Accustrip URS Reader Manual - JANT Pharmacal Corporation
Contents
1. 45 16 Technical Information eei sacas rne orare cuo ata eee deren E ecce einer ceu 46 16 1 Technica D ala cete di ice 8559 8 dca less aeter aeui a dsd 46 16 2 Security Standards iios petat oi N otc RE vem etri Entum dicus 46 17 C Stomer Servic E irit oae eosaep uide det ccu eee eue aa det ede cu as ete 47 Manual V2 00 USA 06 08 4 User Manual 1 Quickstart Unpack the instrument and place it on an even hard surface Connect the power supply and turn the equipment on with the On Off switch Pic 3 3 8 After the self test the start screen will appear on the display INSERT STRIP SN 0001 1025358 m 7 Display 1 Start menu e Dip atest strip into the urine sample for approx one second e Blot by touching the edge of the strip to a paper towel to remove excess urine e Place the strip on the strip holder e Slide or push the strip to the end of the channel Do not touch the reagent pads on the test strip The instrument will automatically detect an applied strip The measurement cycle will be started A progress bar on the display shows the remaining measurement time Note If Autostart Chapter 10 5 is deactivated the measurement must be started using the start control panel Display 1 1 Notice The strip will be drawn into the instrument after 30 sec Manual V2 00 USA 06 08 5 User Manual After approximately 60 sec the result will be displayed on the screen Displ2. 35 10 7 How to change the language erraram 35 10 8 How to set time and date eee serena 36 10 9 How to activate data transfer erraram 37 10 10 How to change the text of the printout header 37 10 11 How to print settings ccccccssecesssececeeeeeeeeeeeeeeeseeeseseeeneeeeenaes 37 11 Cleaning and Maintenance ee eere er eeeeeee 38 11 1 How to clean the housing eeeeseeeeeeeeee 38 11 2 How to clean the strip holder eesssssss 39 12 Table oF RESUS sisal osso EE aE aaa ia cons 40 13 DEL VICE MOI eee e 41 Manual V2 00 USA 06 08 3 User Manual 13 1 How to reset the system Load Default 41 13 2 How to control the LOT control LOT activate 41 13 2 1 Entry of test SUCKS LOT eir abes 42 13 2 2 Warning on expired test strips essere 43 13 3 How to update the instrument eeeeeseeeeeeeereeeeeee 43 14 Interface DescripllIOn oorr rare a nu eroe 3 eue aeuo nee eer a 44 141 2 Shia NIMC TAG Oeo our Due otav dem oat ddnde mec ien 44 14 2 USB 1 151hterTdeO cioe ee een ee ere 44 14 5 Transmission Protocol 5 50 G nessa ed Ed he epu ie a es 44 15 Error Messages und Fault Clearance
3. custrip URS Reader User Manual 4 ai T7 d R T rw Es SG nye A j t 7 Oc o P GF F 7 T 5 n op Y F estOK b ELUSID URS Reader ay CAT NO UA850 User Manual The instrument is CLIA waived for Accustrip urine reagent strips A certificate of CLIA waiver is required to perform the testing in a waived setting If the laboratory does not have a Certificate of Waiver the Application for Certification Form CMS 116 can be obtained at http www cms hhs goc clia The form should be mailed to the address of the local State Agency of the State in which the laboratory resides http www cms hhs gov clia ssa map asp Laboratories with a certificate of waiver must follow the manufacturer s instructions for performing the test If the laboratory modifies the instructions the test no longer meets the requirements for waived categorization A modified test is considered to be high complexity and subject to all CLIA requirements Manual V2 00 USA 06 08 1 User Manual User Manual Content ADs MUNG KS LAR RE TREE 5 PAN IATROGU CUO M eed 7 2 1 System DESCHPUON oco pono cedars E E Pin EE Meal hi Mase Lac ed Ehe de 7 2 1 1 Measuring Principle ccccccccescccnsseeeccnsesesenseussecsasesensenesensansnsess 7 2 1 2 Functional PHnRCID IO eio trii eet exo tausandvuides roe EVE x nua Ua canina ud 8 3 Unpacking and Ser DD used ee arce eee ebore e
