280342_afinion_manual_US.qxd:Layout 1
Contents
1. lh Touch to enter Touch b _ to enter Adjust beeper volume by screen beeper settings beeper volume setting touching _ or Touch w lto accept and return to previous view How to switch OFF the Analyzer Am Switch off the Analyzer by pressing the ON OFF button Figure 1 The Analyzer should be switched off after the end of a working day Please note e When the power is turned off a closing down procedure is initiated The cartridge carriage will move to a safe position and the display will be active a few seconds until the Analyzer shuts down The Analyzer can be switched off or the power supply disconnected without loss of stored results e The Analyzer can only be switched off when the cartridge chamber is empty and the lid is closed If the ON OFF button is pressed and the lid is open the message Close lid will appear on the screen 18 09 38555 QUALITY CONTROL Why quality control testing Quality control testing should be done to confirm that your Afinion AS100 Analyzer System is working properly and providing reliable results Only when controls are used routinely and the values are within the acceptable ranges can accurate results for patient samples be assured Choosing control material Controls recommended by Axis Shield should be used for quality control of your the Afinion AS100 Analyzer System These control kits contain control materials with established acceptable ranges for th2. Afinion AS100 Analyzer User Manual 1115175 09 38555 Dear Customer Congratulations on the purchase of your Afinion AS100 Analyzer Upon arrival of your Afinion AS100 Analyzer we recommend that the serial number along with the soft ware version be recorded in the table provided below The additional rows in the table are to be utilized if a software upgrade is performed on your AS100 Analyzer The recorded information will be of great value if and when a question is reported or the desire to add a new Afinion test to your Analyzer arises Serial number see label on the underside of the Analyzer or on the transport container NOTE The Analyzer must be turned off when the label on the underside is read Software records Date Software version Afinion tests available Upon receipt 1 SW upgrade 2 SW upgrade 3 SW upgrade 4 SW upgrade 5 SW upgrade See display when you switch on the Analyzer see Automatic start up procedure page 13 Notes Technical Support Call 1 877 4 Afinion or 1 877 423 4646 E mail techsupport us axis shield com 09 38555 Afinion AS100 Analyzer System Intended use The Afinion AS100 Analyzer System consists of the Afinion AS100 Analyzer and the Afinion Test Cartridges The Afinion Analyzer System is designed for point of care testing and is for in vitro diagnostic use only CLIA Statements Waived Afinion tests This User Manual is valid for
3. Frequency of control testing Controls should be analyzed With each new shipment of Afinion test kits With each new lot of Afinion test kits Users with a low frequency of testing should analyze controls at least every 30 days When training new operators in correct use of the Afinion AS100 Analyzer Anytime an unexpected test result is obtained After software upgrade of the Afinion AS100 Analyzer The controls should always be analyzed if an unexpected test result is obtained see the Afinion test Package Insert section Test result reporting If local state and or federal regulations require more frequent testing of control materials then quality control should be performed in compliance with these regulations Each laboratory site can benefit from establishing a quality control plan The laboratory director should determine whether additional testing 15 appropriate for their laboratory 19 09 38555 TESTING PROCEDURES Operating precautions When operating the Analyzer Use your fingertip to operate the touch screen Do not use pens or other objects that may scratch or damage the screen Exception If the screen alignment function is required you will need to use a blunt pencil The lid opens automatically but must be closed manually Do not try to open the lid manually The lid protects the cartridge chamber from dust dirt and humidity Empty the cartridge chamber and keep the lid closed when th
4. control mode the barcode label facing left The Analyzer will start The lid opens automatically processing the Cartridge If the lid is left open from A C in the upper left corner The processing time depends previous run and Insert indicates that the Analyzer is in on the test in use Cartridge is disp layed the control mode touch WE then proceed with step e 4a fh Touch id and enter Record the result then Remove the used Test control ID touch v to accept Cartridge from the cartridge Touch oe to confirm If a printer is connected chamber and discard it in a touch Jj to print the suitable waste container result Insert a new Test Cartridge or close the lid manually Entering the control ID will not The lid opens automatically Keep the lid closed to protect interrupt the processing The result will be saved in the the cartridge chamber when the See detailed procedure on control records Analyzer is not in use page 23 Consult the Afinion test Package Insert for control and assay specific information 09 38555 27 TESTING PROCEDURES Viewing result records The patient and control results are stored in the memory of the Afinion AS100 Analyzer The last 500 patient results and the last 500 control results are saved in separate records When exceeding the capacity of 500 results the oldest result will be deleted The following parameters are listed for each run Date and
5. device straight up 09 0555 25 TESTING PROCEDURES Analyzing a patient sample Touch E8 to enter Insert the Test Cartridge with patient sample mode the barcode label facing left The lid opens automatically If the lid is left open from Be sure that the Test Cartridge previous run and Insert is correctly placed in the Cartridge is displayed this cartridge chamber step is omitted and you can start with step 2 4a lh Touch a and enter Record the result then patient ID touch w _ to accept Touch to confirm If a printer is connected touch El to print the result Entering the patient ID will not The lid opens automatically interrupt the processing The result will be saved in the See detailed procedure on patient records page 22 Close the lid manually The Analyzer will start processing the Test Cartridge The processing time depends on the test in use Remove the used Test Cartridge from the cartridge chamber and discard it in a suitable waste container Insert a new Test Cartridge or close the lid manually Keep the lid closed to protect the cartridge chamber when the Analyzer is not in use Consult the Afinion test Package Insert or Quick Guide for assay specific information 26 p9 96555 TESTING PROCEDURES Analyzing a control if m ELEF Touch WE to enter Insert the Test Cartridge with Close the lid manually
