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PointCare NOW

1. e Sampling module e Counting bath module e Syringes module e Optical manifold e Optical bench The modules are connected together by semi rigid tubing 10 4 1 Sampling Module e This module enables the PointCare NOW to draw the sample and perform the WBC and CD4 dilutions e Itis assembled with a rotating rocker moving around a support which allows the system to move the sampling needle up and down e A reliable system of rack gear moves the rocker e The cleaning system of the sampling needle can be removed without tools e The o ring of the needle included in the cleaning system can also be removed without tools 10 4 2 Counting Bath Module This module allows the PointCare NOW to count the WBC measure the HGB and prepare the CD4 dilution Itis made with a manifold maintaining the reagent commutation valves and the counting bath block with their measurement block including the aperture The counting bath assembly and this aperture can be removed without tools Page 10 7 PointCare NOW TECHNOLOGY 10 4 3 Syringes Module This module enables the PointCare NOW to e draw the sample e distribute the reagents e drain the baths e maintain the vacuum necessary for counting e push the waste to the waste container e push the WBC sample and the diluent sheath into the flow cell It consists of a manifold maintaining the fluid commutation valves and the syringes block including five syringes e sampling syringe e lyse
2. 7 3 4 Run Quality Control e From the CBCNOW CD4NOW MENU select the desired control material and select RUN QC LOT e A dialog box will appear asking the user to confirm Seri TS a SS the selected lot number Select OK to continue ae Ma VER ERAN E ho Eb T SIRERE St TEES CR VERL Cy The control material must be used before its expiration ari UE AL TER AS date and stored according to the manufacturer s instructions for use Allow the control sample to come to room temperature before use approximately 15 minutes Mix the control tube by holding the vial horizontally between the palms of the hands and roll the vial back and forth for 20 30 seconds Mix by rapid inversion Vials stored for an extended period of time may require extra mixing e The sample door opens and a dialog box appears instructing the user to MIX AND INSERT CONTROL TUBE e Mix the Control tube by gentle inversion 8 10 times ensuring that no cells remain fixed to the bottom of the tube e Insert the Control tube into the rear test tube slot in the sample door e Select CONTINUE Page 7 9 PointCare NOW QUALITY CONTROL If the control type selected is a CBC Control the sample door will close and the analysis sequence begins If the control type selected is a CD4 Control a dialog box appears instructing the user to MIX GOLD AND RE INSERT o Remove the gold vial from the front slot and mi
3. From the DAILY CHECK MENU select RESTORE QC LOT The RESTORE LOT SCREEN is displayed The lot table contains a list of all lot numbers stored on the USB Flash Drive the level of the control Normal or Low and the type of control DC CBC or CD4 Select the entry number for the desired lot Select RESTORE to restore the desired lot and YES to confirm the selection A dialog box asks the user to confirm the desire to overwrite the originally selected control lot Select YES to confirm and return to the QUALITY CONTROL MENU with the restored lot level and type listed From the DAILY CHECK MENU select the desired control lot and select RUN QC LOT A dialog box will appear asking the user to confirm the selected lot number Select OK to continue Page 7 4 PointCare NOW 7 2 5 Results QUALITY CONTROL The sample door opens and a dialog box appears instructing the user to MIX AND INSERT DAILY CHECK TUBE Mix the Control tube by rapid inversion and gentle shaking 8 10 times Insert the Control tube into the rear test tube slot in the sample door Select CONTINUE At the completion of the cycle the sample door will open and the user will be prompted to REMOVE CONTROL TUBE Remove the control tube and select CONTINUE The control results are displayed The QC RESULTS SCREEN contains a summary of all the Control Lot information entered for that particular lot Included are the ti
4. 2 3 4 Mono Electronic Board e The mono electronic board is located between the fluidics and the reagent tray e The board driven by a 32 bit processor manages the following components Sample needle rocker syringe block motors Display and keyboard Connection mode RS232 Ethernet Printer Measurement Counting hemoglobin measurement Data processing O O O O External barcode reader To avoid the risk of damage only trained service technicians are allowed to access this electronic board Page 2 4 PointCare NOW GENERAL OVERVIEW 2 3 5 Reagent Tray The reagent tray is dedicated to the CD4NOW LiquiPack or the CD4NOW SuperWash Tampi ages freee em dg el ey bei adi Did pama sopresa ae ir pao mis i care ae E Ry Ss e Pa SST A Ey PA 2 3 6 External Power Supply Block A e The PointCare NOW is supplied with an external power supply block Switch on off The PointCare NOW has been certified with the power supply provided with the machine The use of another external power supply block is not guaranteed and will void the warranty Please contact your PointCare representative for assistance 2 3 7 Printer The Epson TMU220 printer is supplied with the PointCare NOW and allows for printing of QC and patient results instrument settings and various other reports 2 3 8 UPS Uninterruptible Power Supply An Uninterruptible Power Supply UPS is supplied with the PointCare NOW A U
5. Sal E A MASE results e FORMAT USB FLASH DRIVE allows the operator to format the USB Flash Drive This will erase all data on the USB Drive and create the Folder System required to write data to and load data from the USB Drive _ e Inthe HEADER section two editable fields are available to allow the user to change the header as it will appear on the results printouts use A Z button to edit the HEADER field e Once modifications are complete press either OK to accept or CANCEL to exit to keep the previous settings Page 3 3 PointCare NOW LAB MANAGER 3 9 EN o ok R a one ae MA 3 9 1 Lab Settings SER a ME ADMINISTRATION AND SETUP The LAB MANAGER option allows the user to access general lab settings OC settings and the archived results manager The LAB SETTINGS screen consists of the following buttons e SYSTEM OPTIONS e USER MANAGER e PRINTER UPDATE e UPGRADE SOFTWARE e LOAD NEW SETTINGS e SAVE SETTINGS e CLINIC NAMES e PRINT LAB SETTINGS e DONE Page 3 4 PointCare NOW ADMINISTRATION AND SETUP 3 9 1 1 System Options DAA E RSS se The SHUT DOWN mn field allows the user to adjust EDO SPD the idle time in minutes before the instrument will perform an automatic shutdown The default setting is 180 minutes e To allow expired CD4NOW reagents to be used on the PointCare NOW select the box to the left of the text e The UNITS drop down menu allows the
6. e If PROCEED is selected a status box will appear that says Performing Clean Cycle Please wait and the clean cycle will begin r THIS CYCLE ES APPROXIMATELY amp MINUTES e When the cycle is complete the user will be returned to the TROUBLESHOOTING MENU 11 5 2 Fluidics e Select FLUIDICS from the TROUBLESHOOTING MENU TANDESET WEA e The FLUIDICS MENU consists of the following buttons x SS e DRAIN ALL e RINSE ALL e BACKFLUSH e INIT PRESS EEE SSA e TROUBLESHOOTING MENU UES WARE TES SST A E 11 5 2 1 Drain All DRAIN ALL launches a cycle to drain the counting baths the flow cell and the syringes 11 5 2 2 Rinse All RINSE ALL launches a cycle to fill the counting baths and the flow cell with diluent 11 5 2 3 Backflush BACKFLUSH launches a cycle to perform a backflush in the WBC aperture and the flow cell Page 11 9 PointCare NOW MAINTENANCE AND TROUBLESHOOTING 11 5 2 4 Init Press INIT PRESS launches a cycle to initialize the pressure 11 5 3 Mechanics Select MECHANICS from the A AA Ki AA e Oa dee TA a MN SEa Mea MEM SE MEY ET MA 11 5 3 1 Motor Init x EES MERN o TROUBLESHOOTING MENU The MECHANICS MENU consists of the following buttons e MOTOR INIT e CHECK VALVES e CHECK NEEDLE e CHECK ROCKER e CHECK SYRINGE e CHECK SENSORS e HGB LED OFF e OPT LED OFF e TROUBLESHOOTING MENU MOTOR INIT launches a
7. Control The printed page will be displayed as shown above e Select DONE to return to the Quality Control Menu Page 7 11 PointCare NOW QUALITY CONTROL 74 QUALITY CONTROL MANAGER The Quality Control Manager Menu display presents the identification of the lots and allows the Laboratory Manager to view previous QC results e To access the QUALITY CONTROL MANAGER MENU select ADMINISTRATION from the MAIN MENU e Select LAB MANAGER then OC MANAGER e The QUALITY CONTROL MANAGER MENU is displayed e Either DAILY CHECK CONTROL OR CBCNOW CD4NOW may be selected depending on the type of control results to be viewed SA GARR Sas q EEA SOREL AR Sr a Page 7 12 PointCare NOW RA SE Ga Sah A A A Gt TRATA Th IAS E A Se IAS MES NEL SES ME SES Aa oo SA EEE 7 4 1 Edit Lot Information be IIT SS e de OS ANA he ee A SID Vi ML Ws WOIT MERENGUE IEA TEn eR ARUBA RE TERARI VE Ni he THA 1 ee ARM EEE DS NI aa AS an AE Ta WAS SHER Gee AN SEMIN Ta hk QE SS Su N Es ei E EA OSs D Pi AAN 7 4 2 Save Lot Information QUALITY CONTROL The QUALITY CONTROL MANAGER is displayed The last active lot is selected by default To choose another lot select the button for the desired lot From the QUALITY CONTROL MANAGER screen select EDIT LOT to modify the lot identification and target values The EDIT
8. LOT INFORMATION SCREEN contains numeric fields for entering the high and low target values for all the reportable parameters for each control type Make changes to the lot number information if desired and press OK The optional barcode reader can be used to enter information automatically see Section 5 3 3 The user will be returned to the QUALITY CONTROL MANAGER screen Select SAVE to save the selected lot to a USB Flash Drive e From the QUALITY CONTROL MANAGER screen select SAVE QC LOT e Confirm to save the selected lot to a USB Flash Drive Page 7 13 PointCare NOW QUALITY CONTROL 7 4 3 Restore Previous QC Lot from Memory Parr kb ea e w AA THESES WNO OCEN Wink a en NO MA WER GR E WOO A VER TA EA CEs ER 7 4 4 View Results Ran SCS EES TINT From the QUALITY CONTROL MANAGER screen select RESTORE QC LOT The RESTORE LOT SCREEN is displayed The lot table contains a list of all lot numbers stored on the USB Flash Drive the level of the control Normal or Low and the type of control CBC CD4 or DC Select the entry number for the desired lot Select RESTORE to restore the desired lot and YES to confirm the selection A dialog box asks the use to confirm the desire to overwrite the oldest lot of that type of control in the internal memory Select YES to confirm and return to the QUALITY CONTROL MANAGER screen with the restored lot level and type lis
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10. cycle that resets the sample door rocker needle and syringe motors 11 5 3 2 Check Valves Sh oh Th gt i gt sh sh E ot a bode a gt CHECK VALVES launches the CHECK VALVES screen The CHECK VALVES screen contains buttons for testing each individual valve and a button ALL EV for testing all of the valves at one time DONE returns the user to the MECHANICS MENU Page 11 10 PointCare NOW MAINTENANCE AND TROUBLESHOOTING 11 5 3 3 Check Needle CHECK NEEDLE performs a complete test of the needle 11 5 3 4 Check Rocker CHECK ROCKER performs a complete test of the rocker 11 5 3 5 Check Syringe CHECK SYRINGE performs a complete test of the syringe 11 5 3 6 Check Sensors e CHECK SENSORS launches the CHECK SENSORS screen e The CHECK SENSORS screen displays readings in real time for monitoring the sensors embedded in the PointCare NOW e Sensor readings include o Current pressure and ambient temperature o Current measured value of the HGB WBC FSC and ALL counting channels Peo SSE ESE a de SEES SS o Home states of the needle rocker and syringe ots GSS TERR SEER SSE o Switch state of the door aa Nh SSE Ga MIANG o State of the holders for Tube 1 Tube 2 and Tube 3 SE SE WERE o Door closed and door open states NS Ki STON o Temperatures of the enclosure and the reagents Saw ie o Heat settings for the enclosure and the reagents e DONE returns the user to the MEC
11. dialog box appears instructing the user to REMOVE GOLD Remove the gold vial and press CONTINUE A dialog box appears instructing the user to MIX GOLD AND REINSERT o Remove the gold vial from the front slot and mix 8 10 times by holding the vial upsidedown and flicking the side of the vial with a finger o Turn the vial right side up and tap on the table 3 4 times to ensure all gold settles to the bottom of the vial Reinsert the vial into the first slot on the sample door A dialog box appears instructing the user to LOCK GOLD Make sure the gold is locked in place before continuing o Rotate the vial locking mechanism clockwise to lock Select CONTINUE The sample door closes and the user is returned to the REAGENT MANAGEMENT MENU Page 5 6 PointCare NOW REAGENTS 5 33 CD4NOW SuperWash Check Level and or Replacement e Select CD4NOW SUPERWASH to access the CD4NOW SUPERWASH INFO screen e The CD4NOW SuperWash is a special reagent used only for the Longterm Shutdown and Shutdown for Shipping cycles e Check the volume remaining in the CD4NOW SuperWash as indicated by the reagent volume icon e If the CD4NOW SuperWash needs to be replaced if a Longterm Shutdown or Shutdown for Shipping is required enter the lot number from the label on the SuperWash box This can be done automatically using the barcode reader see Section 5 3 4 e Press REPLACE REAGENT to accept the new entry and r
