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LKC TECHNOLOGIES RETeval User Manual

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User Manual
Issue Date: February 5, 2024
Rx only
2797
Part no. 96-023-EN

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  • Page 1 User Manual Issue Date: February 5, 2024 Rx only 2797 Part no. 96-023-EN...
  • Page 2 нуждаете, или отидете на www.lkc.com/IFUs HR - Upute za uporabu (IFU) na više jezika pohranjene su na vaš RETeval uređaj kao PDF datoteke i dostupne su za ispis. Povežite RETeval na računalo pomoću priložene priključne stanice i USB kabela. RETeval će se na vašem računalu prikazati kao memorijski flash uređaj.
  • Page 3 RETeval sa zobrazí v počítači ako flashdisk. Vyberte požadovaný návod na použitie alebo prejdite na stránku www.lkc.com/IFUs SL - Natisljiva navodila za uporabo v več jezikih so v obliki datotek PDF shranjena v napravi RETeval. Za povezavo naprave RETeval in računalnika uporabite priloženo priklopno postajo in kabel USB. Naprava RETeval bo v računalniku prikazana kot bliskovni pogon.
  • Page 4 Copyright© 2012 – 2024 LKC Technologies, Inc. LKC Technologies, Inc., established in 1987, is ISO 13485:2016 certified and holds MDSAP and FDA registrations and a CE certificate as a medical device manufacturer with quality products installed in over fifty countries.

  • Page 5: Table Of Contents

    RETeval Complete protocols ....................32 Custom protocols ........................45 Performing a VEP test ......................47 RETeval Complete test results ....................48 Reference Intervals ........................57 Using reference intervals as clinical decision limits ..............58 Turning reference data reporting on and off ................58 Using your own reference data ....................
  • Page 6 The screen is blank but the power light is on................69 The RETeval device won’t connect to my PC ................69 I get a “scan and fix” error from Windows® when placing the RETeval device in the docking station ........................... 69 Results are “not measurable”...

  • Page 7: Welcome To Reteval

    These PDF reports can be transferred to any PC via a USB cable. The RETeval device has an electronic medical record interface to digitally order tests for a patient and transfer results into a supported EMR / EHR system.

  • Page 8: What's In The Box

    RETeval device Measures the response of the eye to light. Docking station Charges the RETeval device and enables data transfer to a PC. Connect to an electrical outlet using the power brick. Dust cover (not Protects the device from dust while not in use.
  • Page 9 Welcome to RETeval ** This item is not supplied when a “no-electrodes” version is ordered. RETeval Device User Manual...

  • Page 10: Getting Started

    If the power brick is connected, charging will be significantly faster than if only a USB connection is present. The charging status is shown on the display. If the display is blank, press the power button to turn it on. The RETeval device is shipped with a partial charge.

  • Page 11: Device Controls

    Getting Started Device controls The RETeval device has an up/down/right/left/select joystick and an on-off power button. Turning the device off You can turn the device off at any time by pressing the power button and holding it down for at least 1 second.

  • Page 12: Settings

    Getting Started Settings Set up the RETeval device for use in your practice. Turn on the device. The device goes through a brief internal test and initialization. Step 1. Select Settings. Step 2. Adjust each setting as you prefer. Language Select the language you want to use for the device’s user interface and...
  • Page 13 The free data barcode application which runs on Windows (https://lkc.com/barcode) and smartphones (search for RETeval on your phone’s app store). If the RETeval device has trouble scanning the barcode, ensure the eyecup is on or very close to the display and the display brightness is set to maximum.

  • Page 14: Selecting Memory

    Getting Started Page size The PDF reports created by the RETeval device can be formatted for either A4 sized paper or letter (8.5” x 11”) sized paper. DR limits As described in DR Assessment section on Page 22, the limit criteria for the classification of normal for this test can be modified here.
  • Page 15 LKC service department. User manual The user manual can be viewed on-screen by pressing . The manual is also provided as a hardcopy, and the PDF is stored on the device. RETeval Device User Manual...

  • Page 16: Performing A Test

    The barcode application does not use the internet and does not store any patient information. If the RETeval device has trouble scanning the barcode, ensure the eyecup is on or very close to the display and the display brightness is set to maximum.
  • Page 17 Align the Sensor Strip such that there is no hair beneath it. ® LKC Technologies recommends the use of NuPrep (made by Weaver and company and sold on the LKC store, https://store.lkc.com), to prepare the patient’s skin in the electrode contact area.

