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LKC TECHNOLOGIES RETeval User Manual

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RET
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User Manual
Issue Date: January 7, 2022
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Summary of Contents for LKC TECHNOLOGIES RETeval

  • Page 1 eval ™ Device User Manual Issue Date: January 7, 2022 Rx only 2797...
  • Page 2 Copyright © 2012 – 2022 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 3: Table Of Contents

    RETeval Complete protocols ......................39 Custom protocols ......................... 51 Performing a VEP test ........................52 RETeval Complete test results ..................... 54 Reference Intervals ......................67 Using reference intervals as clinical decision limits ................ 68 Turning reference data reporting on and off ................. 69 Using your own reference data .....................
  • Page 4 After pressing the Start test button, I get an “Unable to calibrate” error ........78 The screen is blank but the power light is on................. 78 The RETeval device won’t connect to my PC ................. 78 ® I get a “scan and fix” error from Windows when placing the RETeval device in the docking station ..............................
  • Page 5 European Representative ......................102 Company ........................... 102 eval Device User Manual...

  • Page 6: Welcome To Ret Eval

    Welcome to RETeval ™ eval Welcome to RET ™ eval Congratulations on your acquisition of the RET visual electrodiagnostic device. With the eval device, you can offer your patients a convenient retinal diagnostic evaluation. eval Every RET device comes with flicker-based protocols, and through optional upgrades, single- flash based protocols become available through a protocol chooser that enables other electroretinogram (ERG) and visual evoked potential (VEP) testing.

  • Page 7: What's In The Box

    Welcome to RETeval ™ What's in the box eval The RET device is packaged with these items. Check that all items are present. eval device Measures the response of the eye to light. eval Charges the RET Docking station device and enables data transfer to a PC. Connect to an electrical outlet using the power brick.

  • Page 8: Getting Started

    Getting Started Getting Started Connect the cord to the docking station and plug in Attach the power brick plate that matches your electrical outlet to the power brick. Connect the power cord to the docking station. Connect the power brick to an electrical outlet. The power supply accepts 100 – 240 VAC, 50/60 Let the device charge eval The RET...

  • Page 9: Device Controls

    Press SELECT. Main Menu The RETeval device main menu has a top status bar, four buttons, and at the bottom a description of the currently-selected protocol. The status bar shows the time, date, and battery charge state. The four buttons...

  • Page 10: Settings

    Getting Started Settings Set up the RETeval device for use in your practice. Step 1. Turn on the device. The device goes through a brief internal test and initialization. Step 2. Select Settings. Step 3. Adjust each setting as you prefer.
  • Page 11 Page 18. That sample report has LKC Technologies and its address as the practice information, which is the default for all devices. Pressing the barcode symbol enables practice information to be scanned from an external display such as a PC monitor.
  • Page 12 Getting Started Reference data For many tests using Sensor Strip electrodes, reference distributions and reference intervals are built into the device. See page 67. This section lets you turn the reference interval reporting off, which might be convenient, for example, if you know that the subjects you are testing are outside the reference population tested in the database.

  • Page 13: Performing A Test

    PC monitor. Scanning is automatic and does not require the joystick to be pressed. The free data barcode application which runs on Windows (https://bit.ly/retevalbarcodereader) and smartphones (search for RETeval on your phone’s app store). The barcode application does not use the internet and does eval not store any patient information.
  • Page 14 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 15 Performing a test Step 9. Test the right eye. Ask the patient to cover their left eye with the palm of their hand. Doing so will improve their fixation to the red light in the device and also open their eyelids wider to make the pupil more visible.
  • Page 16 Performing a test Wait while the device conducts the test. Testing time depends on the protocol that you have selected and can be less than 10 seconds or as long as a couple of minutes. After the device has indicated that the testing is complete, disconnect the lead from Sensor Strip.

  • Page 17: Viewing Results

    Viewing Results Viewing Results Results on the device The DR Assessment protocol combines implicit time, amplitude, age, and pupil response to create a unified result, which is shown immediately after the test completes. Diabetics with vision-threatening diabetic retinopathy typically have larger results.

