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MediSense PCx User's Manual

1. Disable the prompt for a comment code Prompt for a comment code with the option of not requiring it Require a comment code for every in range and or out of range test result The Memory Full option can notify the operator that the control test memory has reached its limit 1000 tests that have not been uploaded Memory Full has the following options e Lockout additional tests until data is uploaded Prompt to overwrite old test results with new ones Automatically overwrite oldest test results with new ones Questions Refer to Page 10 13 For Customer Care Information e Review Change Test Setup for Control Tests Refer to the beginning of the Review or Change Setup section for step by step instructions to access the appropriate setup menu If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See on the Display What You Do Change Setup 1 Press 1 Test Setup 1 Test Setup 2 5uystem Setup System States 4Date and Time 5eEdit Lists Test Setup 2 Press 3 Control Test 1 l Tests z Patient Test S Control Test 4 Security S Test Type Control Test 3 The administrator will uU m select one of the following options Press 1 Next to review ne Control Test Result skip forward to step 6 Press 2 Change to change Control Test Levels option Control Tezt 4 The administrator will Levels select one or a ilaw combination of
2. If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See on the Display What You Do Comments Data Rewiew 1 Press 1 Patient The Patient History menu 1 Patient History History now appears Control History Proficiency Data 4 Linearity Data Patient History 2 Press 3 Operator ID The monitor will prompt Me tela i for the Operator ID to be 3S perator ID scanned or entered 4 fiction Range aComment Code 6 Date scan or Enter 3 Scan or manually enter The monitor shows the Operator ID the Operator ID via the result of the operator s nequ mq PM P keypad then press most recent patient test Enter result OPERRTOR Questions Refer to Page 10 13 For Customer Care Information What You See What You Do Comments on the Display Pl 324 1530443223 2 98 213 PH 5 8 mmol L 4 The operator can select The number that appears one of the following to the right of 1 Previous options and 2 Next on the monitor indicates the number of Press 1 Previous view A tests available for review the previous test result Press 2 Next view the The display also shows next test result p Patient ID o Operator ID 12 Comment Code ven Venous Sample 5 When finished reviewing the data the operator can Press Clear to return to the Operator ID screen Press Menu to return to the Menu Mode menu Press On Off to turn off
3. The display is returned to the Control Test Memory Full screen Review Change Test Setup for Security The Test Setup for Security menu enables the monitor to establish that certain criteria be met before a test can be performed e In all situations the monitor can be set to Allow Test allow the operator to test Warn tell the operator about the situation and still test or Lockout no testing can be done QC Interval can require control tests to be run at certain time intervals For example every 12 hours at specified times 7 a m 3 p m and 11 p m or after a specified number of patient tests 1 250 The Operator ID can require that the operator ID is on the list of qualified certified operators to continue The Strip Lot Test Strip Lot can require that the test strip lot is on the list of qualified test strip lots to continue Review Change Test Setup for Security Refer to the beginning of the Review or Change Setup section for the step by step instructions to access the appropriate setup menu If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting on the Display What You Do Comments Change Setup 1 Press 1 Test Setup The display shows the Ie Test Setup menu stem Setup S System Status 4 Date and Time 5e Edit Lists Test Setup 2 Press 4 Security The display shows the 1m Security QC Interval atient lest menu SControl
4. uestions Refer to Page 10 13 For Customer Care Information Comments The display is returned to the Glucose Units screen The display shows the Glucose Sample Type screen The display shows the Sample Type options The monitor can be set to always prompt for the sample type or to always default to either Capillary or Arterial or Venous blood samples The display is returned to the Glucose Sample Type screen The display shows the Glucose Action Range screen What You See What You Do Comments on the Display Glucose Aotion Range Disabled 1 fHext zhange Action Range 1 Disabled z Enabled Action Range 20 600 gt 20 Low Hh 600 1 1 mmol L 33 3 mmol L Precision PCx Test Strip Action Range 20 500 gt Low 20 High 500 1 1 mmol L 27 8 mmol L 10 The administrator will select one of the following options Press 1 Next to return to Test Setup Test Type Press 2 Change to change action range 11 The administrator will select one of the following options Press 1 Disabled Skip forward to step 13 Press 2 Enabled 12 Enter the low value and press Enter Enter the high value and press Enter Precision PCx Plus Test Strip Glucose Aetion Range Disabled L Hext Change 13 Press 1 Next to return to the Test Setup Test Type Screen If the action range is disabled the display is returned to the Test Setup T
5. 1 Turn the PCx Monitor off by pressing the On Off button on the keypad 2 Turn the monitor over to view the battery compartment 3 Press the tab on the battery compartment cover and lift the cover up 4 Remove and discard the used batteries in compliance with your local government regulations 5 Insert the new batteries using the and symbols in the battery compartment to position the new batteries with the correct polarity 6 Align the battery compartment cover with the slots on the Precision PCx Monitor then snap the cover into place QI 103 amp 19d d souoneg y eoejdag paunboey sy TE 0 6c IST Lc 9c sc vc JET TT TT JOT 6E ST LE 9L SE PE EE CIL IT OL 6 8 9 S P C E POW seoejins Jouoydg eux ueep Apeg O3 WOI 607 eo ueuojurej u YUON XIS JO3IuOJA 9sconjo pooja Xod uoispaJd Questions Refer to Page 10 13 For Customer Care Information Precision PCx Test Strips The following information regarding the Precision PCx and Precision PCx Plus Test Strip can be found in the test strip instructions for use System Operating Ranges Storage and Handling Quality Control imitations of the Procedure Performance Characteristics Precision PCx Monitor Dimensions Q Length Width Thickness Weight Power Source Battery Life
6. 19 7 cm 7 7 in 7 5 cm 2 95 in 5 1 cm 2 0 in 280 grams 10 ounces Two standard alkaline AA batteries or optional MediSense rechargeable battery pack Battery performance is a combination function of how often the meter is used and the duration time that testing is conducted Alkaline Battery 2 cells 1 5 Volts 2 4 Amp Hours typical capacity Rechargeable Battery Pack 2 cells 1 2 Volts 1 1 Amp Hours minimum capacity Note The MediSense Rechargeable Battery Pack can be recharged for 500 full charge cycles A considerably higher battery cycle life can be obtained if the Precision PCx monitor is placed in the docking station at the end of each use Memory Patient Test Control Test Proficiency Test Linearity Test 4000 1000 60 20 5 levels 4 replicates per level uestions Refer to Page 10 13 For Customer Care Information e The Precision PCx Point of Care System s performance has been evaluated in clinical studies at seven independent sites In all the studies the Precision PCx Monitor was calibrated and used according to the labeling Environmental Specifications Product is intended for indoor use Monitor Operating Temperature 32 F to 115 F 0 C to 46 C Monitor Storage Temperature 11 F to 115 F 24 C to 46 C Altitude Up to 2 195 meters Monitor Humidity From 10 to 90 within the range of 32 F 0 C to 115 F 46 C Mains Supply Voltage Fluctuations 10 Transient O
7. The display shows the Control Test Comment Code If Out of Range screen The display shows the Comment Code If Out of Range options The display returns to the Control Test Comment Code If Out of Range screen The display shows the Control Test Memory Full options Q What You See on the Display Control Test Merory Full Allows Overwrite ltet 2 Chanae Memory Full 1 Allow Overwrite Z Prompt for uverwrite Lookout Control Test Heron Full Allows Overwrite 1 fHext z hange What You Do 15 The administrator will select one of the following options Press 1 Next return to the Test Setup menu Press 2 Change change the Memory Full options 16 The administrator will select one of the following options Press 1 Allow Overwrite Press 2 Prompt for Overwrite Press 3 Lockout 17 The administrator will select one of the following options Press 1 Next return to Test Setup menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor uestions Refer to Page 10 13 For Customer Care Information Comments Allow Overwrite will automatically overwrite the existing data Prompt for Overwrite will notify the operator that the data will be overwritten giving the operator the choice to overwrite the data or not Lockout will lockout the operator from overwriting any data until the data has been uploaded
8. 4 C and 30 C Check that the temperature and humidity conditions in the room where the tests are being performed are within the acceptable operating range Refer to the Precision PCx or Precision PCx Plus Test Strip instructions for use Check that the bottles have not been open for more than 90 days Questions Refer to Page 10 13 For Customer Care Information e Usea new test strip for each test Useonly Precision PCx or Precision PCx Plus Test Strips If test results are out of range despite meeting the above criteria please repeat the test using a new box of control solutions and or test strips If the results are still out of range call Customer Care at 1 877 529 7185 Outside the United States contact the local Abbott Laboratories MediSense office or distributor Troubleshooting Out of Range Linearity Test Results Repeat the test for that linearity solution to make sure that the operator meets the conditions in this checklist No air bubbles are in the linearity bottle s nozzle Calibrate the monitor using the barcode for the test strip used Enter the correct lot number for the linearity solutions Check storage temperature For solution storage temperature range please refer to linearity kit instructions for use Test Strips must be stored between 39 F and 86 F 4 C and 30 C Check that the temperature and humidity conditions in the room where the tests are being performed are within the accepta
9. 4 1 Test Procedure zu die erbe a esee tette iet 4 2 Menu Mode 5 Data REVIEW T n 5 1 Patent HIStOTY up eb ebat OR td lette 5 1 Control EDSLOES co ee p eT ete o RR ER DU CU e 5 15 Proficiency Data sos eo et or avo eee ee 5 25 Linearity D aU oss cette eed renais ee isien eei 5 26 Gi Proficiency Test iicsiececccesssacensvecsacsnssnsecsvecsnocstesecesesotesecsoesesosstesnsees 6 1 Ta PI MICE 7 1 8 Review Change Setup eere esee eerte eene eee ee seen etas tne enu 8 1 Test Setups coser iex eee e e rH IER en ris 8 7 System Setup 2 get etre eee pli see eye 8 34 SVSte mr Status oc Ae nedteeeteie tette tie ebenso tete te 8 40 Date and Tine a eee eer reet cade 8 43 Edit l1s155 te aite Rad qum 8 46 Questions Refer to Page 10 13 For Customer Care Information 9 Datta Upload ep 9 1 Docking Station Optional eee 9 2 10 Troubleshooting otn einn donor nain ota eoo bano in o eto robaron 10 1 Patient Test Results enne 10 1 Out of Range Control Test Results sss 10 2 Error Messages ie eren eite esten rte in etie dense 10 2 Contacting MediSense for Service sss 10 13 Returning an Instrumeht erect pereo the en eene etes eerie 10 16 Limited Warranty eco detect ot OM RENTRER 10 16 11 Maintenance ier reist tego tots ie penses puis ar etes lii pra pu beu iu DS 11 1 Cleaning the Monitor s Exterior Sur