  • Page 18: Troubleshooting

    Press the device against the patient, positioning the device so that the patient’s pupil is inside the large green circle. The RETeval device should be placed straight onto the subject, a small gap between the eye cup and the lateral portion of the face is fine, as long as the amount of ambient light reaching the eye through this gap isn’t excessive.
  • Page 19 Step 12. Remove the Sensor Strips from the patient’s face, starting with the end under the eye. Alternatively, ask the patient to remove the Sensor Strips. Dispose of the Sensor Strips in accordance with local guidelines. Clean the eyecup and other patient-contact parts of the device and Sensor Strip lead. RETeval Device User Manual...

  • Page 20: Viewing Results

    (time-to-peak). The rectangle encloses the middle 95% of peaks in the reference data. RETeval Device User Manual...

  • Page 21: Results On A Pc

    Step 3. The device appears on the PC like an external drive. You can now view results or copy them to the PC as you would files in any directory on the PC. If the RETeval device does not connect as a USB drive on your PC, see the Troubleshooting section below.
  • Page 22 Viewing Results RETeval Device User Manual...

  • Page 23: Reflex Testing

    “Retest”. Protocol” before proceeding. This reflex testing process can be repeated indefinitely. All PDF reports performed with reflex testing will be assembled into one multi-page report. The raw data (.rff) files are not combined. RETeval Device User Manual...

  • Page 24: Choosing A Protocol

    The study had a planned oversampling of low-prevalence retinopathy levels, and the subject population included 106 diabetics with VTDR in at least one eye. The average testing time for the RETeval device during the clinical trial was 2.3 minutes to test both eyes. Table 1: Severity group definitions International Clinical Classification (Wilkinson et al.
  • Page 25 The Troland unit (Td) describes retinal illuminance, which is the amount of luminance that enters the pupil. The RETeval device measures the pupil size in real time and continuously adjusts the flash luminance to deliver the desired amount of light into the eye regardless of the size of the pupil.

  • Page 26: Other Protocols

    For example, patients with high-risk PDR have only a 15.8% chance of having severe vision loss or vitrectomy with 5 years (Davis et al. 1998). Other protocols The RETeval device has two other protocols that are “flashlight” protocols where the device creates either 30 cd/m or 300 cd/m white light.

  • Page 27: Additional Activities

    Additional Activities Removing old results from the device The RETeval device can store up to 50 test results. You must remove results to make room for new tests. There are three ways to remove results. WARNING: Results deleted on the device cannot be recovered. Save results you want to keep on a PC before deleting them off the RETeval device.

  • Page 28: Updating Firmware

    On completion of a test, docking the RETeval device back with the PC enables results to be electronically moved off the device and into the EMR. Contact LKC for more details about currently supported EMR systems and integration options with your EMR.

  • Page 29: Reteval Flicker Option

    Page 22. Flicker protocols The RETeval device supports flicker ERG testing. Brief flashes of light are provided at the beginning of each stimulus period. For example, the built-in protocols use a stimulus frequency of about 28.3 Hz. Background illumination, where present, uses a PWM frequency near 1 kHz, which is well above the human critical fusion frequency and therefore is perceived as steady illumination.

  • Page 30: Custom Protocols

    Custom protocols If there is a protocol that you would like to run that is not built-in, the RETeval device has support for extending the number of options through custom protocols. Contact LKC (email: support@lkc.com) for more information on custom protocols.

  • Page 31: Flicker Test Results

    RETeval Flicker Option Flicker test results Results are shown on the RETeval device when the test is completed successfully. Implicit times change substantially with flash intensity. When referring to the literature for clinical interpretation, it is important that your testing be done at the same flash intensity and background light level.
  • Page 32 = 0 ms, 35 ms and 70 ms. Just before “Start Test” is pressed in flicker tests, the RETeval device attempts to measure pupil size regardless of the stimulus type selected. If the pupil is successfully measured, its diameter will be shown in the PDF report at that test step.
  • Page 33 RETeval Flicker Option RETeval Device User Manual...