4. e 10 10 Customization Manual V2 00 USA 06 08 16 User Manual 5 Analysis of Test Strips Note The instrument will perform an automatic calibration each time a test is run 5 1 How to perform a measurement The instrument is very easy to use In order to start the measurement the test strip is placed on the strip holder The instrument automatically detects a new strip and starts the measurement A progress bar appears which indicates the remaining analysis time After 30 seconds the test strip is drawn into the instrument after 60 seconds it is released After the measurement the instrument will release the analyzed test strip which can now be discarded The result is displayed on the screen and is transferred via the interfaces and or printed according to equipment settings For additional information on the test strip please read the package insert that comes with the strips DANGER OF INFECTION Urine and used test sticks bear the danger of infection Always use protective gloves during handling and disposal The disposal of used test strips should be performed according to the regulations for the handling of potentially infectious material Manual V2 00 USA 06 08 17 User Manual 5 2 Display of Results The sequence number Display 4 1 as well as the patient identification Display 4 2 will be displayed with the results Seq No 0001 lt gt ID 1234567890 2006 02 17 9 47 e BLD 10ER
5. Lay user color block Level 96 Lay user i Acid 5 6 8 Specific 005 95 5 81 8 46 9 1 005 1 010 95 5 100 Gravity 015 100 1 015 1 025 98 5 100 Urobilinogen 0 2 2 5 100 95 5 98 5 Leukocyte 0 25 500 98 5 62 1 100 Manual V2 00 USA 06 08 29 User Manual 9 Quality control testing Test at least one known negative and one known positive specimen or control whenever a new bottle of strips is first opened for each new shipment for each new lot or at least monthly Quality control samples should be run like a patient sample Do not use water as negative control Positive and negative control solutions provide a convenient basis for a quality control program Contact the service number for ordering information If proper results are not obtained consult your local product representative or contact Customer Service by calling the number given at the end of this manual for advise on testing techniques and results 9 1 How to run a quality control test Prepare the urine controls as described in the package insert and test them in test mode Handle the urine control solutions exactly as patient samples Upon pressing Display 18 1 on the start menu LY the CHECK MODE screen will appear MENU CHECK MODE Memory D Memory 49 Peace mode pr Pisanus i Settings ES x Display 18 Main menu Display 19 Check mode Manual V2 00 USA 06 08 30 User Manual By pressing the panel
6. ts te fe ss 8mgrdi 140 umo p se les 65s 65 k 12 mg dl 200 umol hrs a BL O NEG J NeG wec ils T E RE DI Amgd 17ymoll o eo E 2mgldi 35 moll 1 000 1 000 1 000 Amgidl 70 mol l 1005 1 005 1 005 PRO NEG NEG NEG J 01 1 010 1 010 sis 30 mg dl 0 3 g l RR 10 5 1 015 1 015 100 mg di 1 g l 1 1020 1 020 1 020 500 mg di 5 gll 1108 1 025 1 025 1 030 1 030 1 030 POS NEG 25Leu l 25 Leu 25mgad 2 5 mmol l 75Leum 75 Leu 100 mg di 10 mmol l 500Leup 500 Leu yl 300 mg di 30 mmol l Rcx 3 Manual V2 00 USA 06 08 40 User Manual 13 Service Menu The instrument has a password protected service menu To enter the service menu press the touch screen three times during the self test after turning the equipment on Upon request input the PIN 1111 A menu with different options appears SERVICE Load Default LOT activate Program update Sensitivity Display 24 Service menu 13 1 How to reset the system Load Default Select Load default from the service menu The instrument will be reset to delivery status All settings modified by the user as well as the memory will be cleared 13 2 How to control the LOT control LOT activate Select LOT activate from the service menu to activate the LOT control This will minimize the risk of using expired test strips You will be asked for t
7. 00 USA 06 08 44 User Manual 15 Error Messages und Fault Clearance Messages are displayed in plain text and are self explanatory Error Message Error Cause Dry Stick The test strip wasn t ELLE measurement dipped completely with a new strip Wrong Stick A wrong test strip has Use correct test strips been detected wrong type Wrong Stick Position The strip hasn t been New measurement pushed into the strip place strip in right retainer far enough position No Paper Paper roll empty or Replace paper and printer flap open close printer flap Battery Low Batteries are low Exchange batteries or use power pack Instrument doesn t start Power supply not Check whether all installed or defect connections are plugged in and whether the power socket is functioning In case an error message cannot be cleared by following the above instructions please contact your local distributor or Customer Service Manual V2 00 USA 06 08 45 User Manual 16 Technical Information 16 1 Technical Data Required electric supply Mains transformer Input 100 240 V Output 9 V 1 5 A Alternative battery operation with 6 mignon batteries 1 5 V AA Dimensions Height 7 5 cm 3 0 inches Width 16 cm 6 3 inches Depth 20 cm 7 9 inches Weight 710 g without batteries and power pack Range of Ambient Air Temperature 5 40 C 41 104 F Humidity 20 80 16 2 Security standards T