12. notify the carrier of any damage Open the boxes and verify the contents e BOX 1 The instrument box contains PointCare NOW Instrument Waste line with cap 150W switching adapter Power cord PointCare NOW Quality Control Certificate Screwdriver Slot 1 4 Barcode Reader USB Flash Drive Maintenance Pack described in the table on the following page O O O O O O O O e BOX2 The accessory box contains o PointCare NOW User Manual o PointCare NOW Quick Reference Guides o Tape Roll Printer e 1 Paper Roll e 1 Ink Cartridge Page 1 1 PointCare NOW INSTALLATION o Waste Container o Bleach Kit o SuperWash Solution e BOX 4 PointCare NOW UPS or Portable Battery Power System ABD NOTE The System reagents and controls are necessary to operate the system and are supplied in separate boxes NOTE An approved UPS or Battery Power System is mandatory under PointCare warranty conditions Qty 500mm P 500mm P 1000mm P 500mm P 1 1 3 Visual Inspection Open the door on the right side of the instrument using A the key provided in the kit Page 1 2 PointCare NOW INSTALLATION p Te js 1 a the following j X Remove the foam insert from inside the door and check 1 Counting chambers tightly locked in their manifold location 2 Needle s dismountable system located firmly in the rocker 3 WBC counting aperture locked firmly in place Rotates clockwise to lock WARNI
13. on and plugged in properly Select a printer See Section 3 8 Select at least one result on the QC Manager screen Modify the value Enter a valid lot number Enter a Patient ID Enter a valid lot number Ensure the printer is switched on and plugged in properly Ensure the printer is switched on and plugged in properly Ensure the printer is switched on and plugged in properly Replace the paper roll Perform Motor Initialization Re start the PointCare NOW Re start the PointCare NOW Re start the PointCare NOW Re start the PointCare NOW Page 11 16 PointCare NOW MAINTENANCE AND TROUBLESHOOTING SVM BAD VERSION SVM ILLEGAL SERIAL NUMBER SVM UNMATCH SYSTEM INTERNAL TIME OUT SYSTEM FATAL ERROR SYSTEM UNKNOWN ERROR THIS PRINT OUT IS NOT AVAILABLE ON THE Select a different printer See Section 3 8 SELECTED PRINTER USB FLASH DRIVE IS NOT PRESENT Plug a USB flash drive into the back of the instrument WASTE ALMOST FULL Empty the waste container ATTENTION LIQUIPACK HAS EXPIRED PRESS Replace the LiquiPack See Section 5 3 1 REAGENTS BUTTON TO CHANGE REAGENT O ATTENTION GOLD HAS EXPIRED PRESS Replace the GOLD Bottle See Section 5 3 2 REAGENTS BUTTON TO CHANGE REAGENT AO 118 EMERGENCY STOP The user can carry out an emergency stop at any time during any cycle This is done by BRIEFLY pressing the ON OFF button on the PointCare NOW This will immediately stop all movements and cycling of
14. problem continues contact your PointCare representative MESSAGE ACTION ACCESS DENIED YOU ARE NOT ALLOWED Contact someone with the proper access level Clinician or TO ACCESS THIS MENU Administrator ATTENTION CONTROL TUBE HAS BEEN OPEN The selected control lot has been open too long Enter a TOO LONG PLEASE ENTER A NEW LOT IN new lot QUALITY CONTROL MENU ATTENTION CONTROL TUBE HAS EXPIRED The selected control lot has expired Enter a new lot PLEASE ENTER A NEW LOT IN QUALITY CONTROL MENU BACKUP BAD FOLDER DUPLICATION Re start the PointCare NOW BACKUP ERROR HISTORY IS FULL Contact your PointCare representative BACKUP FOLDER NOT FOUND Re start the PointCare NOW BACKUP MEMORY IS ALMOST FULL PLEASE Delete old results see Section 3 9 3 E BACKUP NO MEMORY AVAILABLE FOR Delete old results See Section 3 9 3 A A Re start the PointCare NOW Page 11 15 PointCare NOW MAINTENANCE AND TROUBLESHOOTING HARDWARE A L L OPTICAL ID FAILED HARDWARE F S C BOARD ID FAILED HARDWARE FAN FAILED HARDWARE HEAT ENCLOSURE FAILURE HARDWARE HEAT ENCLOSURE STOPPED HARDWARE HEAT REAGENT FAILURE HARDWARE HEAT REAGENT STOPPED HARDWARE SYSTEM ERROR INFORMATION WRONG PASSWORD INIT PRINTER INPUT PARAMETER CD4 IS INVALID IT MUST BE BETWEEN 0 00 AND 3000 00 INPUT PARAMETER EXT IS INVALID IT MUST NOT BE EMPTY INTERN COUNT ERROR INTERN MEMORY CORRUPTED INTERN NO MEMORY AVAILABLE INTERN RESU
15. reach the analysis display NS This prompt appears when the he o RA AS MA EE Co Nas results memory is almost full x This prompt appears when iE the results memory 1S totally full e To backup and delete results see Section 3 9 3 Patient information is required prior to analysis y SR UTE SS i BES LETS MEA SES MGA SoS Nal GR NAA O o WM Three fields allow the entry of the identification o Patient Name 20 characters max o Patient Identification 16 characters max o Sample Identification 16 characters max Enter the age of the patient o This field accepts numbers up to 99 o If the age of the patient is unknown select the Age UNK box Select the sex of the patient There are 3 options o Unspecified default o Female o Male Page 8 2 PointCare NOW Identification Procedure TEESE ME Sa PEA SELMER ES SAMPLE ANALYSIS Using the drop down menu select the BLOOD DRAW DAY There are 4 options o Today o Yesterday o 2 Days Ago o More Than 2 Days Ago If the day of draw is unknown select the DAY UNKNOWN box This is the default setting if the BLOOD DRAW DAY is not selected Enter the time of draw in the BLOOD DRAW HOUR field o The BLOOD DRAW HOUR field accepts numbers up to 24 o The default time is 0 00 If the time of draw is unknown press the HOUR UNKNOWN box Press to access the keyboard to type out the Patient Name Pati
16. syringe e two waste and vacuum pressure syringes e diluent syringe Only one motor is used to drive the five syringes and the waste output is also included in this manifold 10 4 4 Optical Manifold The optical manifold allows the PointCare NOW to drive the different reagents toward the counting bath module or toward the optical bench It contains seven commutation valves 10 4 5 Optical Bench The optical bench allows the PointCare NOW to measure the leukocyte sub populations It is made of three parts e Illumination module which contains the semi conductor light source a beam adjustment glass smear and lens e Flow cell made with injected plastic in which the sample and the passive sheath flow e Detection module which contains lens photodiodes and the amplifier boards for the two measurement axes Page 10 8 PointCare NOW MAINTENANCE AND TROUBLESHOOTING 11 MAINTENANCE AND TROUBLESHOOTING The quality of the results and the reliability of the PointCare NOW are a direct result of adhering to the maintenance described in this section To perform the maintenance and the repair described in this section it is mandatory to have received adequate training to wear latex or nitrile gloves and to wash hands thoroughly after completion of work according to your laboratory s protocol 11 1 PREVENTIVE MAINTENANCE TABLE This table shows the required level of preventive maintenance for a PointCare NOW NOTE T
17. the PointCare NOW The user will thereafter be forced to perform a system reset see Section 11 5 1 The instrument will automatically perform an emergency stop if the door on the right side of the PointCare NOW is opened during a cycle unless prompted to do so The user will thereafter be forced to perform a system reset see Section 11 5 1 Page 11 17 se PointCare PointCare Technologies Inc 181 Cedar Hill Street Marlborough MA 01752 USA Telephone 1 508 281 6925 Fax 1 508 281 6930 www pointcare net
18. the box e Place the diluent straw white into the diluent bottle the cleaner straw blue into the cleaning solution bottle and the lyse straw yellow into the lyse reagent bottle Tighten all caps Waste e Connect the waste tube red to the top outlet on the back of the instrument e Add 3 waste tablets to an empty waste container e Tighten the cap of the waste line on the empty waste container e Place the waste container on the floor or at a level lower than that of the instrument to ensure proper waste flow to the container Do not modify the type and the length of the waste tube It is mandatory to collect the waste in a container and treat it in compliance with your local legislation Page 1 7 PointCare NOW 1 4 2 System Startup INSTALLATION Before starting be sure that all the reagent and waste tubing lines are properly connected and not pinched or obstructed in any way The reagents must be stored at room temperature 18 30 C for a minimum of 24 hours before use 1 Power Up the Instrument PointCare LOGIN Manase j j CLINIC FACTORY PASSWORD ENGLISH j LOGIN j PointCare Ensure the power supply block is connected Press the ON OFF button on the instrument The cycle LED turns red No cycle can be performed until it turns green The information window may appear for up to 6 minutes to enable an update of all the files 2 Log
19. user to choose the units in which the results are reported The options are Sa EARS wis eee o Standard o SI o MMOL o EXP e Select OK to save changes or CANCEL to return to Y os s the LAB SETTINGS Menu Using expired reagents is beyond the labeling and intended use of the PointCare NOW System PointCare does not recommend the use of expired reagents as this may have a direct impact on the reported patient analysis results 3 9 1 2 Printer Update e The screen contains a list of all the printer drivers available on the USB Flash Drive and a display of the selected printer and its corresponding port e To select a driver press the number beside the printer name and select UPDATE e Select YES to upload the driver o Ifthe selected printer driver is not compatible with the system a prompt will warn the user e Upon driver update the user is returned to the LAB SETTINGS MENU Shoe ENS i TE PE Page 3 5 PointCare NOW 3 9 1 3 Load New Settings ADMINISTRATION AND SETUP e This option is used to load instrument settings provided by your PointCare representative e Select LOAD SETTINGS The instrument searches for the settings file on the USB Flash Drive o The user is warned if the files are not found o If the correct files are found confirm update of previous settings 3 9 1 4 Clinic Names TARD VANADE RS coe A ok AAEM T To ME MG To SE T
20. 1 PointCare NOW QUALITY CONTROL 7 2 DAILY CHECK CONTROLS e To access the Daily Check Control Menu select A SAR a TEENI VeA NA A as T REME USE Taa n a AET DAILY CHECK CONTROL from the QUALITY CONTROL MENU The DAILY CHECK MENU allows the selection and or entering of lot information and displays previous lots used The last lot used is selected by default o To choose another lot select the button for the desired lot EDIT LOT allows modification of the lot ID and the target values for the selected control SAVE QC LOT saves the selected lot ID and target values to the USB flash drive RESTORE QC LOT restores previously saved lots of controls run from the USB drive to the PointCare NOW Select RUN QC LOT to perform QC analysis using the selected control material Select EXIT to return to the MAIN MENU Page 7 2 PointCare NOW 7 2 1 Edit Lot Information A Sra amp ea mh MAA ets TET MST TN Nia SSD ASSES MRE SS UNA SS s i Sa p Lo MARAEA TERS MA E USL ie M Te ARNIS TMA Eo E gt Eo a METAR 5 mE DEE ss SEE NSN Seek WON i Sa 7 2 1 1 Loading OC Information a wate A Ta Sk a A w ATA a TINN Pare h mrm A e pol Teen N AN HRS y SSE MN AR ER A N AA TER Ee ae WO ER oh QUALITY CONTROL From the DAILY CHECK MENU select EDIT LOT to modify the lot ID and target values The EDIT LOT INF
21. 10 7 POL oamp ine Module seai A RARA AA ATA 10 7 105 2ConinebatMo detailed 10 7 TOPS VAISS Mod We atico 10 8 WEPT aM o it iodo 10 8 1000 Optical Bene Meann e a od 10 8 PointCare NOW TABLE OF CONTENTS 11 MAINTENANCE AND TROUBLESHOOTING ssssssessseesseeeceeecccccsssssseseeeeeeecccccossssseeseeeeeecececcosssssseseeeeeeeeeeeeeeeeesssee 11 1 TELEREVENTIVE MAINTENANCE TAR ns lira 11 1 I ATEAN a idos 11 2 HATA OC CAI AAA a a AON 11 2 TE 1 AA a A A a A aA 11 2 OAAS o A leus T Aichi E ts tach en te seta T Sula E Acct T A Desa cteadaineei 11 2 TES Te Oi sos cee rt acta acca oe ee e e A cae he cece ethene 11 3 TLAPREVENTIVCE MEAN ENANA e a Geen 11 3 11 41 Preventive Maintenance IEA A A Boreas 11 3 LADO ai A A A SAA A ASA 11 4 LAS OY TAIL Ia SN al eh htt ba clas sa ae nan aries 11 5 W424 Service NO i ee ee E E 11 6 AAN LEN am tenance NI OO cans ia siadayaio ha ravet ni cosuanassovuaniy vase is 11 7 TLS TROUBLESHOOTING MN o cats ceded id athe Sh deca 11 8 TO A saa ssh sae caution vastus atc ea ean ecesoh penance 11 9 A ETE 11 2 A E E NN TNO E 11 9 Hea o a ET 11 10 UES Sale VIDEO EE E E AE E E AT KOE EET AS KE OE T EAEE E 11 12 EION IEW ETOT LOC rannen iS NASA AET 11 12 LETOVI ONA OS e T A A A AA A 11 13 LO PONTE Sp tion 11 13 11A DROVUBEES AOO FING MESSAGES 11 14 1E POPU pe WOW Sacate rota ara 11 14 11 72 ROp Up Window Messit ES ratita iio d baina 11 15 TESEMBRE EN O O cade 11 17 PointCare NOW BEFORE USE READ THIS BEFORE USING THE EQUIPM
