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1  Use According to Purpose and Responsibility of the Operator 

Please observe the directions in this user manual. In doing so, you will avoid risks and obtain 
correct measurement results. The symbols used have the following meanings: 
 

 
Read this user manual. 
 

 

 
Warning notes are designated using this warning symbol. 
 

 

Mobile Pediatric Autorefractor "plusoptiX A12C" and "plusoptiX A12R" comply with 
the specifications of Guideline 2007/47/EG for medical devices. 
 

 

Mobile Pediatric Autorefractor "plusoptiX A12C" and "plusoptiX A12R" comply with 
the specifications of an application part of type B in EN 60601-1. 
 

 

Only  connect  Mobile  Pediatric  Autorefractor  "plusoptiX  A12C"  and  "plusoptiX 
A12R" to the supplied medical power adapter MES30B-3P1J. 
 

 

 
On/Off button (pressure-operated) 
 

 

The  device  can  be  stored  and  transported  at  temperatures  from  0°C  to  +50°C 
(32°F  to  122°F).  A  temperature  between  +10°C  and  +50°C  (50°F  to  122°F)  with 
non-condensing air humidity between 20% and 80% is required for operation. 

 

Do  not  discard  the  device  in  household  rubbish.  Please  send  the  device  to 
Plusoptix  (Plusoptix  GmbH,  Neumeyerstrasse  46,  90411  Nuremberg,  Germany) 
for  environmentally  friendly  disposal.  Plusoptix  will  reimburse  you  the  costs  for 
return of the device. 

 
 

 

0°C 

+50°C 

12V 

Summary of Contents for A12C

Page 1: ...Page 1 68 Mobile Pediatric Autorefractor plusoptiX A12C plusoptiX A12R User Manual Release 2015 10 16 Plusoptix GmbH Neumeyerstrasse 48 90411 Nuremberg Germany www plusoptix eu Englisch ...

Page 2: ...ock only plusoptiX A12C 28 4 1 4 Activate WLAN only plusoptiX A12C 29 4 1 5 Connect to EMR only plusoptiX A12C 33 4 1 5 1 Transferring data in CSV format only plusoptiX A12C 33 4 1 5 2 Transferring data in GDT format only plusoptiX A12C 35 4 1 6 Export data only plusoptiX A12C 37 4 1 7 Import patient data only plusoptiX A12C 39 4 1 8 Retrieve patients from database only plusoptiX A12C 40 4 1 9 Sav...

Page 3: ...6 Figure 21 Cleaning the plusoptiX P12 67 Table of screenshots Screenshot 1 Setting date and time 10 Screenshot 2 Start screen plusoptiX A12C 13 Screenshot 3 Entering the date of birth 15 Screenshot 4 Entering a first name 16 Screenshot 5 Check measurement result 22 Screenshot 6 Review video screen 23 Screenshot 7 Review database entries screen 24 Screenshot 8 Printing or deleting measurements fro...

Page 4: ...ptiX A12R comply with the specifications of an application part of type B in EN 60601 1 Only connect Mobile Pediatric Autorefractor plusoptiX A12C and plusoptiX A12R to the supplied medical power adapter MES30B 3P1J On Off button pressure operated The device can be stored and transported at temperatures from 0 C to 50 C 32 F to 122 F A temperature between 10 C and 50 C 50 F to 122 F with non conde...

Page 5: ...e The measurement values may not be used directly for the prescription of glasses or contact lenses Responsibility of the operator The operator must ensure that only trained users operate the device At a minimum the training must consist of reading this user manual and instruction in the use of the device A user already trained can perform instruction in the use of the device In addition training ...

Page 6: ...ce immediately Figure 1 Device in cardboard box plusoptiX A12C Please check that the contents of the packaging are complete at time of delivery The scope of delivery includes User Manual for plusoptiX A12 Mobile Pediatric Autorefractor plusoptiX A12C or plusoptiX A12R Medical power adapter MES30B 3P1J 110V 230V power cord in compartment under the plusoptiX A12C or plusoptiX A12R 6 x rechargeable A...