  • Page 34: Reteval Complete Option

    RETeval Complete protocols The RETeval device supports single-flash and flicker ERG testing. Brief flashes of light are provided at the beginning of each stimulus period. A background light is also generated by providing brief flashes of light at about 1 kHz, which is well above the human critical fusion frequency and therefore is perceived as steady illumination.
  • Page 35 (Td). These protocols are identified with “Td” in the user interface and PDF reports. In these protocols, the RETeval device measures the pupil size in real time and continuously adjusts the flash luminance to deliver the desired amount of light into the eye regardless of...
  • Page 36 10 ms as long as all measurements are considered relative to the center of the flash, as done by the RETeval device. If the pupil size is sufficiently small that the required flash energy for a Troland protocol is not obtainable, the RETeval device will produce its maximum flash energy.
  • Page 37 This protocol (ISCEV 6 step, dark adapted first, cd) switches the testing order to do the dark- adapted tests first. The RETeval device performs a calibration at the beginning of every protocol. So that the calibration light flashes do not affect the dark adaptation state of the subject, place the device on the patient’s forehead when requested by the device.
  • Page 38 The next four protocols are similar to the ISCEV 5/6 step protocols above, except pupil- tracking is used to provide constant retinal illuminance, making pupil dilation optional. A 6 mm pupil was assumed to convert the ISCEV standard dilated luminance to Trolands. RETeval Device User Manual...
  • Page 39 141 – Light adaptation timer Left 848 Td Light adapted 85 Td·s ERG Left 85 Td·s @ 2 Hz 848 Td Light adapted 85 Td·s flicker Left 85 Td·s @ 28.3 Hz 848 Td 141 – RETeval Device User Manual...
  • Page 40 The next three protocols are ISCEV photopic based protocols. These are protocols without the scotopic steps included. The protocols are the photopic single flash and flicker in standard dilated ISCEV candela luminance as well as in Trolands. There is also the Troland based ISCEV Flicker protocol. RETeval Device User Manual...
  • Page 41 2022 update to the ISCEV standard (Robson et al. 2022). When using shortened dark adaption times, comparison of the rod responses to the reference data needs additional care, as the reference data was collected with 20 minutes of dark adaption. RETeval Device User Manual...
  • Page 42 The stimulus frequency is 3.4 Hz, and uses either 200 (long protocol) or 100 (short protocol) flashes to reduce the measurement noise. The long protocol records for about 60 seconds; the short protocol records for 30 seconds. RETeval Device User Manual...
  • Page 43 55 ms and 180 ms. Note: the b-wave voltage typically reported (including in the RETeval device) is equal to (b-a). Based on the definition, the W-ratio is the ratio of the waveform height after to before the b-wave. If the PhNR amplitude is the same as the a-wave, the W-ratio is 1.
  • Page 44 (Thompson et al. 2018). These protocols use a red flash without a background. Due to differences in spectral sensitivity, cones are 31 times more sensitive than rods to the RETeval device’s red light. The protocols use a photopic 0.3 cd∙s/m stimulus (or Troland equivalent).
  • Page 45 (Sieving 1993; Sustar, Hawlina, and Brecelj 2006) while keeping the test duration as short as possible. The short protocol uses 100 averages (taking 30 seconds) and the long protocol uses 200 averages (taking 60 seconds). RETeval Device User Manual...
  • Page 46 (green LED, 530 nm) flashes Red extended Right 560 cd/m², 160 cd/m² stimulus, green 209.4 ms on time @ 2.4 Hz background Red extended Left 560 cd/m², 160 cd/m² stimulus, green 209.4 ms on time @ 2.4 Hz background RETeval Device User Manual...

  • Page 47: Custom Protocols

    Page 47 for details on how to do a flash VEP. Custom protocols If there is a protocol that you would like to run that is not built-in, the RETeval device has support for extending the number of options through custom protocols. Custom protocols can be placed in the Protocols folder on the device, and then can be selected through the User Interface in a manner like selecting a built-in protocol.
  • Page 48 (scotopic units) is different as the spectral sensitivity between rods and cones differ. For the RETeval LEDs, the ratio of scotopic to photopic sensitivity is 0.032, 2.3, and 16 for red, green, and blue respectively. As an example, rods are 16 times more sensitive to blue light than cones.

  • Page 49: Performing A Vep Test

    Place a Ag/AgCl ECG electrode as the negative electrode at hairline on the forehead. Fill the cups of the ear clip electrode with electrode gel (not cream) and clip it to the patient’s ear lobe as the ground / right leg drive electrode. RETeval Device User Manual...