  • Page 18: Results On A Pc

    Viewing Results Results on a PC Results can be transferred to the PC in PDF (and other) formats. eval Place the RET Step 1. device into the docking station. Step 2. Connect the USB cable to the docking station and to the PC. Step 3.
  • Page 19 Viewing Results eval Device User Manual...

  • Page 20: Reflex Testing

    Reflex testing Reflex testing Additional testing can be performed on the same patient without having to reenter the patient and electrode information. To perform multiple tests on the same patient do the following steps: Step 1: At the end of Step 2: Review the Step 3: On the last Step 4: Optionally...

  • Page 21: Choosing A Protocol

    Choosing a protocol Choosing a protocol eval The RET device enables you to change the stimulus conditions (called protocols) to best meet your needs via a protocol chooser. The flicker ERG option adds more than 10 protocols with varying flicker eval stimuli.
  • Page 22 Figure 1 (Maa et al. 2016). Figure 1. Dependence of RETeval measurements on diabetic retinopathy severity level. Plots show the mean and standard error of the mean for each severity group listed in Table 1.

  • Page 23: Other Protocols

    Choosing a protocol In addition to showing reference intervals, the DR Assessment Protocol displays clinical decision limits, as specified by you. Unlike reference intervals, which enclose 95% of normally-sighted subjects regardless of how that may classify someone with VTDR, clinical decision limits consider diseased and normal subjects to optimize both test sensitivity as well as test specificity.

  • Page 24: Additional Activities

    Additional Activities Additional Activities Removing old results from the device eval The RET device can store up to 50 test results. You must remove old 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 eval on a PC before deleting them off the RET device.

  • Page 25: Updating Firmware

    Additional Activities Data folder to archive the results in machine-readable formats for programmatic analysis. Step 6. Delete results from the Reports directory to remove them from the device. If you are saving results in multiple formats (e.g., PDF and JPEG), all formats have to be deleted in order to remove the result from the device and make space for future tests.

  • Page 26: Reteval Flicker Option

    RETeval Flicker Option RETeval Flicker Option eval The RET device measures flicker implicit time quickly and accurately by flashing light into the patient’s eye and measuring the time delay (implicit time) and amplitude of the retina’s electrical response as detected on the skin below the eye. The device’s patented technology enables measurements without dilating eye drops using real-time pupil size compensation and uses skin electrodes (Sensor Strips).

  • Page 27: Custom Protocols

    RETeval Flicker Option There are cases where the stimulus compensating for pupil size may be inconvenient. These protocols are identified with “cd” in the user interface and PDF reports. For example, the patient cannot keep their eyelids sufficiently open for the device to measure the pupil, there is a desire to stimulate the eye through a closed eyelid, or there is a desire to match the stimulus of a previous publication.
  • Page 28 RETeval Flicker Option Historical results can be seen from the main menu Results option. Scroll up and down through the list and select the desired test result. The results are stored in chronological order; with the most recent result first. The summary shown above is displayed, as well as the stimulus, electrical amplitudes, and waveforms recorded by the Sensor Strips for each eye for each step.
  • Page 29 RETeval Flicker Option eval Just after pressing “Start Test”, the RET device takes an infrared photograph of the eye, which is displayed on the PDF report. The photograph can be useful to estimate the subject’s dilation state, compliance, and electrode positioning near the eye.
  • Page 30 RETeval Flicker Option eval Device User Manual...
  • Page 31 RETeval Flicker Option eval Device User Manual...