Page 7: ...is also used as a fixation aid Note If a child is not looking at the camera lens in the middle behind the hexagon during the measurement this can lead to a cancellation of the measurement or incorrect measured values of the visual symmetry Therefore do not use any other external fixation aids Note To prevent the protective shield from becoming dirty we recommend that you do not touch it If the pro...

Page 8: ...otected behind a thin transparent plastic cover Two green buttons are visible the On Off button on the right side below the screen and the Shutter on the handle to the right next to the screen Chapters 2 4 Switching the device on and off and 3 4 Starting a measurement and positioning the camera deal with the functions of these buttons The device has three interfaces USB Mini USB and SD card which ...

Page 9: ...geable Nickel Metal Hydride NiMH AA HR6 batteries with a capacity of at least 1900 mAh and a quick charge rate of min 1 A Now remove the battery compartment cover using a 1 cent coin and insert the supplied rechargeable batteries Note When inserting rechargeable batteries please ensure that the contacts are located on the correct side Note The type plate with the serial number S N 120xS xxx xxxx x...

Page 10: ...ies the date and time settings page is displayed on the screen The time and date format selected is highlighted in color 1 Set the current date and time by touching the orange arrows 2 or 3 Use Checkmark button 4 to confirm your entries You can change the date and time as well as the display formats at a later stage in Settings 5 see chapter 4 1 2 Customize basic settings Note If the device is not...

Page 11: ...in color and inactive buttons are displayed in gray They include the button with the tools 4 to reach the Settings the button with the lock 5 to lock the screen This is only displayed when the screen lock is activated in the Settings the button with the green tick 6 to confirm and to save and the button for Cancel 7 which cancels without saving the blue information button 8 to open a Help screen T...

Page 12: ...ps or neon tubes do not affect measurement results To be able to perform a measurement the child must look at the device Ensure that the child is sitting straight and does turn his head across the shoulder The child s knees and nose must point towards the camera The attentiveness of small children is attracted by playing a special warble sound on the device However this works only if the child is ...

Page 13: ...a monocular measurement touch buttons 1 or 2 Buttons 3 and 4 are not shown by plusoptiX A12R You can start a anonymous measurement by pressing the Shutter see chapter 3 4 Starting a measurement and positioning the camera The plusoptiX A12C possesses a patient database To enter new patient data see chapter 3 3 Entering patient data or to call up patient data that has already been saved see chapter ...

Page 14: ...formation can also be saved in the database shown with a dotted line in the figure below Note Pressing the Shutter will start a measurement only once the patient data has been entered completely You must enter either First name Last name or ID number Entries of date of birth examination location and contact information are always optional Data entry with ID number Data entry with first name and la...

Page 15: ...creenshot 3 Entering the date of birth After entering the date of birth you will see a green checkmark 4 as confirmation on the tab You have to enter first name and last name or a patient ID number next This additional information is necessary to be able to uniquely identify the patient in the database at a later stage Simply touch the next tab 5 to move to the next input 1 2 3 4 5 ...

Page 16: ...ouse or keyboard if you prefer this option for entering data Screenshot 4 Entering a first name Once all necessary patient data has been entered that is either date of birth and first name and last name or date of birth and patient ID the Checkmark button 4 in the navigation bar is activated You can now either perform a measurement by pressing the Shutter or save the patient data without performin...

Page 17: ...t a degree of practice is required to estimate this distance It is easier to hold the device a little further away at the start of a measurement and then to move it slowly towards the child Note The screen is fixed at a 45 angle to the camera axis Tilt your wrists downwards to align the camera Pressing the Shutter will start the camera and play back a warble sound You can now see the camera image ...

Page 18: ... seen almost completely because the measurement distance is too big Move the device towards the patient until the picture is in clear focus see next picture The picture is blurred The eyes are close to the edge of the screen because the measurement distance is too small Move the device away from the patient until the picture is in clear focus see previous picture The picture is in clear focus Both...

Page 19: ...ust be aligned with one another The patient must be looking at the hexagonal nose in the camera face Therefore avoid additional fixation aids Check whether green dots are plotted in Gaze charts c Both pupils of the patient can be seen completely Both pupils must not be covered by eyelids eyelashes eyebrows or long hair for example Check whether you can see both pupils completely on screen and that...