10. If no tests are stored for the desired category that was selected the following message will be displayed on the monitor No Stored Tests If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See What You Do Comments on the Display Data Review 1 Patient History 2 Control History S Proficiency Data 4 Linearity Data Level 4 Test 1 S238 02 FH T5 m1254567830123 1 Previous lz Zhout q 15 3 mmol L 1 Press 4 Linearity Data 2 The operator can select one of the following options Press 1 Previous view the previous test result Press 2 Next view the next test result 3 When finished reviewing the data the operator can Press Clear to return to the Data Review screen Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor The monitor now shows the most recent Linearity Test At the top of the display the test level is indicated The Level indicates Level 1 5 while Test indicates 1 4 replicates at that level The number that appears to the right of 1 Previous and 2 Next on the monitor indicates the number of tests available for review The display also shows the following o Operator ID It is outside the intended use of the PCx QCM system to perform a test in linearity mode on a PCx instrument and change the test result record to a patient result in QC
11. Press 5 Date L AI Tests 2 Dperator ID Outside Range 4 Comment Date Control History 3 Enter a date then press Enter Date Enter D Questions Refer to Page 10 13 For Customer Care Information The Control Test History menu now appears The monitor will prompt for a specified date to be entered The monitor will display the most recent control test result for the specified date What You See What You Do Comments on the Display Low 20 6 0 B 29 9B 12 58 PH 2m alesse revise 1 Previous Zont 2 3 mmol L 4 The operator can select one of the following options Press 1 Previous view the previous test result Press 2 Next view the next test result 5 When finished reviewing the data the operator can Press Clear to return to the Enter Date screen Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor The number that appears to the right of 1 Previous and 2 Next on the monitor indicates the number of tests available for review The display also shows the acceptable range for this test and o Operator ID 0 Comment Code Data Review for Proficiency Data The monitor stores the last 60 proficiency test results Please refer to the beginning of the Data Review for the step by step instructions to access the Data Review menu Note If no tests are stored for the desired category that was selected the following messa
12. Press Enter to confirm each time Skip forward to step 9 The display shows the QC Interval Security menu The operator can choose between QC intervals The settings are Time Interval QC Interval based on a set number of hours between control tests Time of Day choose up to three times during the day that QC Interval will take place Number of Patient Tests QC Interval based on the number of patient tests specified QC Time Interval option the Time of Day option or the Number of Patient Tests option The display returns to the Security QC Interval menu The display returns to the Security QC Interval menu Q What You See on the Display GC Interval Patient Tests C0 Tests at nd Lockout 4 Hours 1 Heat 2Chanae Operator ID Hot Certified Allow Test 1 Hext 2 Chanae Operator ID Hot Certified 1 Allow Test ZL arn A Lockout recs Operator ID Hot Certified Lockout 1 Hext Z Change What You Do Comments 8 Enter number of patient The display returns to tests between 1 250 then press Enter 9 Press 1 to continue to the Security Operator ID Not Certified screen 10 The administrator will select one of the following options Press 1 Next to continue skip forward to step 13 Press 2 Change to change Operator ID Security 11 The administrator will select one of the following options Press 1 Allow Test Pre
13. The monitor will prompt for the Sample ID to be scanned or entered The monitor will prompt for the Strip Lot number to be scanned or entered What You See on the Display What You Do Comments Sgan ERN 6 Scan or manually The monitor will prompt enter the test strip lot the operator to insert the number via the keypad test strip then press Enter 7 Open the foil test strip packet at the notch and tear up or down to remove the test strip 8 With the contact bars The monitor will prompt Insert facing up insert the test the operator to apply the Strip strip into the test strip sample to the test strip port until it stops Precision PCx Test Strip Precision PCx Plus Test Strip For Use with Precision PCx with TrueMeasure Technology v2 0 v2 1 and v2 2 For Use with Precision PCx v2 2 Only Manual entry of strip lots with alpha numeric barcodes is not supported Q What You See on the Display Sample hooep ted finaluzing Sample Result in seconds 254 Scan or Enter Comment Code 14 6 mmol L 264 Scan or Enter Comment Code oo 14 6 mmol L amp 1234567S30 2 98 311 PH I Bra 1 Heut Test 14 6 mmol L What You Do 9 Gently invert the sample bottle 3 4 times Comments The monitor beeps when the sample is accepted then apply a drop of the The Sample Accepted sample to the target area on the test strip 10 W
14. a Ai 4p and maximum values Strip Lot List menu for the high control Minimam 216 press Enter after each Maximum value entered Strip Lat 7 The administrator will List of 4 select one of the 1 Add following options 2 Betet Press Clear to return to the Edit Lists menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor Delete Test Strip Lots from the Strip Lot List What You See What You Do on the Display Comments ere po 1 Press 2 Delete 1 Rdd 2 Delete 3S Change Delete 2 Press the number of the TEE enn test strip lot to be S4Lot 191335 deleted Press 6 Exit Enit Strip Lot 3 The administrator will adus be prompted to verify Delete the delete l ReEnter Lot Press 1 ReEnter Lot Delete Return to step 2 Press 2 Delete Strip Lot 4 The administrator will List of 2 select one of the 1 Add following options dien a Press 2 Delete to lots Press Clear to return to the Edit Lists menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor Questions Refer to Page 10 13 For Customer Care Information continue deleting test strip The display shows the Delete list where test strip lot codes can be viewed The display is returned to the Delete List The display is returned to the Strip Lot List menu Change Test Strip Lot on the Strip Lot List What You See on the Display What You Do Comments Ch
15. administrator Press 2 to continue with testing using the Operator ID already entered Testing cannot continue because the Security Operator ID Not Certified Option is Set to Lockout Symptom Error Message Explanation Scan or Enter The lot number or test Strip Lot strip code is invalid S4566T Invalid Lot Format PIZS4SGTHSUIZS The test result is below 2 16 25 dT Pa the measuring limit of 20 the system L Hewt Patient 2 Repeat Test 1 1 mmol L PIZS4SGTESULZS The test result is above 3 16 98 43 7 PH the measuring limit of the 0 maril system l hMest Patient z Repeat Test 3 Patient History gt 33 3 mmol L Precision PCx Test Strip plz3456THSUlz3 9 16 98 447 PH Ora 1 Hext Patient 2 Repeat Test 3X Patient History 727 7 mmol L Precision PCx Plus Test Strip The test strip or the test EN e port is wet defective nnn contaminated or the wrong test strip was bI Strip inserted Error codes 211 212 The test strip was prin removed from the test 111 port during testing 1 Hew Strip Z EMHit Questions Refer to Page 10 13 For Customer Care Information How To Respond 1 Verify the lot number or test strip code 2 If the problem persists notify the system administrator Press 2 Repeat Test verify result using laboratory reference instrument Press 2 Repeat Test verify result using laboratory reference instrument Refer to test strip instructions f
16. Activated barcodes appear in bold type More than one Barcode format can be active at one time Any Barcode can be deactivated by selecting the corresponding number Note Only Barcodes 1 and 2 can be customized The display returns to the Operator ID Barcode screen USS or OPCC will appear after the format if selected The display shows the Alphanumeric Full ASCII screen The display returns to the Operator ID Barcode screen C will appear after the format if Check Digit is selected F will appear if Full ASCII is selected What You See on the Display What You Do Comments Operator ID 16 To access the Truncate The display shows the LIZofS5usz Digits screen press 6 Operator ID Barcode 2Code 39c and continue forward Truncate Digits screen S Code 128 to step 17 4 Codabar SCode 93 Operator ID 17 Press Enter twice The monitor can be set to PIPLe s is for no truncation of ignore a specific number 1 leading or trailing of leading and or trailing Fest __ digits otherwise enter barcode digits Last the number of leading The displ n e display returns to the and trailing barcode AJ Tests Operator ID digits to truncate screen ignore All Tests 18 The administrator will ae oy select one of the 1 15 digits following options L Hest Press 1 Next return to 2 4 hange the Test Setup menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor Review Change Test Setu
17. Numbers The 10 digit keypad can be used to enter identification numbers or to select an option that appears on the display Clear The operator can press Clear to perform the following functions To back up one space while entering numbers on the keypad Clear a numerical code from the monitor after pressing Enter Clear a barcode scanned by mistake Return to a previous screen When Clear is pressed two times all entered numbers shown in the display will be cleared Menu When the Menu key is pressed the following functions can be performed Return to the top of the menu Switch between Test Mode and Menu Mode Test Strip Port Enter When the Enter key is pressed it will confirm the information that was manually entered Barcode Scanner The Barcode Scanner is used to scan barcode information into the monitor The operator will hold the barcode scanner 3 12 inches from the barcode to be scanned When first using the barcode scanner some precautions should be taken while mastering the device Questions Refer to Page 10 13 For Customer Care Information Place the object to be scanned on a flat surface by itself This will prevent other items from being accidentally scanned Press and hold down the Scan button to start the barcode scanner A visible red beam will be emitted from the monitor Slowly move this beam over the barcode on the item to be scanned When the monitor accepts the barcode i
18. The display shows the Time Format Separator screen for hours The 5 options are separators for hours The display returns to the System Setup Time Format screen The display shows the Time Format Separator screen for hours The 5 options are separators for hours What You See on the Display Time Format Separator Time Format Units m ml h Sihh natem Setup Ta FO Format 1 fest z hange System Setup Password 1 fHext z hange 8 38 Enter Old Password What You Do 16 The administrator will select one of the following options Press 1 colon Press 2 period Press 3 h Press 4 H Press 5 none 17 The administrator will select one of the following options Press 1 m Press 2 apostrophe Press 3 h Press 4 none 18 Press 1 to continue to System Setup Password 19 The administrator will select one of the following options Press 1 Next to continue to the System Setup Change all settings to Factory Defaults menu Skip forward to step 24 Press 2 Change to change the Password 20 Enter the current Password up to 8 digits then press Enter Comments The display shows the Time Format Units screen for minutes The 4 options are separators for minutes The display returns to the System Setup Time Format screen The display shows the System Setup Password screen The display will prompt the
