UNISCAN Scanner User Guide
Contents
1. 4 Strip Setup DB Setup Lot No Setup Panel No aee Display Index monu I I 2 Change Number Cursor Display 18 Number Change Cursor s Location Prose lt Minus 1 Prese gt Lot PN Select DB oe 0 el e D D Change Number on Cursor amp ps Lot Select B Press lt Minus 1 Press gt Plus 1 Understanding Results DB Troubleshooting DB Test Results may have different meanings and impacts No Strip Test Strip is not inserted according to local standards and laws Consult the Strip is failed Control line does not appear Use a new Test Strip s 2 Chart Insert in your UNISCAN Test Strip package and Scanner doesnot Check for loose cables or connections local regulations to determine different indications turn on S CNECK to See thatthe unitis plugged Into a power source Re calibrate Scanner Please see Page 8 Test Report Printout Format for Check to make sure that the Strip Insert port is sample Test Results and code definitions not subject to overexposure from external lighting Inconsistent Test Results 68 Test Strip is inserted too soon Insert the for the same Test Strip Test Strip at the designated insertion time Note Valid Test Results will exhibit a small variance upon repeated scans Test Strip is inserted too late Insert the This is normal and consistent2. 11 A Clock Setup Strip Setup Lot PN Select Understanding Test Results Troubleshooting Scanner Maintenance Warranty INDEX B Quick Reference Guide Symbols In vitro diagnostic medical device Authorized representative in the European Community Manufacturer l Temperature Serial number R AT Date of manufacture limitation Consult instructions Catalog number foruse Caution consult Graphic symbols Batch code SH HZ for use in labeling Contents of kit DB UNISCAN Scanner AC Adaptor Calibration Strips one Bright standard one Dark standard User Guide Conditions and Requirements Terms of Use DB Shipping and Storage Ranges Temperature 20 60 C 4 140 F Relative Humidity 10 85 RH Operating Ranges Temperature 15 40 C 59 104 F Relative Humidity 30 85 RH Atmospheric Pressure 700 1060hPa Conditions and Reguirements TS A Terms of Use P Note Recommended for use in a controlled environment Clean work area Room temperature Available power source Stable environmental conditions e g Temperature Relative Humidity UNISCAN Test Strips Do not use non UNISCAN Test Strips with the UNISCAN Scanner If necessary dispose of the UNISCAN Scanner in an environmentally friendly way at the end of its lifetime follow local regul
3. with standard laboratory practices and analyzers Test Strip at the designated insertion time as well Excessive incubation will yield invalid test results Scanner Maintenance General Care Keep dry Avoid extremes or sudden changes in temperature and or humidity Avoid physical impact or rough handling Do not disassemble cleaning Use water only to wipe clean the surface Do not allow water inside Do not use cleansers or glass cleaners containing ammonia Use a 10 bleach solution to disinfect and then use water to wipe clean the surface W w Date of Purchase arranty ED Serial Number Complete the UNISCAN Scanner registration material and submit it as soon as possible If for any reason except obvious abuse the UNISCAN Scanner does not work at any time during the first year after purchase your authorized Suns Bio Med International Corp representative will replace it with a new or equivalent unit free of charge This Warranty Policy applies only to the UNISCAN Scanner and its original buyer It does not apply to UNISCAN Test Strips and disposable materials supplied with the UNISCAN Scanner This Warranty Policy is VOID if either the UNISCAN Scanner or UNISCAN Test Strips are modified or disassembled in any way without prior authorization Only UNISCAN Test Strips can be used with the UNISCAN Scanner This Warranty i
4. UNISCAN Scanner User Guide V1 9509 1000 Notes Read all instructions first Check for and be familiarized with the kit before performing tests Please contact your authorized Suns Bio Med representative if the kit is missing any of its contents 5 The UNISCAN System 1 UNISCAN Test Strips m UNISCAN System UNISCAN Scanner UNISCAN Test Strip The UNISCAN system is a multiple use test system that UNISCAN Test Strips are specially designed and can be used on site in a variety of repetitive testing extensively optimized for qualitative semi quantitative environments The UNISCAN Scanner provides a and quantitative use with the UNISCAN Scanner convenient and portable tool that alleviates test performance dependence on the visual acuity and interpretive skills Use only UNISCAN Test Strips to ensure consistent of the user quality and reliable results and to maintain our complete service support and warranty What you need to know about using the UNISCAN system is included in this User Guide If you have any questions please feel free to contact your authorized Suns Bio Med representative CAUTION Test Performance may be negatively impacted if the test is performed by users with less training familiarity or experi ence who do not follow instructions or use unapproved or non UNISCAN accessories If the equipment
5. anner can connect with a printer via RS232 to print out a Test Result Report yy mm dd hh The printout format may be similar to TABLE 2 Xa yy mm dd hh SN PN K X yy mm dd hh SN Minute SSS SN PN Negative testres Quantitative vae TABLE 2 Examples of PRINT OUT FORMAT Seguential Test Number T Before You Use the DB A Scanner for the 1st Time 0 Setthe Clock Please set the date and time before you start using your new UNISCAN Scanner Date and time are critical to accurate recording of results and record keeping Bright and Dark standard calibration Bright and Dark standard calibration is critical to the UNISCAN Scanner s measurement consistency See Page 14 Scanner Calibration NOTE Do not use the Bright and Dark standard calibration strips if they are discolored scratched or dirty Monthly or more freguently Calibration Schedule S Re calibrate when operating temperature fluctuates in a wide range e g 15 C Before You Start DB Testing with the Scanner 0 Check the STD Curve settings Always check the settings of the Strip Calibration Curve against the Test Strip type Adjust the STD curve settings accordingly See Page 7 for instructions Use the Control Solution The Control Solution contains a known amount of Test Analyte Use the Control Solution to ch