Page 20: ...le in between measurement result screens An orange dot in between the arrows 1 and 2 indicates which of the two three respectively measurement result screens is displayed If a anonymous measurement was performed the measuring report can be saved manually by touching the printer button 3 After touching the printer button 3 the patient data entry screen is displayed by plusoptiX A12C see chapter 3 3...

Page 21: ... are deleted once device is switched off or switches off for power saving automatically Measurement reports saved to a SD card are not deleted when device is switched off or switches off for power saving Check measurement result screen Measurement results are displayed on screen immediately after a measurement was performed Measurement completed is displayed in the status line After an inconclusiv...

Page 22: ...n the middle behind the hexagon during the measurement this can lead to a cancellation of the measurement or incorrect measured values of the visual symmetry Therefore do not use any other external fixation aids The device compares the line of vision of both eyes and indicates the extent of Asymmetry ASY in between In this regard an ASY of 0 indicates perfect symmetry Asymmetric lines of vision ca...

Page 23: ... not cause a measurement to abort Touch Play button 1 to continue playback Note Check after every measurement whether both pupils are equally bright and whether structures are visible within the pupils If brightness is different or structures can be seen the eyes need to be examined closely Video pictures can help identifying the reason for a measurement to abort Pay attention to both pupils They ...

Page 24: ...int button 1 and Delete button 2 Touch Print button 1 to add a print job to the print spooler Multiple copies can be added to print spooler by touching Print button repeatedly 4 and 5 Once a compatible printer is connected all print jobs in the print spooler are printed Touching Delete button 2 marks a measurement to be deleted 6 Multiple measurements can be marked to be deleted All marked measure...

Page 25: ... a new anonymous measurement is started plusoptiX A12C and plusoptiX A12R After a cancelled measurement with patient data plusoptiX A12C only the device remembers the patient data of the last patient and the button 1 is preset This memory function makes it possible to measure the same patient several times in succession without having to enter the patient data again every time By pressing the shut...

Page 26: ...cel button 2 takes you back to the screen from which you called up settings initially Available settings are Customize basic settings 3 see chapter 4 1 2 Set date time 4 see chapter 2 4 Choose language 5 see help text Set up screen lock 6 see chapter 4 1 3 only plusoptiX A12C Configure software 7 see chapter 4 1 13 Activate WLAN 8 see chapter 4 1 4 only plusoptiX A12C Connect to EMR 9 see chapter ...

Page 27: ...The last video file measurement results and print jobs in printer spooler are retained when the screen switches off Time in minutes until the device switches off after inactivity Earlier switch off saves electricity and allows the rechargeable batteries to last longer The device must be switched on again by pressing the On Off button The last video file measurement results and print jobs in printe...

Page 28: ...ted the padlock symbol 1 is displayed in the Navigation bar on every screen Touch Padlock button 1 in the Navigation bar to lock screen As soon as screen is locked it can only be unlocked by entering the six digit PIN Note The padlock symbol is displayed in Navigation bar only if you have activated screen lock in Settings first Note Screen is locked automatically if the device is switched off or s...

Page 29: ...terface is used to connect to either a DHCP server To save battery power WLAN interface is deactivated at delivery Note Switch on DHCP server before activating WLAN interface Touch WLAN button 1 in Settings to move to this screen Touch button 2 to activate the WLAN interface 1 2 Screenshot 12 Activating WLAN ...

Page 30: ...the list by touching the Down arrow 1 Touching the Repeat button 2 will start the search for wireless networks again To de activate WLAN interface touch button 3 The device then switches off automatically and you must switch it on again by pressing the On Off button Once WLAN is activated it will automatically connect to the network each time the device is switched on 1 2 3 Screenshot 13 List of a...

Page 31: ...gation Bar After a short time the screen is closed automatically and the Settings screen appears The plusoptiX A12C is now connected with your wireless DHCP server Some networks require the entry of a password 3 After entering the password confirm your selection with the green tick 2 in the Navigation Bar Screenshot 15 Enter password for WLAN connection 1 2 3 Screenshot 14 WLAN network without pas...