8. sn Rv ecu is aaa 9 3 1 List of delivered parts errar erre areeando 9 3 2 Description of instrument parts erre 10 3 3 Setting up the instrument e e eeeeeerereerena aerea 10 3 4 How to plug the instrument in erre 11 3 5 How to load the printer paper eee 11 3 6 How to install batteries optional es 12 36 1 E leue SO TeS Ett 13 JOZ CAMAN MEE 13 3 7 Use of the instrument seeessseessesesseeeen eene 13 QAM LI OINS T ad 13 ZAL VIDET 14 S73 TROUNO DUNONG c 14 A ISON MOI PP O RN NAU RPA O ND IR E RR ASAE ER AR RO 15 4 1 Flow chart of the Menu Structure eeeeeeeeeeeeeeeeeeeeee 15 4 2 Description of the Menu Items e e eeereerrenea 16 5 Analysis of Test Strips coercere eee desear ke Dad land a ua 17 5 1 How to perform a measurement erre 17 2 Display or Results ios oU Heg octa be diua EER 18 5 3 Measurement Errors eee serena enero 18 5 4 Entering the Patient Identification re 19 5 5 Changing the sequence number SN eee 20 5 0 Fransferririg datado a PC aos dir ter a beiden bein Dao lentes 20 6 Enter the Main Menlo ome ze eeu pev Do n rro iE neve nieces 21 Manual V2 00 USA 06 08 2 User Manual To Recall FOSUMS 2 so 22 7 1 How to scroll t
9. the number of measurements you would like to perform without additional warnings EXPIRE DATE EXPIRE DATE LOT has been Conti E ontinue expired NewLOT O strip Continue C 10strips Display 27 Expire date A Display 28 Expire date B 13 3 How to update the instrument Select Program update from the service menu The instrument now expects the upload of a new firmware Follow the instructions that come with the update file to finalize the update process Manual V2 00 USA 06 08 43 User Manual 14 Interface Description The instrument may be connected to a computer via the RS232 or the USB interface work station or laboratory information system 14 1 Serial Interface Protocol RS232 19200 Baud 8 bit no parity Picture 3 3 4 Connection plug arrangement Pin Signal Description Direction a a TU 2 RxD Datarecepton Input 4 JNo Notconnected 5 GND 9 JSigalgoud J 6 Nc QJNotcomeced 7 Ne JNoetcomeced 8 Nc JNotcomected J 9 Nc Notconnected 14 2 USB 1 1 Interface Please contact your local service provider regarding the necessary driver for your PC 14 3 Transmission Protocol The data is released via the interfaces as plain text The received dataset corresponds to the format of the printout 14 4 Barcode Scanner PC Keyboard A PS 2 jack Pic 3 3 6 is provided for connection of a keyboard or bar code scanner Manual V2
10. will reappear upon pressing Return Display 12 8 Manual V2 00 USA 06 08 23 User Manual 7 2 How to find specific results filtering To find the result you may select the date of the measurement and a specific parameter SET FILTER PAR E PAR WM Display 13 Filtering Manual V2 00 USA 06 08 24 User Manual 7 2 1 Selecting the Day By pressing the panel Day Display 13 9 you will reach the menu displayed below DAY Today All C Date X v Display 14 Select day Set the day with the buttons Display 14 Selecting Date will bring up a screen with the list of available dates only days with measurements are shown on the screen Select the desired date with the up and down arrows and confirm your selection by pressing After confirmation your selection will be displayed on the screen SET FILTER PAR Manual V2 00 USA 06 08 25 User Manual 7 2 2 Selecting Search Criteria Pressing Display 13 10 SET FILTER PAR brings up display Display 15 SELECT PARAMETER ID Seg No T Mot printed Not sent n All X x Display 15 Select parameter Use the arrow keys Display 15 11 to select the desired criteria and confirm with The filter criteria will be displayed on filter settings screen Display 16 Manual V2 00 USA 06 08 26 User Manual 7 2 3 Display suitable matches After setting Day and Parameter the search may be started by press