22. EAN button on the MAIN MENU It is performed as a troubleshooting procedure for repeated flagging or as instructed by your PointCare representative 11 2 3 AutoCycle An AutoCycle is performed at set intervals once the instrument has been turned off This interval will be set by your service representative The AutoCycle flushes the system keeping fluids circulating through the system post shutdown Page 11 2 PointCare NOW MAINTENANCE AND TROUBLESHOOTING 113 CALIBRATION The PointCare NOW System is factory calibrated and does not typically require adjustment Calibration should only be checked if the PointCare NOW controls report values that are out of the supplied ranges If it is suspected that the system is out of calibration contact PointCare Customer Support for guidance Calibration of the PointCare NOW can only be carried out by a qualified PointCare Technical Service Engineer or PointCare Representative and will require a service visit 114 PREVENTIVE MAINTENANCE The PREVENTIVE MAINTENANCE button on the ADMINISTRATIVE MENU allows the user access to maintenance steps and procedures that will assist in the long term care of the PointCare NOW 11 4 1 Preventive Maintenance Screen 2 The PREVENTIVE MAINTENANCE screen consists of the following buttons e BLEACH e GREASE SYRINGE SERVICE NEEDLE e VIEW MAINTENANCE LOG e ADMINISTRATIVE MENU pie Se dr ia b lc a e ae s Page 11 3 PointCare NOW MAINTENANCE A
23. ENT WARNING RISK OF DANGER Indicates a procedure to be strictly adhered to in order to avoid any risks to the operator user damage to the instrument or compromised results BIOHAZARD Indicates that wearing gloves is mandatory before performing the described operation due to risk of contact with materials that may be infectious Indicates hot temperature surfaces and risk of burns Indicates important additional information DANGER Misuse of electrical equipment may cause electrocution burns fire and other hazards e Check that the voltage setting matches the supply voltage e Protective grounding is required plug the PointCare NOW into a supply outlet which has a ground connection e Incase of emergency ensure the power supply outlet of the PointCare NOW is easily accessible e Do not place the power supply adaptor in liquid or put it where it could fall into liquid If the power supply adapter becomes wet unplug it before touching it e Do not use the PointCare NOW if it is not working properly or if it has suffered any damage damage to the supply cord or its plug damage caused by dropping the power supply adaptor e Do not let the power supply adaptor or its flexible cord come into contact with surfaces which are too hot to touch e Donot place anything on top of the PointCare NOW e Donot use the PointCare NOW where aerosol sprays are being used or where oxygen is being administered e Donot use the PointCare NOW ou
24. ERE AB Th SAE Tr SAE NES Tr SE Ea T SEAR DERE T TIRENI TAIETE T To TRINE Ma TU SSE Th SE MA Xu o Rh TANE 3 9 1 5 User Manager Select CLINIC NAMES to edit Clinics names The FACTORY Clinic entry cannot be renamed The default clinic names are CLINIC2 CLINIC20 To rename a clinic select the desired default and click on the A Z button to access the alphabetic keyboard Press VALID to accept the new clinic name Select CANCEL to return to the LAB SETTINGS MENU Select USER MANAGER to access the User Manager Screen The following information is displayed o Table listing the current users o Login Name field to add edit names o Password field to add edit passwords o Field to set user access level User access levels include Administrator Clinician or Operator o Check box to activate user login names Selecting a user from the table will allow the user to edit the Login Name Password Access Level and Active Status Press OK to accept the changes or CANCEL to return to the LAB SETTINGS SCREEN The first entry in the table is Manager This can only be edited by a user with Service access Page 3 6 PointCare NOW ADMINISTRATION AND SETUP 3 9 1 6 Upgrade Software wm e Confirm that the desired USB Drive containing the upgraded software version is plugged into the system e Select UPGRADE SOFTWARE to upgrade the version of software on the PointCare NOW e A list of all the ava
25. ERVIEW PointCare NOW consists of 8 main components 1 Display Pad Dilution hydraulics Mono electronic board Reagent tray External power supply block Printer UPS Uninterruptible Power Supply 8 Barcode reader a Oy Oh se YP Page 2 1 PointCare NOW GENERAL OVERVIEW 2 3 MAIN COMPONENT DESCRIPTIONS 2 3 1 Display Pad ON OFF button Exit ESCAPE Cursors Enter ENTER Cycle in process LED Touch screen LCD display 2 3 2 Main Menu Description nm MA S SONS Sample Administration Analysis Access Section 8 PA Section 3 Quality System Startup Control Ca Section 6 Section 7 Reagent SEMA System Clean Replacement Section 11 2 Section 5 Operator System Logout Shutdown Section 9 1 Section 9 2 Page 2 2 PointCare NOW GENERAL OVERVIEW 2 3 3 Dilution Fluidics The fluidics are located on the right side of the instrument and consist of three modules e Sampling module o Rocker Manages the transverse movement of the needle o Needle Manages the aspiration and dispensing of all samples and reagents e Syringe module o Reagent sampling and waste syringes o Liquid valve manifold assembly and tubing e Counting chambers o WBC counting and hemoglobin measurement chamber o CD4 preparation chamber o Liquid valve manifold assembly and tubing Optical bench Optical manifold chamber WBC counting module Page 2 3 PointCare NOW GENERAL OVERVIEW
26. HANICS MENU 11 5 3 7 HGB LED OFF HGB LED OFF ON turns the hemoglobin LED on or off 11 5 3 8 OPT LED OFF OPT LED OFF ON turns the optics LED on or off Page 11 11 PointCare NOW 11 5 4 Satellite MA A EAA ESE k MANNA AA ha aid ERA h ESA ETT UR TEIS 11 5 5 View Error Log 4 AA A RAS E TE MEA En a Se A AA AAA AA Eb A IA MA O gt RAE E EA A MARS RSE AO PARA MAINTENANCE AND TROUBLESHOOTING Select SATELLITE from the TROUBLESHOOTING MENU The Satellite function of the PointCare NOW is not currently activated and should not be used Select VIEW ERROR LOG from the TROUBLESHOOTING MENU This screen allows the administrator to view the date and time that an error has occurred as well as the code and the origin of the error To see the origin of the error press on the error number located on the left of the date A description of the error appears at the bottom To print the error log select PRINT To save the entire set of log entries in memory to a USB flash drive select SAVE DONE returns the user to the TROUBLESHOOTING MENU Page 11 12 PointCare NOW MAINTENANCE AND TROUBLESHOOTING 11 5 6 View Plots e Select VIEW PLOTS from the TROUBLESHOOTING PID PR447E MENU TEST DATE TINE i482 15 41 e This screen displays the most recent cytograms dotplots SEQ 3 GOLD NO GOLD from the last 40 analyses performed e This scr
27. HESE INSTRUCTIONS NOTE This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help The user may find the following booklet prepared by the Federal Communications Commission helpful How to identify and Resolve Radio TV Interference Problems This booklet is available from the U S Government Printing Office Washington D C 20402 Stock No 004 000 00345 4 Pursuant to Part 15 21 of the FCC Rules any changes or modifications to this equipment not expressly a
28. LT AREA IS LOCKED Contact your PointCare representative Contact your PointCare representative Contact your PointCare representative Contact your PointCare representative Contact your PointCare representative Contact your PointCare representative Contact your PointCare representative Re start the PointCare NOW Enter a valid password for the selected User name Switch on the printer Enter the correct CD4 value between 0 and 3000 Enter a valid ext value Re start the PointCare NOW Re start the PointCare NOW Re start the PointCare NOW Wait before performing a cycle If problem persists re start the PointCare NOW LIQUIPACK ALMOST EMPTY Ensure a LiquiPack is available for replacement and notify a Clinician or Administrator MECA HOME_NOT_FOUND MECA MOTOR GAP MECA NEEDLE NOT IN TOP POSITION MECA MOTOR BUSY Perform a motor initialization or a reset cycle Perform motor initialization Perform a reset cycle Re start the PointCare NOW If this does not solve the error contact your PointCare representative NO PRINTER RESPONSE NO PRINTER SELECTED ONE RESULT MUST BE SELECTED OUT OF RANGE PARAMETER LOT IS INVALID PARAMETER PATIENT ID IS INVALID PLEASE INPUT VALID LOT TO ACCESS MENU PRINTER ERROR PRINTER IS BUSY PRINTER IS OFF PRINTER NO PAPER ROCKER HOME POSITION NOT FOUND RS232 BUFFER FULL RS232 ACK ERROR RS232 INTERNAL ERROR RS232 SYNCHRO ERROR Ensure the printer is switched
29. N displays the LOAD LOT SCREEN The lot table contains a list of all lot numbers stored on the USB Flash Drive the level of the control Normal or Low and the type of control CBC or CD4 Select the entry number for the desired lot and select LOAD The user will be returned to the EDIT LOT INFORMATION SCREEN and all fields will be automatically filled in with the information for that lot Select EXIT to return to the EDIT LOT INFORMATION SCREEN without loading new lot information e From the QUALITY CONTROL MENU select SAVE QC LOT e Confirm to save the selected lot to a USB Flash Drive 7 3 3 Restore Previous QC Lot from Memory S SEMEENER A D TE Wink Pa A eN NO MA WER ER SOAS WO A VER T EHS A A GAEL O O AA VER T Se MNO O MA VER NONO NO From the QUALITY CONTROL MENU select RESTORE QC LOT The RESTORE LOT SCREEN is displayed The lot table contains a list of all lot numbers stored on the USB Flash Drive the level of the control Normal or Low and the type of control CBC or CD4 Select the entry number for the desired lot Select RESTORE to restore the desired lot and YES to confirm the selection A dialog box asks the user to confirm the desire to overwrite the oldest lot of that type of control in the internal memory Select YES to confirm and return to the QUALITY CONTROL MENU with the restored lot level and type listed Page 7 8 PointCare NOW QUALITY CONTROL
30. ND TROUBLESHOOTING 11 4 2 Bleach Bleaching is necessary once a week to clean the WBC and CD4 baths or when PointCare NOW is continuously flagging one measured parameter e Select BLEACH from the PREVENTIVE MAINTENANCE DO WOU WISH TO BLEACH NOW PRESS CONTINUE TO R N BLEACH MENU to begin the cycle e The user will be asked to confirm performing a bleach cycle CANCEL e Selecting CANCEL will return the user to the PREVENTIVE MAINTENANCE MENU e If bleaching was required a prompt will warn the user that they have chosen to ignore the recommended bleaching INSERT GREEN TOPPED TUBE This warning will appear daily until bleaching is performed e Selecting CONTINUE will open the sample door Place a bleach tube in the last position in the sample door e Selecting CONTINUE will close the sample door and commence the bleaching of the PointCare NOW CANCEL CONTINUE components e The instrument will then run for a few seconds to drain the baths The user will be asked to Open side door and wipe both baths with cotton swab When complete close and lock the side door Use the key to open the side door and wipe the baths as pictured below WARNING Do not press OK until after you have finished cleaning the baths e When finished wiping the baths use the yellow key to close the door then press OK to finish the bleach cycle e Once the cycle has completed the sample door will open and the user will be pro
31. NG Do not touch moving parts when the machine is switched on 1 2 INSTALLATION LIMITATIONS 1 2 1 Installation Location To ensure that the PointCare NOW functions correctly place the instrument on a table that can support the weight of the instrument printer and reagents around 30 Kg Leave a space of 10 cm at the rear of the instrument to ensure a well ventilated space Instrument should not be exposed to direct sunlight 1 2 2 Installation environment e Indoor use e Altitude up to 2 000 m e Temperature 18 C to 34 C 64 F to 93 F e Maximum relative humidity 80 for temperatures up to 31 C decreasing linearly to 70 relative humidity at 34 C non condensing e MAINS supply voltage fluctuations up to 10 of the nominal voltage e Transient over voltages typically present on the MAINS supply e Rated pollution degree II Please contact a PointCare representative if the instrument is to be used in special conditions altitude higher than 2 000 m or special power supply conditions Page 1 3 PointCare NOW INSTALLATION 13 ELECTRICAL CONNECTIONS All connections are on the rear panel of the instrument SYMBOL CONNECTION LOCATION 0 Ethernet connection F TCP IP INN External barcode o connection RS232C M OIOI RS232C Connection ny Power cord connection Ground no connection No output or input connections except the printer barcode reader power supply and USB Flash Drive supplied by Poi