6. HbA1c Test Cartridge or Analyzer failure Capillary cracked or damaged Barcode label not readable dirty or damaged No sampling device inserted Used sampling device belongs to another Afinion test Label on sampling device not readable dirty or damaged Test Cartridge previously used Test Cartridge has passed expiration date The date in the Analyzer Is incorrectly set Test Cartridge temperature too low Test Cartridge temperature too high Test Cartridge not recognized by the Analyzer Action to take Repeat the test with a new sample and Test Cartridge Ensure that the capillary is completely filled with no air bubbles Repeat the test with a new sample and Test Cartridge Ensure that only the tip of the capillary is in contact with the sample Repeat the test with a new sample and Test Cartridge Ensure that proper sample material is used see Package Insert for the Afinion test in use section Specimen collection and storage Repeat the test with a new sample and Test Cartridge The time from filling the capillary until analyzing the Test Cartridge should be as short as possible Consult the Afinion HbA1c Package Insert Repeat the test with a new sample and Test Cartridge Repeat the test with a new sample and Test Cartridge If the problem persists restart the Analyzer and run controls Repeat the test with a new sample and Test Cartridge Inspect the sampling device before use and
7. ID must be entered for each Test Cartridge to be analyzed If the patient ID function is disabled OFF a run number will automatically replace the patient ID and be displayed in the upper left corner of the screen This numbering is reset every 24hrs each day at 00 00h Disabling the patient ID function Configuration menu Parent 10 Parent ID Cw OCR A Touch C to enter Touch OM to Touch W to accept patient ID on off option disable the patient ID and return to the configuration function menu Enabling the patient ID function Configuration menu Parent ID Parent 10 G Ca 4 lh Touch A to enter Touch O OFF J to Touch 1 to accept patient ID on off option enable the patient ID function and return to the configuration menu 09 38555 15 GETTING STARTED Setting date The correct date should always be set because the date and time for the analysis are stored and displayed in the patient and control records The date format is YYYY MM DD where YYYY is the year MM is the month 01 to 12 and DD is the day 01 to 31 Configuration menu m za date time settings date setting Touch to confirm and return to previous view fh Touch _ to enter Touch Cf to enter Enter today s date Setting time The correct time should always be set because the date and time for the analysis are stored and displayed in the patient and control records The time format is hh mm where h
8. Test nama Ca 5 l J Y 8 lh Touch E I to enter Enter patient ID by numbers The entered patient ID will the patient ID option and or touch ABE to enter appear on the screen letters The patient ID icon will remain Touch to confirm and in view to allow corrections to return to previous view be made If a barcode reader is connected to the Analyzer then this can be used to scan a bar coded patient ID 22 09 38555 TESTING PROCEDURES Using the control ID function In quality control testing a suitable control ID must always be entered The lot number of the control material is recommended as a suitable control ID The control ID function cannot be disabled Entering control ID It is recommended to enter the control ID during processing of the Test Cartridge in the Analyzer Entering the control ID will not interrupt the processing It is also possible to enter the control ID before processing Both letters and numbers can be entered maximum 16 characters The control ID will be stored in the memory and displayed along with the other specific data for this run see Viewing result records page 28 To enter the control ID during processing do the following 5 Ah Mii i Tast nama i Test nama CB h Touch id jto enter the Enter control ID by numbers The entered control ID will control ID option and or press ABC to enter appear on the screen letters The
9. handle with care Repeat the test with a new sample and Test Cartridge If the problem persists restart the Analyzer and run controls Repeat the test with a new sample and Test Cartridge Repeat the test with a new sample and Test Cartridge Ensure that the sampling device and Test Cartridge have the same label color Repeat the test with a new sample and Test Cartridge Ensure that the label is clean Repeat the test with a new sample and Test Cartridge Check expiration date on the Cartridge pouch or box Repeat the test using a new sample and a new Test Cartridge from another lot Check the date in the Analyzer to make sure It is set correctly Repeat the test with a new sample and Test Cartridge Repeat the test with a new sample and a new Test Cartridge within recommended operating temperature range see Package Insert for the Afinion test in use Repeat the test with a new sample and a new Test Cartridge within recommended operating temperature range see Package Insert for the Afinion M test in use section Test procedure The software version required for this test is not installed Contact your local supplier for assistance 09 38555 213 214 215 216 INFORMATION CODES AND TROUBLESHOOTING Cause Test Cartridge or Analyzer failure Controls are not run after the software upgrade of the Analyzer Action to take Repeat the test with a new sample and Test Cartridge If the problem pers