19. You Do Comments Q on the Display Delete Operator ID 1 Enter ID 2 Select ID 3 Delete All Operator ID fill ID Verify Delete 1 Don t Delete Z Delete All Operator ID List Emptu 1 Add 1 Press 2 Delete 2 Press 3 Delete All 3 The administrator will do one of the following options Press 1 Don t Delete Return back to step 2 Press 2 Delete All 4 The administrator will select one of the following options Press Clear to return to the Edit Lists menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor uestions Refer to Page 10 13 For Customer Care Information The display shows the Delete Operator ID menu The display prompts the operator to verify the delete The IDs are deleted from the list and the display returns to the Operator ID List menu Change One Operator on the Operator List by Entering ID What You See on the Display What You Do Comments pag IU 1 Press 3 Change The display shows the List of 16 Change Operator ID 1 Rdd menu 2 Delete 3S Change Change 2 Press 1 Enter ID The display shows the Operator ID Scan or Enter Operator ID l Enter ID menu Z 5elect ID scan or Enter 3 Press Scan or manually The display shows the Operator ID enter the Operator ID Operator ID Expiration Sere eae Sie eee via the keypad and Date and prompts the press Enter operator to enter a new 0 PE RAT OR expiration dat
20. continue with test 3 Lockout a test strip lot that is not on the test strip lot list operator may not continue The display returns to the Security Strip Lot Not on List screen Review Change Test Setup for Test Type The options set with the Review Change Test Setup for Test Type apply to different tests that may be performed such as glucose Use this menu to review or change these setups for Test Type Units Display test results in certain measurement units The options are mg dL mmol L Sample Type Distinguish between different types of blood samples used for patient tests The options are Prompt to select the blood sample type for each patient test Default to Capillary or Arterial for all patient tests Default to Venous for all patient tests Action Range Set the range low and high when action should be taken based on the patient result obtained The options are Disable the action range Enable and set the action range Questions Refer to Page 10 13 For Customer Care Information e Review Change Test Setup for Test Type Refer to the beginning of the Review or Change Setup section for the step by step instructions to access the appropriate setup menu If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See on the Display What You Do Comments Change Setup 1 Press 1 Test Setup The display shows i l
21. docking station has an additional role as a recharge station for the MediSense rechargeable battery pack optional The rechargeable battery pack must be in the monitor to take advantage of this option Identifying Monitor Functions Through the monitor the operator can view information make selections and enter information The location of all the monitor functions are shown on the following page Test Strip Port After the operator scans the barcode or manually enters information via the monitor keypad the operator will insert a new test strip into the test strip port to perform a test Display Here is where menu options error codes and test results are viewed Press and hold 9 on the keypad to turn on or off the backlight for the monitor display Keypad The keypad contains the following controls On Off Press this button to turn the monitor on or off The monitor will auto matically turn off after 4 minutes if the monitor is left on but has not been used Scan Press the Scan button to use the laser barcode scanner The barcode scanner enables the operator to scan the information into the monitor instead of manually entering the data by using the keypad The scanner can automatically enter the test strip information calibration control range lot number and expiration date as well as the operator ID patient ID and control lot number Manual entry of strip lots with alpha numeric barcodes is not supported
22. error message may appear on the monitor Error messages are shown in the Troubleshooting section of this manual Further troubleshooting information for any data upload question is provided in the QC Manager manual Error Messages Please Wait for Data Upigad Last Upload Incomplete Redock Meter Questions Refer to Page 10 13 For Customer Care Information eo Docking Station The Precision PCx System offers an optional docking station that provides a means for hands free automatic data transfer upload download between the Precision PCx Monitor and a PC running the QC Manager application software The QC Manager program will allow messages to be monitored and managed from a variety of MediSense monitors and systems that will be used throughout the hospital Please refer to the QC Manager Manual for more information The docking station must be connected to a power source for battery recharge only via the AC adapter supplied with the docking station Once the monitor is placed into the docking station and a connection is established data will be automatically transferred The docking station also serves as a battery recharge station for the Precision PCx Monitor equipped with the optional rechargeable battery pack Note Use only MediSense rechargeable battery pack The docking station has a swivel base that allows it to sit on a desktop or to be mounted to a wall using the mounting plate supplied by MediSense Instructi
23. formats used on the following page to illustrate how to review change the date and time are as follows Date month day year Time 12 hours If another date and or time format is selected other than the ones stated above the monitor will guide the operator or administrator through screens that are very similar to the ones that appear on the following pages Questions Refer to Page 10 13 For Customer Care Information e Review Change Setup for Date and Time Refer to the beginning of the Review or Change Setup section for step by step instructions to access the appropriate setup menu If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See What You Do Comments on the Display Change Setup 1 Test Setup 2 System Setup AX System States 4 Date and Time Edit Lists Tire 5 15 PH ltet 2 Ching Set Time 5 16 PM 04 15 Set Time S16 PI 4 15 LAMH 2PH Time 53 15 PH 1 Hext 2 Change 1 Press 4 for Date and Time 2 The administrator will select one of the following options Press 1 Next to continue to Date menu skip forward to step 6 Press 2 Change to change current time 3 Enter the time in hours and minutes then press Enter Include leading zeros 04 for 4 4 Select either 1 AM or 2 PM 5 Press 1 Next to continue to Date menu The display shows the Time menu The disp
24. forward to step 7 Press 2 Warn Press 3 Lockout 5 The administrator will select one of the following options Press 1 Hours Press 2 Days Questions Refer to Page 10 13 For Customer Care Information The display shows the Test Setup menu The display shows the Upload Interval menu The display shows the current settings in bold If 2 is pressed the display shows the Upload Interval options If 2 or 3 is pressed the display will show the upload interval hours and days option The display prompts for the number of days hours to be entered What You See What You Do Comments on the Display Upload Interval 24 Hours Hours All fests Upload Interval Warn 24 Hours 1 fext 2 Change All fests Operator ID Disabled 1 Hext z Change Operator ID Operator ID 1 13 digits Mininwurn Maximum 6 Enter 1 99 hours or 1 99 days then press Enter 7 Press 1 to continue to the All Tests Operator ID screen 8 The administrator will select one of the following options Press 1 Next return to the Test Setup menu Press 2 Change 9 The administrator will select one of the following options Press 1 Disabled skip forward to step 13 Press 2 Optional Press 3 Required 10 The administrator will enter minimum and maximum numbers between 1 15 Key in the minimum number of digits for an operator ID then press Enter Key in
25. operator to enter the current Password The display prompts the operator to enter a New Password What You See What You Do Comments on the Display Enter Hew Password Verify Hew Password System Setup Fassword l Heut Z Change uztem Set hange al Settings to Factory Defaults fest zXhange Confirm 1 Change to Factory Defaults 2 Don t Change uztem Set hange al Settings to Factory Defaults 1 Hext z hange 2 Enter the New Password then press Enter 22 Re enter New Password press Enter to confirm 23 Press 1 to continue to System Setup Change all settings to Factory Defaults menu 24 The administrator will select one of the following options Press 1 Next to return to Change Setup menu Press 2 Change to change all settings to Factory Defaults 25 The administrator will select one of the following options Press 1 Change to Factory Defaults Press 2 Don t Change 26 The administrator will select one of the following options Press 1 to return to Change Setup menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor Questions Refer to Page 10 13 For Customer Care Information The display asks the operator to re enter the password to confirm the New Password then press Enter The display returns to the System Setup Password menu The display shows the System Setup Change all se
26. option uestions Refer to Page 10 13 For Customer Care Information Comments The display shows the Control Test Result option The control test results can be set to appear as numeric or Pass Fail The display shows the Control Test Result menu Pass Fail indicates whether the control test result is in range or out of range The display is returned to the Control Test Result menu The display shows the Control Test Comment Code If In Range screen The display shows the Comment Code If In Range options What You See What You Do Comments on the Display Comment Cade If Inrange 1 Disabled Z ptional 3 Required Control Test Comment Cade Tf ut of Eanse 1 Disabled Z ptional Required Control Test 10 The administrator will select one of the following options Press 1 Disabled Press 2 Optional Press 3 Required 11 Press 1 to continue to the next option 12 The administrator will select one of the following options Press 1 Next to continue to Memory Full menu Skip forward to step 15 Press 2 Change to change the Comment Code If Out of Range options 13 The administrator will select one of the following options Press 1 Disabled Press 2 Optional Press 3 Required 14 Press 1 Next to continue to the Memory Full menu The display returns to the Control Test Comment Code If In Range screen
27. recent test result for code via the keypad the selected comment Soan or Enter then press Enter code Comment Code Questions Refer to Page 10 13 For Customer Care Information e What You See What You Do Comments on the Display 5 8 mmol L 4 The operator can select one of the following options Press 1 Previous view the previous test result Press 2 Next view the next test result 5 When finished reviewing the data the operator can Press Clear to return to the Comment Code screen Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor The number that appears to the right of 1 Previous and 2 Next on the monitor indicates the number of tests available for review The display also shows p Patient ID o Operator ID 12 Comment Code ven Venous Sample Data Review for Patient History by Selected Date Please refer to page 5 2 of the Data Review section for the step by step instructions to access the Data Review menu Note If no information is stored for the desired category that was selected the following message will be displayed on the monitor No Stored Tests Note If no tests match the criteria specified this message will be displayed on the monitor No Tests Match Request If the monitor displays a message not indicated in these procedures please refer to the section 10 Troubleshooting What You See on the Display What Y