Page 32: ...g symbol is displayed below to the WLAN symbol 3 Warning symbol 4 indicates that password is incorrect Warning symbol 5 indicates that DHCP server has not allocated an IP address Warning symbol 6 indicates that DHCP server is out of range or that no WLAN network connection is established 1 2 3 4 5 6 Screenshot 1 Viewing an active network connection WLAN active IP address Screenshot 16 Active WLAN ...

Page 33: ...r EMR system provider if this Plusoptix device is compatible Please read chapter 4 1 4 Activate WLAN to connect the device to your wireless DHCP server first Then touch EMR button 1 in Settings to move to EMR set up pages 4 1 5 1 Transferring data in CSV format only plusoptiX A12C Patient data can be imported from your EMR system in form of a simple CSV file Touch CSV button 2 to choose CSV file f...

Page 34: ...port a SD card has be connected to the device File names for input 2 i e patient data and output 3 i e measurement result files as well as transfer directory information are displayed on screen The information in the output file URL plusoptix12 transfer output csv is formatted this way Measurement date time internal ID last name first name date of birth patient ID location contact OD_Sph OD_Cyl OD...

Page 35: ... the file extension is incremented by one each time for each subsequent measurement remoplus001 remoplus002 remoplus003 etc The measurement results that are saved in file remoplus 001 can be formatted in different ways Touch button 5 to use an extended GDT format Using buttons 6 and 7 you can choose between the strict GDT formats with the results in 6220 6 or 84xx tuple 7 Using button 8 you can al...

Page 36: ...data is displayed in Header on start screen 1 and under Repeat Measurement 2 Note Note that it is now impossible either to enter patient data manually or to retrieve patient data from the database The associated button is grayed out 3 1 2 3 Screenshot 20 Start screen with an active connection to EMR ...

Page 37: ...d save a copy of your database on a regular basis To do so connect an USB storage device and ensure that no filters are activated i e none of the buttons on screen are highlighted in orange Now touch Checkmark button 2 The entire patient database is now saved on the USB storage device as a DB file Note Checkmark remains inactive 3 until an USB storage device is connected This backup copy can be us...

Page 38: ...des all aborted measurements i e no measurement results were obtained 4 Report includes all patients with the set date of birth 5 Report includes all patients measured on the set date 6 Report includes all patients born button 4 is active or measured button 5 is active on the set dates or between these dates 7 Report includes all measurements that were performed at the set examination location If ...

Page 39: ...olumn titles in the first row are not imported Although a patient s data is located in the first row of the CSV table this first set of patient data is not imported Save your CSV table on an USB storage device and connect it to the device Then touch Data import 2 in Settings 1 A list of all CSV tables that exist on the USB storage device will be displayed on screen Select the CSV table to be impor...

Page 40: ...played in a short list To select a patient from this short list simply touch the corresponding entry in the short list If you make a mistake when entering patient information you can delete the last character by touching Backspace button 2 The name or ID number of the patient is then displayed in the header and all measurement results for this patient to date are displayed in the information secti...

Page 41: ...our measurement report and then touch the green checkmark 2 The measurement report is then saved Note The connection of an external keyboard is necessary for the input of the patient data on the plusoptiX A12R To be able to allocate these PDF files to individual patients the patient information is part of the file name If a patient ID is entered instead of or in addition to the patient name this p...

Page 42: ... install printer drivers terminates both the license as medical measuring device as well as the guarantee DYMO LabelWriter 450 and 450 TURBO To create a printout with the DYMO LabelWriter 450 450 TURBO you must connect the power supply unit to the DYMO printer and connect the printer to the device with a USB cable Use DYMO labels of the size 54 x 70 mm 2 x 2 in plusoptiX P12 The plusoptiX P12 is b...

Page 43: ... USB cable see chapter 4 1 12 File access with URL removable medium pdf Connect SD card directly to your workplace computer Start Windows Explorer or Apple Finder and open the file to be printed You can print out the file on any optional printer connected with your network or workplace computer Note The connection over a Mini USB cable is available for all A12x devices from the supplement 01F in t...