10. is the cartridge chamber The cartridge chamber is designed to receive the Test Cartridge in one orientation only The lid must be manually closed but opens automatically When a new Test Cartridge is placed in the chamber manually closing the lid will initiate the analysis Vhen the analysis Is complete the lid will open automatically The lid protects the cartridge chamber from dust dirt and humidity during processing and when the Analyzer is not in use A e The lid must be manually closed but opens automatically Do not open the lid manually e Use the fingertips only on the touch screen Do not use pens or other sharp instruments 5 1 2 4 Figure 3 1 Text message 2 Icons 3 The lid in open position 4 The cartridge chamber with a Test Cartridge Screen saver The screen saver will turn on after 3 minutes if the touch screen is not in use To re activate touch the screen Light signals the red and green LEDs The red diode is illuminated when the Analyzer is busy A flashing red light is seen when an information code is displayed The green diode is illuminated when the Analyzer is free and ready for use A flashing green light indicates completion of an analysis Sound signals A short beep indicates completion of an analysis Iwo beeps indicate an information or error message 09 38555 ANALYZER SYSTEM DESCRIPTION How the Afinion AS100 Analyzer System works The Afinion AS100 Analyzer System uses differen
11. the Afinion tests waived under the Clinical Laboratory Improvement Amendment of 1988 CLIA 88 A CLIA Certificate is needed to perform testing in a waived setting If the laboratory modifies the Afinion test or Afinion AS100 Analyzer instructions the test no longer meets the requirements for waived categorization A modified test is considered to be highly complex and is subject to all applicable CLIA requirements Conformity to the IVD directive The Afinion AS100 Analyzer meets all provisions in the European directive 98 79 EC on In Vitro Diagnostic Medical Devices and is CE marked accordingly Safety standards The Afinion AS100 Analyzer is tested and conforms to the safety standards IEC EN 61010 1 IEC EN 61010 2 081 and IEC EN 61010 2 101 and to the EMC standard IEC EN 61326 Axis Shield PoC AS PO Box 6863 Rodel kka NO 0504 Oslo Norway ISO 9001 and ISO 13485 certified company 09 38555 INTRODUCTION Intended use of the Afinion AS100 Analyzer System About this User Manual Examining the package contents ANALYZER SYSTEM DESCRIPTION Description of the Afinion AS100 Analyzer Description of the Afinion Test Cartridge How to operate the Analyzer How the Afinion AS100 Analyzer System works Internal process control Calibration GALLERY OF ICONS The icons and their function Other symbols and signs GETTING STARTED Locating your Analyzer Connecting power supply Connecting additional equ
12. time run number patient ID control ID operator ID lot numbers of Test Cartridge and Test Result If a printer is connected the test results can be printed one by one Viewing patient results Start up menu Main menu mum ryued lh Touch S to enter Touch amp 8 to enter The last patient result 15 main menu patient records displayed To view more results touch kg or _ amp _ Ifa 15 connected touch 4 to print the result Viewing control results Start up menu Main menu mum rrr lh Touch C g J to enter Touch UB to enter The last control result is main menu control records displayed To view more results touch i of Ifa a 15 connected touch to print the result 28 09 38555 INFORMATION CODES AND TROUBLESHOOTING When an information code appears Information codes that might appear during use of the Afinion AS100 Analyzer refer to specific information or error messages he code numbers the possible causes and actions to take are listed below If the Analyzer detects a problem during processing of a Test Cartridge the test will automatically be aborted and the Test Cartridge will be safely moved to the cartridge chamber Proceed as follows N Record the code number and touch w J to accept cee The lid opens automatically Remove the lest Cartridge Look up the possible cause If the lest Cartridge is not from th
13. 2 3 x 3 0 in 58 x 77 mm 640 x 480 pixels 500 patient results and 500 control results via USB flash drive 5 232 USB 1 1 Separate AC to DC power cord adapter Double insulated 100 240 VAC 50 60 Hz 42 W 24 VDC 5 1 75A 0 2 x 0 1 in 5 5 x 2 5 mm plug Positive on inner pin IEC EN 60950 UL 1950 USA and Europe EN 60601 UL 2601 Japan Approved for in vitro diagnostic medical devices 15 32 C 59 89 F 10 90 non condensing Dry clean horizontal surface Avoid direct sunlight According to specifications for the Afinion test in use Storage and transport in the original container Temperature Relative humidity Accessories 40 to 70 C 40 to 158 F 10 93 at 40 C 104 F For information regarding recommended barcode reader and printer please call 1 877 4 Afinion 1 877 423 4646 or email techsupport us axis shield com 34 09 38555 SYMBOLS AND ABBREVIATIONS The following symbols and abbreviations are used in the product labeling and instructions for the Afinion AS100 Analyzer System Symbol Abbreviation CE T g J LOT 2 N TEST CARTRIDGE CONTROL C OL Cll O O Z J CLEANING KIT MA A Bebe ESE LED D HIS LIS ESD 8 DC gt Explanation Conformity to the European directive 98 79 EC on in vitro diagnostic medical devices In Vitro Diagnostic Medical Device Catalog number Lot number Serial number Test
14. Cartridge Control C Control C Cleaning kit Waste Electrical and Electronical Equipment VVEEE Contents are sufficient for one test Contents are sufficient for 15 tests Expiration date year month Storage temperature limitations Manufacturer Operator s handling Warnings and precautions Biological risk Consult the Afinion user instructions Clinical Laboratory Improvement Amendment of 1988 Light Emitting Diode Personal Computer Identification Hospital Information System Laboratory Information System Liquid Crystal Display Alternating Current Direct Current oie 09 38555 ouunyzeusis MMM 0 00C P8ESLLL
15. SHIELD DISCLAIMS ALL WARRANTIES WHETHER EXPRESS OR IMPLIED WRITTEN OR ORAL WITH RESPECT TO THE AFINION AS100 ANALYZER INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AXIS SHIELD S MAXIMUM LIABILITY ARISING OUT OF THE SALE OF THE AFINION AS100 ANALYZER OR ITS USE WHETHER BASED UPON WARRANTY CONTRACT TORT OR OTHERWISE SHALL NOT EXCEED THE ACTUAL PURCHASE PRICE PAID BY THE BUYER FORTHE AFINION AS100 ANALYZER IN NO EVENT SHALL AXIS SHIELD BE LIABLE FOR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS LOSS OF DATA OR LOSS OF USE DAMAGES ARISING HEREUNDER OR FROM THE SALE OF THE AFINION AS100 ANALYZER THIS WARRANTY MAY NOT BE TRANSFERRED BY THE BUYER The acknowledgement of claims shall be reported to your Axis Shield Technical Care Specialist at 1 877 4 Afinion or 1 877 423 4646 or by E mail to techsupport us axis shield com 33 09 38555 TECHNICAL SPECIFICATIONS Afinion AS100 Analyzer Analyzer Size Weight Display Camera Capacity of result records SW update Communication interface Power supply Power cord adapter Input Output Output connector Adapter standards Operating conditions Temperature Relative humidity Location Test Cartridge temperature 12 6 x 6 7 x 6 in 320 x 170 x 170 mm 11 Ibs 5 kg Standard LCD color display with back light and integrated touch panel Resolution 240 x 320 pixels Visible area
