Welch Allyn RETeval-DR Directions For Use Manual Download Page 1

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Welch Allyn

RETeval-DR

™

Directions for use

Summary of Contents for RETeval-DR

Page 1: ...Welch Allyn RETeval DR Directions for use...

Page 2: ...following US patents and their foreign counterparts 7 540 613 and 9 492 098 Additional patents pending The RETeval DR Sensor Strips may be covered by one or more of the following US patents and their...

Page 3: ...ral warnings and cautions 7 Controls and connectors 11 Setup 13 Unpack the system 13 Docking station 14 Charge the battery 14 Connect the sensor strip lead 15 Thumb joystick 15 Device settings 16 Oper...

Page 4: ...infect 37 Clean and disinfect 37 Clean the ganzfeld 37 Troubleshooting 39 Specifications 43 Maintenance 45 User maintenance 45 Remove the eyecup 45 Replace the eyecup 45 Biocompatibility 45 Calibratio...

Page 5: ...The RETeval DR device is intended to generate photic signals and measure and display evoked responses generated by the retina and the visual nervous system The operators of the device are intended to...

Page 6: ...ubber 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 Directions for use No internal c...

Page 7: ...nual identify conditions or practices that could result in damage to the equipment or other property or loss of data This definition applies to both yellow and black and white symbols Consult operatin...

Page 8: ...601 1 IEC Std 60601 1 6 IEC Std 60601 1 IEC Std 62366 ISO Std 15004 1 ISO Std 15004 2 IEC 60601 2 40 Certified To CSA Std No 60601 1 Temperature limit Keep away from rain Lot Code Expiration Date Glob...

Page 9: ...the serial number on the device 1 Remove the battery cover 2 Pivot the battery away from the device to locate the serial number The serial number begins with the letter R Locate the serial number in...

Page 10: ...6 Equipment serial number Welch Allyn RETeval DR...

Page 11: ...statement in this manual could lead to damage to the equipment or other property or loss of patient data General warnings and cautions WARNING Patient or operator injury risk Use of accessories transd...

Page 12: ...cturer CAUTION Do not use the device in direct sunlight Strong ambient light may affect results CAUTION Use only the provided power brick described in Accessories CAUTION Only connect the RETeval DR d...

Page 13: ...CAUTION Only use the cleaning or germicidal cleaner agent types listed or damage may occur Directions for use About warnings and cautions 9...

Page 14: ...10 About warnings and cautions Welch Allyn RETeval DR...

Page 15: ...ce Used to test for diabetic retinopathy 2 Docking station Charges RETeval DR and enables data transfer to a PC Connect to an electrical outlet using the supplied power brick 3 LCD display Displays in...

Page 16: ...the device on and off 6 Thumb joystick Allows you to move through menus perform functions and select parameters by moving the joystick up down right left select 7 Eyecup Blocks ambient light during t...

Page 17: ...uded Number Item Description 1 RETeval DR device Used to test for diabetic retinopathy 2 Sensor strip lead Connects the device to sensor strips for testing 3 Docking station Charges the RETeval DR dev...

Page 18: ...se you need to store or ship the system Docking station You can place the device in the docking station to charge the device or to connect and transfer data to a computer or laptop Charge the battery...

Page 19: ...sert the power cord receptacle for the power brick into the power brick port on the back of the docking station 2 Insert the power brick plate that is appropriate for your location into the power bric...

Page 20: ...e and then press the joystick 2 Scroll either up or down to advance to the desired language and then press the joystick 3 Scroll left to return to the Main display Change the date and time The device...

Page 21: ...and then press the joystick 2 Scroll down to select the desired intensity and then press the joystick The device automatically returns to the Settings menu 3 Scroll left to return to the Main menu Pra...

Page 22: ...use all of the address fields scroll to and press the joystick on each of the remaining address screens The device automatically returns to the Main screen Change the paper size The PDF reports creat...

Page 23: ...ile the firmware updates The device will restart automatically when the firmware is updated Adjust reference interval The score produced by the DR Assessment Protocol correlates with the presence and...

Page 24: ...elect the new upper point of the reference interval Max and press the joystick Reset device to factory default settings You can reset the device to the factory default settings Follow the steps below...

Page 25: ...deleted on the device cannot be recovered Save the results you want to keep on a computer or laptop before deleting them from the device 1 Power on the device and ensure that the device is charged 2 S...

Page 26: ...22 Setup Welch Allyn RETeval DR...

Page 27: ...elete the data 1 Press the Power button to turn the device on The Initializing screen appears as the device powers on 2 Press the Power button to turn the device off The screen shuts off immediately b...

Page 28: ...24 Operating instructions Welch Allyn RETeval DR...

Page 29: ...The patient should not talk smile or move during the test Doing so will increase the test time Ensure that there is no hair between the sensor strip and the skin The sensor strips must be able to adhe...

Page 30: ...for a single examination only Sensor strips may not adhere well if re used causing an excessively high electrode impedance and potentially preventing the device from producing a result 1 Scan a sensor...