11. Disp 19 3 the sample selection will appear Select the type of control sample you want to analyze CHECK MODE Negative Positive x v Displa y 20 Control sample After pressing the instrument expects the test strip 9 2 How to review old QC measurements The equipment saves the results of the last 20 QC measurements in separate memory They may be displayed by selecting memory Display 19 2 and may be printed for documentation purposes Manual V2 00 USA 06 08 31 User Manual 10 Equipment Settings Enter the main menu by pressing the menu key Y to reach the SETTINGS display press Display 21 1 MENU SETTINGS Memory Password Printer Check mode Sound Autostart Battery Language i Settings Date Time x xv Display 21 Main menu Display 22 Settings 10 1 How to modify strip settings 10 1 1 Units The instrument can report the results in different units Conventional e g 10 mg dL SI e g 56 mmol L ARB Plus System e g Conventional ARB SI ARB Choose the desired unit from the menu Manual V2 00 USA 06 08 32 User Manual 10 1 2 Order of Parameters The output order of the parameters may be customized via a list of selections The parameters need to be selected in the desired order and confirmed by pressing L After the last parameter the equipment will ask whether the setting is to be saved Save by pressing _ or go back to the p
12. Y uL UBG NORM BIL NEG PRO NEG NIT NEG KET NEG lt gt GLU 50 mala gt pH SG 1 010 LEU NEG o Display 4 Result y 4 Result Positive findings are clearly marked by an asterisk on the printout and on the display Display 4 3 Additionally it is possible to enable an acoustic signal on positive findings The printout is light sensitive and may turn yellow when exposed to light during storage For archiving purposes the printouts should be kept in a dark place patient file or as a photocopy The result displayed may be printed again by pressing Display 4 4 The return panel Display 4 5 will lead back to the start screen 5 3 Measurement Errors If the display shows Measuring Error instead of a result please read the instructions in Chapter 14 Error Messages and Fault Clearance Repeat the measurement In case of permanent errors please contact Customer Service Manual V2 00 USA 06 08 18 User Manual 5 4 Entering the Patient Identification The patient identification needs to be entered before starting the analysis This can be done as follows a Directly on the equipment Pressing in the start menu brings up an alphanumeric keypad Enter the ID using the keys To enter characters i e Miller press Display 5 1 to change the character entry Repeated pressing on the same field within 0 5 seconds switches through the characters displayed on the key Wrong entries may be erased by pressi
13. ammed settings an acoustic signal will be given on positive findings Disable or enable this signal by choosing ON or OFF in the box Positive 10 5 How to deactivate and activate the autostart Select Autostart in the settings menu In basic mode the instrument automatically detects an applied test strip and starts the measurement This function may be deactivated via an option panel lf Autostart is deactivated the analysis must be triggered by pressing a panel in the Start menu 10 6 How to set energy saving options for the battery mode Select Battery in the settings menu Settings in this menu will only apply when the instrument is operated with batteries To increase the lifetime of the batteries the LCD backlight and the printer can be turned off using the option panels 10 7 How to change the language Select Language in the settings menu The language of the instrument menu can be switched to the following languages using the respective selective list English German Spanish French Italian Portuguese Polish Turkish and Hungarian Manual V2 00 USA 06 08 35 User Manual 10 8 How to set time and date Select Date Time in the setting menu To change press on the respective number A numerical pad appears Enter the correct number and confirm by pressing v The date may be formatted in three ways The active format is shown on a button Display 23 1 on the right hand side of th