16. commended above e Do not allow liquid to drip off the Cleaning Swab into the Analyzer If liquid drips into the Analyzer optics can be destroyed e Do not immerse the Analyzer in water or other liquids Clinical and Laboratory Standards Institute CLSI Guideline M29 A3 Protection of Laboratory Workers From Occupationally Acquired Infections Approved Guideline Third Edition ISBN 1 56 238 567 4 32 09 38555 MAINTENANCE AND WARRANTY Disposal of the Analyzer Ui For correct disposal according to the Directive 2002 96 EC WEEE contact your local Afinion supplier Software upgrade li Consult the Afinion AS100 Analyzer SW Upgrade Package Insert Warranty Axis Shield warrants solely to the Buyer that the Afinion AS100 Analyzer will be free from defects in materials and workmanship when given normal proper and intended usage and will perform in accordance with Axis Shield s specifications for a period of twelve months from the date of delivery At its expense Axis Shield agrees to repair or at Axis Shield s option replace with a new or recon ditioned unit any Afinion AS100 Analyzer which is under warranty and not performing substantially in accordance with applicable product specifications provided that the Buyer has given Axis Shield notification of such warranty claim within the warranty period If Axis Shield is unable after reason able efforts to repair or replace the Afinion M AS100 Analyzer not pe
17. contro ID icon will remain Touch to confirm and in view to allow corrections to return to previous view be made 09 38555 23 TESTING PROCEDURES Preparing for an Afinion analysis ny Enter operator ID optional See procedure on page 21 The patient ID or control ID can be entered before or during processing of the Test Cartridge in the Analyzer See procedures on page 22 and 23 Tear strip Open the foil pouch im Grip the handle and remove the Test Cartridge from the pouch Discard the desiccant bag and foil pouch in suitable waste containers Once opened the Test Cartridge has limited stability 24 Handle 0 fi i 2 Optical reading area Inspect the Cartridge Do not use the Test Cartridge if it is damaged or if loose desiccant particles are found on the Test Cartridge Use the handle to avoid touching the optical reading area 09 38555 Allow the Afinion Test Cartridges to reach recommended operating temperature before use Switch on your Afinion Analyzer so it is ready for the day s first analysis Consult the Afinion test Package Insert or Quick Guide for assay specific information ID area XX NN i Mark the Test Cartridge with the patient or control ID Use the ID area on the opposite side of the Test Cartridge An ID label can also be used Do not write on the barcode label or allow it to become wet d
18. dapter 24 volt power supply e Quick Guides for the available Afinion tests e User Manual e Installation video CD Rom If the package unit is found incomplete please report missing items or shipping damage to your supplier It is recommended to keep the shipping box in case of later transportation of the Analyzer 09 38555 5 ANALYZER SYSTEM DESCRIPTION Description of the Afinion AS100 Analyzer Figure 1 shows the main exterior parts of the Afinion AS100 Analyzer Figure 1 1 ON OFF button Turns the power to the Analyzer on and off 2 Red and green LEDs Light emitting diodes LEDs that indicate whether the Analyzer is busy or not 3 Touch screen Allows you to communicate with the Analyzer through touch icons and messages 4 Thelid Covers and protects the cartridge chamber 5 Cooling ribs Facilitate temperature control 6 Connectors For connecting to power cord adapter Options for printer barcode reader and or PC connections AN Do not open the lid manually 09 38555 ANALYZER SYSTEM DESCRIPTION Description of the Afinion Test Cartridge The Afinion Test Cartridge is unique for each analyte to be measured as the reagent composition reagent volumes and the integrated devices are test specific The Test Cartridge and the sampling device labels have a unique color for each test The Test Cartridges are separately packed in foil pouches to protect the chemicals and plastic devices from ligh
19. e Afinion AS100 Analyzer System Handling and testing controls li Consult the Package Insert that comes with each control kit for detailed instructions on handling and storage of the control material To run a control follow the procedure in the section Testing procedures page 20 28 The measured value should be within the acceptable range stated on the control vial label or in the control package insert If the control results are within the acceptable ranges patient samples may be tested and results reported If the result obtained for a control is outside the acceptable limits make sure that The control vial has not passed its expiry date The control vial has not passed its open vial expiry date The control vial and Afinion Test Cartridges have been stored according to recommendations There is no evidence of bacterial or fungal contamination of the control vial Correct any procedural error and re test the control material If no procedural errors are detected it is recommended to examine the laboratory s quality control record to investigate the frequency of control failures Ensure that there is no trend in out of range quality control results Re test the control material using a new control vial Patient results must be declared invalid when controls do not perform as expected Contact your customer service representative 1 877 4 Afinion or 1 877 423 4646 for advice before analyzing patient samples