28. the 2 Hormal following options 3S High low control Press 2 Normal to activate normal control Press 3 High to activate high control Press 4 to return to Control Test Levels screen 4 Press 1 Low to activate Comments The display shows the Test Setup menu The display shows the Control Test Levels screen The monitor can be set to perform any combination of low normal and high control tests The display shows the Control Test Levels options The activated control level s are in bold type Q What You See on the Display Control Tezt Levels Lou High eut zhange Control Test Result Humeric 1 Hext zhange Result 1 Humeric Z Pazz fF all Control Tezt Result Pass Fail 1 Hext zhange Control Test What You Do 5 Press 1 Next to continue to the Control Test Result menu 6 The administrator will select one of the following options Press 1 Next to review In Range Comment Code skip forward to step 9 Press 2 Change to change the result to Numeric or Pass Fail 7 The administrator will select one of the following options Press 1 Numeric Press 2 Pass Fail 8 Press 1 Next 9 The administrator will select one of the following options Press 1 Next to continue to Control Test Comment Code If Out of Range menu Skip forward to step 12 Press 2 Change to change the In Range Comment Code
29. the monitor How To Respond Press 1 to return to the Data Review Menu Press 1 to return to the previous screen 1 Remove the monitor from the docking station 2 Place the monitor back into the docking station If the error appears again contact MediSense Customer Care Place the monitor back into the docking station Contacting Abbott Laboratories M ediSense Products for Service Abbott Laboratories MediSense Products is committed to helping you resolve any problems with the Precision PCx Point of Care System For technical assistance please call Customer Care at 1 877 529 7185 twenty four 24 hours per day Outside the United States contact your local office or distributor listed below Abbott Diagnostics MediSense Products Victoria Australia Tel 1 800 801 478 In New Zealand Tel 0800 106 100 Abbott Gesellschaft m b H MediSense Produkte Wien Osterreich Tel 01 891 22 271 ABBOTT S A N V Diagnostics Division MediSense Products Louvain la Neuve Belgium Tel 32 10 47 53 25 MediSense Canada Ontario Canada Tel 1 800 461 8481 Abbott Danmark A S MediSense Produkter Gentofte Danmark Gratis Tel 8081 5354 Abbott Cientifica SA Divisi n MediSense Madrid Espafia Tel 900 300 119 Abbott Oy MediSense Espoo Finland Tel 358 9 7518 418 MediSense France Rungis France Tel 0800 10 11 56 Questions Refer to Page 10 13 For Customer Care Information ABBOTT MediSe
30. to be entered if this setting has been enabled Note If a Patient ID prompt is not seen skip down to step 5 What You See What You Do Comments on the Display Sean or Enter Patient ID PATIENT Sean or Enter Strip Lot Select Sample Type 1 Capillaruy or firteria 2 Venows 4 Press Scan to scan the Patient ID barcode or manually enter the Patient ID via the keypad then press Enter 5 Press Scan to scan the test strip barcode or manually enter the test strip lot number via the keypad then press Enter 6 The operator can select one of the following Press 1 Capillary or Arterial Press 2 Venous 7 Open the foil test strip packet at the notch and tear up or down to remove the test strip Manual entry of strip lots with alpha numeric barcodes is not supported Questions Refer to Page 10 13 For Customer Support Information After entering the Patient ID the test strip lot screen appears next After the test strip lot number has been entered the Sample Type screen will appear if this setting has been enabled If it does not appear skip down to step 7 Note Use VENOUS MODE only for venous samples that have been in capped tubes and have not been mixed with air Use CAPILLARY or ARTERIAL MODE for all other samples What You See What You Do Comments on the Display 8 With the contact bars The Apply Sample screen Insert facin
31. uestions Refer to Page 10 13 For Customer Support Information Comments NOTE The Outside Action Range screen will appear if the Patient Test Out of Range Comment Code is enabled and the following two conditions are met A The Action Range is set up B The test result is out of the Action Range NOTE The In Range Action Range screen will appear if the Patient Test In Range Comment Code is enabled and the following conditions are met A The action range is defined B The test result is within the Action Range What You See Comments on the Display What You Do pSPeSSSZIUIZA3 13 The operator can 9 1 38 4 26 Hr select one of the FL following options i Hext Patient Repeat lest Press 1 Next Patient S Patient History Press 2 Repeat Test 5 8 mmol L Press 3 Patient History If 1 is selected the Scan Patient ID screen will appear Return to step 4 to continue with testing on the next patient If 2 is selected the Scan or Enter Strip Lot screen will appear Return to step 5 to repeat the test If 3 is selected the monitor will display the last test result for this patient as well as allow the operator to view previous results Refer to the section entitled Data Review for Patient History for further information Important If the blood glucose result appears to be inconsistent lower or higher than expected there may be a problem with the test strip Repeat the test
32. 1 FA 3 Gara m23456T850123 1 Previous Zont X3 5 mmol L 1 4 The operator can select one of the following options Press 1 Previous view the previous test result Press 2 Next view the next test result 5 When finished reviewing the data the operator can Press Clear to return to the Comment Code screen Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor The number that appears to the right of 1 Previous and 2 Next on the monitor indicates the number of tests available for review The display also shows the acceptable range for this test and o Operator ID 2 Comment Code X Outside Range Data Review for Control History for Selected Date Please refer to page 5 2 of the Data Review section for the step by step instructions to access the Data Review menu Note If no tests are stored for the desired category that was selected the following message will be displayed on the monitor No Stored Tests Note If no tests match the criteria specified this message will be displayed on the monitor No Tests Match Request If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See What You Do Comments on the Display Data Review 1 Press 2 Control 1 Patient History History z Lontrol History AS Proficiency Data 4 Linearity Data Control History 2
33. 1 Lot 2 Lot 191335 SLot 120515 Mormak 39 115 Minimum _ 2 Hasirum Strip Lot 195165 High 211 340 Minimum 216 Hasirmum 8 58 j Press 3 Change Press the number of the test strip lot to be changed Key in the minimum and maximum values for the low control press Enter after each number Key in the minimum and maximum values for the normal control press Enter after each number Key in the minimum and maximum values for the high control press Enter after each number The displays shows the change list where test strip lot codes can be viewed Press the number of the test strip lot to change the control solution ranges The display prompts the operator to enter in the test strip lot minimum and maximum values for the low control test The display prompts the operator to enter in the test strip lot minimum and maximum values for the normal control test The display prompts the operator to enter in the test strip lot minimum and maximum values for the high control test The display returns to the Change Lot menu Q What You See on the Display Lot 15 Slot 191335 Sot 120515 amp E it What You Do 6 The administrator will select one of the following options Press the number of another test strip lot to continue changes Press 6 to Exit to the Strip Lot List menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor u
34. 545678320123 Press 1 Previous view indicates the number of FH aeter a the previous test result tests available for review 5 8 mmol L Press 2 Next view the The display also shows next test result p Patient ID o Operator ID 12 Comment Code ven Venous Sample 2432101235 4 When finished ae j 28 431 PH reviewing the data the mafdL operator can 0123456 7890123 Press Clear to return to Previnus 1 A 2 Hent the Patient History menu 421 9 mmol L Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor Data Review for Patient History by Patient ID Please refer to page 5 2 of the Data Review section for the step by step instructions to access the Data Review menu Note If no information is stored for the desired category that was selected the following message will be displayed on the monitor No Stored Tests Note If no tests match the criteria specified this message will be displayed on the monitor No Tests Match Request If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See on the Display What You Do Comments Data Review 1 Press 1 Patient The Patient History menu 1 Patient History History now appears Control History S Proficiency Data 4 Linearity Data Patient History 2 Press 2 Patient ID The monitor will prompt L AI T r 5 Pa m for the Patient ID to be 3 pe
35. 97 4109 Tel 502 597 4141 ADD M xico M xico Distrito Federal Tel 55 24 41 75 Tel 01 800 711 2208 ADD Peru Lima Peru Tel 800 37233 ADD Puerto Rico Barceloneta Puerto Rico Tel 787 846 8412 Tel 1 800 981 1244 ADD Uruguay Montevideo Uruguay Tel 598 2 513 3955 ADD Venezuela Caracas Venezuela Tel 800 37233 ADD Greater China North Point Hong Kong Tel 852 25668711 ADD Indonesia Jakarta Indonesia Tel 62 21 520 1007 ADD Korea Seoul Korea Tel 82 2 3429 9234 ADD Malaysia Selangor Malaysia Tel 603 519 1919 ADD Pakistan Karachi Pakistan Tel 92 21 501 5454 ADD Philippines ADD Taiwan Metro Manila Philippines Taipei Taiwan Tel 63 2 637 8253 Tel 886 22 505 0828 Tel 63 2 689 0414 ADD Thailand ADD Singapore Bangkok Thailand World Trade Center Singapore Tel 66 2 252 2004 Tel 65 278 8343 A MediSense representative will address the problem and or instruct you to return the monitor Do not return the Precision PCx Monitor or any part of the system for repair until you receive authorization from a MediSense representative To help ensure efficient resolution of the problem complete the following steps before calling MediSense Review the troubleshooting information in this section 2 Obtain the most recent control results and record them below Control Solution Low Normal High If used If used If used Results Expected Range Test Strip Lot Number C
36. CUR OM aoe press Enter certification Expiration 0 PE RAT OR Date for the operator using the two digit number format for the date Operator ID 3 Enter the expiration The display is returned 12345678901 2345 date then press Enter to the Operator ID List moldy ur menu Operator ID 4 The administrator will List of 16 select one of the 1 Add following options dien Press Clear to return to z the Edit Lists menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor Delete One Operator on the Operator List by Entering ID Q What You See What You Do on the Display Operator ID 1 Press 2 Delete Y Delete Press 1 Enter ID Operator ID 1 Enter ID 2 Select ID oa Delete All Scan or Enter Operator ID W Press Scan or manually enter the Operator ID via the keypad and press Enter D un 4 e A The administrator will MS select one of the Delete following options i ReEnter ID Press 1 ReEnter ID z Delete Return to step 3 Press 2 Delete 5 The administrator will select one of the following options Delete Operator ID 1 Enter ID 2 Select ID 5 Delete RII Press Clear to return to the Operator ID List Menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor uestions Refer to Page 10 13 For Customer Care Information Comments The display shows the Delete Operator ID menu The display sh