  • Page 50: Reteval Complete Test Results

    (starting on Page 57) for further details. Just before “Start Test” is pressed in flicker or flash tests, the RETeval device attempts to measure pupil size regardless of the stimulus type selected. If the pupil is successfully measured, its diameter will be shown in the PDF report at that test step.
  • Page 51 RETeval Complete Option An example PDF report for the ISCEV 6 step, dark adapted first, Td protocol is shown below RETeval Device User Manual...
  • Page 52 RETeval Complete Option RETeval Device User Manual...
  • Page 53 RETeval Complete Option RETeval Device User Manual...
  • Page 54 RETeval Complete Option RETeval Device User Manual...
  • Page 55 An example of a photopic negative response protocol with reference data is shown below. By default, the reference data coloring is not shown to reduce confusion between reference limits and clinical decision limits (See Page 58). To turn on/off coloring, see Color Coding on Page 11. RETeval Device User Manual...
  • Page 56 5-minute dark adaption 20-minute dark adaption An example of the white/white on-off (long flash) protocol is shown below. The off response can be seen starting at about 163 ms, about 18 ms after the stimulus is turned off. RETeval Device User Manual...
  • Page 57 230 ms, about 21 ms after the stimulus is turned off, as indicated by the stimulus waveform. An example flash VEP report is shown below. In this report, the stimulation waveform is shown. See Page 12 for turning this feature on/off. RETeval Device User Manual...
  • Page 58 RETeval Complete Option RETeval Device User Manual...

  • Page 59: Reference Intervals

    RETeval device. Please ensure both the birthdate and the system date on the RETeval device are correct for accurate age-matching of the reference interval information. ERG results also depend on the electrode type used.

  • Page 60: Using Reference Intervals As Clinical Decision Limits

    Never draw diagnostic conclusions from a single exam and heed the subject’s medical history. It is the clinician’s responsibility to make diagnostic interpretations of RETeval measurements. Test specificity Test specificity is the probability a test correctly identifies healthy subjects. About 1 in 40 visually normal subjects will be flagged as “red”...

  • Page 61: Using Your Own Reference Data

    Notepad, vi, or Emacs). If you want to add your own reference data information, it can be added to this file and the RETeval device will automatically start using it. The reference data is version controlled by the year and week number as specified in the database file, along with the first 7 characters of a cryptographic hash (sha1) of the file.
  • Page 62 Pupil area ratio. Flash: 32 Td·s : 4 Td·s white @ 28. Hz, Background: 0 Td white Cursor 5% limit (90% CI) 50% (90% CI) 95% limit (90% CI) Age coefficients Pupil area ratio 1.7 (1.6 – 1.7) 2.2 (2.1 – 2.2) 3.0 (2.8 – 3.3) m = -0.00534 RETeval Device User Manual...
  • Page 63 = 0.0516 Waveform amplitude / µV 12.1 (11.3 – 12.8) 20.1 (19.5 – 20.6) 33.2 (31.7 – 34.5) m = -0.0504 4 Td·s flicker ERG. Flash: 4 Td·s white @ 28. Hz, Background: 0 Td white RETeval Device User Manual...
  • Page 64 / ms 25.7 (25.5 – 25.9) 27.7 (27.6 – 27.7) 29.9 (29.8 – 30.1) m = 0.0326 b-wave / µV 16.3 (15.0 – 17.8) 31.8 (30.7 – 32.8) 53.6 (50.8 – 56.0) m = -0.0662 RETeval Device User Manual...
  • Page 65 / µV 10.6 (9.6 – 12.2) 18.5 (15.7 – 21.1) 28.8 (27.1 – 30.7) m = 0.0392 PhNR min time / ms 61.1 (58.5 – 65.0) 88.0 (81.1 – 97.7) 182.0 (173.0 – m = -0.218 189.0) RETeval Device User Manual...
  • Page 66 166.0) OP total amplitude / µV 18.0 (12.3 – 30.7) 49.3 (45.7 – 52.7) 83.3 (75.1 – 91.8) m = -0.0565 Dark adapted 283 Td·s ERG. Flash: 283 Td·s white @ 0.05 Hz, Background: 0 Td RETeval Device User Manual...
  • Page 67 0.271 107.0) 139.0) p3 Time / ms 160.0 (156.0 – 193.0 (190.0 – 240.0 (229.0 – -0.131 168.0) 195.0) 248.0) Amplitude / µV 8.1 (7.1 – 9.4) 14.3 (13.6 – 15.2) 22.8 (21.6 – 24.6) 0.0328 RETeval Device User Manual...

  • Page 68: Troubleshooting Hints

    Measure the patient’s right eye first The RETeval device is designed to measure the patient’s right eye first. If you only want to measure a patient’s left eye, use the skip button to proceed past the right eye screen without testing the patient.