32. NTOUT SAMPLE ANALYSIS The following information will be displayed on the Result Report Re LSE ES SERS Soa ey A SES Vee e ce ee a Ree SER aE EES AE THAR E ra A ANDAN E MUERE ah TEN b A EA SSE PEL A MARE EN RA al SA AA AAA A HERE ni Tn MARIA SES AA Sy Sh She EA b A MIE OE A Cs AT E E Tal aL gc E SEE TEL z a la Ma Tsing Bz ART i A A lla sE E 7 ial ee ce cee A a AAA iL Mh Shane Example of a Patient Result Printout The header which will identify the clinic where the test was performed Patient name Patient ID Sample ID Patient sex Patient age Tube type Clinic location Operator Date of test dd mm yyyy format Time of test 24 hour format Sequence ID Lot number and expiration date of the LiquiPack and Gold Pack Results o WBC Count o Hgb o Lymphocyte LYM and o Monocyte Mono and o Neutrophil Neut and o Eosinophil Eos and o CD4 and Details Note Some results will not be shown if certain PointChecks are reported Instrument serial number Software version number Page 8 8 PointCare NOW SAMPLE ANALYSIS 8 5 RESULTS ARCHIVES The PointCare NOW can save up to 8000 patient results and up to 50 000 additional results can be saved on a USB flash drive e From the ADMINISTRATIVE MENU select VIEW RESULTS to enter the archive display e Select the desired data storage location from the drop down menu Options are o Inter
33. O 5 1 SIA NE ae eee NA 5 1 DI REAGEN E REPEACEMENT sarnane a O ota At A eee 5 2 5 3 1 CD4NOW LiquiPack Check Level and or Replacement ooooconocccoonononanonnconnnnonononccnnccnononononancnanccnnnannss 5 2 5 3 2 CD4NOW Gold Pack Check Level and or Replacement coocononnnoononocononncanncnnnananccanccnononnonancnnnnonnnonns 5 3 5 3 3 CD4NOW SuperWash Check Level and or Replacement oooccnnncnnononocononnnonncnonananncnnnonononan nono nonancnanncns 5 7 9 0 4 Darcode Re ddr A Acoli Oks cae tlecledl eerie tode 5 8 6STARTU DL E AS cc can esse EIA 6 1 OLE VERIFICATIONS BEFORE gt FARINA IS SARA AA A TENE 6 1 G2 IN A ga ceetam adits gs eect seein arctan T Neate eas acting tat had E ENA E TES 6 1 OSO LTARTOF AFTER OHT MEN Ec SEDES AS AA A stab EEEE 6 1 Te OUALITY CONTROLS iia 7 1 AS O a Te 7 1 ADAN ECON TROL celtas 7 2 F227 oa AAA A A A II A 7 3 PP lao A saide bad scisda a a a a dadeaasdusbaadindidessiauseuewbebas 7 4 72 estore Previous OC Lor trom Menor Y niatiesidscctycosnisdesavsceeitedndassacuavatenusdadasdtarueda tas nasa a a aia 7 4 LA QUAY CONO EAS A 7 4 DNRC SUNS citar tt aaiseba marsala E pace sasan ena E EAA A EAA TT A 7 5 7 3 GBEINOW 7 CAN GW CON ROMS id AAA AAA sen acute ae AE AAA 7 6 Feo CLE EOP Oma MEO ea a e e E 7 7 Tid DAVES LO A A EEEE T EE E EEE EEES 7 8 PointCare NOW TABLE OF CONTENTS ao Restore Previous OC Lol irom Menor ia 7 8 Foe R OU aay Controls oi ia 7 9 SRC SUS pr poca 7 11 TAOGALILY CONTROL MANAGER AA A 7 12
34. OD THAT 15 MORE URS OLD CANCEL CONTINUE Page 8 4 PointCare NOW HO SYRINGE DRAWS CANCEL CONTINUE SAMPLE ANALYSIS A dialog box appears instructing the user that no syringe drawn blood samples may be analyzed on the system Press CONTINUE if the sample was NOT syringe drawn Syringe drawn patient samples are not recommended for use on the PointCare NOW and results cannot be guaranteed PointCare recommends the use of Vacutainer type draws such as BD Ref 367861 REMOVE GOLD CONTINUE Ml GOLO AND RE INSERT A dialog box appears instructing the user to REMOVE GOLD Remove the gold by first turning the locking mechanism anti clockwise and then removing the vial Press CONTINUE A dialog box appears instructing the user to MIX GOLD AND RE INSERT o Remove the gold vial from the front slot and mix 8 10 times by holding the vial upside down and flicking the side of the vial with a finger o Turn the vial right side up and tap on the table 3 4 times to ensure all gold settles to the bottom of the vial o Reinsert the vial into the first slot on the sample door Press CONTINUE Page 8 5 PointCare NOW SAMPLE ANALYSIS MIX AND INSERT BLOOD TUBE e A dialog box appears instructing the user to MIX AND INSERT BLOOD TUBE e Mix the blood by gentle inversion 8 10 times NOTE Syringe drawn blood is not an acceptable specimen on the PointCare NOW e Insert the blood tube e
35. ORMATION SCREEN contains fields for entering the lot number and low and high target values for all the reportable parameters for each control type A Z Make changes to the lot number information if desired READ BARCODE The barcode reader can be used to enter lot number and expiration date automatically see Section 5 3 4 Select OK to save changes and return to the QUALITY CONTROL MENU Selecting LOAD from the EDIT LOT INFORMATION SCREEN displays the LOAD LOT SCREEN The lot table contains a list of all lot numbers stored on the USB Flash Drive the level of the control Normal or Low and the type of control DC CBC or CD4 Select the entry number for the desired lot and select LOAD The user will be returned to the EDIT LOT INFORMATION SCREEN and all fields will be automatically filled in with the information for that lot Select EXIT to return to the EDIT LOT INFORMATION SCREEN without loading new lot information Page 7 3 PointCare NOW 7 2 2 Save Lot Information QUALITY CONTROL e From the DAILY CHECK MENU select SAVE QC LOT e Confirm the desire to save the selected lot to a USB Flash Drive 7 2 3 Restore Previous QC Lot from Memory SSS MET Sk NY THT Pare hk Pam a all EES A Pa eee NO MA WER GR E WO A VE TA AAA Sk ER Sk Sale NO SR VER AA A NO O O O NMRA VER NONO NO SE ee SA EA A Set Sei TG a SS oe Tete St Taa y ha SS
36. PS sometimes called a battery backup is a device which maintains a continuous supply of electric power to connected equipment by supplying power from a separate source Page 2 5 PointCare NOW GENERAL OVERVIEW when utility power is not available PointCare recommends having the UPS connected to a power supply at all times so it is immediately available for battery backup Having the UPS connected is mandatory to maintain the warranty 2 3 9 Barcode Reader The barcode reader allows the operator to easily scan in lot numbers and expiration dates of reagents as well as identification of patient samples Page 2 6 PointCare NOW ADMINISTRATION AND SETUP 3 3 1 ADMINISTRATION AND INSTRUMENT SET UP OPERATOR IDENTIFICATION nn 15 83 re ee ee 8 Ara e After the instrument initialization is complete the LOGIN manae LOGIN screen is displayed e Inthe LOGIN window the previous operator s CLINIC Factor rj login information appears PASSWORD EMGLISH z e To log into the software PointCare NOW allows LOGIN four access levels o Operator Clinician PointCare O o Administrator O Service Entering an ID and password Select the required operator login name from the drop down box Select the proper clinic name from the drop down box Place the cursor in the Password window Enter the operator password using the numerical keypad JENGLISH j The drop down menu ____ enables the op
37. PointCare NOW User s Manual PN 629108F E PointCare Technologies Inc Fj ES ia p O n T a r e O Marlborough MA 01752 USA El EE i PointCare NOW TABLE OF CONTENTS TABLE OF CONTENTS BEFORE USE ns cielo asas 1 LINSTA LEATIO NN aa ao ooo asias 1 1 LIUNPACRN O errar oeste orar restos oran otro 1 1 A aa A e EO O PP OU III 1 1 AD cy or el a A o ER E E O ne rors See ree ee nee eee ee ere 1 1 M UALS ea a no RI esti E E eta dters 1 2 I2INSTALLATION EITA ON sita E ir aos 1 3 E allein ero A o A e IA 1 3 122 TiS a BU eNO CsA EO A E rc son oi sed EE 1 3 LS BLECTRICAE CONNECUONS anodino EEE E ci 1 4 A ol Bera Ct o ON o E An 1 4 A a A eli e CI RI 1 4 dao Barcode Reader C Oil MOC OMt eaaa A E E AA EOE NN E OTS 1 5 koat Poner o ESEE EEEa 1 5 kao Power nppl Conmmecsh Otitis e TE oraa TEE Ea E E 1 5 1 4 CONNECTING AND PRIMING REAGENTS dai oer ocd TEEI EEEE EEEE EOU aE E ea aiii 1 7 E E E E a a E TE E E A S E E E EE 1 7 E Dy SUC Ga CU E E E A E A E E 1 8 LAS MAGA Venice es R E E E a a a 1 9 L44 Starnup 2 iy abe aul oa pal cia AO POR APC n O E a a ee ee re 1 11 LS UN SPORT A TION IND EO RAGE epeari ceive EEA EE E EEE EE AEREE EEES ER 1 11 2 GENIT VED VE VY Sos 2 1 Dl GEN le INES RIMA TOM pr E A E E E A E E A E A E E 2 1 DED AI T IE NU o P OEI T AS N TE E E E AE E A A AI A A E 2 1 A3 MAINC OMPONENT DESCRIPTION a eset ess aso nenene EEA NEE e ee iaa 2 2 PE ei as Lo EE E A o E AE e E A E E A qetesatas 2 2 ZO VAT STC oo APA E A 2 2
38. Press CONTINUE CONTINUE Lock GOLD e A dialog box appears instructing the user to LOCK GOLD e Turn the locking mechanism clockwise and ensure that it is firmly locked in place e Press CONTINUE to begin the sample analysis MARE SURE GOLD 15 LOCKED In BEFORE PRESSING CONTINUE CANCEL CONTINUE Page 8 6 PointCare NOW SAMPLE ANALYSIS 83 RESULTS The PATIENT RESULTS SCREEN includes the following information Su Summary of patient information Patient Name Patient ID PID Sample ID SID Patient sex male female O O O O Patient age years o Blood age hours e Tube Type 1 for normal e Time and date of test e Sequence number of the sample e Clinic location e Operator identification e Lot numbers for the Gold Pack and LiquiPack e Results Table o White blood cell count WBC Hemoglobin HGB Lymphocyte LYM and Neutrophil NEU and Monocyte MON and Eosinophil EOS and o CD4 and e Details summary box O O O O O e A result with associated PointChecks will display a description in the DETAILS box o Press the DETAILS box for further details on the specific PointChecks o See Section 11 6 for detailed PointCheck descriptions potential causes and remedial actions e Select PRINT to print the results for the analysis if automatic printing has not been selected e Select DONE to return to the Main Menu Page 8 7 PointCare NOW 8 4 RESULTS PRI
39. automatically decontaminated With PointSafe fluidics users are not exposed to the biohazardous conditions encountered with standard methods of CD4 lymphocyte enumeration such as removing the blood tube caps pipetting the samples and reagents into open tubes vortex mixing in open tubes and disposing of contaminated reaction tubes and pipette tips PointCare NOW DualZone Instrument Platform The PointCare NOW instrument platform combines two diagnostic systems in one unit and is operated like a small automated hematology analyzer The HemaZone delivers a four part white cell differential a total white cell count and a hemoglobin concentration measurement The ImmuZone generates both absolute count and the percent of lymphocyte CD4 T cell counts expressed as a percent of total lymphocytes The PointCare NOW uses a label to change the natural light scatter characteristics of the CD4 subclass of lymphocytes to perform CD4 enumeration The label consists of anti CD4 antibodies coupled to small gold particles The particles are only slightly larger than an antibody When the particles bind to the surface of a cell they add to the natural light scatter of the cell but only in the directions that are sensitive to optical eranularity Two detectors are set at specific angles to differentially monitor the changes caused by the colloidal gold label In the PointCare NOW System the ALL Axial Light Loss detector is used to identify any cell car
40. ce it with a new LiquiPack NOTE It is normal for there to be small amounts of some LiquiPack reagents remaining in one or two of the bottles when the reagent volume reaches 0 Any remaining reagents should be discarded Enter the lot number from the label on the new LiquiPack box This can be done automatically using the barcode reader see Section 5 3 4 Press REPLACE REAGENT to accept the new entry and prime the reagent This will take a few minutes e Anew entry is automatically entered in the instrument reagent log see Section 11 3 5 5 3 2 CD4NOW Gold Pack Check Level and or Replacement SERRE AS AS a Sts ME e Select CD4NOW GOLD PACK to access the CD4NOW GOLD PACK INFO screen e The CD4NOW GOLD pack includes the gold reagent accel reagent and reconstitution fluid Page 5 3 PointCare NOW Fa See Ma l Sha Bottle Number REAGENTS e The CD4NOW GOLD PACK INFO Screen is displayed e Information on this screen includes lot number bottle number and expiration In addition it displays the number of uses remaining for the current bottle If the CD4NOW GOLD Pack needs to be replaced enter the lot information and bottle number e To enter the lot information automatically using the barcode reader see Section 5 3 4 e The bottle number must be entered manually There are five individual bottles in each Gold Pack and they are numbered one through five After entering the lot i