20. e Analyzer is not in use If an information code appears on the screen during the analysis please consult the Information codes and troubleshooting section page 29 Do not move the Analyzer when a Test Cartridge is being processed Do not turn the Analyzer upside down when a Test Cartridge is being processed When handling the Test Cartridge 20 Do not use Test Cartridges after the expiration date or if the Test Cartridges have not been stored in accordance with the recommendations Do not use the Test Cartridge if the foil pouch the desiccant bag or the Test Cartridge itself is damaged The Test Cartridges must reach recommended operating temperature before use Do not open the foil pouch until just before use Once opened the Test Cartridge has limited stability Handle and dispose the Test Cartridges and sample collection equipment as potential bio hazardous materials Use personal protective equipment Do not re use any part of the Test Cartridge Consult the Package Insert that comes with each Afinion test kit for assay specific information 09 38555 TESTING PROCEDURES Using the operator ID function Entering operator ID optional If required the operator s identification ID can be entered before processing an Afinion Test Cartridge Both letters and numbers can be entered maximum 16 characters The operator ID will be stored and displayed in the lower left corner of the screen The entered operato
21. e instructions The manufacturer provides a toll free line for technical support Call 1 877 4 Afinion or 1 877 423 4646 The toll free number is available for use only in the United States of America E mail techsupport us axis shield com Before asking for assistance please record the following information Afinion M AS100 Analyzer serial number SN see page 1 e Software version number see page 1 Afinion M test type e Test Cartridge lot number see foil pouch or kit container e Control name and lot number see vial label e Control results obtained e Description of the problem with reference to information codes and error messages a 09 38555 MAINTENANCE AND WARRANTY Cleaning and maintenance No maintenance of the Afinion AS100 Analyzer is required other than cleaning the exterior and cartridge chamber Cleaning the exterior Cleaning the exterior of the Afinion AS100 Analyzer should be performed whenever necessary Most spills and stains can be removed with water or a mild detergent Am Switch off the Analyzer Unplug the power supply when the shut down procedure is completed Clean the outside of the Analyzer and the touch display with a clean lint free and non abrasive cloth dampened in water or a mild detergent lo disinfect the exterior of the instrument first remove as much as possible of the spilled material with a cloth dampened in the disinfectant 2 glutaraldehyde or 0 5 sodium hypochl
22. e table below and take ejected restart the Analyzer actions to solve the problem If the problem persists contact Do not re use the Test your local Afinion supplier Cartridge see Service information page 31 Do not re use a Test Cartridge that has been rejected by the Analyzer Collect a new sample and repeat the test with a new Test Cartridge Information messages caused by assay specific limitations 103 104 105 106 107 108 Cause Hemoglobin too low Hemoglobin too high HbA1c too low HbA1c to high Creatine too high Blood in urine Action to take Consult the Afinion HbA1c Package Insert section Test result reporting Consult the Afinion HbA1c Package Insert section Test result reporting Consult the Afinion HbA1c Package Insert section Test result reporting Consult the Afinion HbA1c Package Insert section Test result reporting Consult the Afinion ACR Package Insert Consult the Afinion ACR Package Insert 29 09 38555 INFORMATION CODES AND TROUBLESHOOTING Error messages caused by sample or Test Cartridge failure 30 201 202 203 204 205 206 207 208 209 210 211 212 Cause Insufficient sample volume Empty capillary Air bubble in capillary Capillary incompletely filled Excess sample on the sampling device exterior Wrong sample material Coagulated sample Hemolysed blood sample Afinion
23. formation code will be displayed on the touch screen see Information codes and troubleshooting page 29 If the Analyzer is unable to use the display only the red LED will be flashing When the Analyzer is switched on for a longer period it will automatically restart once a day to ensure that a self test Is done regularly This procedure will not interrupt any Test Cartridge measurements The fail safe mechanisms Fail safe mechanisms are included to secure safe processing The integrated camera inspects the test cartridges initially before the process starts If defects are detected e g broken capillary the cartridge is used past its expiration date the Test Cartridge is rejected and an information code is displayed During processing vital functions and components e g pumps heater are supervised When problems are detected by the built in safety mechanism the process will be aborted and an information code will be displayed Calibration The Afinion AS100 Analyzer has been manufactured to deliver reliable and accurate results During manufacturing the Analyzers are calibrated against a reference system This procedure has been established to ensure that all Analyzers operate within identical tolerance limits Test specific calibration data are established for each lot of test cartridges and then stored in the barcode label When the Test Cartridge enters the Analyzer the integrated camera reads the barcode The calibration da
24. h is the hour from 00 to 23 and mm is minutes from 00 to 59 Configuration menu 2 so a 867 Y o EE La lh Touch df _ to enter Touch E8 _ to enter Enter time _ date time settings time setting Touch to confirm and return to previous view 16 09 38555 GETTING STARTED Adjusting screen contrast The screen contrast can be adjusted Configuration menu A Touch E J to enter Touch _ to enter Adjust screen contrast by screen beeper settings screen contrast setting touching Tm or 3 Touch wv to accept and return to previous view Aligning screen The screen must be realigned if the buttons do not respond accurately when touched It is not necessary to align screen as a part of the initial configuration Configuration menu 3 Am Touch i to enter Touch _ to enter Tap the cross hair object screen beeper settings screen alignment function in the upper left corner using a blunt pencil to be precise Repeat for the object appea ring in the lower right corner and in the center of the screen The previous screen view will automatically return 17 09 38555 GETTING STARTED Adjusting beeper volume One beep means that the test is completed and result displayed Two beeps means that an information or error code Is displayed The beeper volume can be adjusted If adjusted to a minimum no beep will be heard Configuration menu