14. ay 2 and transferred to the printer and interfaces RESULT seq Nr 0001 ID 1234567890 2006 02 17 BLD UBG BIL PRO NIT KET GLU pH SG LEU gar 10 ER Y uL E NORM NEG NEG NEG NEG 50 mg dl 5 0 1 010 NEG Display 2 Result By pressing the printer symbol Display 2 2 the result can be printed again Choosing the return panel Display 2 3 will lead back to the start screen Another analysis may be started by applying the next test strip Notice To start a new measurement it is not necessary to go back to the start screen A new strip is detected at any time and the measurement is then started automatically Manual V2 00 USA 06 08 User Manual 2 Introduction The instrument is a reflection photometer for the analysis of urine test strips When measurements are performed under standardized conditions measured values may be displayed printed and transferred to a computer The instrument is designed for in vitro diagnostic use IVD and should be used by healthcare professionals only 2 1 System Description 2 1 1 Measuring Principle The test strip moves below a fixed measuring head on a slide with an embedded reference pad The reflectometric analysis of the test strip and the reference field take place during withdrawal and release of the slide Pic 2 1 Measuring Principle The strip is illuminated with an LED and a detector registers the intensity of light reflected b
15. e date Select a date format by pressing this button Displayed Format Abbreviation Meaning Example Year Month Day 2007 12 17 Day Month Year 17 12 2007 Month Day Year 12 17 2007 The time format may be changed to 12 or 24 hours with the button displayed next to the time Display 23 2 DATE TIME Y X x Display 23 Date time Manual V2 00 USA 06 08 36 User Manual 10 9 How to activate data transfer Select Interface on the settings menu The data transfer via the interfaces can be activated or deactivated via an option panel 10 10 How to change the text of the printout header Select Customization in the settings menu The first two lines of the printout may be filled with a user specific identifier Each line contains 23 characters To enter the text an external keyboard or the alphanumerical pad on the display can be used The keys on the touch screen are linked to several letters Repeated pressing within half a second switches through the letters displayed on the key 10 11 How to print settings Select Print Settings on the settings menu to print the equipment settings for documentation purposes Thermo printings fade with time Therefore please copy the printout or store it in a dark place Manual V2 00 USA 06 08 37 User Manual 11 Cleaning and Maintenance DANGER OF INFECTION Urine and used test sticks bear the danger of infection Alwa
16. he LOT of strips currently used The system will give a warning when the test strips are expired After 100 measurements the system will ask for the LOT number of the next tube Manual V2 00 USA 06 08 41 User Manual 13 2 1 Entry of test sticks LOT If LOT control is activated the actual LOT number of the test strips can be entered using Strip in the menu Settings When selecting LOT number a numerical pad will appear which can be used for entering the LOT printed on the stick packaging If the entry does not have the format expected for a LOT number an error message will appear After entering the LOT information on the number of strips from that LOT is requested If three boxes of the same LOT are present please enter 300 for the number of strips LOT CODE NUMBER OF STRIP 100 x 4 Display 25 LOT code Display 26 LOT size NOTICE The instrument counts the number of strips If the number of measurements reaches the previously entered number of strips for that LOT the instrument will request the entry of a new LOT number Then please enter the LOT number of the strips you want to use Manual V2 00 USA 06 08 42 User Manual 13 2 2 Warning on expired test strips The date of expiry of the test strips is calculated from the LOT number If the expiry date has passed a warning will appear Display 27 If you choose to continue without entering a new LOT Display 28 appears Please choose
17. he instrument is in compliance with directive 89 336 EEC and conforms to the German EMV Law Furthermore it complies with directive 73 23 EEC This equipment and the designated test strips are in compliance with IVD directive 98 79 EC Manual V2 00 USA 06 08 46 User Manual 17 Customer Service If you have any questions after reading the manual or if you need further technical assistance please contact Customer Service Telephone 800 676 5565 E mail info accutest net Jant Pharmacal Corporation 16255 Ventura Blvd Suite 505 Encino California 91436 USA Manual V2 00 USA 06 08 47