41. e desired lot EDIT LOT allows modification of the lot ID and the target values SAVE QC LOT saves the selected lot ID and target values to the USB flash drive RESTORE QC LOT restores previously saved lots of controls run from the USB drive to the PointCare NOW Select RUN QC LOT to perform QC analysis using the selected control material Select EXIT to return to the MAIN MENU From the QUALITY CONTROL MENU select EDIT LOT to modify the lot ID and the target values Ta h o a tTa EIN SASS TET MST TN Shh SEL He ASST SRR MES Sea So a e Mkh ASS AS Ea SAL Se My Fm SN RS NE EDLA Ss An NE The EDIT LOT INFORMATION SCREEN contains fields for entering the lot number and low and high target values for all the reportable parameters for each control type A Z Make changes to the lot number information if desired READ BARCODE The barcode reader can be used to enter lot number and expiration date automatically see Section 5 3 4 Select OK to save changes and return to the CBCNOW CD4NOW MENU Page 7 7 PointCare NOW 7 3 1 1 Loading OC Information De ee Ter W gt wa t SARS a Rana Ses EE O TINT 7 Par bh A Sa A Ot THEE oS OCEN Wink Pa kee NO O MA WER ER EA MO En VER T He MO O ER VER 7S A NA A WER T Se MWO A WER 7 3 2 Save Lot Information QUALITY CONTROL Selecting LOAD from the EDIT LOT INFORMATION SCREE
42. e figures below for the hemoglobin measurement A A NEUTROPHILS EOSINOPHILS LYMPHOCYTES MONOCYTES CD4 Positive LYMPHOCYTES CD4 Negative LYMPHOCYTES 40 Page 10 5 PointCare NOW TECHNOLOGY 10 1 3 Hemoglobin Measurement The hemoglobin measurement is directly done in the WBC chamber by spectrophotometry at 555 nm Hemoglobin is detected after formation of a chromogen of oxyhemoglobin cyanide free technique A blank measurement is done for each analytic cycle and during system start up An automatic offset circuit for the LED 555 nm allows the PointCare NOW to maintain the blank at a constant level It is not necessary to adjust this setting An automatic offset circuit for the LED 555 nm allows the PointCare NOW to maintain the blank level at the same range It is not necessary to adjust this range with a potentiometer 10 2 LEUKOCYTE ANALYSIS The leukocyte number analysis is done by impedancemetry in the WBC counting chamber The other ten parameters are obtained by flow cytometry measurement LYM ON ON sr UY CDa Page 10 6 PointCare NOW TECHNOLOGY 10 3 ERYTHROCYTE ANALYSIS The erythrocyte analysis is done by analysis of the hemoglobin inside the WBC chamber as previously described Pathologies adjustment section 3 4 4 1 Hemoglobin Anemia HGB lt HGB b 10 4 HYDRAULIC DESCRIPTION The hydraulics of the PointCare NOW are very simple and made of the following modules
43. een displays o Patient ID o Test time and date o Sequence number o Dotplots for the CBC NO GOLD analysis and for 3 5 the CD4 GOLD analysis M o All count and percentage values a 1 o Associated flag characters for each parameter if 583 applicable E To print the patient results associated with the dotplot select PRINT e To save the entire set of plots in memory to a USB flash drive select SAVE e To scroll through the results press the lt lt or gt gt buttons on the bottom of the screen e DONE returns the user to the TROUBLESHOOTING MENU 11 6 POINTCHECKS The PointCare NOW uses sophisticated software to monitor 53 internal control points These PointChecks ensure the quality of the reported results identify sample abnormalities and help provide clinical guidance to the clinician A PointCheck can either appear as a result noted by an or the absence of a result noted by on the screen and on the print out A short description of all PointChecks appears by clicking on Details at the bottom of the Results screen To assure quality results standard proper Blood Handling Protocols must be followed 1 The blood sample MUST be less than 8 hours old 2 The blood sample MUST be given a minimum of 10 minutes post draw to allow anticoagulant to diffuse prior to analysis on the PointCare NOW 3 The blood sample MUST NOT be drawn using a syringe 4 The blood sa
44. el of the waste container Please also check the paper and ribbon quantity in the printer 5 2 POWERING UP e Press ON OFF button on the printer to start e Switch on the PointCare NOW power supply the power supply can stay on e Press ON OFF button on the PointCare NOW e The initialization screen is displayed and the PointCare NOW performs a home position check ppa PLEASE WAIT of the four motors e The cycle LED turns red No cycle can be performed until it turns green aja P E l n Fa a 15 93 e Enter your login and password as described in Section 3 1 LOGIN naNAGER CLINIC actor PASSWORD EMGLISH LOGIN PointCare Page 5 1 PointCare NOW 5 3 REAGENT REPLACEMENT REAGENTS The reagents must be stored for a minimum of 24 hours at room temperature before From the MAIN MENU press REAGENTS to access the REAGENT MANAGEMENT MENU 5 3 1 CD4NOW LiquiPack Check Level and or Replacement SAE SERS Na x SO a SS ck SEES ME AS ah WMR MEH Select CD4NOW LIQUIPACK to access the CD4NOW LIQUIPACK INFO screen The CD4NOW LiquiPack includes diluent cleaning reagent and lyse reagent Page 5 2 PointCare NOW CE Se ok SER O SN A ae A pl REAGENTS e Check the volume remaining in the CD4NOW LiquiPack as indicated by the reagent volume icon and LEFT value e If the LiquiPack needs to be replaced remove the empty LiquiPack and repla
45. ent ID and or Sample ID To enter or modify identification place the cursor in the selected field using the touch screen or the arrow keys To enter a number use the keypad on the right of the screen To enter a letter use the alphabetic keyboard To accept the entry and return to the previous screen press OK To return to the previous screen without saving changes press CANCEL AU NOTE SID number can be entered manually from the patient sample tube label or automatically using the barcode reader see Section 5 3 4 Page 8 3 PointCare NOW SAMPLE ANALYSIS 8 2 3 Sample Run e Once the PATIENT INFORMATION SCREEN is complete press BEGIN SAMPLE SANA Ea SEMEN EE NES E UREA y SE SERS a LETS MBA SERA A A 0A SRE RM Wear latex or nitrile gloves and wash hands thoroughly according to your laboratory s methods after completion of work NOTE If the reagent and or instrument is not at the required set temperature a message prompt will appear indicating that heating is in progress Once the temperature setting of the enclosure and or the reagent is reached the analysis can continue WORNING e Ifthe blood draw time is over 8 hours a dialog box will appear warning the user that running blood over eight hours old is not recommended e Ifthe user wants to run the sample anyway press CONTINUE e Press CANCEL to return to the Main Menu without running the sample DOES HOT RECOMMEND BLO
46. er to confirm starting the cycle Select OK to continue At the end of the cycle the user will be prompted to REMOVE STRAWS FROM LIQUIPACK AND CAP LIQUIPACK BOTTLES Select OK to continue When the cycle has completed the user will be prompted to REMOVE ALL TUBES FROM THE SAMPLE DOOR Select DONE after removing all tubes and the PointCare NOW will power off Remove the LiquiPack from the reagent tray The instrument is now ready for transportation The SHUTDOWN FOR SHIPPING option enables the user to shutdown the PointCare NOW for shipment Before performing a shutdown for shipping cycle ensure that the SuperWash reagent information has been entered See Section 5 3 3 PLEASE SELECT TYPE OF SHUTOOWM MOBILE SHUTOOWH SHUT OC FOR SHIPPI HG CANCEL Select SHUTDOWN FOR SHIPPING from the Special Shutdown Menu to start the cycle A prompt will ask the user to confirm starting the cycle Select OK to continue The sample door will open and a prompt will ask the user to INSERT GREEN TOPPED TUBE Insert a bleach tube and select CONTINUE Page 9 4 PointCare NOW HOWE STRAWS FROM LIGUIPACK TO SUPERWASH LOGGING OUT AND SHUTDOWN The user will then be prompted to MOVE STRAWS FROM LIQUIPACK TO SUPERWASH Install the SuperWash in the reagent tray and select DONE Midway through the cycle the user will be prompted to REMOVE ALL STRAWS FROM THE SUPERWASH Select DONE af
47. erator to change the language For information on entering new operator IDs and passwords and for adding clinic names see Section 3 4 1 5 Page 3 1 PointCare NOW ADMINISTRATION AND SETUP 3 2 SYSTEM INFORMATION 2 INFORMATION e Press the date and hour displayed in the upper right corner on most screens to access the SERIAL NUMBER 226107 B00850 af nd OPERATOR eee system information window 15 8 ilil al ACCESS ADMINISTRATOR e The following system information is displayed SETUP VERSION pcT a25 o Instrument Serial Number SOFT VERSION WS A A2 BAd4 LOADER LA Ae BOARD SATELLITE SH User Login Name User Access Level Setup Version Software Version Loader Version Board Serial Number o Satellite Modem Serial Number e To return to the MAIN MENU press OK O O O O O 3 3 ADMINISTRATIVE MENU The ADMINISTRATIVE MENU can be accessed from the MAIN MENU screen only by those with Administrator Clinician or Service privileges The ADMINISTRATIVE MENU screen consists of the following buttons e VIEW RESULTS e GENERAL SETUP e LAB MANAGER e PREVENTIVE MAINTENANCE e SPECIAL SHUTDOWN e TROUBLESHOOT e SERVICE e MAIN MENU e The LAB MANAGER SPECIAL SHUTDOWN PREVENTIVE MAINTENANCE and TROUBLESHOOT buttons shall only be available if the user logged in has Administrator privileges e The SERVICE button shall only be enabled if the user logged in has Service priv
48. eturn to the Reagent Management Menu e Anew entry is automatically entered in the instrument reagent log see Section 11 3 5 Page 5 7 PointCare NOW 5 3 4 Barcode Reader REAGENTS If the barcode reader is available select READ BARCODE A dialog box will provide instructions on how to read the barcode on the required reagent patient sample or control tube Once the bar code has been successfully read the reagent or control lot number and expiration fields or the patient sample ID will be automatically entered Page 5 8 PointCare NOW STARTUP 6 STARTUP 6 1 VERIFICATIONS BEFORE STARTING Before starting PointCare NOW PointCare recommends checking the reagent levels in each bottle and the level of the waste container See Section 5 Please also check the paper quantity in the printer 6 2 DAILY STARTUP e From the Main Menu press STARTUP to initiate the Startup cycle e A dialog box will appear asking the user to confirm that all reagents are present Select PROCEED to continue The cycle LED turns red No cycle can be performed until it turns green During the startup cycle the PointCare NOW will A e perform 1 to 3 blank cycles to check the background level This level should not to exceed SEES PTE XN the following ratios aN o WBC 0 5 o HGB 0 5 If the background level is higher than the limits listed above PointCare NOW displays a STARTUP FAILED message Pre
49. h a nozzle and creates a jet ina passive fluid The jet remains intact in the fluid as it passes through the focal region of the LED This principle not only eliminates hydrodynamic focusing but also allows the instrument to perform the hemoglobin measurement with the same dilution as is used for white cell counting which further lowers instrument complexity Page 10 3 PointCare NOW TECHNOLOGY Well defined sample flow jet Optical window a Light beam 455 nm wavelength K Passive fluid used to sweep out cells after analysis Injector nozzle that creates sample jet in passive fluid LIGHT INTENSITY SAMPLE FLOW For each cell in the optical detection area two pulses are generated one for the Axis Loss Light ALL measurement and one for the Forward Side Scatter FSC measurement The result of those two axes of measurement are used to create a high definition matrix and dot plots that enables the PointCare NOW to identify four WBC populations The CD4 positive lymphocytes are distinguished from CD4 negative lymphocytes based on the change in light FSC scatter properties with the use of proprietary non fluorescent reagents Page 10 4 PointCare NOW TECHNOLOGY The four part differential and CD4 positive lymphocyte are obtained from the dot plot clusters after action of the lytic reagent This reagent destroys red blood cells leaving white blood cells intact It also stabilizes the oxyhemoglobin chromogen se
50. he graph enables the user to display all the registered results The J and H keys enable the user to move the cursor to different control runs on the plots shows the number of the result indicated by the cursor on the plots Select DONE to return to the OC BATCH SUMMARY screen Page 7 15 PointCare NOW SAMPLE ANALYSIS 8 SAMPLE ANALYSIS 8 1 PREPARATIONS BEFORE ANALYSIS The human venous blood sample must be collected in a 2mL or 4mL EDTA K2 Ethylene Diamine Tetracetic Acid di potassic tube in sufficient quantity The tube must be filled to its full capacity The results can be obtained for 8 hours after the blood draw if the sample is stored at room temperature The blood sample must be correctly homogenized before analysis It is recommended to gently invert the sample 8 10 times by hand prior to analysis An insufficient volume of blood for the quantity of anticoagulant or improper mixing may cause an erroneous result It is recommended to carry out Quality Control QC before any analysis see Section 7 Read the analytical limitations see Section 4 4 before performing sample analysis A Allow the reagents to come to room temperature before use A Diluted samples may NOT be run on the PointCare NOW Page 8 1 PointCare NOW 8 2 ANALYSIS 8 2 1 Run Sample Sa To A S AS h oe NO a gt 8 2 2 Entering Patient Information SAMPLE ANALYSIS e From the MAIN MENU press RUN SAMPLE to