  • Page 32: Reteval-S Option

    RETeval-S Option RETeval-S Option eval The RET -S option provides a commonly-used set of flicker and flash protocols. These protocols can be used to assess both rod and cone function. Protocols that test rod function will take significantly longer to perform due to the dark adaption periods required. The device’s patented technology enables measurements without dilating eye drops using real-time pupil size compensation and uses skin electrodes (Sensor Strips).
  • Page 33 RETeval-S Option Subtests in protocols display the waveform results after each measurement period and enable the operator to repeat the step as many times as desired. Automated cursor placements are computed to the average cursor placement across all repetitions. Any subtest can be skipped without affecting the rest of the protocol.
  • Page 34 RETeval-S Option Flash then flicker, cd Description Flash luminance energy Background (0.33, 0.33 white) luminance flashes (0.33, 0.33 white) Dark adaptation timer Both Dark adapted 3.0 ERG Right 3 cd·s/m² @ 0.1 Hz Dark adapted 3.0 ERG Left 3 cd·s/m² @ 0.1 Hz...
  • Page 35 RETeval-S Option Flicker then flash, Td Description Flash luminance energy Background (0.33, 0.33 white) luminance flashes (0.33, 0.33 white) 141 – Light adapted 85 Td·s Right 85 Td·s @ 28.3 Hz 848 Td flicker ERG 141 – Light adapted 85 Td·s Left 85 Td·s @ 28.3 Hz...

  • Page 36: Reteval-S Test Results

    RETeval-S Option Flicker: 32Td·s Description Flash luminance energy Background (0.33, 0.33 white) luminance flashes (0.33, 0.33 white) 141 – 32 Td·s flicker ERG Right 32 Td·s @ 28.3 Hz 141 – 32 Td·s flicker ERG Left 32 Td·s @ 28.3 Hz Flicker: 3 cd·s/m...
  • Page 37 RETeval-S Option measuring the pupil size during the test and will instead report the average pupil diameter during the test. eval Just after pressing “Start Test”, the RET device takes an infrared photograph of the eye, which is displayed on the PDF report. If replicates are taken, the photograph displayed is from the last replicate.
  • Page 38 RETeval-S Option An example PDF report for the protocol is shown below. Flicker then flash, Td eval Device User Manual...
  • Page 39 RETeval-S Option eval Device User Manual...

  • Page 40: Ret Eval Complete Option

    RETeval Complete Option eval Complete Option eval eval The RET Complete option makes the RET device a full-featured, ISCEV standard compliant (McCulloch et al. 2015) ERG device. The DR Assessment protocol and the protocols in the Flicker ERG option provide quick results for a number of diseases that can be assessed via cone responses.
  • Page 41 RETeval Complete Option ambient light level is approximated by taking the geometric mean of the light level measured inside the integrating sphere (ganzfeld) by a photodiode with an ambient light optical filter bonded onto it. Many of the protocols have constant retinal illuminance, which are described by the Troland unit (Td).
  • Page 42 RETeval Complete Option For the dark adapted 0.1 Hz 85 Td s and 3 cd s/m² tests, oscillatory potentials and cursors are · · reported. The oscillatory potential waveform is obtained by applying an 85 Hz – 190 Hz bandpass filter.
  • Page 43 RETeval Complete Option light adaptation. ISCEV recommends 20 minutes of dark adaptation and 10 minutes of light adaptation. ISCEV 6 step, light adapted first, cd Description Flash luminance energy Background luminance (0.33, 0.33 white) (0.33, 0.33 white) flashes Light adapted 3.0 ERG Right 3 cd·s/m²...
  • Page 44 RETeval Complete Option ISCEV 6 step, dark adapted first, cd Description Flash luminance energy Background luminance (0.33, 0.33 white) (0.33, 0.33 white) flashes Dark adaptation timer Both Dark adapted 0.01 ERG Right 0.01 cd·s/m² @ 0.5 Hz Dark adapted 3.0 ERG Right 3 cd·s/m²...
  • Page 45 RETeval Complete Option ISCEV 5 step, dark adapted first, cd Description Flash luminance energy Background luminance (0.33, 0.33 white) (0.33, 0.33 white) flashes Dark adaptation timer Both Dark adapted 0.01 ERG Right 0.01 cd·s/m² @ 0.5 Hz Dark adapted 3.0 ERG Right 3 cd·s/m²...
  • Page 46 RETeval Complete Option ISCEV 6 step, dark adapted first, Td Description Flash luminance energy Background luminance (0.33, 0.33 white) (0.33, 0.33 white) flashes Dark adaptation timer Both Dark adapted 0.28 Td·s ERG Right 0.28 Td·s @ 0.5 Hz Dark adapted 85 Td·s ERG Right 85 Td·s @ 0.1 Hz...
  • Page 47 RETeval Complete Option ISCEV 5 step, dark adapted first, Td Description Flash luminance energy Background luminance (0.33, 0.33 white) (0.33, 0.33 white) flashes Dark adaptation timer Both Dark adapted 0.28 Td·s Right 0.28 Td·s @ 0.5 Hz Dark adapted 85 Td·s ERG Right 85 Td·s @ 0.1 Hz...
  • Page 48 RETeval Complete Option ISCEV Photopic Flicker, Td Description Flash luminance energy Background luminance (0.33, 0.33 white) (0.33, 0.33 white) flashes 141 – Light adapted 85 Td·s flicker Right 85 Td·s @ 28.3 Hz 848 Td 141 – Light adapted 85 Td·s flicker Left 85 Td·s @ 28.3 Hz...
  • Page 49 72 ms, pmin: minimum voltage between 30 ms and 100 ms. Note the b-wave voltage typically reported (including in the RETeval device) is equal to (b-a). To generate the displayed waveform, novel and proprietary processing methods are used that are based on the study of 92,000 sweeps from 219 subjects across 2 sites, who were randomly split into a training set (80%) and a validation set (20%).
  • Page 50 RETeval Complete Option 560 cd/m² red light to attenuate the response from the L and M cones and a flash brightness of 1 cd·s/m² at 4.2 Hz. The resulting signal is very small, so a large amount of signal averaging is required.
  • Page 51 RETeval Complete Option On-off long: w/w 250/40 cd Description Stimulus luminance Background luminance (0.33, 0.33 white) (0.33, 0.33 white) flashes White extended stimulus, Right 250 cd/m², 40 cd/m² white background 144.9 ms on time @ 3.5 Hz White extended stimulus, Left 250 cd/m²,...

