Symbols ATTENTION: This symbol is intended to advise the user of the presence of important operating or maintenance requirements. 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 S09 device will void the warranty. Refer all servicing to Plusoptix authorized service representatives listed in the section ³Service and Maintenance´ (Chapter 10). Do not sterilize the plusoptiX S09 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. The CE mark on this device indicates that it has been tested and conforms

0123 to the provisions noted within the 2007/47/EG Medical Device Directive.

At the end of life time (electronic waste): Please ship your device back to the company you have purchased it from. The company will refund the shipping cost. ESD sensitive device: Discharge human body by touching a grounded plane or use ground strips before installation or touching the connectors. This symbol shows that this product keeps the requirements for an application part type B of EN 60601-1.

Page 4 of 44

1.2

Handling of the plusoptiX S09 The plusoptiX S09 is an optical electronic measuring device. The construction and functionality of the plusoptiX S09 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 S09 will last you for many years without any trouble.

1.3

Exclusive use of the plusoptiX S09

The exclusive use the plusoptiX S09 device is to measure spherical equivalents, astigmatism, asymmetry of the corneal reflexes and pupil size in real time. Both eyes are measured at the same time (binocular) from one meter (3.3 ft) away from the child. Note: Detecting different refractive values in both eyes without dilating is only possible with a binocular measurement of refractive data in real time, like with the plusoptiX S09. 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. The measurement results can only be translated into a prescription for glasses/contact lenses by a licensed eye care professional and are not to be taken directly for a prescription.

1.4

Operation of the plusoptiX S09 Check all cable connections from the mains as well as the VGA cable between the plusoptiX S09 device and the monitor and, if present, the connection between keyboard, mouse and network 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 switching on the plusoptiX S09 system. Use only the delivered medical power adapter MES30B-3P1J and the delivered cables. The plusoptiX S09 complies with the requirements of the directive of medical devices 2007/47/EG.

1.5

Duties of the operator The operator must ensure that only personnel who have been trained in handling of the plusoptiX S09 are permitted to operate the system. All users must read the operating manual and take note of the safety instructions and provisions. Note: Training courses on the operation of the plusoptiX S09 subject to safety notes and provisions for medical products are available on request. Where the operator connects systems other than those supplied by Plusoptix, he should ensure that these comply with norms EN 60601-1 and EN 606011-1 in conjunction with the plusoptiX S09. Page 5 of 44

2.

Delivery The plusoptiX S09 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 manufactorer

CE conform

Recycleable

Cover

Camera Cradle

Medical power unit

2 USB Sticks

Cables

Inside the paper carton the measuring device is placed in a preformed inset to avoid damages to the plusoptiX S09 device during transportation. Paper carton size: Preformed insert: Weight:

51 cm x 41 cm x 20 cm (20 inches x 16 inches x 8 inches) Polyurethane foam (volume weight 28 kg / CBM) 3.5 kg (7.7LB) carton including plusoptiX S09 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 the company you have purchased the device from.

Page 6 of 44

2.1

Storage The plusoptiX S09 device can be stored in the original package when the storage room fulfils the following requirements: Temperature: Humidity:

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

Keep the plusoptiX S09 device away from any heat source.

2.2

Unpacking 2SHQWKHFDUWRQRQOLQSRVLWLRQÄ7KLVVLGHXS³. After unpacking the plusoptiX S09 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 the company you have the device purchased from 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 place.

2.3

Setting up When you set up the plusoptiX S09 make sure that no cable can be reached by children. Protect the plusoptiX S09 from direct sunlight.

Page 7 of 44

3.

Connecting and switching on the system

3.1

Connection For operation, the plusoptiX S09 must be connected to a monitor and keyboard with a mouse. The monitor must fulfill the following system requirements: Resolution: 1024 x 768 pixels Interface: VGA Four (4) USB ports of type A are available on the plusoptiX S09 for connecting e.g. keyboard, mouse, printer or USB-sticks. Where a monitor is already available at a workstation, a switch can be used to connect this monitor to the plusoptiX S09. This allows you to save space by using the monitor for your practice network and for the plusoptiX S09. The plusoptiX S09 can also be attached to your practice network using an RJ-45 connection (network cable) via a GDT interface. Plusoptix supplies the software required for operation via a GDT interface at no charge, should you wish to connect the plusoptiX S09 to your network. In this case please consult your practice network support personnel. Fig. 1: Connect the VGA cable from the monitor to the plusoptiX S09. The keyboard and mouse can be connected to the plusoptiX S09 by means of a USB cable or a wireless USB adapter. Attach the 12V DC connector to the plusoptiX S09 and the medical power unit to a 110 ± 220 V AC (50 ± 60 Hz) power plug. Ensure that the power plug is switched off after close of business. This is a precaution in case a short-circuit occurs during night-time which may cause a fire. Fig. 2: Location of the connectors on the plusoptiX S09