6. ations System Introduction DB UNISCAN System UNISCAN Scanner UNISCAN Test Strip The UNISCAN Scanner performs color signal analysis on 8 reacted immunodiagnostic UNISCAN Test Strip Digital signal processing and a mechanical design enhance the system s measurement accuracy The handheld Scanner is portable and provides an instrument based analysis and record in seconds thus reducing human error and guesswork in the test process Scanner Specification B Display 16 x 4 Backlit LCD Test Analysis Functionality 6 selectable control panels for different Test Strips Each control panel can process up to 3 test analytes Testing Time lt 20 seconds Test Result Log Capacity 135 sets of test results Data Interface RS232 Print Function Supports RS232 Printer Power Supply AC DC Switching Adaptor ES18U09 P1J MEAN WELL Enterprises Co Ltd Input 100 240V AC 50 60Hz 0 5A Output 9V 2A 18W Max Dimensions LxWxH 20 x 10 x 3 5cm Weight Approximately 280g Scanner Layout 9 X CORR CDA m 1 A 0 2 S J LCD display On Off 5 Strip insert port Test Strip Layout DB Sample Test Strip with 3 Test Lines Test Strip Grip Test Line Display Area Sample Well Legend 0 Ti 72 m Control Line Test Line 1 Test Line 2 n Insert this
7. direction Test Line 3 lt lt The number of Test Lines varies for each Test Strip type Control Panel and Test Analyte DB Specs Input Guide P Six control panels are provided to correspond exactly with different types of UNISCAN Test Strips Each control panel contains different settings so that the UNISCAN Scanner can accurately calculate the appropriate set of test values For instance Test requires the use of Panel 1 in order to calculate the test result value Test Strip Calibration The number of Test Lines is different for each Test Strip The chemical composition of each Test Line is different for each analyte The calibration characteristics for each production lot of Test Strips will vary so calibration data is necessarily established for each Test Line upon production The user must set the Panel No correctly according to the Test Strip type and then input the Strip Calibration Curve i e STD curve data Only now will the analyte be evaluated properly Analyte item to be tested Input the above parameters using the toggle button on the device See Page 16 for step by step instructions TABLE 1 Examples of CONTROL PANEL AND TEST ITEM Note X Y and Z are used figuratively here to represent different types of test analytes a DD M test Report Printout Format 10 The UNISCAN Sc
8. eck whether the Scanner and Test Strip are working together properly you get a False result do not proceed to use the Scanner to test samples Contact your authorized Unison Biotech representative for more details Monthly Control Solution Schedule Check the system when using a new lot of Test Strips B Power On Selection Menu Index 10 Make Warming Up Display Index Menu eE Selection Display UNISCAN Scanner Info 3 Calibration Setup Date Time 4 Clock Setup 5 Strip Setup 6 Lot PN Select Index Menu ID Strip Testing PER ne Serial No E s gt Of gt To Change A pilad No Strip Test Record Inguiry DB sere Display Serial Nd 9 gt Serial rin o a a Scanner Calibration EB 9 Display PI lug in Bright amp Insert Dark Strip Take out Bright Strip Bieta A Display Scanning Warning Do not use the Bright and Dark standard strips if they are discolored scratched or dirty Keep them away from dust dirt and UV filled light sunlight Clock Setup DB Display Year gt Change Year Display Month k Change Month 4 Change Hour Display Hour Change Day Display Day Display Min Change Min Change Sec 9 IN 10 10 10 Display Sec
9. is used in a manner notin accordance with its recommended or intended use then the safety and effectiveness of the equipment may be impaired Sudden or extreme changes in environmental conditions such as temperature relative humidity outdoors to indoors will be detrimental to UNISCAN system performance and equipment Bleach will react negatively with UNISCAN Test Strips and cause false results If a diluted bleach solution is used to disinfect the UNISCAN Scanner then please be sure to wipe away completely any bleach from the Scanner witha cloth dampened with water IMPORTANT Please read all instructions and practice the test before using the UNISCAN Scanner to perform live tests The UNISCAN system is intended for testing and or screening purposes Itis not intended for diagnostic or confirmatory use Tests can be performed only with specified sample types such as urine and only with UNISCAN Test Strips Perform all guality control checks as directed See Page 10 INDEX Symbols A Contents of kit B Conditions and Reguirements Terms of Use System Introduction Scanner Specification Test Strip Layout 9 Control Panel and Test Analyte Specs Input Guide Test Report Printout Format 8 Before You Use the 2 3 Reader for the 1st Time 9 6 Before You Start Testing with the Reader se 10 Power On Selection Menu Index
10. s in lieu of all other warranties express or implied including any implied warranty or merchantability or fitness for a particular purpose Contact your authorized representative before you attempt to return your Scanner or any other products Quick Reference Guide Add Sample Process Test Strip Wait Insert Remove the Test Strip from the As the Test Strip begins Wait and allow the Test Strip to Operate the UNISCAN Scanner foil pouch and place it a dry processing a color band will mature for the designated flat surface Add sample into gradually appear across the incubation time Insert into the the sample well Test Line Display area in the UNISCAN Scanner middle of the Test Strip to process and analyze the Test Strip Interpret accordingly Do not use test results when Incubation time exceeds the Use a timer if necessary defined limit Caution A The designated incubation time is based on performing the test at room temperature B If the test cartridge is functioning normally then a control band will appear across the upper area of the window V1 9509 1000 Suns Bio Med International Corp 1120 8580 Alexandra Road A Richmond BC V6X 4B3 Canada Tel 604 233 8886 Fax 604 233 8858 _ E MAIL sales suns ca Website www suns ca
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