51. he Login screen without renacer shutting down the system This will allow another user to log into the system without requiring a CLINIC actor rj i startup cycle PASSWORD ENGLISH j P cy LOGIA PointCare Page 9 1 PointCare NOW LOGGING OUT AND SHUTDOWN 9 2 STAND BY AND SHUT DOWN There are two types of standard shutdowns available on the PointCare NOW Daily Shutdown and Long Term Shutdown Daily shutdown should be used when the instrument is being shutdown after daily use and will be started up within two weeks Long term shutdown should be used when the instrument will not be used BUT NOT SHIPPED for longer than 2 weeks If the system is to be shipped Shutdown for Shipment must be performed see Section 9 3 9 2 1 Daily Shutdown e From the MAIN MENU press SHUTDOWN e Select DAILY SHUTDOWN e PointCare NOW automatically performs a shut down cycle e All the fluidic circuits are rinsed and cleaned with the cleaning reagent e At the end of the cycle the PointCare NOW automatically turns off NOTE After a shutdown it is impossible to perform an analytical cycle without initiating a startup cycle see Section 6 2 If a shutdown cycle is not performed on the PointCare NOW an automatic shutdown cycle will be performed This interval can be set by an Administrator PointCare NOW must remain unused after shutdown for at least three hours in every 24 hour period to allow for prope
52. he syringes will then be moved to the home position and the user will be returned to the PREVENTIVE MAINTENANCE MENU 11 4 4 Service Needle e Select SERVICE NEEDLE from the PREVENTIVE CONSULT MANUAL FOR MAINTENANCE MENU e The user will be asked to confirm servicing the needle ENDE and then will be instructed to consult this manual 0 Open the side door using the yellow key and wipe the needle with a cloth dampened with alcohol e Select CANCEL to return to the PREVENTIVE MAINTENANCE MENU Page 11 6 PointCare NOW MAINTENANCE AND TROUBLESHOOTING Select VIEW MAINTENANCE LOG from the PREVENTIVE MAINTENANCE MENU The PointCare NOW manages a simplified log allowing the user to print save and display all the events performed for the following actions O O O O O O O O O O O O O O O O O O 0 70 ADM Login with the Administrator code STC Login with the Service Technician code INT An intervention has been performed SUF Startup cycle failed SDN Shutdown cycle successful LTS Long term shutdown performed LIQ LiquiPack reagent changed GOL Gold reagent changed BLH Bleach cleaning performed ACN Clean performed either auto or manual SYR Syringe greasing performed CAL Calibration performed DCN Daily Check Normal Control run DCL Daily Check Low Control run Q4L CD4 Low Control run Q4N CD4 Normal Control run DLP Daily Check Low passed DNP Daily Check Normal passed NST New set
53. his table is made for an average number of 50 samples per day For more please increase proportionally the number of maintenance performances MAINTENANCE DAILY WEEKLY HALFA YEAR Admin Reagents level 4 J ES a Piston greasing A e Reagents Level Control see Section 5 3 o o o Bleach Baths Cleaning o aa e Startup see Section 6 e Automatic Cleaning The cleaning is automatically driven by the PointCare NOW software Manual cleaning of the PointCare NOW can be performed using the CLEAN button on the MAIN MENU after analysis of pathologic samples or if numerous flags are being encountered frequently see Section 11 2 e Bleach and Baths Cleaning see Section 11 3 2 e Shutdown see Section 9 2 e Cover Cleaning Clean the cover and the interior of the sample door with a wet paper towel and disinfectant to eliminate trace amounts of blood and dust e Piston Greasing see Section 11 3 3 Page 11 1 PointCare NOW MAINTENANCE AND TROUBLESHOOTING 112 CLEANING There are three types of cleaning sequences performed by the PointCare NOW o AutoClean o Clean o AutoCycle 11 2 1 AutoClean A clean cycle will be forced by the PointCare NOW software after 20 runs have been performed This cycle ensures that the PointCare NOW is operating optimally by cleaning the needle and baths in order to eliminate high background 11 2 2 Clean Manual cleaning of the PointCare NOW can be performed using the CL
54. ilable software version releases on the USB stick is shown e Select the entry number for the desired software version release from the list and select UPGRADE e Select YES to confirm the software upgrade e A message prompt will inform the user that the software upgrade was successful Selecting OK will allow the instrument to reboot and complete the upgrade SRR VEER l e If the software version release is not compatible with the system the user will be alerted and the software SS ERE SST l as version will remain at the current release e Select CANCEL to return to the LAB SETTINGS MENU 3 9 1 7 Save Settings e Select SAVE SETTINGS to save all settings to the USB flash drive A prompt will ask the user to confirm the save as it will override any settings already on the USB flash drive 3 9 1 8 Print Lab Settings e Select PRINT LAB SETTINGS to print a list of the instrument settings e Select YES to confirm printing the settings 3 9 2 OC Manager See Section 7 4 Page 3 7 PointCare NOW ADMINISTRATION AND SETUP 3 9 3 Archive Manager e The Archive manager allows the user to delete or save z patient entries for a specific date range or for all entries Aa Teas MEE in internal memory men saved the patient entries are a stored on the USB flash drive ook A a oR es Page 3 8 PointCare NOW SPECIFICATIONS 4 SPECIFICATIONS 41 ANALYTICAL SPECIFICATIONS Time to Result
55. ileges 3 4 VIEW RESULTS The VIEW RESULTS option allows the user to access the approximately 8000 analysis files that the PointCare NOW can store in its internal memory or to access files from an external source such as the USB Flash Drive See Section 8 6 for more information Page 3 2 PointCare NOW ADMINISTRATION AND SETUP 3 5 PREVENTIVE MAINTENANCE The PREVENTIVE MAINTENANCE option allows the user to access maintenance steps and procedures that will assist in the long term care of the PointCare NOW See Section 11 for more information 3 6 TROUBLESHOOT The TROUBLESHOOT option allows the user to access troubleshooting steps and procedures that will assist in the resolution of issues that may occur on the PointCare NOW See Section 11 for more information 3 7 SPECIAL SHUTDOWN The SPECIAL SHUTDOWN option enables the user to shutdown the PointCare NOW for transportation See Section 9 for more information 3 8 GENERAL SET UP e The DATE amp TIME window allows the user to modify the date and the time a e PRINTER allows the operator to select the printer SS e PAPER SIZE allows the operator to select the paper size e IGNORE STARTUP ALARM allows the user to continue a aha analysis without notification if startup fails due to high ss o background counts e The AUTO PRINT window allows the operator to select automatic printing for sample analysis QC and startup aa AAA RE TASER ERENS TREE
56. in The operator s login screen appears Select the desired Login name from the pull down menu and enter the correct Password see Section 3 1 Select the Clinic and Language and press LOGIN to continue Page 1 8 PointCare NOW INSTALLATION 3 Main Menu e The MAIN MENU is displayed 1 4 3 LiquiPack Verification Prior to priming the PointCare NOW requires that CD4NOW LiquiPack reagent information be entered e From the MAIN MENU press REAGENTS to access the REAGENT MANAGEMENT MENU AS E A h SAS h KiE h S AR h or NO a N aye To SEES Page 1 9 PointCare NOW INSTALLATION e Press CD4NOW LIQUIPACK to access the CD4NOW LIQUIPACK INFORMATION y KARAT AS SEE ME e Enter the lot number from the label on the LiquiPack box This can be done automatically using the barcode reader see Section 5 3 3 e Press REPLACE REAGENT to accept the new entry e Anew entry is automatically entered in the instrument log see Section 11 3 5 and a prime cycle will begin This will take a few minutes Page 1 10 PointCare NOW 1 44 Startup after Shipment INSTALLATION When starting the PointCare NOW for the first time it is necessary to perform a complete prime of the fluidic circuit and a background count by running a Startup After Shipment cycle From the MAIN MENU select STARTUP A dialog box appears that informs the user that an extended startup must be performed When
57. ll to allow current to flow from one compartment containing an isotonic electrolyte solution to another compartment with the same solution The aperture itself has a fixed electrical impedance for current flow at constant voltage Placing a cell with intact membrane in the aperture causes the impedance to rise The rise in impedance is approximately proportional to the volume of the cell To use the impedance aperture as a white cell counter a controlled dilution of whole blood is lysed to remove red cells and leave white cells intact This dilution is introduced into one compartment of the impedance aperture module A vacuum is used to flow the cell dilution through the aperture If the dilution is sufficiently high only one cell at a time will be in the aperture The passage of a cell through the aperture is recorded as a voltage pulse caused by the cell s impedance After a controlled volume passes through the aperture and a calibration factor is applied the original white cell concentration can be calculated Page 10 2 PointCare NOW TECHNOLOGY VACUUM Aperture Electrode Detection area VOLTAGE Voltage pulse at the electrode terminal Counting pulse 10 1 2 Four Part Differential and CD4 Measurement The innovative optical detection system see figures on the following pages eliminates the complex system of hydrodynamic focusing used in conventional flow cytometers and hematology analyzers The sample flows throug
58. lt 8 minutes Throughput 7 samples hour Sample Tube Vacutainer style 2mL or 4mL K2 EDTA filled to full capacity Sample Volume 40 ul approx Measurement Principle WBC Impedance Four part differential and CD4 Optical flow cytometry Hemoglobin Spectrophotometry at 555 nm Reportable range Page 4 1 PointCare NOW SPECIFICATIONS 4 2 PERFORMANCE SPECIFICATIONS The following performance specifications are a summary of data from the PointCare NOW 510k The data is a representation of typical performance of a PointCare NOW System 4 2 1 Linearity Six serial dilutions of a concentrated whole blood specimen were prepared to achieve a range of concentrations Measurements in quadruplicate were made for each level on a PointCare NOW System The table below is a representation of typical linearity of the PointCare NOW System 4 2 2 Precision Whole blood samples were analyzed in 10 replicates for each sample The table below is a representation of typical precision of the PointCare NOW System wacaen 60 S lt 3 NOTE For precision studies on the PointCare 20 NOW 5 tubes of the same blood can be analyzed lt 7 twice each Do not run a whole blood sample lt 7 more than twice on the PointCare NOW 5 ask coa 600 10 10 A Page 4 2 PointCare NOW SPECIFICATIONS 4 2 3 Carryover Carryover was measured by analysis of three high level samples followed by three blank samples CD4NOW Diluent Carr
59. me and date of test the Clinic where the test was run the Operator performing the test the lot numbers of the reagent packs used the type of units selected and the Results Table Page 7 5 PointCare NOW QUALITY CONTROL e Ifaresult is above the target high value a will appear to the right of the result and the result will be displayed in boldface A 1 e Ifaresult is below the target low value a will appear to the right of the result and the result will be displayed in boldface e Ifa result cannot be reported will be displayed instead of the result e Select PRINT to print the results for the Control The printed page will be displayed as shown above e Select DONE to return to the Daily Check Menu 7 3 CBCNOW CD4NOW CONTROLS There are four types of fixed whole blood controls two hematology controls CBCNOW Normal and CBCNOW Low and two CD4 controls CD4NOW Normal and CD4NOW Low e Toaccess the CBCNOW CD4NOW Control Menu select CBCNOW CD4NOW from the QUALITY CONTROL MENU CAR A SARS Eas SSA Wook Sa Page 7 6 PointCare NOW SA O WEES Ee Seri TS a SSA ee A Gt TT Sea TH TR 7 3 1 Edit Lot Information QUALITY CONTROL The CBCNOW CD4NOW MENU allows the selection and or entering of lot information and displays previous lots used The last lot used is selected by default o To choose another lot select the button for th