  • Page 69: The Device Shows "Excessive Electrode Noise

    3. The Sensor Strip may be defective, try another Sensor Strip. The device shows “Excessive electrode noise” The RETeval device monitors the electrical noise of the connection between pads on the Sensor Strip or other electrode types. The electrode noise (including power-line interference) is found by computing 2 √...

  • Page 70: The Device Won't Let Me Press The Start Test Button When I Can See The Eye

    (making the timing faster). The eyecup is designed to block external light from reaching the eye. If the RETeval device senses too much ambient light, an error message will display on the screen. After pressing Restart, to reduce the amount of ambient light reaching the eye, try the following items: 1.

  • Page 71: The Screen Is Blank But The Power Light Is On

    USB connection. If an alternative USB drive works in the same USB port, but the RETeval device won’t connect, then the USB cable, docking station, or device may be defective. Try swapping out components to isolate the failure if you have any replacement components;...

  • Page 72: Results Are "Not Measurable

    Device language is set to an unfamiliar language If the device is set to a language you do not know, follow these steps to change languages. Step 1. Turn on the RETeval device. If the device is already on, turn it off, wait 5 seconds, then turn it back on.

  • Page 73: An Error Code Is Reported

    Record the error code and call LKC for service (+1 301 840 1992 or email support@lkc.com). In addition, save and send to LKC any files found in the /Diagnostics folder on the device. Pressing OK will cause the RETeval device to reboot, which may correct the problem. RETeval Device User Manual...

  • Page 74: Works Cited

    FDA Advisory Committee. 2009. Sabril® (vigabatrin) for Oral Solution for Infantile Spasms. Fishman, G A, D G Birch, G E Holder, and M G Brigell. 2001. Electrophysiologic Testing: The Foundation of the American Academy of Ophthalmology. RETeval Device User Manual...
  • Page 75 Neurology:40-5. Kato, K., M. Kondo, M. Sugimoto, K. Ikesugi, and H. Matsubara. 2015. "Effect of Pupil Size on Flicker ERGs Recorded With RETeval System: New Mydriasis-Free Full-Field ERG System." Invest Ophthalmol Vis Sci 56 (6):3684-90. doi: 10.1167/iovs.14-16349.
  • Page 76 (1):43-52. doi: 10.1007/s10633-006-9013-1. Sustar, M., B. Stirn-Kranjc, M. Hawlina, and J. Brecelj. 2008. "Photopic ON- and OFF- responses in complete type of congenital stationary night blindness in relation to stimulus intensity." Doc Ophthalmol 117 (1):37-46. doi: 10.1007/s10633-007-9101-x. RETeval Device User Manual...
  • Page 77 Zhang, X., J. B. Saaddine, C. F. Chou, M. F. Cotch, Y. J. Cheng, L. S. Geiss, E. W. Gregg, A. L. Albright, B. E. Klein, and R. Klein. 2010. "Prevalence of diabetic retinopathy in the United States, 2005-2008." JAMA 304 (6):649-56. doi: 10.1001/jama.2010.1111. RETeval Device User Manual...

  • Page 78: Regulatory And Safety Information

    (e.g., diabetic retinopathy, glaucoma). Latex statement The components of the RETeval device that could contact the user or patient were not made with natural rubber latex. This includes all items that could be contacted during normal operation, and all other functions, such as user maintenance and cleaning, as are defined in the User Manual.

  • Page 79: Specifications

    All specifications are subject to change. Contraindications Use of the RETeval device is contraindicated under these conditions: • Do not use with patients diagnosed with photosensitive epilepsy. • Do not use Sensor Strips with patients who are allergic to the Sensor Strip gel.

  • Page 80: Cleaning And Disinfection

    Regulatory and Safety Information Some patients may feel discomfort when viewing the flickering light that the RETeval device creates to test their eyes. This discomfort usually subsides quickly when the test procedure is completed. Cleaning and Disinfection WARNING: Consult the cleaning agent and germicidal cleaner agent manufacturer instructions for their proper use and germicidal efficacy prior to their use.

  • Page 81: Calibration And Storage

    62 kPa and 106 kPa (-4000 m to 13,000 m). Service / Repairs The RETeval device contains no user serviceable parts other than the eyecup, battery, and electrode leads, which can all be replaced without the need of tools.

  • Page 82: Essential Performance

    LKC will service RETeval devices that are within their lifetime. Firmware updates and support may require an annual subscription service after the initial one-year warranty period. The expected battery life is at least 1 year. If the RETeval device fails to hold a charge, a new battery can be ordered.

