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P/N 2018-10B Rev A 6– Release

QuickSee

Model QS1.0-B

Directions for Use

Summary of Contents for QuickSee

Page 1: ...P N 2018 10B Rev A 6 Release QuickSee Model QS1 0 B Directions for Use...

Page 2: ......

Page 3: ...Monocular Mode 20 Results Screen 21 Notice Messages 22 Basic Settings 24 Bluetooth Printer 26 Advanced Settings 27 QuickSee Companion App 31 Installing the Companion App 31 Pairing the QuickSee 32 Dow...

Page 4: ...nded to measure the refractive power of the eye by measuring light from the retina using the optical technique of wavefront aberrometry It is intended for use on subjects 5 years of age and up Indicat...

Page 5: ...4 A 115 V OUTPUT Output Voltage DC 5 0 V Output Current 0 2 4 A PROTECTION Overload 110 200 rated output power Over Voltage 110 140 rated output voltage NOTE Please do not discard the box and packagin...

Page 6: ...simple as having the subject look at a distant object through the device The device provides a quick measurement of a subject s refractive error Each measurement provides binocular assessment and allo...

Page 7: ...bborn stains use with a small amount of water or a non abrasive cleaner Always keep the back viewing lens free of fingerprints dirt and dust 7 When plugging the AC power connector into the QuickSee DO...

Page 8: ...nctional subsystems If all the systems are functional the device will start normally Turning off to ensure basic safety as well as the safety of the components of the device If all the systems are fun...

Page 9: ...on Polymer Battery cell IEC62133 2012 certified Ratings 3 7 V 8000 mAh 29 6 Wh Replacement or substi tution of this battery may only be performed by PlenOptika service engi neers If you experience an...

Page 10: ...arger will easily insert into the USB power connector on the QuickSee Using excessive force to connect the power charger can damage the device and will void the warranty 4 Plug the AC power cord into...

Page 11: ...ff and confirm by pressing the check mark Avoid Powering Off via the power button when handling device be mindful to not press into the power button continuously for 7 seconds as this force shuts down...

Page 12: ...battery Power Saving Modes Pressing and releasing the power button briefly will put the device into Power Saving Mode In Power Saving Mode In Power Saving Mode the screen is off and less battery is c...

Page 13: ...rned on in the Basic Settings menu Start To begin the data entry and screening measurement process select the button This will allow you to Enter subject information such as Patient ID auto fills unle...

Page 14: ...D or OU icon to start screening the left right or both eyes You will be able to enter subject data even after the screening if desired Icons on screen Drop Down Menu goes to menu for new Patient Patie...

Page 15: ...y information by touching the field you wish to change After the change is completed select to save information and return to the Home Screen Alternatively select to return to the Home Screen There ar...

Page 16: ...ect entries will be highlighted If this happens select and edit the highlighted field When editing the Patient ID Number text can also be entered with the alpha numeric keypad For example the letter A...

Page 17: ...the device select Patient Log from the Home Screen s drop down menu The main Patient Log screen will appear Main Patient Log Screen Scroll up and down the main patient log and click on a Patient ID n...

Page 18: ...ou can scroll between past measurements with the arrows below each eye TEST 2 3 or return to the Patient Log Screen by clicking on the file icon Patient Screen On the Patient Screen you can enter Pati...

Page 19: ...2 Have patient hold device to face with both hands and look through the device at a distant object ideally at least 6 meters 20 feet away Over 3 meters 9 feet is acceptable 3 Make sure there is no sp...

Page 20: ...4 until the eyes represented by two dots and the outer circles become centered and green 6 When properly aligned the patient will often see two images and red dots con verge to one though it is also p...

Page 21: ...he green arrow and the measurement will begin NOTE You can enter auto trigger mode before the measurement begins by hold ing the orange arrow until it starts blinking Measurement will begin automatica...

Page 22: ...Patient will only see a red dot in the eye being measured right eye alignment process shown here 3 When measurement is complete the prescription will be displayed for that eye for example right eye me...

Page 23: ...l fill with the results This figure describes the results screen and the information contained Patient Information Menu Patient Number Scroll Through Results Re measure Both Eyes Binocular Mode New Pa...

Page 24: ...easurement is not acquired within three minutes after entering into acquisition mode If no successful measurements were taken due to device tilting or non alignment the following message may appear if...

Page 25: ...lp patient center eye s Too much accommodation Ensure patient focuses on distant target It may be tempting for the subject to focus on the red dot or a close by object Ask the patient to look past the...

Page 26: ...c Settings Selecting Settings in the Drop Down will take you to screens to alter the Basic Settings menu Settings which can be changed include date time sound on off Bluetooth on off screen timeout an...

