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USER MANUAL 

RETEVET™ PORTABLE ERG  

T +49 7461 96 580 0 | F +49 7461 96 580 90 | [email protected] | www.eickemeyer.com

Equipment Identifi cation

Each RETevet™ device has a unique serial number for identifi cation. The serial number can be seen by choosing Settings, then 

System

 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. The serial number has the form 
R######, interpreted as follows:

R

Product code is R

###### Production sequence number (5 or 6 digits)

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 (2nd edition)

•  IEC 60601-1 Medical electrical equipment (3.1 edition) CB Scheme IEC 60601-1 Medical electrical equipment (3rd edition) 

CB Scheme AAMI ES60601-1 Medical electrical equipment

•  CSA C22.2#60601-1 Medical electrical equipment
•  CENELEC EN60601-1 Medical electrical equipment (3rd edition)
•  IEC 60601-1-2 Electromagnetic compatibility, including Japan deviations (4th edition) IEC 60601-1-6 Usability
•  IEC 62366 Usability
•  IEC 60601-1 Medical electrical equipment (2nd edition) CB Scheme
•  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

11. INTELLECTUAL PROPERTY

The RETevet™ device may be covered by one or more of the following US patents and their foreign counterparts: 9,492,098.

RETevet™ and RETeval™ are trademarks of LKC Technologies, Inc.

The fi rmware contained in the RETevet™ device is copyrighted © 2011 – 2019 by LKC Technologies, Inc. Use of the fi rmware 

outside of the RETevet™ device is prohibited. All rights reserved.

Содержание 173610

Страница 1: ...USER MANUAL TELEPHONE 49 7461 96 580 0 www eickemeyer com Item no 173610 RETEVET PORTABLE ERG ...

Страница 2: ...ce 17 5 Performing an ERG Test 18 6 Viewing Results 20 General 20 Results on the Device 20 Results on a PC 20 Flicker Results on the Device Versus on a PC 26 7 Additional Activities 28 Removing Old Results from the Device 28 Removing and Replacing the Eyecup 28 Updating Firmware 29 8 Troubleshooting Hints 30 9 References 33 10 Regulatory and Safety Information 34 Applicability 34 Intended Use 34 I...

Страница 3: ...perty 44 12 Contact Information 45 Support 45 Warranty 45 Purchasing Supplies and Accessories 45 Service Repairs 46 Copyright 2012 2019 LKC Technologies Inc LKC Technologies Inc established in 1987 is ISO 13485 2016 MDSAP certified and an FDA registered medical device manufacturer with quality products installed in over fifty countries ...

Страница 4: ...n and your practice or institution information These PDF reports can be transferred to any PC via a USB cable What s in the Box The RETevet device is packaged with these items Check that all items are present RETevet device Measures the response of the eye to light Docking station Charges the RETevet device and enables data transfer to a PC Dust cover Not shown Protects the device from dust while ...

Страница 5: ...ion is present The charging status is shown on the display If the display is blank press the power button to turn it on The RETevet device is shipped with a partial charge Connect the Electrodes Connect the 3 plug electrode lead to the blue lead connector shown in the figure above and then connect the electrodes in the following way corneal electrode to the red plug reference electrode to the black...

Страница 6: ...f the currently selected protocol The status bar shows the time date and battery charge state The four buttons enable the operator to start a new test view previous results change system settings and choose the protocol that will run when starting a new test At the bottom of the screen the currently selected protocol is displayed Settings Set up the RETevet device for use in your practice 1 Turn o...

Страница 7: ...mation is displayed on the report above the patient information as shown in the sample report on Page 22 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 Scanning is automatic and does not require the joystick t...

Страница 8: ...ion stopping after an internal precision metric is reached Some protocols have multiple stimulus conditions which are presented sequentially with a short 1 s dark pause between the conditions A counter on the screen shows progress for these multi stimulus protocols The RETevet device provides flicker intensities of 3 and 10 cd s m without a background light and the ISCEV standard 3 cd s m flash with...

Страница 9: ...mmed cursor times and amplitudes you should examine the cursor dots on the waveform to ensure that no waves are missed 5 Light adapted cone response LA 3 0 provides an overall assessment of outer and inner retina in the day vision 6 Light adapted flicker LA 3 0 flicker is a robust response of the cone pathway and an excellent tool for a quick assessment of the retinal function Flash conditions in th...

Страница 10: ...l basis for the guidelines The protocol ECVO 5 step can be used to assess the functioning of the rod and cone pathways in the retina Rod function is assessed with a series of dim flashes after a period dark adaptation 20 minutes is recommended Next cone function is tested after 10 minutes of light adaption Waiting or examination room ambient light is close to 30 cd m which is likely sufficient or th...