Page 44: ... a storage medium with a different formatting and this medium is recognized by the device you will be asked whether you wish to format the storage medium as FAT 32 The advantage of a SD is that it fits flush with the device and does not protrude from the device housing Consequently the SD card can remain in the device during measurements All measurement reports see chapter 4 1 9 Save and print a m...

Page 45: ...ownwards The connection with Mini USB is used for Printing a measurement report PDF file see chapter 4 1 10 URL removable medium pdf Download Software Updates see chapter 4 1 13 Note To use the Mini USB interface the WLAN interface must be deactivated If there is an active WLAN connection the Mini USB interface is deactivated 4 1 13 Download Software Updates We recommend to check regularly whether...

Page 46: ...download with the help of status messages on the screen After the download the software update is saved on the SD card and a confirmation is displayed As soon as you acknowledge this with OK the device restarts automatically and thereby installs the software update Attention When saving the software update all data stored on the SD card are deleted Therefore use only blank SD cards Screenshot 23 D...

Page 47: ...n the signal strength of the WLAN and the Internet connection a software update over WLAN can take about 30 40 min Downloading Software Update via Mini USB cable If there is no WLAN connection available the software update can be downloaded via Mini USB cable see Figure 17 Note Depending on the internet connection a software update via Mini USB cable can take about 15 25 min Figure 16 Software Upd...

Page 48: ...sponding file folder File access with URL Removable medium pdf Start Plusoptix Image Downloader to download the Software Update Figure 17 Software Update via Mini USB cable Action recommendations on the device Action recommendations on your workplace computer Parallel processes ...

Page 49: ... device ports are located upside down that is the plugs must also be turned around before being inserted i e the USB symbol faces downwards If a connected mouse or keyboard malfunctions please first check whether batteries are inserted Then switch on the mouse or keyboard If your input device still malfunctions it is not supported by installed drivers Use input devices from another manufacturer in...

Page 50: ...s b The device switches off again immediately If the device switches off again immediately the rechargeable batteries are likely to be discharged Connect the 12V charging cable to charge the batteries Check whether the power supply unit is receiving current green LED on top of the power adapter lights up You can use the device while it is being charged To do so simply switch the device on while th...

Page 51: ...r on the screen Ensure that the mouse pointer hovers above the button Please read chapter 4 1 14 External mouse or keyboard if you prefer this option c Screen flickers during a measurement If the camera lens of the device is too close to a person or an object the integrated infrared LEDs automatically switch off The camera image on the screen is then not exposed and shows up black After a second t...

Page 52: ...he cause of the error It is generally easier to identify causes of error on camera pictures rather than on the measurement result page The following overview provides a list of all error messages that are stored in the software a Picture out of focus b Patient does not focus on camera c Pupils too big d Pupils too small e Pupils not found f Too much IR ambient light g Measurement incomplete h Corn...

Page 53: ... focus Cause This error message is displayed if the patient is too close to the camera or too far from it Reason The camera is focused at a fixed measurement distance of 1 meter 3 3 feet and measures from a distance of between 95 cm 3 1 feet and 105 cm 3 5 feet Tip You can determine the correct measurement distance on the basis of the camera image which should appear in clear focus on the screen a...

Page 54: ...ing at the hexagonal nose in the camera face Reason To prevent incorrect refraction measurements in the periphery of the eye both eyes must be directed at the center of the camera Tip Position the child so that knees and nose are in line with the camera Do not use any external fixation aids and remain calm Both corneal reflexes must be located in the center of the pupils in measurement result page...

Page 55: ...e examination room so that the pupils become smaller d Pupils too small Cause This error message is displayed if one or both of the pupil diameters is smaller than 4 0 mm Reason In the case of small pupils the pupillary reflex may be underexposed which results in cancellation of the measurement without result Where measurement results are nonetheless displayed these have a larger tolerance Tip Dar...

Page 56: ...he camera image in the event of this error message Cause This error message is displayed if the software is unable to recognize pupils in the camera image the pupillary reflex appears unusual or the pupils are partially covered by hair lashes or eyelids Reason In order to perform a measurement both pupils must be completely visible and the infrared light of the camera must be reflected from the co...