18. hrough memory eee 23 7 2 How to find specific results filtering esssssssussss 24 fe T SBaleclino The DAY sto cn me Ede EE bv E Ue uas 25 7 2 2 Selecting Search Criteria esses 26 7 2 3 Display suitable matches esses nens 27 7 3 How to delete results from memory een 28 8 Expected waiver performance e ccseeeeeeeeeeee n 29 9 Quality control testigo ecce eee vet cete exec cene aa 30 9 1 How to run a quality Control test eee 30 9 2 How to review old QC measurements 31 TO Equipment Seltlfids x occid eec orco Oo Sadia cerise evocare iaa 32 10 1 How to modify strip settings eee 32 TO TATUS ausa eas ac a le Die M IM o t uL ELLE 32 10 1 2 Order of Paramelers oe Les seruo phu egeo a piu Rue ndo 33 10 1 8 Test SUCK BOT a ee v tec e uero bue ie Lu 33 10 2 How to protect settings from unauthorized access 34 10 3 How to turn the printer on and off iene 34 10 4 How to enable and disable acoustic signals 34 10 4 1 Acoustic confirmation of user inputs eee 34 10 4 2 Acoustic warning on positive results usus 35 10 5 How to deactivate and activate the autostart 35 10 6 How to set energy saving options for the battery mode
19. ing v SET FILTER PAR Day Today PAR Positive OX Y Display 16 Filtering Manual V2 00 USA 06 08 2f User Manual When suitable matches are found an option will appear allowing to print the datasets Display 17 12 send them to a PC Display 17 13 or display them on the screen Display 17 14 ae Print Sent Q Pitas ES Display 17 Search result If no matching results are found the equipment returns to the memory menu 7 3 How to delete results from memory Pressing Lp Display 11 4 will delete all data in the memory You will need to confirm this again on another screen Manual V2 00 USA 06 08 28 User Manual 8 Expected waiver performance At 3 sites 66 untrained users with no laboratory experience tested randomized samples using the Accustrip urine reagent strips and the Accustrip URS Reader The CLIA waiver study demonstrated that the performance of the Accustrip URS Reader is acceptable in the hands of non technical users when only the Quick Reference Guide is used to learn and perform tests The performance of the Accustrip urine reagent strip with the instrument in the hands of the Lay users met the primary performance criteria that 90 of the results should be within one level of the expected results Table 1 Percent Agreement of the instrument Results to Target Levels for Lay users Analyte Concentrations Exact Concentration Exact and tested Agreement 96 One 1
20. ng Display 6 2 1234567890 4 1294567890 2 3 3 ABC ABC oer 123 4 3 5 E s GHI JKL wo e IE E E PORS TUV WXYZ X V X v Display 5 Entering ID numerics Displa y 6 Entering ID letter b Using a standard PC keyboard Connect the keyboard to the PS 2 jack in the backside of the instrument User inputs on the keyboard will automatically be interpreted as Patient Identifications Using a bar code reader Connect the barcode reader to the PS 2 jack in the backside of the instrument Barcode readings will automatically be interpreted as Patient Identifications Manual V2 00 USA 06 08 19 User Manual After entering the patient identification start the measurement The Patient Identification is saved together with the diagnostic findings Attention A new ID cannot be entered before the present analysis has been completed 5 5 Changing the sequence number SN Pressing the field in the start menu brings up a numerical pad Enter a new sequence number using the keys on the pad All following measurements will now be counted from this number on Display 7 Seq Input 5 6 Transferring data to a PC The results may be transferred to a PC via the USB or RS232 interface A detailed description of the interface can be found in Chapter 14 Interface Description Manual V2 00 USA 06 08 20 User Manual 6 Enter the Main Menu Pressing Y on the sta
21. nter C Pic 3 9 Printer D Unroll the paper roll by 5 cm and place the roll in the paper compartment with the end on the lower side Fix the end of the paper to the housing with your forefinger while closing the flap Pic 3 8 3 6 How to install batteries optional The instrument can be operated with type AA batteries independent of the mains supply The battery compartment is on the underside of the equipment Notice the designated polarity marked on the battery compartment while inserting the batteries Pic 3 10 battery compartment Manual V2 00 USA 06 08 12 User Manual 3 6 1 Instrument self test The instrument will perform an automatic self test each time it is turned on If an error message appears the instrument will not start measurements In this case please contact your local service provider 3 6 2 Calibration The instrument will perform an automatic calibration each time a test is run 3 7 Use of the instrument All user inputs are done via a touch screen touch display All functions are activated directly by slight pressure with the finger on explicit pictograms or text representing the menu items 3 7 1 Buttons Framed areas react to pressure and trigger the action linked to it The caption of an area describes its function Examples Confirm perform action Cancel action e g display of equipment settings Manual V2 00 USA 06 08 13 User Manual 3 7 2 Scroll Arrows Press the