Страница 11: ... adapted 3 0 Left 3 cd s m 1 15 Hz Off 1 Dark adapted 10 0 Left 10 cd s m 0 05 Hz Off 1 Light adaptation timer Right Off 30 cd m Light adapted 3 0 Right 3 cd s m 2 Hz 30 cd m 20 Light adapted 3 0 flicker Right 3 cd s m 28 3 Hz 30 cd m 141 424 Light adaptation timer Left Off 30 cd m Light adapted 3 0 Left 3 cd s m 2 Hz 30 cd m 20 Light adapted 3 0 flicker Left 3 cd s m 28 3 Hz 30 cd m 141 424 Protoco...

Страница 12: ...ft eyes dark adapted tests are completed Waiting or examination room ambient light close to 30 cd m is likely sufficient or one can use the built in light adaptation 10 min period This protocol is recommended for anesthetized or sedated animals when the progression of dark adaptation needs to be evaluated for example in Progressive Retinal Atrophy PRA Miyadera Acland and Aguirre 2012 PRA is a bilat...

Страница 13: ...wn timer press Start Test to continue Dark adapted 0 01 0 01 cd s m 0 2 Hz Off 1 Dark adapted 3 0 3 cd s m 1 15 Hz Off 1 Dark adapted 10 0 10 cd s m 0 05 Hz Off 1 Light adaptation timer Off 30 cd m Light adapted 3 0 3 cd s m 2 Hz 30 cd m 20 Light adapted 3 0 flicker 3 cd s m 28 3 Hz 30 cd m 141 424 PupilLightReflex protocol generate 1000 cd m red 621 nm or blue 470 nm light as selected by the operat...

Страница 14: ...he Dog Cat Nonhuman Primate 6 step dark adapted first protocol Dog Cat Nonhuman Primate 6 step dark adapted first Description Eye Flash Luminance Energy 0 33 0 33 White Background Luminance 0 33 0 33 White Flashes Dark adaptation timer Both Off Off Dark adapted 0 01 Right 0 01 cd s m 0 5 Hz Off 3 Dark adapted 3 0 Right 3 cd s m 0 1 Hz Off 3 Dark adapted 10 0 Right 10 cd s m 0 05 Hz Off 3 Dark adapte...

Страница 15: ...k adapted 8 0 Right 8 cd s m 0 1 Hz Off 3 Dark adapted 25 Right 25 cd s m 0 05 Hz Off 3 Dark adapted 0 06 Left 0 06 cd s m 0 5 Hz Off 3 Dark adapted 8 Left 8 cd s m 0 1 Hz Off 3 Dark adapted 25 Left 25 cd s m 0 05 Hz Off 3 For testing rats and mice dimmer stimuli are typically used Dembinska et al 2001 Dembinska et al 2002 Polosa et al 2019 Photopic and scotopic tests can be performed separately o...

Страница 16: ...t is not built in the RETevet device a custom protocol can be created for you Contact EICKEMEYER for more information on how to obtain and use a custom protocol Typically custom protocols should define which tests will be run and what will be the conditions of those tests such as the stimuli intensity frequency color duration and type on off ramp or sinusoidal stimuli Custom protocols must be trans...

Страница 17: ...trol if binocular recordings are made Preparing the Animal Preform ERG testing before photography or indirect ophthalmoscopy if dark adapted recordings are desired because 60 minutes are needed for the rods to fully recover from bright light exposures Tuntivanich et al 2005 Dilate the pupils using for example a combination of 0 5 proparacaine and 1 of tropicamide Wait 20 30 minutes for full dilati...

Страница 18: ...teral canthus in veterinary clinic or at the base of the ear in research or pharmaceutical testing and ground electrode on the top of the head or between the shoulder blades Place the electrodes in the following order ground reference active electrode If the ERG Jet electrode is used fill half of it just before positioning it on the cornea An eye retractor speculum can be used or the eye must be ke...

Страница 19: ... with the electrodes Remove the eye cup if needed Select Start Test to start the test after the pupil has been placed in the green circle At the beginning of each test the RETevet device automatically recalibrates the light intensity and color This process takes about one second Wait while the device conducts the ERGs Testing time depends on the protocol that you have selected and can be less than...

Страница 20: ... When referring to the literature for clinical interpretation it is important to verify the material and methods before drawing conclusions Viewing the results on the device is used to quickly assess the results and decide upon the next steps without printing the results Examining the results on a PC displayed as a ready to print pdf file allows for more detailed data analysis printing archiving an...