Fig. 1

Fig. 2

plusoptiX S09

VGA cable for monitor medical power unit MES 30B - 3P1J

USB wireless adapter for mouse and keyboard 12VDC cable

Page 8 of 44

RJ-45

on/off switch

12VDC 4 x USB VGA

3.2

Switching on the system Switch on the monitor before you switch on the plusoptiX S09 (see Fig. 2 on page 8 for the on/off switch). After loading the software (approx. 1.5 minutes) the ³Plusoptix Start Page´ appears. You can now start measurements. Note: When using the system for the first time, first click on ³Settings´ to adjust the settings as required for operation.

Plusoptix Start Page Settings

Click here to open the instruction manual*

This brief description only appears after the system has been switched on.

Please make sure that no USB-stick is inserted in the plusoptiX S09 during switching on, because it can lead to problems during booting. The USB adapters from keyboard and mouse as well as probably connected printers are excluded from this.

Page 9 of 44

4.

Settings For the first start-up it is recommended to adapt settings e.g. general (basic settings), printer, network (GDT), your address and system to the conditions of your practice. At each page appears D VHFXULW TXHU ZKHUH RX KDYH WR WSH LQ ³<(6´ WR SHUIRUP VHWWLQJV LI RX DUH DXWKRUL]HG WR GR WKDW ,I RX DUH QRW DXWKRUL]HG FOLFN RQ ³&DQFHO´ Then you just can have a look at the existing settings and not perform any settings.

4.1

General (Basic settings) &OLFNRQ³6HWWLQJV´DQGWKHQRQ "General" to perform basic settings.

Click here to switch the video image on the monitor from black and white to false colours. You can see the brightness profile of the pupils in colour (Brückner test). Click here to test the volume of the warble sound. Click here and move the slide to the left using the mouse to decrease the volume of the warble sound, or to the right to increase the volume. Click here to measure the astigmatism in minus cylinder or plus cylinder.

Page 10 of 44

4.2

Accounting

4.2.1 Accounting %HORZ³$ $FFRXQWLQJ´WKHWRWDORIFUHGLWVDIWHUWKHODVWORDGLQJLVUHSRUWHG)URPWKLV amount every screening result ³3DVV´ DQG ³5HIHU´ ZLOO EH GHGXFWHG DQG WKH DYDLODEOH amount of credits is shown. %HORZ³% 3ULQWRUGHUID[´RXFDQFRPSOHWHand print the order fax for new credits (see chapter 6 Ordering new credits). %HORZ³& /RDGFUHGLWV´you can enter the load code you received to load new credits (see chapter 6 Ordering new credits). &OLFNRQ³6HWWLQJV´DQG WKHQRQ³$FFRXQWLQJ´

Page 11 of 44

4.2.2 Logbook Logbook enables you to monitor the usage of your credits and to double check if your accounting billed all screenings to your patients. <RX KDYH WKH SRVVLELOLW WR UHYLHZ DOO VFUHHQLQJV UHVXOWLQJ LQ D ³3DVV´ RU ³5HIHU´ VFUHHQLQJUHVXOWDVZHOODVDOOLQFRQFOXVLYHVFUHHQLQJUHVXOWVLQDQ³5HIHURUWUDJDLQ´ screening result. Simply check the appropriate box to add or remove screening results from the list. Logbook entries are displayed in chronological order. &OLFNRQ³6HWWLQJV´WKHQRQ ³AFFRXQWLQJ´DQGRQ³/RJERRN´

Click here to see all patients with screening UHVXOW³5HIHURUWUDJDLQ´, i.e. inconclusive screenings. Click here to see all patients with screening UHVXOW³5HIHU´ Click here to see all patients with screening UHVXOW³3DVV´

Page 12 of 44

4.3

Installing a printer To be able to print a screenshot, a self-adhesive label for the patient paper record or a screening result, suitable printer must be installed. You can attach the printer to the plusoptiX S09 directly via the USB or via your practice network.

&OLFNRQ³6HWWLQJV´DQGWKHQRQ3ULQWHU

Click here to select the network printer. Click here to select the printer to be used to print the corresponding document.