37. D one of the following 2 Select ID options Press Clear to return to the Operator ID menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor Questions Refer to Page 10 13 For Customer Care Information Change Setup for Edit Test Strip Lot List Refer to the beginning of the Change Setup section for step by step instructions to access the Change Setup menu If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See What You Do Comments on the Display Change Setup 1 Press 5 Edit Lists The display shows the 1 fest orm Edit Lists options 2 54y5tem Setup 3 System Status bbs ae See a De 4 Date and Time PR adding de eung 5 Edit Lists or changing a test strip lot number Edit Lists 2 Press 2 Strip Lot List The display shows the Strip Lot List menu and 1 Operator List the number of items on the list The example provided is a list of 3 The list can be edited by adding deleting or changing entries Z 5trip Lot List Strip Lot List of 3 NOTE 1 Add If there are no test strip 2Delete lots on the test strip lot 3 Change list the display shows List Empty The Delete and Change options will not appear If the list is full the Add option will not appear Add a Test Strip Lot to the Strip Lot List What You See on the Display What You Do Comments Scan or Enter Strip Co
38. M Data Management System Linearity test results outside the test strip assay range should only be used to set linearity performance on the PCx instrument The performance of the test strips has not been verified outside the assay range listed on the test strip instructions for use Proficiency Test The Proficiency Test menu enables the operator to perform unknown sample test challenges if required by facility policy Use the following procedures to perform a proficiency test If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See What You Do Comments on the Display T Press the On Off button to turn on the monitor ABBOTT y1 98 224 PM 2 Press Menu 1 Patient Test 2 Control Test 9 1 28 451 PA 3 Press 2 Proficiency 1 Bata Review Test 2 Proficiency Test Linearity Test 4 eview Setup S Change Setup scan or Enter 4 Scan or manually enter perator ID the Operator ID via the UE keypad then press OPERATOR Scan or Enter 5 Scan or manually enter Sampir IU the Sample ID via the 1274567890 keypad then press Enter PROF Questions Refer to Page 10 13 For Customer Care Information The Abbott logo screen appears for a few seconds followed by the product name the software version screen then the Test Mode menu The Menu Mode screen now appears The monitor will prompt for the Operator ID to be scanned or entered
39. MediSense Precision PCx Point of Care System Healthcare Professional Operator s Manual for Blood Glucose Monitoring M ediSense Precision PCx Precision and QC Manager are trademarks of Abbott Laboratories 2002 Abbott Laboratories ABBOTT Warning This manual is protected by copyright law Unauthorized reproduction or distribution of this manual or any portion of it may result in severe civil and criminal penalties and will be prosecuted to the maximum extent under the law Table of Contents Introduction 1 Manual Organization sccscssssssssssssssssssssessscssessessessscssessesses 1 1 Precision PCx Menu Tree eseeeeeeeeee nennen 1 2 2 Overview Understanding the Precision PCx Point of Care System c cssssssssscssssssssssessssssssssssscssesssssescssssessesses 2 1 Test Mode 3 cUuc Mil cm MG 3 1 Operating Guidelines for all Samples 3 1 Collecting Blood Samples pe pro i eer ex 3 1 Obtaining Capillary Blood Samples 3 1 Obtaining Venous Blood Samples sss 3 2 Obtaining Arterial Blood Samples 3 2 DDISPOSINS of Waste scs rip vue que e pev NER e quis ae 3 3 Test Procedure niece cte ete a 3 3 4 Control Tesb ue cacvessovcritos en Fo sienitd rien FO Rie ned a ED UE 4 1 Operating Guidelines for Control Solutions
40. Test 4 Security Se Test Type Security 3 The administrator will The display shows the aes select one of the options for the QC 24 Hours following options Interval Controls Expired L Press 1 Next to menu The options are to Lies a continue to Security Allow Test even if the Operator ID Not Certified QC interval has expired screen and skip forward to Warn the operator that step 10 even though the QC interval has expired the test may continue or Lockout the system until the required control tests are performed Press 2 Change to change the QC Interval Controls Expired option Questions Refer to Page 10 13 For Customer Care Information What You See What You Do Comments on the Display GG Interual Controls Expired 1 Allow Test 2 LJarn 3 Lockout QC Interval Securitu 1 Time Interval Time of Day Patient Tests 3C Interval 24 Hours Time of Day 1 amp 00 RH S 200 LAM 2PH 4 The administrator will select one of the following options Press 1 Allow Test Press 2 Warn Press 3 Lockout 5 The administrator will select one of the following options Press 1 Time Interval continue to step 6 Press 2 Time of Day skip to step 7 Press 3 Patient Tests skip to step 8 6 Enter a Time Interval number between 1 99 then press Enter Skip forward to step 9 7 Enter up to 3 times of the day in chronological order starting at midnight
41. The syringe can briefly touch the test strip without affecting the test result Disposing of Waste Observe the following guidelines when disposing of biohazardous waste Dispose of used lancets in an approved sharps container Discard used capillary tubes disposable transfer pipettes or tips and test strips in an approved biohazard container Follow your facility s biohazard disposal policy Patient Test Procedure Use the following procedure to perform patient tests Note The word Strip on the display always refers to the test strip If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting Questions Refer to Page 10 13 For Customer Care Information What You See What You Do Comments on the Display ABBOTT 9 1 28 2 24 PH 1 Patient Test 2 Control Test Scan or Enter Operator ID OPERATOR 1 Press On Off to turn on monitor 2 Press 1 to select Patient Test 3 Press Scan to scan the Operator ID barcode or manually enter the Operator ID via the keypad then press Enter The Abbott logo screen will appear for a few seconds followed by the product name software version screen and then the Test Mode menu After the patient test is selected the Operator ID screen will appear if this setting has been enabled Note If an Operator ID prompt is not seen skip down to step 4 The display will prompt for a Patient ID
42. ait for the monitor to analyze the sample and display the test result 11 If the operator is prompted to enter a comment code continue to step 12 otherwise skip forward to step 13 12 Scan or manually enter the comment code via the keypad then press Enter 13 The operator will select one of the following options Press 1 Next Test Press Menu to return to the Menu Mode Press On Off to turn off the monitor uestions Refer to Page 10 13 For Customer Care Information Screen will be displayed The test starts automatically as the sample is accepted The monitor counts down 20 seconds then displays the test result The monitor returns to the Results menu The comment code number that was entered will appear in a box to the left of the test result The operator can refer back to step 5 for the steps to perform any additional proficiency testing at this time Linearity Test The Linearity Test menu enables the operator to verify method linearity using a Linearity Assessment Kit Please use the following procedures to perform a Linearity Test If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See What You Do Comments on the Display ABBOTT 9 1 28 2 24 PM 1 Patient Test 2 Contral Test 2 1 28 451 FH iData Review 2 Proficiency Test 2 Linearity Test 4 Revieur Setup S Change Setup Scan a
43. al entry of strip lots with alpha numeric barcodes is not supported Questions Refer to Page 10 13 For Customer Care Information Symptom Error Message Operator ID 18333 Is Hot on the ator List ReEnter ID 2 Conitinue Scan or Enter Operator ID iIMOBSIH Invalid ID Hot on List Operator ID 123456 7S9017345 Date Expired 1 ReEnter ID 2 Lonitinue Sean or Enter Operator ID Invalid ID Date Expired Explanation The Operator ID just entered is not on the list of acceptable Operator IDs defined for this monitor The menu item 2 Continue appears and testing is permitted because the Security Operator ID Not Certified option is set to Warn The Operator ID entered is not on the list of acceptable Operator IDs defined for this monitor The Operator ID entered has expired 2 Continue appears and testing is permitted because Security Operator ID Not Certified option is set to Warn The Operator ID or test strip lot number scanned or entered has expired How To Respond 1 Verify and re enter the ID using the barcode scanner 2 Manually enter the ID 3 If the problem persists notify the system administrator Press 2 to continue Testing cannot continue because the Security Operator ID Not Certified option is set to Lockout 1 Verify and re enter the ID using the barcode scanner 2 Manually enter the ID 3 If the problem persists notify the system
44. ample June 27 1999 becomes 06 27 99 The display shows the Date Format Separator options The numbers can be separated with a slash dash period or no punctuation The display is returned to the System Setup Date Format menu What You See What You Do Comments on the Display pu Setup te Format du ma yr eut z hange naten Setup pele pannat Heut zChange Time Format Time Forrnat Separator a ah 4 H Senaone Time Format 11 Press 1 to continue to System Setup Time Format menu 12 The administrator will select one of the following options Press 1 Next to continue to System Setup Password skip forward to step 19 Press 2 Change to change the Time Format 13 The administrator will select one of the following options Press 1 1 12 AM PM Press 2 1 12 am pm 14 The administrator will select one of the following options Press 1 colon Press 2 period Press 3 h Press 4 H Press 5 none 15 If the administrator selects one of the following options Press 3 0 23 Press 4 00 23 Questions Refer to Page 10 13 For Customer Care Information The display shows the System Setup Time Format menu The display shows the Time Format options The four options to use are 12 hour clock using capital AM PM 12 hour clock using lowercase am pm a 0 24 hour clock and a 01 24 hour clock
45. be viewed or changed Set units of measurement Set sample type prompts Set action ranges The action range can also be changed in QC Manager Refer to the QC Manager Operator s Manual for more information Note Default action range is 20 600 Questions Refer to Page 10 13 For Customer Care Information Review Change Test Setup for All Tests The options that are associated with the Review Change Test Setup for All Tests apply to all test types Use this menu to review or change these options for all tests Upload Interval The monitor can be set up to warn or lockout a task if the monitor has not been uploaded at a regularly scheduled interval The upload interval options are Allow Test allows the testing to continue No message will appear on the monitor Warn allows the testing to continue but the operator will receive a message that the upload interval as specified below has expired e Lockout does not allow any testing until the data has been uploaded This option is set to designate a required maximum number of hours or days from 1 to 99 between data uploads When a task is selected and the upload interval has expired the operator will receive a message that the Upload Interval has expired If Upload Interval is expired the monitor will prevent an operator from doing other tasks until the stored data is uploaded Operator ID The Operator ID menu has the following options which can be viewed or chan
46. bed 1 Precision PCx Monitor Class I EQUIPMENT energized from an external electrical power source 2 Docking Station Class II EQUIPMENT energized from an external electrical power source 3 Rechargeable battery pack Type B degree of protection against electric shock P N 125 484 Rev 0 3 03 Questions Refer to Page 10 13 For Customer Care Information e