Страница 21: ...esults is patient ID_birthdate_testdate pdf where the birthdate is yymmdd 2 digit year month day and the test date testdate is yymmddhhmmss 2 digit year month day hour minute second With this file naming convention past patient results will sort next to their current results Any spaces in the patient ID are removed in the filename The PDF displays Practice information as specified in Settings See pag...

Страница 22: ...ET PORTABLE ERG T 49 7461 96 580 0 F 49 7461 96 580 90 export eickemeyer com www eickemeyer com You can print fax or email these PDF files just as you would any file on your PC An example PDF report is shown below from a dog ...

Страница 23: ...23 USER MANUAL RETEVET PORTABLE ERG T 49 7461 96 580 0 F 49 7461 96 580 90 export eickemeyer com www eickemeyer com ...

Страница 24: ...24 USER MANUAL RETEVET PORTABLE ERG T 49 7461 96 580 0 F 49 7461 96 580 90 export eickemeyer com www eickemeyer com ...

Страница 25: ...25 USER MANUAL RETEVET PORTABLE ERG T 49 7461 96 580 0 F 49 7461 96 580 90 export eickemeyer com www eickemeyer com ...

Страница 26: ...s use the fundamental because this measure has been reported to be more accurate for managing patients with ischemia Severns Johnson and Merritt 1991 and more robust to the lighting conditions the patient experienced before the test McAnany and Nolan 2014 The dotted lines indicate the measurement values extracted from the waveforms When viewing the results on the PC the PDF shows three periods In ...

Страница 27: ... USER MANUAL RETEVET PORTABLE ERG T 49 7461 96 580 0 F 49 7461 96 580 90 export eickemeyer com www eickemeyer com An example PDF report for the 3 cd s m with a 30 cd m background protocol are shown below ...

Страница 28: ...luding patient results and custom protocols would be deleted and reset to factory condition Removing Results Using the PC To remove results from the device using a PC follow these steps 1 Place the RETevet device into the docking station 2 Connect the USB cable 3 Wait for the device to appear as an external drive on the PC 4 Navigate to the Reports directory on the device 5 Make sure that any resu...

Страница 29: ... and download the update 2 Connect the USB cable to the PC 3 Place the device into the docking station 4 Wait for the device to appear as an external drive on the PC 5 Copy the firmware update file from the directory on the PC to the Firmware directory on the device 6 Eject the external drive that represents the device from the PC 7 Remove the device from the docking station 8 Select Settings then S...

Страница 30: ...ETevet device monitors the electrical impedance of the connection between the electrodes If the impedance is too high the Next button won t be displayed During a test if the electrical impedance gets too high or the inputs saturate the analog to digital converter the electrodes disconnected message is displayed The impedance and or electrode noise can be too high because of the following reasons 1...

Страница 31: ...he Power Light is on You can turn the device off at any time by pressing the power button The screen goes blank immediately but the device takes a few more seconds to turn off completely If the power button is pressed just after the last blink the display will fail to turn back on Press the power button again to turn the device off If the power button fails to turn back on hold the power button fo...

Страница 32: ...y the cursor placement algorithm In other cases the waveform looks worse than expected based on other clinical history For these cases you can try the steps suggested above under The device shows Excessive electrode noise Reset Settings You can reset the RETevet device to the factory default settings Follow these steps if there are problems with the device or if advised to do so by Support Turn on...

Страница 33: ... Petersen Jones and K Narfstrom 2013 Guidelines for clinical electroretinography in the dog 2012 update Doc Ophthalmol 127 2 79 87 doi 10 1007 s10633 013 9388 8 McAnany J and P Nolan 2014 Changes in the harmonic components of the flicker electroretinogram during light adaptation Doc Ophthalmol 1 8 McGee D H O Dembinska and M M Gruebbel 2005 Evaluation of triamcinolone acetonide following intravitre...

Страница 34: ...The operators of the device are intended to be veterinary professionals and scientists Indications for Use RETevet is indicated for use in the measurement of visual electrophysiological potentials including electroretinograms ERG RETevet is intended as an aid in diagnosis and research of visual pathway dysfunctions or ophthalmic disorders e g diabetic retinopathy glaucoma Latex Statement The compo...

Страница 35: ...ge DC coupled Flicker Frequency Approximately 28 3 Hz Data Resolution Approximately 71 nV bit Input Range 0 6 V Sampling rate Approximately 2 kHz Timing accuracy electronic eye 0 1 ms Timing precision human eye 1σ Typically 1 ms Safety Battery powered Complies with optical electrical and biocompatibility safety standards Power source Li Ion battery allows testing of approximately 70 patients befor...