  • Page 52: Custom Protocols

    RETeval Complete Option VEP protocols Flash VEP protocols flash light in the eye and measure the visual system’s response on the back of the head (Odom et al. 2010). There are two flash VEP protocols: a 3 cd·s/m² @ 1 Hz protocol and a 24 Td·s @ 1 Hz.

  • Page 53: Performing A Vep Test

    RETeval Complete Option square wave (on-off) stimuli can be specified. Using the on-off stimulus specification, one can, eval for example, experiment with variable-duration flashes. The RET sinusoidal stimulus has been carefully constructed to minimize the harmonic distortion (< 1% per harmonic), so that any harmonics in the response are attributable to nonlinearities in the visual system.
  • Page 54 / right-leg drive connection. Part numbers for these items can be found in Purchasing supplies and accessories on page 101 or on the LKC store (https://store.lkc.com/reteval-accessories). eval Device User Manual...

  • Page 55: Reteval Complete Test Results

    RETeval Complete Option eval Complete test results eval Incremental results are shown on the RET device after each test (except for flicker-only tests), with the option to repeat the test or continue to the next test. Successful cursor placement is indicated by dashed lines on the waveform indicating their location.
  • Page 56 RETeval Complete Option An example PDF report for the protocol is shown below. ISCEV 6 step, dark adapted first, Td eval Device User Manual...
  • Page 57 RETeval Complete Option eval Device User Manual...
  • Page 58 RETeval Complete Option eval Device User Manual...
  • Page 59 RETeval Complete Option eval Device User Manual...
  • Page 60 RETeval Complete Option An example PDF report for the protocol is shown below. ISCEV 5 step, dark adapted first, cd eval Device User Manual...
  • Page 61 RETeval Complete Option eval Device User Manual...
  • Page 62 RETeval Complete Option An example of a photopic negative response protocol with reference data is shown below. In this report, the stimulation waveform is shown. See page 11 for turning this feature on/off. eval Device User Manual...
  • Page 63 RETeval Complete Option eval Device User Manual...
  • Page 64 RETeval Complete Option An example of an S-cone protocol is shown below. Note s-cone wave occurs just after 40 ms and is not the b-wave cursor, which is an LM-cone response (Gouras, MacKay, and Yamamoto 1993). eval Device User Manual...
  • Page 65 RETeval Complete Option 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. eval Device User Manual...
  • Page 66 RETeval Complete Option An example of the red/green on-off (long flash) protocol is shown below. The off response can be seen starting about 230 ms, about 21 ms after the stimulus is turned off, as indicated by the stimulus waveform.
  • Page 67 RETeval Complete Option An example flash VEP report is shown below. eval Device User Manual...