25. ipment How to switch ON the Analyzer Automatic start up procedure Setting the configuration How to switch OFF the Analyzer QUALITY CONTROL Why quality control testing Choosing control material Handling and testing controls Frequency of control testing TESTING PROCEDURES Operating precautions Using the operator ID function Using the patient ID function Using the control ID function Preparing for an Afinion analysis Collecting a specimen with the Test Cartridge Analyzing a patient sample Analyzing a control Viewing result records Table continues on next page 09 38555 TABLE OF CONTENTS NO O NO OO NI 10 11 16 12 13 13 13 14 18 19 19 19 19 20 21 22 23 24 22 26 ay 28 TABLE OF CONTENTS INFORMATION CODES AND TROUBLESHOOTING When an information code appears 29 Information messages caused by assay specific limitations 29 Error messages caused by sample or Test Cartridge failure 30 Error messages caused by Analyzer failure 31 Service information 37 MAINTENANCE AND WARRANTY Cleaning and maintenance 52 Disposal of the Analyzer 33 Software upgrade 25 Warranty 33 TECHNICAL SPECIFICATIONS Afinion AS100 Analyzer 34 Accessories aU SYMBOLS AND ABBREVIATIONS 35 4 09 38555 INTRODUCTION Intended use of the Afinion AS100 Analyzer System Afinion AS100 Analyzer System consisting of the Afinion AS100 Analyzer and the Afinion Test Cartridges 15 for in vit
26. irty or scratched lf an ID label is used this must fit into the ID area TESTING PROCEDURES Collecting a specimen with the Test Cartridge e The patient sample material and control material to be used is specific for each Afinion test N e The length of the capillary in the sampling device and thereby the sample volume might also vary for the different Afinion tests e The time from filling the capillary until analyzing the Test Cartridge should be as short as possible e Do not use the Test Cartridge if dropped on the bench or floor after the sample has been collected Consult the Afinion test Package Insert or Quick Guide for assay specific information Examples Collecting capillary blood I Collecting control i material H i Bag fh Remove the sampling device Fill the capillary hold the Immediately and carefully from the Test Cartridge sampling device close to replace the sampling device horizontal and bring the tip into the Test Cartridge of the capillary into contact with the surface of the sample Make sure that the capillary fills completely It is not possible to overfill Do not wipe off the capillary Use the handle to keep the Avoid air bubbles and excess The time from filling the capillary Test Cartridge steady against sample on the outside of the until analyzing the lest Cartridge the table and pull the sampling capillary should be as short as possible
27. ists restart the Analyzer and run controls Run one Afinion Control following the procedure on page 27 Analyzing a control Error messages caused by Analyzer failure 301 302 303 304 305 ERROR 27 28 29 Cause Self test failed Analyzer failure Analyzer temperature Is too high Analyzer temperature Is too low Printer improperly connected Malfunction of the printer Touch screen failure Start up procedure failed Self test error Analyzer in Severe instrument failure non operative mode Service information N Action to take Restart the Analyzer Restart the Analyzer and run controls Repeat the test with a new sample and Test Cartridge Wart until the Analyzer has cooled down Ensure that the operating temperature is within recommended range 15 32 C 59 89 F Repeat the test with a new sample and Test Cartridge Ensure that the operating temperature is within recommended range 15 32 C 59 89 F Repeat the test with a new sample and Test Cartridge Switch off the Analyzer reconnect the printer and restart the Analyzer If the message persists see the printer User Manual Restart the Analyzer Contact your local supplier for assistance Contact your local supplier for assistance The laboratory must notify the manufacturer of this test system of any performance perceived or validated that does not meet the performance specifications as outlined in th
28. nter beeper volume setting Accept a setting or a test result Print result on connected printer Disable patient ID function turns OFF when touched Enable patient ID function turns ON when touched 09 3853555 Icon Name J Enter Backspace Increase Le Decrease d Scroll up re Scroll down Other symbols and signs GALLERY OF ICONS Function Enter and return to previous view Delete previous character Increase contrast volume Decrease contrast volume View next result in the patient or control records View previous result in the patient or control records Other symbols signs and abbreviations that may appear during operation of the Afinion AS100 Analyzer are explained below hese symbols or signs are only informative and cannot be activated like the Icons Symbol Meaning a Wait Information code Operator ID Patient ID Control ID Control O ID Operator ID P ID Patient ID C ID Control ID RUN Run number LOT Lot number Appears when Hour glass icon that appears 10 the start up procedure Icon used along with a code number that corresponds to specific information or an error message see Information codes and troubleshooting Icon illustrates the operator ID Icon illustrates the patient ID Icon illustrates the control ID The letter C will appear on the screen when the control mode is selected Abbreviation used 10 the patient and control records Abb
29. orite The surface of the Analyzer should be exposed to the disinfectant for at least 10 minutes Allow the Analyzer to air dry Plug in the power supply and switch on the Analyzer e The Analyzer must be switched off and unplugged before cleaning e Do not use any cleaning liquid or equipment other than those recommended above e Do not immerse the Analyzer in water or other liquids Cleaning the cartridge chamber The Afinion AS100 Analyzer Cleaning Kit REF 1115269 should always be used for cleaning the cartridge chamber The cartridge chamber should be cleaned immediately if materials or liquids are spilled in the cartridge chamber For regular maintenance removal of dust particles etc the cartridge chamber should be cleaned every 30 days Am Touch WE to open the lid Unplug the power supply Wet a Cleaning Swab with 3 drops of water or a disinfectant 2 glutaraldehyde or 0 5 sodium hypochlorite Do not soak Carefully remove spills and particles from the cartridge chamber using the moistened swab _ To disinfect the cartridge chamber the surface of the chamber should be exposed to the disinfectant for at least 10 minutes Wipe off any residual liquid from the cartridge chamber using a new dry Cleaning Swab Close the lid Plug in the power supply and switch on the Analyzer AN e The Analyzer must be unplugged before cleaning e Do not use any cleaning liquid or equipment other than those re