47. beginning of the Change Setup section for step by step instructions to access the Change Setup menu If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting Q What You See What You Do on the Display Change Setup 1 Press 5 Edit Lists Test Setup 2 System Setup S System States 4 Date and Time teEdit Lists Edit Lists 2 Press 1 Operator List 1 perator List Z 5trip Lot List erator ID st of 16 2 r Add Delete Change ta hm uestions Refer to Page 10 13 For Customer Care Information Comments The display shows the Edit Lists options The Operator List or the Strip Lot List can be edited The display shows the Operator ID options and the number of operators on the list This example shows a list of 16 The list can be edited by adding deleting or changing entries NOTE If there are no IDs on the list the display shows List Empty The Delete and Change options will not appear f the list is full the Add option will not appear Add an Operator to the Operator List What You See on the Display What You Do Comments Operator ID 1 Press 1 Add The display shows the List of 16 Scan or Enter Operator ID 1 hdd screen z lelete o Change Scan or Enter 2 Press Scan or manually The display shows the Operator ID enter the Operator ID Operator ID Expiration via the keypad and Date menu Enter a
48. ble operating range Refer to the Precision PCx or Precision PCx Plus Test Strip and linearity kit instructions for use Check linearity kit insert for open bottle expiration date Usea new test strip for each test Useonly Precision PCx or Precision PCx Plus Test Strips If test results are out of range despite meeting the above criteria please repeat the test using a new linearity kit and or test strips If the results are still out of range call Customer Care at 1 877 529 7185 Outside the United States contact your local Abbott Laboratories MediSense office or distributor Error Messages In this section you will find information relating to error messages that appear on the display when errors are detected by the Precision PCx Monitor For each corresponding message an explanation is given and appropriate responses are described In many situations it may be possible to proceed with some of the functions at least temporarily before attending to the problem For example when the batteries are too low to permit testing it may be possible to review data for a short time If any problem persists record the error message displayed include the three digit error code if any and call Customer Care at 1 877 529 7185 Outside the United States contact the local Abbott Laboratories MediSense office or distributor Note Check Precision PCx display for proper performance before every test If at any time the display scre
49. certain limit the monitor will display a warning message Power can be boosted by inserting new alkaline batteries into the monitor or by recharging the MediSense rechargeable battery pack in the docking station 2 Press 1 Next to view The display shows the M the Temperature temperature of the area where the monitor is zw Lent 3 Press 1 Next to view The display shows the Temperature the Patient Test and amount of memory that 275 C Control Test Memory has been used to store Used patient test results and L Hewi control test results 72 5 F Patient Test 4 Press 1 Next to view The display shows the aed d Led the Software Version software version screen Control Test Memory Used LI 1 Hout Questions Refer to Page 10 13 For Customer Care Information D What You See on the Display MediSense Precision Pex ver 1 0 1 Hext RBOOO SIM 699296 What You Do 5 The administrator will select one of the following options Press 1 to return to Review Change Setup menu Press Menu to return to Menu Mode Press On Off to turn off the monitor Comments Review Change Setup for Date and Time The Review Change Setup menu allows the date and time to be reviewed or changed Depending on the format selected for date and time this function is performed in Test Setup System Setup Date Format and Time Format menu the instructions that appear on the display will vary The date and time
50. completely filled Do not use collection tubes that contain fluoride or oxalate If the blood is collected from an intravenous line clear the line before drawing the sample into a syringe that contains sodium heparin lithium heparin or EDTA Use the sample within 30 minutes of collection Invert the tube with the sample several times immediately before removing the sample Use a disposable transfer pipette to obtain a sample from the center of the collection tube Apply a drop of blood directly to the target area on the test strip covering the entire area Note Use VENOUS MODE only for venous samples that have been in capped tubes and have not been mixed with air Use CAPILLARY or ARTERIAL M ODE for all other samples How to Obtain an Arterial Blood Sample Useonly fresh whole blood samples Clear the arterial line QI before drawing a blood sample into a syringe that A lt S contains sodium heparin EX OWO or lithium heparin or EDTA Use the sample within Precision PCx Test Strip Precision PCx Plus Test Strip 30 f ll For Use with Precision PCx with TrueMeasure Technology minutes of collection v2 0 v2 1 and v2 2 For Use with Precision PCx Mix the syringe several v2 2 Only times immediately before applying the sample to the target area on the test strip Allow a drop of blood to form at the tip of the syringe Cover the entire target area on the test strip with the blood sample
51. d to the target area on the test strip The monitor automatically begins testing as soon as the sample is detected on the test strip Results are displayed in 20 seconds The monitor s design and operation are similar to other MediSense monitors making it easy to educate patients on home self testing procedures The risk of contamination to operator and patient is minimized since the blood does not enter the monitor The Precision PCx System uses unique biosensor technology to obtain accurate results over a broad range of patient hematocrit levels and sample types Precision PCx Test Strips and Precision PCx Plus Test Strips with TrueMeasure Technology are approved for use with arterial venous capillary and neonatal whole blood samples The monitor s exterior surface needs only to be wiped down once a day or as needed and the batteries need to be replaced or recharged when necessary Questions Refer to Page 10 13 For Customer Care Information Accurate Calibration Built In Security Options Patient and Quality Control Data Management Data Networking Battery Power The barcode on each test strip packet label ensures accurate calibration before each test begins Options in the Precision PCx Monitor enable the requirement of Patient and Operator IDs to include minimum and maximum lengths Other security options include QC Interval requires quality control tests at regular intervals Operator Secur
52. d year Time Format This option presents time in a 12 or 24 hour clock and separates numbers with different punctuation Set Password This option allows the password to be changed Restore Defaults This option restores the monitor to factory settings Review Change Setup for System Setup Refer to the beginning of the Review or Change Setup section for the step by step instructions to access the appropriate setup menu If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See on the Display What You Do Comments Change Setup 1 Test Setup 2 System Setup X System States 4 Date and Time 5eEdit Lists System Setup Language Enalizh 1 Hest 2 Change Language 1 English 2 Franpais 3 Deutzch System Setup Language Enalizh 1 Hest 2 Change System Setup Beeper Enabled 1 Hext 2Chanae 1 Press 2 System Setup 2 The administrator will select one of the following Press 1 Next to continue to System Setup Beeper menu skip forward to step 5 Press 2 Change to change the language 3 The administrator will select the appropriate language 4 Press 1 Next to go to System Setup Beeper 5 The administrator will select one of the following options Press 1 Next to go to System Setup Date Format menu skip forward to step 8 Press 2 Change to change the beeper setting Questi
53. data the operator can Press Clear to return to the Control History menu Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor Data Review for Control History by Comment Code Please refer to page 5 2 of the Data Review section for the step by step instructions to access the Data Review menu Note If no tests are stored for the desired category that was selected the following message will be displayed on the monitor No Stored Tests Note If no tests match the criteria specified this message will be displayed on the monitor No Tests Match Request If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See on the Display What You Do Comments Data Review 1 Press 2 Control The Control Test History 1 Patient History History menu now appears 2 Control History AS Proficiency Data 4 Linearitu Data Control History 2 Press 4 Comment The monitor will prompt ee ID Code for the comment code to 3 Outside Range be scanned or entered 4 Comment aDate Control History 3 Scan or manually enter The monitor will display the comment code via the result of the most the keypad then press recent control test for the Scan or Enter Enter specified comment code Code Questions Refer to Page 10 13 For Customer Care Information e What You See What You Do Comments on the Display Low 30 60 Siz sB 23
54. de Strip Code 19133538503131 1 Continue 2 Change Control Ranges 1 Press 1 Add 2 Press Scan or manually enter the test strip lot number via the keypad and press Enter 3 The administrator will select one of the following options Press 1 Continue Press 2 Change to change the control ranges 4 Key in the minimum and maximum values for the low control press Enter after each value entered 5 Key in the minimum and maximum values for the normal control press Enter after each value entered The display shows the Scan or Enter Strip Code screen The display shows the Strip Code option The operator can return to the Strip Lot menu to add additional test strip lots or can continue to the next menu to set minimum and maximum control solution ranges for the test strip lot The display prompts the operator to enter in the test strip lot minimum and maximum values for the low control test The display prompts the operator to enter in the test strip lot minimum and maximum values for the normal control test The display prompts the operator to enter in the test strip lot minimum and maximum values for the high control test Manual entry of strip lots with alpha numeric barcodes is not supported Questions Refer to Page 10 13 For Customer Care Information What You See on the Display What You Do Comments 15 Lot 6 Key in the minimum The display returns to the
55. e Operator ID 4 Enter a new expiration The Operator ID 23426 date and then press expiration date is grau mo dulur Enter changed The display 2a ume returns to the Change Operator ID menu Change 5 The administrator will Operator ID select one of the 1 Enter ID following options 2 Select ID Press Clear to return to the Operator ID List menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor Change One Operator on the List by Selecting ID What You See on the Display What You Do Comments Operator ID 1 Press 3 Change The display shows the List of 16 Change Operator ID 1 fidd menu 2 Delete o Change Change 2 Press 2 Select ID The display shows a list Operator ID of Operator IDs 1 Enter ID 2 Select ID Change 3 The administrator will The display lists the 1 12345 select one of the Operator ID expirati 2 203456 p piration 24567 following options date er Press the number of the The display will prompt More ID to be changed for a new expiration date Press 6 More to view to be entered additional IDs or Press 6 Exit Operator ID 4 Enter a new expiration The Operator ID 23436 date for each operator expiration date i j9 29 p piration date is motdu yr then press Enter changed The display ee ee ER returns to the Change Operator ID menu an To change another ID return to step 2 Change 6 When finished the Operator ID operator will select 1 Enter I