  • Page 68: Reference Intervals

    Reference Intervals Reference Intervals LKC has gathered reference values (CLSI 2008, Davis and Hamilton 2021) in order to establish corresponding reference intervals. Reference intervals are sometimes referred to as “normal data” or “normative data”. If reference data is available for a test and reference data reporting is on (see next section), age- eval matched reference data will automatically be displayed by the RET device.

  • Page 69: Using Reference Intervals As Clinical Decision Limits

    Reference Intervals tailed reference interval). Thus, it would be atypical for a patient with normal vision to have an ERG waveform peak outside this rectangular box. An atypical result may still be colored green if it is not associated with disease (coloring follows the 1-tailed reference interval). Measurement 2-tailed 95% (percentile)

  • Page 70: Turning Reference Data Reporting On And Off

    Reference Intervals Turning reference data reporting on and off Reference data reporting can be turned on and off through the user interface and through custom protocols. Turning off reference data can be useful, for example, if you know that the subjects you are testing are outside the reference population tested in the database (e.g., testing subjects significantly outside the age range, testing natural-pupil subjects with constant luminance protocols, or testing non-human animals).
  • Page 71 Reference Intervals Some subjects (n=118) were tested after artificial dilation, while others were tested with natural pupils and constant Troland stimuli that compensate for pupil size (n=233). Dilated subjects who did not dilate to at least 6 mm were excluded from tests that did not compensate for pupil size. Far outliers (defined as 3 interquartile ranges away from the 25th and 75th percentiles) were removed after age correction that used a robust (bisquare) linear least squares fit.
  • Page 72 Reference Intervals Waveform implicit time / 23.6 (23.4 – 24.0) 25.2 (25.1 – 25.3) 27.3 (27.0 – 27.8) 0.0439 Waveform amplitude / µV 20.2 (19.4 – 21.4) 31.2 (30.0 – 32.1) 46.6 (44.7 – 47.7) -0.0959 16 Td·s flicker ERG. Flash: 16 Td·s white @ 28. Hz, Background: 0 Td white Cursor 5% limit (90% CI) 50% (90% CI)
  • Page 73 Reference Intervals Cursor 5% limit (90% CI) 50% (90% CI) 95% limit (90% CI) Age slope Fundamental implicit time 25.3 (24.9 – 25.7) 27.3 (27.1 – 27.5) 29.1 (28.9 – 29.3) 0.036 / ms Fundamental amplitude / 4.3 (4.0 – 4.6) 8.0 (7.7 –...
  • Page 74 Reference Intervals PhNR P-ratio -0.0 (-0.1 – 0.0) 0.1 (0.1 – 0.2) 0.3 (0.3 – 0.4) 0.000958 PhNR W-ratio 0.8 (0.8 – 0.8) 0.9 (0.9 – 0.9) 1.1 (1.0 – 1.1) -0.00073 Light adapted 3 cd·s/m ERG. Flash: 3 cd·s/m white @ 2.
  • Page 75 Reference Intervals a-wave / ms 8.1 (7.0 – 10.4) 12.3 (11.6 – 13.0) 14.8 (14.5 – 15.2) 0.00343 a-wave / µV -1.2 (-2.2 – -0.0) -3.2 (-3.6 – -2.8) -5.2 (-5.9 – -4.4) 0.0122 b-wave / ms 18.7 (18.2 – 19.6) 24.6 (23.9 –...

  • Page 76: Troubleshooting Hints

    Troubleshooting Hints Troubleshooting Hints eval The RET device runs internal tests and self-checks frequently. Device failures are obvious; the device will stop functioning and warn the user rather than producing erroneous or unexpected results. If the device displays an error message, follow the instructions on the screen to remediate the error, or contact Support at support@lkc.com.