60. mple MUST NOT be exposed to extreme temperatures or direct sunlight Page 11 13 PointCare NOW MAINTENANCE AND TROUBLESHOOTING The cap on the blood tube must NEVER be removed The blood sample MUST be run on the PointCare NOW prior to any other instrumentation The blood sample MUST be drawn to full capacity i e no short draws allowed The blood sample MUST NOT have clots present in the tube The blood sample MUST be mixed 8 12 times by rapid inversion prior to analysis eS StS a For detailed information on the causes and resolution of PointChecks refer to the most recent revision of the following forms e F 259 PointCheck Resolution Guide Flowchart e F 258 PointCheck Resolution Guide 11 7 TROUBLESHOOTING MESSAGES 11 7 1 Pop Up Windows There are five types of pop up windows INPUT ERROR INPUT ERROR The entered data is not valid Input a a WARNING You must perform or confirm the action O TE described in the window NL ES ye LE as TEE A INFORMATION window ERROR Given for system hardware errors OSB FLASH DRIVE 15 HOT FRESEHT aK Page 11 14 PointCare NOW MAINTENANCE AND TROUBLESHOOTING ACCESS DENIED The user s access level does not permit entry to the selected screen or menu ae TE i MEA a a Tee A SE o a ee Ba 11 7 2 Pop Up Window Messages This section informs the operator on what action to take when a troubleshooting message appears on the screen If the
61. mpted to dispose of the bleach tube e Selecting DONE will return the user to the PREVENTIVE MAINTENANCE MENU Page 11 4 PointCare NOW MAINTENANCE AND TROUBLESHOOTING 11 4 3 Syringe Greasing e Select GREASE SYRINGE from the PREVENTIVE CONSULT MANUAL FOR MAINTENANCE MENU to place the piston of the syringe module in the greasing position EE e The user will be asked to confirm greasing of the syringe and then will be instructed to consult this manual e Selecting CANCEL will bring up a dialog box informing the user that they have chose to ignore recommended syringe greasing This warning will appear until syringe greasing is performed Wear latex or nitrile gloves and wash hands with a disinfectant after completion of e Open the door on the right side of the instrument see Section 1 1 3 e Puta small drop of grease on a finger Due to moving parts there is a risk of fingers being pinched between pistons and the syringe body e Puta thin film of grease around each piston Page 11 5 PointCare NOW MAINTENANCE AND TROUBLESHOOTING e Turn the two big pistons waste pistons with the help of the T20 key supplied in the instrument maintenance kit e Continue to put a thin film of grease around each piston e The other pistons can be turned with fingers e Once syringe greasing has been completed the user must close and lock the instrument door and then press OK on the pop up box T
62. mption mL Software Version 2 3 0 002 Consumption with one background run 4 3 4 Power Supply Block Height 55 mm 127 mm 230 mm Power Supply Input 100 to 240VAC 2A 230VAC at maximum load 4A 115VAC at maximum load 50 60Hz 4 3 5 Printer TM U220 Height 138 5 mm approx 160 mm approx 248 mm approx Power Input 100 to 240 VAC 50 to 60 Hz 24V at 1 5 A max 7 mm Impact 9 needles Up to 188 cps characters per second Page 4 5 PointCare NOW SPECIFICATIONS 4 4 REAGENTS SPECIFICATIONS Refer to the Instructions for Use of each reagent for storage details Reagents used in the PointCare NOW System are CD4NOW LiquiPack containing diluent lyse reagent and cleaning reagent CD4NOW Gold Pack containing gold reagent accelerant and reconstitution fluid e CD4NOW SuperWash e CD4NOW Bleach e CD4NOW Waste Tablets 4 5 ANALYTICAL LIMITATIONS MAINTENANCE The maintenance procedure and the quality control procedure must be followed as described in this Users Manual Patient results can be affected if the procedures are not followed Each result out of lab linearity limits or with an alarm should be checked with a manual blood smear Diluted samples may NOT be run on the PointCare NOW Page 4 6 PointCare NOW REAGENTS 5 REAGENTS 5 1 VERIFICATIONS BEFORE STARTING Before starting the PointCare NOW PointCare recommends checking the reagent levels in each bottle and the lev
63. nal Memory o USB Flash Drive e Select the desired date by pressing the appropriate YEAR MONTH in the left hand list and the appropriate DAY from the right hand list e Press SELECT Sh MiL E OUTRO CERATI aN MEL h ae l Page 8 9 PointCare NOW SAMPLE ANALYSIS 8 5 2 View Results e To return to the SELECT RESULT DATE SCREEN press NEW DATE e To proceed with the date chosen select the desired sequence number e The Patient Name Patient ID and Sample ID for the selected sample is shown at the bottom of the bell I ee a screen e Press VIEW to access the Patient Results Screen EE aa AE ns O os RARO EIA e Press PRINT to send the result to the printer e Press SAVE to save the result from internal LOTA TE memory to a USB Flash Drive AAR SOE o If SAVE is selected while reviewing results from the USB Flash Drive the instrument will alert the user that this function is not available o If SAVE is selected while reviewing results AL ra e We EL a a MER ah AA da A pues from the instrument s internal memory the tii instrument asks the user to confirm saving the result from internal memory to the USB Flash Drive e Press DONE to return to the View Results Screen Page 8 10 PointCare NOW LOGGING OUT AND SHUTDOWN 9 LOGGING OUT AND SHUTDOWN 9 1 LOGGING OUT e From the MAIN MENU press LOGOUT La re e This returns the user to t
64. nformation and vial number press REPLACE REAGENT The sample door opens and a dialog box prompts the user to DISCARD USED GOLD VIALS Rotate the vial locking mechanism anti clockwise to remove the used gold and accelerant reagents Remove all tubes Discard the used gold and accelerant vials into a biohazardous waste container Select CONTINUE Page 5 4 PointCare NOW REAGENTS The instrument prompts the user to INSERT NEW REAGENTS Place the CD4NOW Gold Reagent in the front slot of the sample door Place the CD4NOW Accelerant Reagent in the middle slot of the sample door Place the blue topped CD4NOW Reconstitution Fluid in the rear slot of the sample door Select CONTINUE The instrument prompts the user to MAKE SURE GOLD IS LOCKED IN BEFORE PRESSING CONTINUE Rotate the vial locking mechanism clockwise to lock in the gold reagent and accelerant Select CONTINUE to initiate the Reconstitute Gold sequence The sample door closes and a dialog box informs the user of the status of the preparation of the gold reagent Lot number information is stored in the instrument memory and the gold usage counter is reset e When the reconstitution sequence is complete the instrument prompts the user to DISCARD USED BLUE TUBE e Discard the used CD4NOW Gold Reconstitution Fluid vial into a biohazardous waste container e Select CONTINUE Page 5 5 PointCare NOW REAGENTS A
65. ntCare can be made without Printer connection 4 Dg L n the authorization of a PointCare representative 1 3 1 USB Connections The PointCare NOW is equipped with two 2 USB connections A USB flash drive is provided with the instrument and can be used to backup patient results QC results instrument settings and other useful information Software updates can also be uploaded to the instrument via the USB flash drive 1 3 2 Ethernet Connection The PointCare NOW does not currently support mono or bi directional interfaces via Ethernet connection Page 1 4 PointCare NOW INSTALLATION Attempts to interface to or from the PointCare NOW may void the PointCare warranty or service agreements 1 3 3 Barcode Reader Connection Use the RS232C external barcode reader connection on the rear of the PointCare NOW to connect the barcode reader cable 1 3 4 Printer Connection Use the parallel port on the rear of the PointCare NOW to connect the printer cable Please refer to the EPSON TMU220 printer user s manual for more information 1 3 5 Power Supply Connection The PointCare NOW must be connected to the UPS with the power supply block provided with the starter kit Choose a well ventilated place for the block and ensure the UPS is connected to an outlet with the correct ground connection Having the UPS connected is mandatory to maintain the warranty The power supply block must be placed at the rear of the inst
66. oli ccccaties a E E aa cumin nasal die ae EEEE iMate oa Mech ah R TOE 7 13 Tee 2 CaN OL MOLI OM A NO 7 13 74 3 Restore Previous QC Eot from Men ti 7 14 AEN EWR S a E E E tac ten tesaa uatiedaee 7 14 AA o Levey CON di 7 15 8 SAMPLE ANALYSIS iii da ai AA AAA AA AAA AA AA AAA AAA A A AAA 8 1 S L PREPARATIONS BEFORE IAN ALY SIS ses sods tiniee na ae a a a a AAR 8 1 LAN NI 8 2 Zi LU SAP A A A 8 2 322 entero Patent Intorma CON iia 8 2 zan ple kU a MRR A RT PONTO REO ONTO in eno ri oe ae 8 4 o RES CM Sant ote NA AA ase pee ona 8 7 OE RESOLTO RIN Bit Ne mromee ten ere tee ree er rie re ie Oe eee eee ER ee ee ENTE a eee nee ee 8 8 6 5 RESULT ARCHIVES isa cose seta sol A AS AA A AAA A 8 9 Bro Select Result Date ado 8 9 DANI EW RESET 8 10 Su Panne KESS ainda 8 10 9 TOGGINCGOUTAND SHUTDO W Ni ias 9 1 I IES ENCON a O 9 1 9 2 STAND BY AND SHUTDOWN anisses enoni AAA AAA AAA AAA 9 2 ADE A a E E 9 2 922 Lone tern DUC OW o A eustmrteieuastesuasecnuceaet 9 3 I SPECIAL SHUTDOWN oaia A E E eta se E EA a 9 3 O A N aN OE A E E ENR 9 4 932 SMUG OWL HOT S NPP series ones cosas a 9 4 10 TECHNOLOG Y opririi a a a e e a 10 1 10 DETECTION GPF RIN GIB E o O S 10 2 TOE Ladle VVC OUI EIN Cs a A E E a tomes donbivaytousensd st otatumiaenaaumeouneny 10 2 10 1 2 Four Part Ditterential and CD4 Measurement A A AA 10 3 10o Hemoglobin Mea sure e 10 6 10 2 EEUKOC KIT ANALYS Sa A A A 10 6 10 EBRYITROCYTEANALY S salina tdi 10 7 IMATYDRAUTIE DESCRIPTION mincinos ina E E E R
67. pproved by PointCare Technologies may cause harmful interference and void the FCC authorization to operate this equipment The symbol SS on the product indicates that this product may not be treated as household waste Instead it shall be handed over to the applicable collection point for the recycling of electrical and electronic equipment By ensuring this product is disposed of correctly you will help prevent potential negative consequences for the environment and human health which could otherwise be caused by inappropriate waste handling of this product For more detailed information about recycling of this product please contact your local city office or your distributor of this product 11 PointCare NOW INSTALLATION 1 INSTALLATION 11 UNPACKING 1 1 1 Introduction The PointCare NOW is an automated hematology analyzer flow cytometer for in vitro diagnostic use in clinical laboratories by authorized technicians e Only human blood and PointCare approved artificial control blood should be analyzed with this system e Only the reagents specified in this manual are permitted for use e Optimum performance can only be achieved if the cleaning and maintenance procedures are carefully followed If the PointCare NOW has been stored at a temperature less than 10 C it must be left at room temperature 18 34 C for 24 hours before operation 1 1 2 Unpacking Procedure Before unpacking the instrument inspect the shipping box and
68. r cleaning of the system Page 9 2 PointCare NOW LOGGING OUT AND SHUTDOWN 9 2 2 Longterm Shutdown Longterm shutdown should be performed when the instrument will not be used for longer than two weeks This cycle requires the use of the SuperWash reagent see Section 5 3 3 e From the MAIN MENU press SHUTDOWN e Select LONGTERM SHUTDOWN e A prompt will ask the user to confirm starting the PLEASE SELECT TYPE OF SHUTOOWM cycle and a status screen will allow the user to follow the progress of the cycle e Follow the on screen instructions e At the end of the cycle the PointCare NOW automatically turns off 93 SPECIAL SHUTDOWN e Select SPECIAL SHUTDOWN from the ADMINISTRATIVE MENU e A dialog box will open giving two options MOBILE SHUTDOWN and SHUTDOWN FOR SHIPMENT EE Se ae Hoa AA a b Page 9 3 PointCare NOW 9 3 1 Mobile Shutdown LOGGING OUT AND SHUTDOWN The MOBILE SHUTDOWN option enables the user to shutdown the PointCare NOW for transportation between clinics or for movement within the laboratory NOTE The Mobile Shutdown is not meant for use in situations where the instrument will be packaged for shipment or shutdown for two weeks or more PLEASE SELECT TYPE OF SHUTOOWM MOBILE SHUTOOWH SHUT OC FOR SHIPPI CANCEL HG 9 3 2 Shutdown for Shipping Select MOBILE SHUTDOWN from the Special Shutdown Menu to begin the cycle A prompt will ask the us
69. rument and if possible away from all reagents and waste to avoid contact with any liquid To electrically disconnect the PointCare NOW remove the power supply plug from the UPS Before plugging the power cord into the instrument first ensure that the power block switch is in the OFF position Page 1 5 PointCare NOW INSTALLATION Properly connect the power cord to the instrument flat side must be towards the fluidics door Turn the power block switch to the ON position Now the instrument may be turned on The PointCare NOW has been certified with the power supply provided with the machine The use of another external power supply is not guaranteed and will void the warranty Please contact your PointCare representative NOTE Only the PointCare NOW instrument and printer should be connected to the UPS Page 1 6 PointCare NOW INSTALLATION 14 CONNECTING AND PRIMING REAGENTS PointCare NOW works only with the reagents described in this manual 1 4 1 Reagent Connections LiquiPack Before handling the reagents carefully read the specifications described in the reagent insert and MSDS sheets im al ee ee a iaia EDH pora iaa pdm wre error mt ds Saree MT pi e Tear off the top of the box lid Remove the caps of the bottles e Place the CD4NOW LiquiPack in the dedicated location on the left side of the instrument NOTE Ensure that none of the fluid lines are pinched behind