30. r ID will be memorized and displayed in the patient and control records The entered operator ID remains in use by the Analyzer until this ID is deleted a new ID is entered or the Analyzer is switched off Start up menu Main menu Oporalor ID Ei Am Touch El J to enter the Touch to enter the Enter operator ID by numbers main menu operator ID option and or touch ABC to enter letters Touch to confirm and return to previous view If a barcode reader is connected to the Analyzer then this can be used to scan a bar coded operator ID 21 09 38555 TESTING PROCEDURES Using the patient ID function The patient ID function is ON as a default setting As long as this function is enabled the patient ID must be entered for each patient sample to be analyzed The patient ID function can be disabled see Setting the configuration page 14 Entering patient ID It is recommended to enter the patient ID during processing of the Test Cartridge in the Analyzer Entering the patient ID will not interrupt the processing It is also possible to enter the patient ID before the proces sing Both letters and numbers can be entered maximum 16 characters The patient ID will be stored in the memory and displayed along with the other specific data for this run see Viewing result records page 28 To enter the patient ID during processing do the following Palier ID graen E ee Tesi nara 1 3
31. reviation used in the patient records Abbreviation used 10 the control records Abbreviation used in the patient and control records for the run number of the analysis This numbering is reset each day at 24 00h Abbreviation used in the patient and control records for the lot number of the Test Cartridge 09 38555 11 GETTING STARTED Locating your Analyzer lh Place your Afinion AS100 Analyzer on a dry clean stable and horizontal surface Make sure that the Analyzer is located with sufficient surrounding airspace at least 5 inches on each side Acclimate the Analyzer to ambient operating temperature 15 32 C 59 89 F before use AN The Analyzer might be impaired by e Condensing humidity and water e Heat and large temperature variations e Direct sunlight e Vibrations e g from centrifuges and dishwashers e Electromagnetic radiation e g from mobile phones e Movement of the Analyzer during processing of a Test Cartridge Connecting power supply fh Connect the power cable to the power cord adapter Insert the plug from the power cord adapter into the power socket Figure 4 in the back of the Analyzer Plug in the power cord to a wall outlet Always use the correct supply voltage The power supply voltage must match the information quoted in the section Technical specifications page 34 E Al A MM L S 1E p d ue mo g Figure 4 1 Not in use 2 USB A connectors for p
32. rforming substantially in accor dance with applicable product specifications the Buyer s sole remedy shall be the refund of an amount not to exceed the actual purchase price paid by the Buyer for the Afinion AS100 Analyzer All repairs will be done during normal working hours All replaced parts shall become Axis Shield s property Axis Shield may reguire the Buyer to ship the Afinion M AS100 Analyzer to Axis Shield or elsewhere at Axis Shield s expense for warranty service to be performed Notwithstanding the foregoing Axis Shield shall have no obligation to make repairs replacements or corrections which result in whole or in part from i an act of God or other unforeseen catastrophe ii any error omission or negligence of the Buyer iii improper or unauthorized use of the Afinion AS100 Analyzer iv operating errors or the disregard of warnings and precautions described in this Afinion AS100 Analyzer User Manual v repairs performed to the Afinion AS100 Analyzer by any person other than an authorized Axis Shield service representative vi use of the Afinion AS100 Analyzer in a manner for which it was not designed vii causes external to the Afinion AS100 Analyzer such as but not limited to power failure or electric power surges or vill use of the Afinion AS100 Analyzer in combination with equipment components or software not supplied by Axis Shield EXCEPT AS STATED IN THIS SECTION OF THE USER MANUAL AXIS
33. rinter and or barcode reader 3 RS 232 port for PC 4 Power input for power supply connection 12 09 38555 GETTING STARTED Connecting additional equipment Optional accessories not provided with your Afinion AS100 Analyzer are e External barcode reader for reading barcoded sample or operator identification e Printer for optional print out of test results e PC for data transfer to HIS or LIS systems For additional information regarding the recommended barcode reader printer and PC connection please call 1 877 4 Afinion 1 877 423 4646 or email techsupport us axis shield com See figure 4 for correct connection of the external equipment AN Connecting the equipment should be done while the Analyzer is switched off How to switch ON the Analyzer Switch on the Analyzer by pressing the ON OFF button Figure 1 An automatic start up procedure will be initiated Please wait AN Do not open the lid manually Automatic start up procedure Start up menu Fanning sa i The automatic start up procedure will be initiated shortly after the Analyzer has been switched on The Analyzer s software version XXX will appear in the upper left corner of the screen and a self test will run for approximately 4 minutes The red light on the top of the Analyzer will turn on indicating that the Analyzer is busy The Analyzer is ready for use when the start up menu is displayed and the green indicator light turns on If the Anal