22. nter flap for paper replacement 4 Serial Interface Connection of a computer 5 USB Interface Connection of a computer 6 PS 2 Interface Connection of a keyboard or a bar code scanner 7 Mains Connection Contact for the provided power pack 8 On Off Switch I O Turning the equipment on and off 3 3 Setting up the instrument Place the instrument on a hard even surface where humidity and temperature are fairly constant Make sure that the instrument is allowed to acclimate to room temperature prior to use Make sure that you e Do not place the instrument near strong electromagnetic fields e Do not place the instrument near heating plates ovens or radiators e Do not expose the instrument to strong light sources i e direct sunlight Manual V2 00 USA 06 08 10 User Manual 3 4 How to plug the instrument in Pic 3 4 Power pack Pic 3 5 DC in Three adapters are provided for adapting the power pack to the available mains connection The adapter matching the mains connection is plugged on to the power pack Pic 3 4 After plugging the power pack cable into the jack DC in Pic 3 3 7 and connecting the power pack to the power socket the instrumentis ready for operation 3 5 How to load the printer paper Pic 3 6 Printer A Pic 3 7 Printer B Open the printer flap by pressing the rectangular key next to the paper outlet Pic 3 6 Manual V2 00 USA 06 08 11 User Manual Pic 3 8 Pri
23. reprogrammed order by pressing x 10 1 3 Test Stick LOT The LOT administration of the instrument is deactivated in the default setting See Chapter 13 2 LOT activate Manual V2 00 USA 06 08 33 User Manual 10 2 How to protect settings from unauthorized access Select Password in the settings menu if you want to protect the instrument settings with a PIN An option panel with the choices ON and OFF will be displayed Selecting ON will enable the PIN protection After enabling the PIN protection a numerical pad will appear Enter a 4 digit PIN and confirm by pressing The PIN will be asked for upon the next attempt to change the settings Attention A forgotten PIN can not be reconstructed Only a complete reset of the instrument will delete the PIN protection This will result in loss of all results and settings 10 3 How to turn the printer on and off Selecting Printer in the settings menu will bring up an option panel Choose the desired option and confirm 10 4 How to enable and disable acoustic signals Select Sound in the settings menu to enter the settings for acoustic signals 10 4 1 Acoustic confirmation of user inputs In the preprogrammed settings all user inputs are confirmed with an acoustic signal Disable or enable these signals by choosing ON or OFF in the box Touch Manual V2 00 USA 06 08 34 User Manual 10 4 2 Acoustic warning on positive results In the preprogr
24. rt screen will bring up the main menu SN 0001 P x ID 1025358 TEST STRIP INSERT STRIP E ww Display 8 Start menu From Memory H Check mode jo Settings ES Display 9 Main menu here the other functions e g memory 7 Recall results the test mode 9 Quality Control Testing as well as the settings 10 Equipment Settings can be reached Manual V2 00 USA 06 08 21 User Manual 7 Recall results The instrument has memory for 200 measurements Every result is automatically saved after the analysis After 200 measurements new data will overwrite the oldest saved dataset Access the memory by pressing Display 10 1 in the Main menu v List Memory D H Check mode oi KF Settings Search ote X Display 10 Main menu Display 11 Memory mode gt PD SD Manual V2 00 USA 06 08 22 User Manual 7 1 How to scroll through memory Pressing Display 11 2 will bring up Display 12 Scrolling through the memory is possible by pressing the arrows Display 12 5 on the right side The next gt or previous result will be displayed Seg Mo 0001 ID 1234567890 2006 021 847 BLD 10 ER Yul UBG HORM BIL NEG PRO NEG NIT NEG KET NEG GLU 50 mg dl pH 5 0 SG 1 010 LEU NEG Display 12 Memory contents It is possible to print Display 12 6 and send Display 12 7 the dataset displayed The memory menu