A pdf-SULQWHU ³3')´ LVDOUHDGLQVWDOOHGRQWKHSOXVRSWL;6 Is the pdf-printer selected a printer, it is necessary to insert a USB stick into one of the free USB ports on the plusoptiX S09. After a successful measurement and after clicking RQ³0HDVXUHPHQWUHSRUW´RU³6FUHHQVKRW´WKHGRFXPHQWZLOOEHVDYHGDXWRPDWLFDOORQ the stick. After about 10 seconds you can remove the stick from the device and print the document at one computer with a connected printer. The order fax can also be saved on an USB stick.

Page 13 of 44

4.4

Practice network (GDT) To connect the plusoptiX S09 to an existing practice network, proceed as follows: &OLFNRQ³6HWWLQJV´DQGWKHQRQ*'7

Output format of the measurement results in the network - Parser: output in field identifiers - Human readable: formatted text output Adherence to GDT standard when transmitting measurement values. A selection can be made between formatted text and field identifiers 8410 to 8421. Enter the name of the plusoptiX S09 in the network here. The paths for data input to the plusoptiX S09 and for data export to the network are extracted from this value. The plusoptiX S09 will be reached at all Windows computers via this path. Identifiers for data exchange in the practice software (PLUS: plusoptiX S09; REMO: your EMR software. This identifier depends on your network system).

Specifications for the GDT-standard is available at: http://www.plusoptix.eu/gdt

Page 14 of 44

4.5

Referral criteria To change the age group and the referral criteria, proceed as follows: &OLFNRQ³6HWWLQJV´DQGWKHQRQReferral criteria".

Double-click on the field in which you wish to change the value.

To change, enter either the number using the keyboard or click upwards or downwards RQWKHDUURZXQWLOWKHUHTXLUHGYDOXHDSSHDUV&RQILUPRXUFKDQJHESUHVVLQJ³(QWHU´ on your keyboard. 3OHDVHQRWHWKDWWKH³IURP´DJHRIWKHVHFRQGWKLUGHJOLQHPXVWEH WKHVDPHOLNHWKH³WR´DJHRIWKHOLQHDERYH VHe picture above).

Page 15 of 44

4.6

My Address Enter the name, address, telephone, fax and email address of your practice here, to enable the details to appear on the measurement report. You will find an example of the measurement report in chapter 5.2. COLFNRQ³6HWWLQJV´DQGWKHQRQMy address".

Click here to enter the name of your practice. Click here to enter the address, telephone, fax and email address of your practice.

Page 16 of 44

4.7

System The system settings have been carried out by the company you have bought the device from. In case you would like to change some system settings, please proceed as follows: &OLFNRQ³6HWWLQJV´DQGWKHQRQSystem".

Click here to set the current data and time of day. Click here to select the date format for entering the date of birth. Click here to set the keyboard layout. Click here to activate additional licenses. Click here to select the language for the operator interface.

OnFHRXKDYHSHUIRUPHGDOOVVWHPVHWWLQJVFOLFNRQ³%LQRFXODU´WRUHWXUQWRWKHVWDUW page. You can then begin measurements (see chapter 5).

Page 17 of 44

5.

Binocular measurement

5.1

Measurement procedure Step 1: If the plusoptiX S09 is not connected to a practice network please enter the patient data. These data should be entered before the child will be seated for measurement. Enter patient data. The following data are valid: a) Patient data (Surname, first name, date of birth and gender) or b) Patient data and ID or c) ID and gender This brief description only appears after the system has been switched on.

Page 18 of 44

Step 2: Hold the camera approximately 1.20 metres (3.3 feet) away from the child at eye level and start the camera by pressing once on the trigger in the handle. A warble VRXQGFDQEHKHDUGWRGUDZWKHFKLOG¶VDWWHQWLRQWRWKHFDPHUD$YRLG the child observing the monitor. The attention span of young children is extremely short. Consequently, distractions during measurement such as the monitor image or other persons in the room should be avoided.

1m (3.3 feet)

C amera

Loudspeaker Trigger

Handle

Note: You can repeat the warble sound as often as required during measurement to attract the attention of the child to the camera once again.

Page 19 of 44

Step 3: $OLJQWKHFKLOG¶VHHVLQWKHZKLWHER[RQWKHPRQLWRU

Gaze chart right eye

Gaze chart left eye

Now move the camera slowly forwards until you can see green circles around both pupils and you hear another warble sound. You are now 1 m from the child; the measurement will start automatically. Do not change the distance after this point. Within one second, a ping tone will signal the end of measurement. The measurement values will be displayed between the gaze charts, and the screening result "Pass" RU³5HIHU´ appears at the left side of the screen.

Page 20 of 44