Page 57: ...e seen by the fact that the nose is visible from the side f Too much IR ambient light Cause This error message is displayed if too much infrared light is present in the examination room Reason The measurement takes place with infrared light and other infrared light sources e g sun halogen lamps globes etc are an interference factor Tip Close the curtains to shut out sunlight and switch off dim or ...

Page 58: ...he left pupil by hair Cause This error message is displayed if a measurement has started but could not be completed Reason Once a measurement has started it must be completed within 0 5 seconds this corresponds to 360 camera images Tip Immediately restart the measurement by pressing the shutter twice Position the child so that her knee and her nose are in line with the camera Ask the child to lift...

Page 59: ...r and more infrared light is reflected to the camera i Monocular Cover OS Cause This error message is displayed if the software detects two pupils in the camera image in monocular measurement mode Reason Although the software can distinguish between the left and the right eye one eye must be covered to avoid any possibility of confusion e g OD selected but OS to be measured Tip In the case of squi...

Page 60: ...mes with a 12 month ship in warranty from the date of purchase A warranty extension is available Please contact Plusoptix or your authorized Plusoptix dealer if you want to purchase a warranty extension The warranty becomes null and void in the case of external damage improper use incorrect cleaning or transportation without device cardboard box The warranty also becomes null and void if the devic...

Page 61: ...rfaces standards only plusoptiX A12C Physical layer Supports 802 11 b and g standards Network architecture types Communication to wired networks via Access Points Security WPA and WPA2 Transmit power 802 11b g 50 mW 17 dBm typical Frequency range 2 400 2 4897 GHz Operating channels 1 11 for North America and others 1 13 for Europe and others Channels Supports 802 11d Will associate with any 802 11...

Page 62: ...environments as specified below Owner and user of the device are responsible that a use in such an environment is assured This product conforms to the EMC standard IEC 60601 1 2 This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference i...

Page 63: ...rs are covered with synthetic material the relative humidity should be at least 30 Electric fast transient burst IEC 61000 4 4 2 kV for power supply lines 2 kV for power supply lines Mains power supply should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power supply should be that o...

Page 64: ... switching on the status lamp flashes green and the printer is ready for operation If it does not flash the rechargeable batteries have to be charged see Inserting and charging rechargeable batteries If the status lamp flashes red the paper compartment is not properly closed or a new roll of paper has to be inserted If the blue control lamp in the infrared receiver is illuminated data is received ...

Page 65: ...of min 1 A Figure 19 Bottom of plusoptiX P12 Inserting the batteries Place the top side of the printer on a flat working surface Then remove the battery compartment cover with a 1 Cent coin and Insert the supplied batteries Note Ensure when inserting the rechargeable batteries that the plus and minus battery contacts are at the correct side If you insert one or more batteries incorrectly by mistak...

Page 66: ...tment by slightly lifting the unlocking lever on the paper compartment cover Figure 20 Open cover and insert paper Unwind a little paper from the roll so that approx 1 inch protrudes from the paper compartment Ensure that the paper layers remain tightly wrapped about the roll core Then place the paper roll in the paper compartment as shown After this close the cover of the paper compartment by pre...

Page 67: ... the printer until the blue control lamp turns off Note If the infrared transmission is interrupted during a printing order the print out of the label is also interrupted To obtain a complete print out a new printing order has to be sent Cleaning If the print quality should deteriorate it is necessary to clean the printing head paper sensor tear off edge and drive roller To do so Open the cover of...

Page 68: ...e 0 to 50 C Humidity 10 to 80 non condensing Operation Temperature 10 to 50 C Humidity 20 to 80 non condensing Dimensions Dimensions 159 6 x 89 6 x 45 6 mm 6 28 x 3 53 x 1 8 in Weight 0 35 kg 12 35 oz Power supply MES30B 3P1J Input 110 to 240 VAC 50 to 60 Hz 0 8 A Output 12 VDC 2 5A Rechargeable batteries Sanyo HR 3UTGB 1 2V Type Size Nickel metal hydride NiMH AA HR6 Power Quantity 1900 mAh 4 each...

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