34. ro diagnostic use only Afinion AS100 is a compact multi assay analyzer for point of care testing It is designed to analyze the Afinion Test Cartridges The Afinion Analyzer System is easy to use rapid and gives reliable and accurate results About this User Manual This User Manual will guide you through installation operation and maintenance of your Afinion AS100 Analyzer The User Manual also explains how the Analyzer works describes the quality assurance system and assists you In troubleshooting For analyzing patient samples or controls please also read the test specific information given in the Package Inserts found in the Afinion test kits The Quick Guides highlight the main steps of the test procedures and contains information on proper quality control routines It is recommended that you become familiar with the user instructions before you start operating the Afinion AS100 Analyzer Some of the information in this User Manual is accompanied with a symbol that points you to the following particulars lh Operator s handling AN Warnings and precautions References to the Package Inserts and Quick Guides for the specific Afinion tests and control kits Examining the package contents When unpacking check the contents against the list below and examine the components for signs of shipping damage The Afinion AS100 package unit includes Afinion AS100 Analyzer e Power cable e Power cord a
35. t dirt and humidity A single Test Cartridge contains all necessary reagents for one test and is ready to use An integrated sampling device is used for collection of the patient sample or control The Test Cartridge cannot be re used Figure 2 illustrates an Afinion Test Cartridge with its functional parts Left side Right side Ta Figure 2 1 Sampling device For collection of patient sample or control 1a closed position 1b lifted position 2 Capillary Glass capillary to be filled with sample material 3 Reaction wells Contains all necessary reagents for one test 4 Handle For correct finger grip 5 Barcode label Contains assay and lot specific information for the Analyzer 6 Optical reading area Area for transmission measurement 7 ID area Space for written or labeled sample identification 09 38555 ANALYZER SYSTEM DESCRIPTION How to operate the Analyzer The Afinion AS100 Analyzer has two main user interfaces the touch screen and the cartridge chamber The Analyzer is easily operated using the icons that appear on the screen Only the icons you need to use at each operative step are displayed When an icon is touched it will turn grey and its function will be activated Text messages that appear on the screen will help guide you through the testing procedure The functions of the icons are explained in the Gallery of icons page 10 The other main operative part of the Afinion AS100 Analyzer
36. t chemical and mechanical assay methods combined with advanced computerized processing and measuring technology A Test Cartridge with patient sample or control is placed in the cartridge chamber of the Analyzer By manually closing the lid the Test Cartridge is transported into the analysis compartment of the Analyzer Test and lot specific information is obtained from the barcode label which then initiates the processing of the Test Cartridge The sample and reagents are automatically transferred between the wells A monochrome solid state camera monitors the entire process When the assay is completed light emitting diodes LEDs illuminate the final reaction area which can be either a colored membrane or a reaction well he camera detects the reflected or transmitted light which Is converted to a test result and displayed on the touch screen When the user accepts the result the lid covering the cartridge chamber opens automatically and the used Test Cartridge can be removed and discarded The Analyzer is then ready for the next run Internal process control The Analyzer self test A self test is performed during start up of the Analyzer to ensure that the instrument is operating according to established specifications I he self test validates e Hardware and software integrity e Test Cartridge transport system e Liquid transport system Camera vision system If the self test fails at any point the red LED will start flashing and an in
37. ta for the actual lot are transferred to the instrument and used for calculating results Calibration by the operator is thus not required 09 38555 GALLERY OF ICONS The icons and their function Touching an icon on the screen will activate the function of this icon All the icons that may appear during operation of the Afinion AS100 Analyzer are explained below by their function Icon Name Patient sample mode Control mode Patient ID Control ID Patient records Control records Main menu Operator ID Settings Language Patient ID on off Date Time Exit Date Time Screen Beeper Screen contrast Screen alignment Beeper volume Accept Print ON OFF Table continued on next page 10 Function Select patient sample mode Select control mode Enter patient ID Enter control ID View patient result records View control result records Enter main menu operator ID patient records control records and configuration menu Enter operator ID Enter configuration menu language patient ID on off date time and screen beeper Enter language selection Enable disable patient ID function Enter date time settings date and time Exit current menu and return to previous screen view Enter date setting Enter time setting Enter screen and beeper settings screen contrast screen adjustment and beeper volume Enter screen contrast setting Enter screen alignment function E
38. yzer fails during the start up procedure an information code will appear referring to a message given in the Information codes and troubleshooting page 29 09 38555 13 GETTING STARTED Setting the configuration Before using your Afinion AS100 Analyzer you should set the configuration according to your needs To enter the configuration menu do the following Entering configuration menu Start up menu Main menu Configuration menu fh Touch l2 to enter Touch to enter Select an item for configuration main menu configuration menu see following pages The following items can be set from the configuration menu Language Patient ID on off Date and time e Screen contrast screen alignment and beeper volume To set these items please comply with the following instructions Choosing language The default setting by the manufacturer is English Other languages are available Configuration menu Language 3 h Touch a to enter Touch the arrow in the window Touch 02 1 to accept language selection to view other languages and return to the configuration Scroll down until you find the menu preferred language 14 09 3835355 GETTING STARTED Disabling or enabling patient ID function The patient identification ID function can be enabled or disabled The patient ID function is enabled as a default setting by the manufacturer When the patient ID function is enabled ON the patient
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