  • Page 77: The Device Shows "Excessive Electrode Noise

    Troubleshooting Hints The device doesn’t show the button after I connect to the Sensor Next Strip (or other electrode type) or after pressing the button, I Start test get an “The electrodes have been disconnected” error eval The RET device monitors the electrical impedance of the connection between pads on the Sensor Strip or other electrode types.

  • Page 78: The Device Won't Let Me Press The Start Test Button When I Can See The Eye

    Troubleshooting Hints and sold on the LKC store, https://store.lkc.com), soap and water or an alcohol wipe and reapply the Sensor Strip. 3. The Sensor Strip may be defective, try another Sensor Strip. The device won’t let me press the button when I can see the Start test eval When using Troland-based protocols, the RET...

  • Page 79: After Pressing The Start Test Button, I Get An "Unable To Calibrate" Error

    15 seconds, then release and press the power button to turn the device off. If all else fails, remove and reinstall the battery, which is located in the handle of the device. The RETeval device won’t connect to my PC eval The RET...

  • Page 80: I Get A "Scan And Fix" Error From Windows

    Troubleshooting Hints I get a “scan and fix” error from Windows ® when placing the RETeval device in the docking station eval When removing the RET device from the docking station, always eject the external drive that represents the device from the PC.

  • Page 81: Device Language Is Set To An Unfamiliar Language

    Troubleshooting Hints 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. eval Step 1. Turn on the RET device. If the device is already on, turn it off, wait 5 seconds, then turn it back on.

  • Page 82: Works Cited

    Works Cited Works Cited Ahmadi, M, and Q Q Rodrigo. 2013. "Automatic denoising of single-trial evoked potentials." NeuroImage:672-680. Audo, I., M. Michaelides, A. G. Robson, M. Hawlina, V. Vaclavik, J. M. Sandbach, M. M. Neveu, C. R. Hogg, D. M. Hunt, A. T. Moore, A. C. Bird, A. R. Webster, and G. E. Holder. 2008. "Phenotypic variation in enhanced S-cone syndrome."...
  • Page 83 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 84 Works Cited McCulloch, D. L., M. F. Marmor, M. G. Brigell, R. Hamilton, G. E. Holder, R. Tzekov, and M. Bach. 2015. "ISCEV Standard for full-field clinical electroretinography (2015 update)." Doc Ophthalmol 130 (1):1-12. doi: 10.1007/s10633-014-9473-7. Miller, N R, M A Johnson, S R Paul, C A Girkin, J D Perry, M Endres, and G L Krauss. 1999. "Visual dysfunction in patients receiving vigabatrin: clinical and electrophysiologic findings."...
  • Page 85 Works Cited Viswanathan, S., L. J. Frishman, J. G. Robson, R. S. Harwerth, and E. L. Smith, 3rd. 1999. "The photopic negative response of the macaque electroretinogram: reduction by experimental glaucoma." Invest Ophthalmol Vis Sci 40 (6):1124-36. Viswanathan, S., L. J. Frishman, J. G. Robson, and J. W. Walters. 2001. "The photopic negative response of the flash electroretinogram in primary open angle glaucoma."...

  • Page 86: 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 87: Specifications

    Regulatory and Safety Information Specifications Red LED Green LED Blue White Light source (621 nm) (530 nm) (470 nm) (RGB) Flash luminance 0.0001 – 0.001 – 17 0.0001 – 5 0.002 – energies (cd∙s/m Background 0.03 – 0.2 – 3500 0.03 –...

  • Page 88: Cleaning And Disinfection

    Regulatory and Safety Information • Do not use Sensor Strips with patients who are allergic to the Sensor Strip gel. • Avoid use when the orbit structure is damaged or surrounding soft tissue has an open lesion. eval Some patients may feel discomfort when viewing the flickering light that the RET device creates to test their eyes.

  • Page 89: Sterilization

    (https://store.lkc.com/reteval-accessories). To replace the battery, slide the battery compartment door off. Gently pull near the connector to remove the battery. Install the new battery, and slide the battery door back into place. To maintain proper function and compliance to regulatory requirements, do not attempt to disassemble the device.