Страница 36: ...uid cleaners may damage the LED lights and camera inside it Cleaning and Disinfecting the Exterior Cleaning of the patient contacting parts of the device eyecup and sensor strip lead is recommended between patient uses The RETevet device is chemically compatible to wipes containing 70 isopropyl alcohol and with wipes containing alkyl dimethyl benzyl ammonium chloride The use of other wipes may dam...

Страница 37: ...xperience as such the RETevet device has no Essential Performance as pertains to risk Operating Environment Temperature 10 35 C 50 95 F Humidity 10 90 non condensing Air pressure 62 106 kPa 80 m 260 feet 4 000 m 13 000 feet Lifetime The lifetime of the device is 7 years or 10 000 test protocols performed whichever comes first The manufacture date of the device can be found on the device labels The ...

Страница 38: ...itrous oxide Do not connect the RETevet device to the docking station while measuring a patient This will compromise the quality of recordings and subject isolation Do not modify this equipment without authorization of the manufacturer Do not use batteries from other sources as it may result in a hazard such as excessive temperatures fire or explosion Do not use the device in direct sunlight Strong...

Страница 39: ...Declaration Emissions The RETevet device is intended for use in the electromagnetic environment specified below The customer or user of the RETevet device should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The RETevet device uses RF energy only for its internal function Therefore its RF emissions are very...

Страница 40: ...rential 2 kV Common Mains power quality should be that of a typical commercial hospital or home environment Voltage Dips Dropout IEC 61000 4 11 0 UT 0 5 cycle at 0 45 90 135 180 225 270 and 315 UT 1 cycle 70 UT 25 30 cycles for 50 Hz and 60 Hz respectively Single phase at 0 0 UT 250 300 cycle for 50 Hz and 60 Hz respectively Single phase at 0 0 UT 0 5 cycle at 0 45 90 135 180 225 270 and 315 UT 1 ...

Страница 41: ... D is the recommended separation distance in meters Field strengths from fixed transmitters as determined by an electromagnetic site survey should be less than the compliance levels V1 and E1 Interference may occur in the vicinity of equipment containing a transmitter To assure continued effectiveness only use cables and accessories supplied by EICKEMEYER which are specifically designed for use with...

Страница 42: ...vet complies with exemption 6 a which allows Lead as an alloying element in steel for machining purposes and in galvanized steel containing up to 0 35 lead by weight China RoHS2 Compliance Statement The RETevet product line is RoHS compliant in accordance with the China RoHS Directive GB T26572 2011 on Requirements of concentration limits for certain restricted substances in electrical and electro...

Страница 43: ... as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment USB port Li Ion 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 Sto...

Страница 44: ...uipment 3 1 edition CB Scheme IEC 60601 1 Medical electrical equipment 3rd edition CB Scheme AAMI ES60601 1 Medical electrical equipment CSA C22 2 60601 1 Medical electrical equipment CENELEC EN60601 1 Medical electrical equipment 3rd edition IEC 60601 1 2 Electromagnetic compatibility including Japan deviations 4th edition IEC 60601 1 6 Usability IEC 62366 Usability IEC 60601 1 Medical electrical...

Страница 45: ...r authorized by us 3 Provide for the cost of repairing instruments that have obviously been abused subjected to unusual environments for which they have not been designed or an attempt has been made to disassemble the device resulting in damage to the device We will be happy at any time to discuss by phone letter FAX or e mail suspected defects or aspects of instrument operation that may be unclea...

Страница 46: ... other than the eyecup and battery both of which can be replaced without the need to tools To maintain proper function and compliance to regulatory requirements do not attempt to disassemble the device Other than the replacement parts mentioned above and cleaning as described elsewhere in this manual no user maintenance is required to maintain proper function and regulatory compliance ...

Страница 47: ...47 USER MANUAL RETEVET PORTABLE ERG NOTES T 49 7461 96 580 0 F 49 7461 96 580 90 export eickemeyer com www eickemeyer com ...

Страница 48: ... EICKEMEYER Sp z o o Al Jana Pawła II 27 00 867 Warszawa T 48 22 185 55 76 F 48 22 185 59 40 info eickemeyer pl www eickemeyer pl DENMARK EICKEMEYER ApS Solbakken 26 Hammelev 6500 Vojens T 45 7020 5019 info eickemeyer dk www eickemeyer dk NETHERLANDS EICKEMEYER B V Bellweg 44 4104 BJ Culemborg T 31 345 58 9400 info eickemeyer nl www eickemeyer nl ITALY EICKEMEYER S R L Via G Verdi 8 65015 Montesil...

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