  • Page 83: Electromagnetic Compatibility (Emc)

    Use of most commercial electrodes with leads 1 meter or less long should work. Guidance and Manufacturer’s Declaration – Emissions The RETeval device is intended for use in the electromagnetic environment specified below. The customer or user of the RETeval device should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment –...
  • Page 84 RETeval device. Guidance and Manufacturer’s Declaration – Immunity The RETeval device is intended for use in the electromagnetic environment specified below. The customer or user of the RETeval device should ensure that it is used in such an environment. Immunity Test...
  • Page 85 IEC 61000-4-8 Guidance and Manufacturer’s Declaration – Immunity The RETeval device is intended for use in the electromagnetic environment specified below. The customer or user of the RETeval device should ensure that it is used in such an environment. Immunity Test...

  • Page 86: Rohs

    Recommended Separations Distances for the RETeval device The RETeval device is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the RETeval device can help prevent electromagnetic interference by maintaining a minimum distance between...
  • Page 87 EU RoHS exemption 6(a). Due to the possible presence of trace amounts of lead in this component the RETeval device has been categorized with an Environment Friendly Use Period (EFUP) of 25 years.

  • Page 88: California Proposition 65

    Female Reproductive Toxicity Methylene Chloride 75-09-2 Cancer Female Reproductive Toxicity Bisphenol A 80-05-7 N-Hexane 110-54-3 Male Reproductive Toxicity The above warning is applicable to the RETeval device and its associated supplies and accessories (shown on Page 93). RETeval Device User Manual...

  • Page 89: Symbols

    USB port Contains “Lithium Ion”. This symbol indicates “General recovery / recyclable” and must not be disposed of as unsorted municipal waste and must be collected separately. Manufacturer Manufacture date Storage temperature range RETeval Device User Manual...
  • Page 90 AAMI Std ES 60601-1, CENELEC EN Std 60601-1, IEC Std 60601-1-6, IEC Std 60601-1, IEC Std 62366, ISO Std 15004-1, ISO Std 15004-2, IEC Std 60601-2-40 Certified To: CSA Std No. 60601-1 Refer to the operation instructions (i.e., this manual) to assure proper and safe operation. RETeval Device User Manual...

  • Page 91: Equipment Identification

    Regulatory and Safety Information Equipment identification Each RETeval device has a unique serial number for identification. The serial number can be Settings System seen by choosing , then on the user interface. The serial number can also be found on the bottom of the docking station and under the battery, viewable after removing the battery cover and pivoting the battery away from the device.

  • Page 92: Approvals

    UL 60601-1 UL Standard for Safety medical electrical equipment (2nd edition) CSA C22.2#601.1 Medical electrical equipment (2nd edition) CENELEC EN60601-1 Medical electrical equipment (2nd edition) IEC 60601-1-6 Usability (2nd edition) ANSI/AAMI/ISO 10993-1 Biological evaluation of medical devices RETeval Device User Manual...

  • Page 93: Intellectual Property

    Intellectual Property Intellectual Property The RETeval device may be covered by one or more of the following US patents and their foreign counterparts: 7,540,613; 9,492,098; and 9,931,032. The RETeval device Sensor Strips may be covered by one or more of the following US patents and their foreign counterparts: 9,510,762 and 10,010,261.

  • Page 94: Contact Information

    Contact support staff via email (support@lkc.com) or by phone at: +1 301 840 1992. Warranty LKC Technologies, Inc. unconditionally warrants this instrument to be free from defects in materials and workmanship, provided there is no evidence of abuse or attempted repairs without authorization from LKC Technologies, Inc.

  • Page 95: Purchasing Supplies And Accessories

    Battery 81-266 Eyecup 81-269 Dust cover 81-298 RETeval mounting arm, which holds the device in an arm that mounts to a table. 91-193 Sensor Strip lead (i.e., the cable that connects the device to a Sensor Strip) 91-194 RETeval adapter cable for DIN electrodes 91-235 Small Sensor Strip lead (i.e., the cable that connects the device to a...

  • Page 96: European Representative

    Cambridge CB24 9BZ United Kingdom Company LKC Technologies, Inc., established in 1987, is ISO 13485:2016 certified and holds MDSAP and FDA registrations and a CE certificate as a medical device manufacturer with quality products installed in over fifty countries. LKC Technologies, Inc.

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