  • Page 90: Essential Performance

    (2) the biological risk associated with reuse across patients has not been analyzed. Precautions • All servicing of this equipment is to be performed by LKC Technologies, Inc. or by a center approved by LKC Technologies, Inc. • Medical Electrical Equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided herein.

  • Page 91: Electromagnetic Compatibility (Emc)

    Regulatory and Safety Information • WARNING: To avoid the risk of electric shock, avoid accidental contact between an eval electrode connected to the RET and other conductive parts (e.g., metal) before applying the electrode to the patient. For example, connect electrodes to the patient eval before plugging them into the RET or use Sensor Strip electrodes.
  • Page 92 Regulatory and Safety Information Electromagnetic Environment – Guidance Emissions Test Compliance eval The RET device uses RF energy only for its internal RF emissions Group 1 function. Therefore, its RF emissions are very low and are CISPR 11 not likely to cause any interference in nearby electronic equipment.
  • Page 93 Regulatory and Safety Information 0 % UT; 250/300 0 % UT; 250/300 cycle for 50 Hz and cycle for 50 Hz and 60 Hz, respectively 60 Hz, respectively Single phase: at 0° Single phase: at 0° Power Frequency 30 A/m, 50 Hz or 30 A/m, 50 Hz or Power frequency...
  • Page 94 Regulatory and Safety Information eval Recommended Separations Distances for the RET device eval The RET device is intended for use in the electromagnetic environment in which radiated eval disturbances are controlled. The customer or user of the RET device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile eval RF Communications Equipment and the RET...

  • Page 95: Rohs

    Regulatory and Safety Information RoHS RoHS2 Compliance Statement eval The RET product line is RoHS compliant in accordance with EU RoHS Directives 2002/95/EC, 2011/65/EU, 2015/863, and the Council of 8 June 2011 on The restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS Directives).

  • Page 96: California Proposition 65

    Regulatory and Safety Information California Proposition 65 Warning: This product can expose you to chemicals including lead, which are known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/ Substance Tables: The table below lists substances which may be contained within this product.

  • Page 97: Symbols

    Regulatory and Safety Information Symbols Symbol Description / Function Council Directive Compliance 2797 Power button. Press to turn device on and off when not in docking station. Turn screen on and off when in the docking station. Type BF applied part, as defined in IEC 60601-1. The applied parts are the Sensor Strips.

  • Page 98: Equipment Identification

    Regulatory and Safety Information Lot number Catalog number Use by date ETL Listed mark indicating proof of product compliance. Conforms To: 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.

  • Page 99: Approvals

    Regulatory and Safety Information Approvals This product has been tested for and complies with the requirements of the following standards: ISO 15004-1 Ophthalmic instruments, General requirements ISO 15004-2 Ophthalmic instruments, Light protection hazard IEC 60601-2-40 Medical electrical equipment (2 edition) IEC 60601-1 Medical electrical equipment (3.1 edition) CB Scheme IEC 60601-1 Medical electrical equipment (3 edition) CB Scheme...

  • Page 100: Intellectual Property

    LKC Technologies, Inc. RET and RETeval-DR is a registered trademark of LKC Technologies, Inc. in the following countries: Canada, China, Japan, Mexico, Russian Federation, South Korea, and the United States of America. eval The firmware contained in the RET device is copyrighted ©...

  • Page 101: Contact Information

    LKC Technologies, Inc. This Warranty is binding for one year from date of shipment and is limited to servicing and/or replacing any instrument, or part thereof, returned to the factory for that purpose with transportation charges prepaid and which are found to be defective.

  • Page 102: Purchasing Supplies And Accessories

    Contact Information We will be happy to discuss by phone, letter, FAX, or e-mail any problem you may be experiencing. Purchasing Supplies and Accessories Users may purchase supplies and accessories by contacting your local distributor or visiting the LKC store (https://store.lkc.com/). Refer to this parts list: Part Number Item eval...
  • Page 103 T: +31 70-345-8570 F: +31 70-346-7299 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.

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