56. e illustrates the multiple sub menu layers For ease of understanding in using the monitor this manual is organized into sections which follow the menu It is recommended that the Introduction and Overview sections of this manual be read thoroughly prior to using the monitor for testing These sections will acquaint users with the Precision PCx Point of Care System s features and operating controls so it can be used more effectively Questions Refer to Page 10 13 For Customer Care Information eo Precision PCx Menu Tree Test Mode 1 Patient Test 1 Data Review 2 Control Test Menu Mode All Tests rt by Patient ID Operator ID Action Range Comment Code Date 1 Patient History so All Tests Operator ID OutsideRange Comment Code Date 2 Control History sort by 3 Proficiency Data 4 Linearity Data 2 Proficiency Test 3 Linearity Test Setup 4 Review 5 Change 1 Test Setup 1 All Tests Upload Interval Operator ID Format 2 Strip Lot List 2 Patient Test Patient ID Format Comment Code Memory Full 3 Control Test Levels Results Format Comment Code Memory Full 4 Security QC Interval Operator ID Strip Lot 5 Test Type Glucose Units SampleType Action Range 2 System Setup Language Beeper On Off Date Format Time Format Password Factory Settings 3 System Status Battery Power Temperature Memory Gauge Software Version 4 Date and Ti
57. ecision PCx Monitor The Precision PCx Monitor requires little routine maintenance During testing the sample remains outside the monitor which significantly reduces the possibility of contamination This section describes the maintenance tasks for the monitor Cleaning the exterior surface of the monitor Replacing the batteries It is a good idea to record any maintenance that is performed on the monitor in the Six Month Maintenance Log that is at the end of this section The log may be photocopied Cleaning the Exterior Surface Cleaning the exterior surface of the Precision PCx Monitor is recommended daily The monitor needs only to be cleaned with a water moistened cloth or a sponge and a mild detergent It is suggested that the monitor be turned off while it is being cleaned Do not use any solvents Do not immerse flood with any liquid or autoclave the monitor Battery Life The average alkaline battery life is approximately 60 days based on an average of 30 tests per day depending on barcode usage Please refer to the rechargeable battery pack insert for more information Questions Refer to Page 10 13 For Customer Care Information Replacing the Batteries Use the following procedure to install new batteries in the Precision PCx Monitor The Precision PCx Monitor requires two 2 AA alkaline batteries or use the rechargeable battery pack which is available from Abbott Laboratories MediSense Products
58. en becomes difficult to read discontinue use of monitor and call Customer Care or your local Abbott Laboratories M ediSense office or distributor When You Turn on the Monitor or During Use Symptom Error Explanation How To Respond Message The display is blank The monitor has little or Verify proper battery no power installation See Maintenance for further information If the problem persists do one of the following Install new batteries See Maintenance for more information Place the monitor into the docking station to recharge the battery pack if the system has this option Battery power is getting Do one of the following Low low Testing will be Install new batteries See Battery available for a limited Maintenance for more Power time information Place the monitor into the docking station to recharge the battery pack if the system has this option Press 1 to continue Questions Refer to Page 10 13 For Customer Care Information e When You Turn on the Monitor or During Use Symptom Error Message Lour Battery Power Turning Off 001 Error nnn Error codes 311 319 Error nnn Error codes 611 623 Error nnn Error codes 711 739 Explanation Battery power is too low for testing The monitor will turn off in 10 seconds The monitor has a problem that prevents it from operating There may be a problem in the stored data The moni
59. er to the Precision PCx or Precision PCx Plus Test Strip instructions for use for test strip specification information Reasons Glucose Results May Be Higher than Expected Hematocrit is lower than the acceptable limit for the test strips as indicated on test strip instructions for use Serum or plasma samples were used instead of whole blood e Room temperature gt 104 F 40 C Relative humidity gt 90 e Venous blood tested in capillary or arterial mode Reasons Glucose Results May Be Lower than Expected Hematocrit is higher than the acceptable limit for the test strips as indicated on test strip instructions for use Room temperature 59 F 15 C Capillary or arterial blood tested in venous mode Relative humidity 10 Hyperglycemic hyperosmolar state with or without ketosis Severe dehydration hypotension or shock Water or alcohol remaining on the puncture site e Venous or arterial whole blood sample not tested within 30 minutes after collection Troubleshooting Out of Range Control Test Results Repeat the test for that control solution to make sure that the operator meets the conditions in this checklist No air bubbles are in the control bottle s nozzle Calibrate the monitor using the barcode for the test strip used Enter the correct 5 digit lot number for the control solutions Check storage temperatures Solutions and test strips must be stored between 39 F and 86 F
60. est Setup the Test Setup menu 2 System Setup S System Status 4 Date and Time S Edit Lists Test Setup 2 Press 5 Test Type The display shows the LR Tests Test Setup Test Type z Patient Test menu S Control Test 4 Security STest Type Test WP 3 Press 1 to continue to The display shows the Test Type Glucose Units option Glucose Units screen 1 Glucose Glucose 4 The administrator will The display shows the ay iL select one of the Units options following options 1 Heut Press 1 Next to z hange continue to Glucose Sample Type menu skip forward to step 7 Press 2 Change to change the test measurement units Q What You See on the Display 1 madL z mrmol L Glucose ma dL ltet z hange blucose Sample Type Frompt i eut zhange Sample Type 1 Prompt 2 Capillary or Art Venous Glucose Sample Type Capillary or Arterial i Hext Change What You Do 5 Choose one of the following options Press 1 mg dL Press 2 mmol L 6 Press 1 to continue to the next menu 7 The administrator will select one of the following options Press 1 Next to continue to Glucose Action Range menu skip forward to step 10 Press 2 Change to change Sample Type prompt 8 The administrator will select one of the following options Press 1 Prompt Press 2 Capillary or Arterial Press 3 Venous 9 Press 1 to continue to the Glucose Action Range menu
61. est Type screen If the action range is enabled the display shows the action range The display shows the Glucose Action Range options The display shows the Action Range screen When the action range is enabled the display shows an Action Range Low and High values screen Enter a low action range value and a high action range value The display is returned to the Glucose Action Range screen Refer to test strip instructions for use for Action Range What You See What You Do Comments on the Display 14 The administrator will select one of the following options Press Clear to return to Test Setup menu Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor Questions Refer to Page 10 13 For Customer Care Information Review Change Setup for System Setup System Setup enables the look or appearance of the data shown on the display to be customized The monitor can be formatted to present information in a way that is more comfortable or familiar to work with Use this menu to review or change the setup for these features Language This option presents the data in English or another language Beeper This option turns the monitor beeper on or off The monitor beeps to alert the operator of certain functions Date Format This option presents the date in mm dd yy dd mm yy or yy mm dd format The user can select the punctuation that separates month day an
62. estions Refer to Page 10 13 For Customer Care Information Comments Data Upload Once the test results have been collected during a prescribed period of time they will then be uploaded into the MediSense QC Manager Data Management System The QC Manager Data Management System provides a simple and automated way to collect report and transfer data to a personal computer PC Data upload is initiated by the computer and requires no special steps by the operator as long as the monitor is connected properly and the QC Manager Program is running For the data upload to begin either the monitor must be in the optional docking station or the communications cable must be plugged into the data port on the monitor Once the connection is established communication between the monitor and the PC will begin automatically The monitor can send and receive data During data upload the monitor cannot be used for testing When this occurs the monitor will display the following message Please Wait for Data Upload Testing is preempted while the monitor is sending or receiving data Please Wait for Data Upload The technical details of the data upload are described in the QC Manager manual Data is transferred in ASTM E 1381 format If the monitor is removed before data transmission is complete no data will have been uploaded The data will be uploaded as part of the next data transmission If a problem occurs with the data upload an
63. ete electrical ratings for the AC adapters are as follows Reorder No 98207 01 120 VAC operation Globetek Model WD 1 C2000LCP A Input 120 VAC 60 Hz 35W Output 7 5 VDC 2A Reorder No 98212 01 240 VAC Operation Jerome Industries Corp Model ILDK 7 Input 230 VAC 50 Hz 1A Output 7 8 VDC 1 2 A Signal Output and Signal Input Parts The following is recommended by UL for the Intended signal input and signal output connections complying with this requirement UL 2601 1 The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system Consideration relating to the choice shall include Use of the accessory in the PATIENT VICINITY Evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 601 1 and or IEC 601 1 1 harmonized national standard Patient Vicinity UL 2601 1 In areas in which patients are normally cared for the patient vicinity is the space with surfaces likely to be contacted by the patient or an attendant who can touch the patient This encloses a space within the room 1 83 m 6 feet beyond the perimeter of the bed examination table dental chair treatment booth and the like in its intended location and extending vertically 2 29 7 1 2 feet above the floor Equipment Equipment shall be classified by marking and or identification as descri
64. face 11 1 Replacing the Batteries essere 11 2 Six Month Maintenance Log eee 11 3 12 SPCCHICATIONS siseicacssscerceccsetscessseossodcsonsncsdecestesesetessessesetedcsebeseadseons 12 1 Other Information oisi oet emotes eed 12 2 Questions Refer to Page 10 13 For Customer Care Information gt MediSense Precision PCx Point of Care System Introduction Welcome to the MediSense Precision PCx TM Point of Care System the portable hospital whole blood testing system The Precision PCx System simplifies patient monitoring for point of care whole blood glucose testing by nurses physicians diabetes educators laboratory staff and other healthcare professionals who need quick accurate results The Precision PCx System includes the following Features and Benefits Hand Held Monitor Simplified Data Entry Easy Operation Rapid Test Results Easy Home Training Infection Control Improved Test Strip Technology Minimal Maintenance The hand held design of the monitor allows it to be easily brought to the patient for testing The monitor contains a built in barcode scanner which allows the operator to enter patient identification operator identification test strip lot number and other pertinent data by simply scanning a barcode To perform a test a test strip is inserted into the monitor s test strip port and a small drop of blood is applie