Page 31: ...make the pupil more visible 2 Connect the lead to the sensor strip below the patient s right eye and then select Next If the Next button is not present the electrical connection to the patient is poo...

Page 32: ...ccurs 8 After the device has indicated that the testing is complete disconnect the lead from the sensor strip 9 Repeat Steps 1 8 to test the opposite eye 10 Clean the eyecup sensor strip lead and othe...

Page 33: ...l will classify the test result as either High Normal or Low depending upon the reference interval selected The default reference interval is set at 7 0 19 9 This reference interval can be adjusted re...

Page 34: ...or proliferative DR 53 85 Ungradable ETDRS level View results You can view test results either from the device or from a computer or laptop Test result details can be viewed on the device from the Re...

Page 35: ...il areas is quantitated in the plot Results from a computer or laptop Results can be transferred to a computer or laptop in PDF format The file naming convention for results patientID_birthdate_testda...

Page 36: ...ts and then press the joystick 2 Scroll through the list for the desired result and then press the joystick The result appears in the device display screen Delete results from the device CAUTION Resul...

Page 37: ...anently 3 Select Yes 4 If you choose not to delete all test results scroll left to select No and then press the joystick The device automatically returns to the Memory screen 5 Scroll left to return t...

Page 38: ...34 Test results Welch Allyn RETeval DR...

Page 39: ...s charged 3 Place the RETeval DR device in the docking station Wait for the device to appear in the computer or laptop directory as an external drive 4 Copy the firmware update file from the computer...

Page 40: ...installed on a PC connected to a RETeval DR device the RETeval Data Analyst software utility runs in the background to collect test results in a format that qualifies as de identified health informat...

Page 41: ...cleaned when there is visible dust inside or when the device fails to calibrate at the start of a test Welch Allyn recommends that you clean the eyecup and sensor strip lead between each patient The...

Page 42: ...38 Clean and disinfect Welch Allyn RETeval DR...

Page 43: ...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 can be...

Page 44: ...ce to a computer or laptop browse to the Data directory on the device and copy the resulting rff file to your computer or laptop named null_ _ rff where the s are numbers Contact Welch Allyn Technical...

Page 45: ...the device back on If the power button fails to turn back on hold the power button for 15 seconds then release and press the power button to turn the device off If this does not resolve the issue remo...

Page 46: ...42 Troubleshooting Welch Allyn RETeval DR...

Page 47: ...upil area in mm2 Input Type Custom 3 pin connector with positive negative and right leg drive signals Noise 0 1 Vrms at the flicker frequency for flicker protocols CMRR 100 dB at 50 60 Hz Frequency Ra...

Page 48: ...to 1 0 ms therefore the RETeval DR device must operate with no unintended deviations in settings and with typical operation Contact Welch Allyn Technical Support www welchallyn com service if changes...

Page 49: ...and regulatory compliance Remove the eyecup To remove the eyecup grasp the rubber nearest the silver bezel and pull gently Replace the eyecup 1 To replace the eyecup orient the eyecup so that the slo...

Page 50: ...r the device when not in use Store the device at temperatures between 40 C and 35 C 40 F and 95 F Store sensor strips between temperatures between 40 C and 35 C 40 F and 95 F Short term shipping condi...

Page 51: ...is product is contaminated this directive does not apply WARNING Batteries may explode or cause burns if disassembled crushed or exposed to fire or high temperatures WARNING To disconnect mains from t...

Page 52: ...stic purposes To assure continued effectiveness only use cables and accessories supplied by Welch Allyn which are specifically designed for use with the RETeval DR device Guidance and Manufacturer s D...

Page 53: ...0 MHz 6 V in ISM radio bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz Portable and mobile communications equipment should be separated from the RETeval DR device by no less than the distances calcul...

Page 54: ...R device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the RETeval DR device as recommended below accordin...

Page 55: ...trodiagnostic Device Lithium Ion For information about any Welch Allyn product contact Welch Allyn at www welchallyn com about company locations DR assessment protocol The DR Assessment Protocol is de...

Page 56: ...nt macular edema as shown below Maa et al 2016 The DR Assessment Protocol uses two or three sets of 4 16 and 32 Td s flickering white stimuli 28 3 Hz with no background light The number of sets is det...

Page 57: ...icative of vision threatening DR in the study population When weighted for the prevalence found in a typical diabetic population the device has a sensitivity of 83 a specificity of 78 and a negative p...

Page 58: ...doi 10 1016 j jdiacomp 2015 12 005 Wilkinson C P F L Ferris 3rd R E Klein P P Lee C D Agardh M Davis D Dills A Kampik R Pararajasegaram J T Verdaguer and Group Global Diabetic Retinopathy Project 2003...

Page 59: ...WELCH ALLYN S OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACMENT OF PRODUCTS CONTAINING A DEFECT WELCH ALLYN IS NOT RESPONSIBLE FOR ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM...

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