25. up and down arrows Display 3 2 on the right side of the screen to scroll through a list of information on the left side of the screen Once the desired information Display 3 1 on the left side is highlighted press L to confirm your selection SETTINGS O o er Fassword Frinter Sound Autostart lt gt Battery Language Date Time Interface X x Display 3 Selective lists Pressing will select the highlighted line You can leave the menu by pressing x 3 7 3 Round buttons These buttons typically appear on screens that require a selection among serial items The button with a filled circle is the current selection Today CO All Date Pressing the circle will activate a selection Save your selection by pressing Y Pressing x will quit the menu without performing any changes Manual V2 00 USA 06 08 14 User Manual 4 User Menu 4 1 Flow chart of the Menu Structure cw o HI Nemo ior Manual V2 00 USA 06 08 1 User Manual 4 2 Description of the Menu Items e SN 5 5 Changing the sequence number SN e ID 5 4 Entering the Patient Identification e Py Standby e V Main menu e Memory T Recall results e Check mode 9 Quality control testing e Settings e 10 2 Password e 10 1 Strip Parameters e 10 3 Printer e 10 4 Sound e 10 5 Autostart e 10 6 Battery e 10 7 Languages e 10 8 Date Time e 10 9 Interface e 10 11 Print Settings
26. y the test strip at three different wavelengths Using an Manual V2 00 USA 06 08 T User Manual internal calibration the results are calculated from the reflection values Whenever samples are strongly alkaline a density correction is automatically conducted 2 1 2 Functional Principle A measurement is started by placing a strip on the holder If the Autostart feature is turned off the measurement is started by pressing the start panel linthe display The result is shown on the display printed out and released via the interfaces after the measurement has been completed After three minutes the instrument will go to stand by Touching the screen will reactivate the instrument All user inputs are performed via the touch screen 3 Use of the instrument Manual V2 00 USA 06 08 8 User Manual 3 Unpacking and Set Up 3 1 List of delivered parts instrument reflectometer Power pack 100 240 V 47 63 Hz 9V Printer paper User manual this booklet Pic 3 1 Content Read the operating manual for the instrument carefully before the first startup in order to ensure an error free operation Manual V2 00 USA 06 08 9 User Manual 3 2 Description of instrument parts Pic 3 2 Front view Pic 3 3 Backside view Actuator Function 1 1 Touch Screen Control of equipment functions 2 Test Strip Slide Test strip retainer and automatic start of analysis 3 Printer Flap Opening the pri
27. ys use protective gloves during handling and disposal The disposal of used test sticks should be performed according to the regulations for the handling of potentially infectious material 11 1 How to clean the housing The instrument housing may be wiped with a cloth Mild cleaning agents or disinfectants may be used Ensure that no moisture permeates the equipment Manual V2 00 USA 06 08 38 User Manual 11 2 How to clean the strip holder Wipe off urine residues from the strip holder with a lint free cloth after each measurement This prevents crustification and drying of urine residues The strip holder can be removed from its transport mechanism and should be cleaned with water and when necessary with cleaning agent or disinfectant Make sure that the instrument is turned off before removing the test slide After cleaning the strip holder should be put back onto its transport mechanism carefully The rectangular notches of transport mechanism and stick retainer must be placed on top of each other Pic Notch B Pic 8 1 test slide Pic 8 2 NotchA Pic 8 3 Notch B bottom view Manual V2 00 USA 06 08 39 User Manual 12 Table of Results Param Param CONV SI ARB NEG NEG 10 Ery ul 10 Ery ul NORM NORM NORM 50 Ery ul 50 Ery ul 50 mg dl 2 8 mmol l 250 Ery ul 250 Ery ul 150 mg dl 8 3 mmol l NORM NORM NORM 500 mg dl gt 27 8 mmol 2 magia 35 umol l l 4mgd 7Oumoll
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