70. rying the CD4 antigen on the basis of the granularity added by the colloidal gold label The FSC Forward Scatter detector is used in combination with the ALL Page 10 1 PointCare NOW TECHNOLOGY detector to discriminate four basic classes of white blood cells lymphocytes monocytes neutrophils and eosinophils Two parameter discrimination is used to eliminate monocyte interference from the CD4 lymphocyte count It also provides a four part white cell differential count The PointCare NOW optical system uses a long lifetime low power consumption LED light source rather than the traditional laser light source Power consumption for the total system is approximately 150 Watts at maximum which is much lower than the multi kilowatt levels of power consumption encountered with laboratory flow cytometers The PointSmart automated gating software automatically identifies dot plot clusters for cell enumeration This software also identifies abnormal clusters When abnormal clusters occur and accurate cell enumeration is compromised the software alerts the user via a screen message and does not report a result Operators are locked out of this software and cannot alter gates results or PointCheck messages 10 1 DETECTION PRINCIPLE 10 1 1 WBC Counting White blood cell counting is done with an impedance orifice technique see figure on following page This technique uses an aperture that is about ten times the diameter of a white blood ce
71. ss OK and perform a new start up If the user chooses to proceed with sample analysis every result will be printed with Startup not done message on the results page 63 STARTUP AFTER SHIPMENT If the PointCare NOW was Shutdown for Shipment an extended startup cycle will proceed when the STARTUP button on the MAIN MENU is selected see Section 1 4 4 Page 6 1 PointCare NOW QUALITY CONTROL 7 QUALITY CONTROL 7 1 INTRODUCTION Quality controls allow the user to verify the stability of the PointCare NOW analytical performance when operating The PointCare NOW handles two different types of control materials a latex bead suspension Daily Check and fixed whole bloods CBCNOW and CD4NOW PointCare recommends running at least one type of control at the beginning of each work day before performing sample analysis If the tolerances indicated on the control result sheet are exceeded repeat the control analysis If the error persists contact your local PointCare representative The PointCare NOW stores in memory up to 100 results per lot for 2 different Daily Check lots and four different CBCNOW and CD4NOW lots Results of each lot can be viewed in tables and Levey Jennings graphs e From the MAIN MENU press QUALITY CONTROL to access to the QUALITY CONTROL MENU The control material must be used before its expiration date and stored according to the manufacturer s instructions for use Page 7
72. tdoors e Always switch off the PointCare NOW and disconnect the power adaptor before dismantling any part e The PointCare NOW is an automated hematology analyzer flow cytometer for in vitro diagnostic use in clinical laboratories by authorized persons o Only human blood or PointCare approved artificial control blood should be run o Only the reagents mentioned in this manual are permitted for use o The optimum performance can only be achieved if the cleaning and maintenance procedures are carefully followed e All parts and surfaces of the PointCare NOW are potentially infectious Wearing protective gloves and washing hands with disinfectant after work is highly recommended e Always replace or use parts supplied by PointCare distributor e Basic safety precautions should always be taken If the equipment is not used according to the manufacturer s instructions injury may result e The treatment of waste and the disposal of an instrument or its parts must be done in compliance with the local legislation e Any additional output or input connections except the printer and the barcode reader supplied by PointCare cannot be added without the PointCare representative authorization e Do not open the door located on the right side of the instrument see Section 1 1 3 when a fluidic cycle is in progress as it will cause an immediate stop To re start shut the door and run a reset cycle see Section 11 2 2 PointCare NOW BEFORE USE KEEP T
73. ted Select VIEW RESULTS on the QUALITY CONTROL MANAGER screen to view the QC BATCH SUMMARY screen QEU A ARA AE CEA ES ILS 7 E A Te GT This Screen includes o QC lot drop down box o Scroll grid with selectable entries of all results from selected lot o List of mean standard deviation and CV for all parameters of selected results To select multiple entries select SEL next to the desired entries Selected entries will have an arrow beside them in the SEL column A minimum of 2 entries must be selected to calculate the Standard Deviation and CV Select DEL NOT SELECT to delete entries not selected in the left column Select PRINT to print the selected entries Select SAVE to save the QC batch to a USB flash drive Page 7 14 PointCare NOW 7 4 5 Levey Jennings ci Wa a SS E8N AY SE AMMAR SS MET Th Eh oh Eh ite wie Shy Shs Bh Shy aE Th Shs 7 Sh Eh QUALITY CONTROL Select LJ on the OC BATCH SUMMARY screen to display the LEVEY JENNINGS PLOT screen This screen enables the user to view the Levey Jennings plot for each quality control lot The column on the left shows each parameter with the target values and the limits The value under the name of the parameter is the value where the cursor is located on the plot The J and 22 keys enable the user to display the plots of the other parameters for that lot The cursor 11 l located under t
74. ter removing all straws from the SuperWash Cap the SuperWash bottles When the cycle has completed the user will be prompted to REMOVE ALL TUBES FROM THE SAMPLE DOOR Select DONE after removing all tubes and the PointCare NOW will power off When the instrument has turned off remove the SuperWash from the reagent tray A Startup After Shipment cycle will be required when the instrument is powered on again see Section 6 3 Page 9 5 PointCare NOW TECHNOLOGY 10 TECHNOLOGY The PointCare NOW system is based on an optical measurement technology developed as a portable blood cell analyzer with a comprehensive test menu that combines basic hematology tests with enumeration of CD4 lymphocytes PointCare NOW PointSafe Fluidics System The PointCare NOW fluidics system is designed to prevent operator contact with blood blood or fluid aerosols and liquid waste The operator inserts a capped phlebotomy blood sample tube into a receiving slot in the instrument The tube is then automatically taken inside the instrument and a door closes and locks to prevent user interaction with fluids The instrument automatically pierces the cap and withdraws a precise aliquot of whole blood that is then biochemically processed internally to give a result The door opens and the capped tube is returned to the user after the results are displayed on the instrument screen Waste generated during the test is confined to a sealed container and
75. the user selects PROCEED a series of dialog boxes will appear asking the use to confirm that the waste tubing has been connected to the back of the instrument and that the straws have been inserted into the LiquiPack reagent bottles Press OK The Startup After Shipment sequence is initiated The cycle LED turns red No cycle can be performed until it turns green Upon successful completion of the Startup After Shipment cycle the MAIN MENU will be displayed 1 5 Storage temperature 10 C to 50 C TRANSPORTATION AND STORAGE e If the PointCare NOW has been stored at a temperature less than 10 C it must be left at room temperature for 24 hours before use e Before transport outside the laboratory perform a complete cleaning with a disinfectant in compliance with the local legislation e Before storage or transport a special shutdown cycle is required See Section 9 for details Page 1 11 PointCare NOW GENERAL OVERVIEW 2 GENERAL OVERVIEW 2 1 GENERAL INFORMATION PointCare NOW is a fully automated analyzer performing hematological analysis and CD4 count on whole blood collected in EDTA K2 tubes e Analysis volume 40 ul whole blood e Throughput 7 samples hour e 12 analysis parameters BC White Blood Cells LYM Lymphocytes in and Neutrophils in and EOS Eosinophils in and CD4 CD4 positive T lymphocytes in and Erythrocyte parameter HGB Hemoglobin 2 2 OV
76. tings loaded DEL Results deleted in archive Each column is identified by a number At the right of the screen the following information for the selected column is displayed e The date 82 18 2884 e The number of analyses run during that day MUM 2 e The number of the column PAY 365 Page 11 7 PointCare NOW MAINTENANCE AND TROUBLESHOOTING SELECTION e To print the log report press PRINT Pega eines e Selecting ALL prints all entries DAY FROM TO e Selecting DAY allows the user to select the range of days to print 115 TROUBLESHOOTING MENU The TROUBLESHOOT option allows the user access to troubleshooting steps and procedures that will assist in the solution of issues seen on the PointCare NOW A If any problem cannot be solved call your PointCare representative En The TROUBLESHOOTING MENU consists of the following buttons e SYSTEM RESET e FLUIDICS e MECHANICS e SATELLITE e VIEW ERROR LOG e VIEW PLOTS e ADMINISTRATIVE MENU AAA A AAA Mr in a a eL AS Page 11 8 PointCare NOW MAINTENANCE AND TROUBLESHOOTING 11 5 1 System Reset e Selecting SYSTEM RESET from the TROUBLESHOOTING DO YOU WISH TO PERFORM A menu will launch a message prompt asking the user Do you FULL SYSTEM RESET CYCLE l E wish to perform a full system reset cycle This cycle takes approximately 6 minutes PROCEED e If CANCEL is selected the user will be returned to the Troubleshooting Menu
77. x 8 10 times by holding the vial upside down and flicking the side of the vial with a finger o Turn the vial right side up and tap on the table 3 4 times to ensure all gold settles to the bottom of the vial o Reinsert the vial into the first slot on the sample door Select CONTINUE A dialog box appears instructing the user to LOCK GOLD Rotate the vial locking assembly clockwise to lock Select CONTINUE to begin the CD4 Control analysis At the completion of the cycle the sample door will open and the user will be prompted to REMOVE CONTROL TUBE Remove the control tube and select CONTINUE The control results are displayed Page 7 10 PointCare NOW QUALITY CONTROL 7 3 4 Results e The QC RESULTS SCREEN contains a summary of all the Control Lot information entered for that particular lot Included are the time and date of test the Clinic where the test was run the Operator performing the test the lot numbers of the reagent packs used the type of units selected and the Results Table e Ifaresult is above the target high value a will appear to the right of the result and the result will be displayed in boldface A 1 e Ifaresult is below the target low value a will appear to the right of the result and the result will be displayed in boldface e Ifa result cannot be reported will be displayed instead of the result e Select PRINT to print the results for the
78. yover is analyzed for the two calibrated parameters WBC and HGB and additionally for the cytometer CYT The table below is a representation of typical and maximum carryover of the PointCare NOW System ae The percentage carryover is calculated using the following formula Blank 1 Blank 3 x 100 High 3 Blank 3 Carryover 4 2 4 Accuracy The degree of agreement between the PointCare NOW System and multiple reference methods was studied using normal and abnormal whole blood samples across three sites in the U S and the Caribbean Page 4 3 PointCare NOW SPECIFICATIONS 4 3 PHYSICAL SPECIFICATIONS 4 3 1 General Ambient temperature from 18 to 34 C Relative Humidity 80 maximum at 31 C Storage temperature 10 to 50 C If the PointCare NOW has been stored at a temperature less than 10 C it must stay at room temperature 18 34 C for 24 hours before switching it on 4 3 2 Instrument Height 350 mm approx Width 250 mm approx 340 mm approx 12kg approx Power Supply Output 24V 5A DC Electric Consumption During cycle 75 VA 30 10 Stand By 20 VA 30 10 Maximum 110 VA 30 10 TFT Color LCD 240 320 Mode portrait Backlight Barcode Option Barcode reader C39 Barcode 2 interleaved 5 Memory Capacity 8000 Files Demographics and results QC 7 levels 100 Files per level Page 4 4 PointCare NOW SPECIFICATIONS 4 3 3 Reagent Consu

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