Page 27: ...tart end of measurements or notice messages Bluetooth is for pairing the device with a phone with the QuickSee Companion app installed or with a suitable printer see Bluetooth Printer Section Set Time...

Page 28: ...the box next to Printer on Basic Settings The device will then search for Bluetooth devices Once successfully paired the orange printer button will appear on the bottom left corner of the Results Scr...

Page 29: ...oggle on off the color blindness display set ting as well as the automatic acquisition trigger The eye layout eye notation and shutdown time can be set there as well Drag to scroll down on the advance...

Page 30: ...h and hold anywhere on the screen for at least 2 seconds to prompt the device to enter auto trigger mode The play icon in acquisition mode will start to blink and once the patient s eyes are aligned t...

Page 31: ...the screen right or the reverse by selecting the reverse button on eye layout Eye notation can also be changed from OS OD OU to L R L R to indicate a patient s Left Right Both eyes The Shutdown Timeo...

Page 32: ...data from the device To reset all settings to default values reset device to factory firmware version and erase all patient data from the device select RESET and you will be presented with a warning s...

Page 33: ...follow instructions on the page to down load and install the app QuickSee Companion App The QuickSee Companion App works on Android devices and can be used to trans fer patient logs as well as perform...

Page 34: ...the sticker for successful pairing You can also scan QR code to enter the serial number Press USE QR CODE and scan the QR code next to the serial number If the device has been paired with the same Qui...

Page 35: ...ial Number Pairing Success Screen 3 If the QuickSee s Bluetooth is not turned on or the Bluetooth device cannot find an available QuickSee the Companion App will walk you through how to turn on the Bl...

Page 36: ...ient data click the Download Data tab on the Main Screen and click the download button Download Data Screen Download in Progress Once the data is downloaded as a csv file the Download Success screen w...

Page 37: ...Update Confirmation Screen will appear Press to confirm Update or Restore Firmware Update Confirmation Screen If you choose to update the software the Installation Progress Screen will appear Af ter i...

Page 38: ...the device pairing troubleshooting screens If you press on About the version of the software installed will be shown on the About Screen About Screen Companion App Drop Down Menu On the Main Menu the...

Page 39: ...s and hold the power button for 7 seconds until the screen goes black and then release the power button 2 Wait about one minute and then perform the normal start up process NOTE This may cause some da...

Page 40: ...r or user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving or broadcasting antenna Increase the separation between the Quick...

Page 41: ...er than those supplied with the instrument exception for cables sold by the manufacturer of the equipment as replacement parts may result in increase emission or decrease immunity of the equipment or...

Page 42: ...11 2015 A1 2016 Frequency MHz Quasi Peak Limit dB V Avg Limit dB V Measured Quasi Peak Limit dB V Measured Avg Limit dB V Ambient temperature 21 C Relative humidity 41 0 15 to 0 50 79 66 N A N A 0 50...

Page 43: ...the power supply should be that one of a typical commercial or clinical environment Surge IEC 61000 4 5 2014 Differential mode 1 kV Differential mode 1 kV The quality of the power supply should be tha...

Page 44: ...0MHz to 800MHz D 2 3 x P from 800MHz to 2 5GHz Where P is the nominal maximum power of the transmitter output expressed in Watts W as specified by the transmit ter manufacturer and d is the recommende...

Page 45: ...output maximum nominal power of the transmitter in Watts specified by the transmitter manufac turer Notes 1 At 80 MHz and 800 MHz it is applicable the higher frequency range 2 This line guide could n...

Page 46: ...libration Requirements None Ambient Lighting Requirements Works in most lighting conditions Specialized Furniture Requirements None Storage Transport Travel hard shell case included FDA Status FDA Cla...

Page 47: ...swer No to message Save changes Access dropdown menu Bluetooth enabled Access patient information screen Access help screen Notice read warning message Add new patient Print to Bluetooth Printer 34 Ba...

Page 48: ...de If the device is ON or in Standby mode a long press 7 seconds will force shutdown Serial number of the device Packaging storage and shipment Indicates the correct upright position of the package Pa...

Page 49: ...return of any product if PlenOptika has not approved the return in advance and provided you with a Returned Materials Authorization number RMA All returns must be packaged as instructed by PlenOptika...

Page 50: ...IONS INCLUDING WITHOUT LIMITATION STATE LICENSING MEDICAL AND PHAR MACY LAWS AND IS LIABLE FOR ANY VIOLATION OF THE SAME PLENOPTIKA AND ITS PRODUCTS DO NOT GIVE MEDICAL ADVICE PROVIDE DIAGNOSISES OR P...

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Page 52: ...ontact PlenOptika If you have questions about the QuickSee or any other PlenOptika product please contact customer support Email support plenoptika com Phone 1 617 681 4648 Address PlenOptika 8 St Mar...

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