65. for Overwrite or Lockout The number of test records available is displayed Data should be uploaded as soon as possible Test memory for the selected test type is full The Test Memory Full option for that test type is set to Prompt for Overwrite or Lockout The menu item 2 Continue appears only if this option is set to Prompt for Overwrite Tests may be performed the oldest stored test results of the selected type will be overwritten with new results If the option is set to Lockout data must be uploaded before testing can start Memory space becomes available once records have been uploaded They do not have to be erased How To Respond For data upload 1 To upload the data do one of the following Place the monitor in the docking station if the system has this option Plug the communica tions cable into the data port and connect to the laptop Refer to QC Manager manual 2 If the problem persists notify the system administrator Press 1 to continue testing 1 To upload the data do one of the following Place the monitor in the docking station if the system has this option Plug the communications cable into the data port and connect to the laptop Refer to QC Manager manual 2 If the problem persists notify the system administrator Press 1 to exit to other functions or Press 2 to continue testing and overwrite the oldest stored results D
66. g up insert the will appear Strip test strip into the test strip port until it stops NS lary or j Th itor b h pen pepali 9 Apply a drop of blood e monitor beeps when directly from the the sample is accepted patient s finger or from The Sample Accepted a syringe to the target screen will appear For area on the test strip detailed description of the test strip target area refer to page 2 2 The test starts Sample Rccepted automatically as the i sample is accepted 3 10 Wait for the monitor The monitor counts down Analyzing Sample to analyze the sample 20 seconds then displays Result in and display the test the test result result seconds pSSres4X2l i 9 1 98 426 Les 11 Note the test result If the test result is above and whether it falls or below the action range mafdL outside the action an up or down triangle i Hent Patient range appears in front of the test Fegpeat lest result S Patient History 5 8 mmol L Q What You See on the Display Outside Action Range 395 Soan or Enter Comment Code A21 9 mmol L 105 Soan or Enter Comment Code 5 8 mmol L Remove Strip t What You Do For Out of Range results refer to your institution s protocol The monitor may be enabled to scan or enter a 1 to 2 digit comment code If there is no prompt to enter a comment code skip down to step 12 12 Remove the test strip from the monitor when finished testing
67. ge 10 13 For Customer Care Information 3 Connect the network cable to the RJ 45 network jack and to the serial port of the terminal server Figure 3 1 Connect the AC adapter to a power source 2 Connect the RS 232 cable to a serial port on a networked PC at the nurses station and to the docking station data transfer port 3 Connect the network cable to the RJ 45 network jack and to the serial port of the networked PC at the nurses station Figure 4 1 Connect the AC adapter to a power source 2 Connect the RS 232 to an approved external modem and to the docking station data transfer port 3 Connect the approved external modem to a standard telephone jack using a modem connection Note This connection may require a special adapter to convert the 9 pin serial cable end to a 25 pin connector Mounting Instructions 4 Wall Mount Instructions This operation is similar to mounting a telephone on the wall 1 Drill the holes according to the wall mount 2 Place the wall mount on the wall and insert the enclosed four screws 3 Align the two holes in the dock station with the two mounting anchors 4 After aligning the holes press in and then down to secure the docking station Questions Refer to Page 10 13 For Customer Care Information Troubleshooting Troubleshooting Patient Test Results This section describes conditions that can cause out of range patient test results Ref
68. ge Test Setup System Setup System Status Date and Time and Edit Lists by following the appropriate steps for these procedures Comments Review Change Setup for Test Setup The Review Change Setup menus enable the operator to review change the test settings Under the Test Setup Menu the following options can be viewed or changed All Tests Patient Test Control Test Security Test Type In the All Tests menu the following options can be viewed or changed Upload Interval for sending stored data to other systems Establish Operator ID requirements and barcode format In the Patient Test menu the following options can be viewed or changed Establish Patient ID requirements and barcode format Set the requirement for out of range and or in range comment codes Management of memory full overwrite In the Control Test menu the following options can be viewed or changed Enable high normal and or low control testing Control test results presented as numeric or Pass Fail Set the requirement for in range and or out of range comment codes Management of memory full overwrite In the Security menu the following options can be viewed or changed Set QC interval requirements Set requirements to prevent testing by non certified operators Set requirements to prevent testing using test strip lots that have not been qualified for use In the Test Type menu the following options can
69. ge will be displayed on the monitor No Stored Tests If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting Q What You See on the Display Data Review 1 Patient History 2 Control History S Proficiency Data 4 Linearity Data amp 12343567T8 S 2 9B8B zwz PH T i maid e 1234567890125 1 Prewious a 2st 1 2 5 mmol L What You Do 1 Press 3 Proficiency Data 2 The operator can select one of the following options Press 1 Previous view the previous test result Press 2 Next view the next test result 3 When finished reviewing the data the operator can Press Clear to return to the Data Review screen Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor uestions Refer to Page 10 13 For Customer Care Information Comments The monitor now shows the most recent proficiency test result The number that appears to the right of 1 Previous and 2 Next on the monitor indicates the number of tests available for review The display shows the following s Sample Type or ID o Operator ID 0 Comment Code Data Review for Linearity Data The monitor stores the last linearity panel that includes a maximum of 4 replicates for 5 levels 20 tests Please refer to the beginning of the Data Review section for the step by step instructions to access the Data Review menu Note
70. ged Disabled Optional or Required entry of an Operator ID for all testing Require a minimum and a maximum number of digits for the length of an Operator ID Allow any combination of five common barcode formats used in the facility I2 of 5 with or without check digit Code 39 with or without check digit alphanumeric or ASCII format Code 128 Codabar Code 93 Truncate ignore leading and or trailing barcode digits Note The display shows selected options in bold type Review Change Setup for All Tests Refer to the beginning of the Review Change Setup Section for step by step instruction to access the appropriate setup menu If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See What You Do Comments on the Display Change Setup Test Setup 2 System Setup X System States 4 Date and Time S Edit Lists Test Setup L AI Tests 2 Patient Test Control Test 4 Security teTest Type All fests Upload Interval Allow Test 1 fHext z hange Upload Interval Expared 1 Allow Test z Llarn 3 Lockout Upload Interval 24 Hours 1 Hours z Daus 1 Press 1 for Test Setup 2 Press 1 for All Tests 3 The administrator will select one of the following options Press 1 Next skip forward to step 8 Press 2 Change 4 The administrator will select one of the following options Press 1 Allow Test skip
71. he Precision PCx Monitor When opening a new bottle write the current date on the bottle label Each bottle of control solution is stable for 90 days after opening replace cap tightly after each use Discard all unused solutions 90 days after opening nvert the control solution bottle several times to ensure thorough mixing before use Invert and tap the capped control solution bottle to remove air bubbles from the nozzle of the bottle Do not scan one test strip packet s barcode and use a test strip from another packet This may cause incorrect assay results to be generated Replace the correct cap on the bottle and tighten the cap immediately after each use Store the control solutions at temperatures between 39 and 86 F 4 and 30 C Do not use control solutions after the expiration date printed on the bottles and the box The Precision PCx Monitor does not accept control solutions that have passed their expiration date When To Test Control Solutions Asrequired by your facility s quality policy or local regulatory requirements When you question blood glucose results When you open a new lot of test strips o Questions Refer to Page 10 13 For Customer Care Information Control Test Procedure Use the following procedure to perform control tests Note The word Strip on the display always refersto the test strip If the monitor displays a message not indicated in these procedures please refer to
72. here are now two types of Precision PCx test strips that may be used for testing with this system The target area of the original Precision PCx biosensor test strip is on the top of the strip The target area of the new Precision PCx Plus Test Strip with TrueMeasure Technology is at the end of the strip Only Precision PCx branded test strips should be used for testing with this system Note For data management Precision PCx Plus Test Strips can be used only in conjunction with QC Manager 3 0 Inside each carton of test strips are test strip instructions for use The instructions contain important information about the test strip such as Storage and Handling Sample Collection and Preparation Quality Control and Limitations of the Procedure The section Limitations of the Procedure contains the operating ranges for the system and the test strips Please read the instructions for use carefully Lot Number Lot Number Barcode number Expiration Date Barcode number Control Test Ranges Expiration Date Control Test Ranges Barcode Barcode Precision PCx Precision PCx Plus Test Test Strip Strip with TrueMeasure Technology Target Area Contact Bars Contact Bars Precision PCx Test Strip Precision PCx Plus Test Strip with For Use with Precision PCx v2 0 v2 1 and v2 2 TrueMeasure Technology For Use with Precision PCx v2 2 Only Target area A small green and Target area A white area where white oval where yo
73. into the test strip port 6 Open the foil test strip packet at the notch and tear up or down to remove the test strip 7 With the contact bars The monitor will prompt facing up insert the test the operator to apply the strip into the test strip desired control solution port until it stops to the test strip Insert Strip Precision PCx Test Strip Precision PCx Plus Test Strip For Use with Precision PCx with TrueMeasure Technology v2 0 v2 1 and v2 2 For Use with Precision PCx v2 2 Only Manual entry of strip lots with alpha numeric barcodes is not supported Questions Refer to Page 10 13 For Customer Care Information What You See What You Do Comments on the Display Appa Low Solution Sample hooep ted Analyzing Sample Result in 2 7 mmol L 8 Gently invert the required control solution bottle 3 4 times then apply a drop to the target area on the test strip 9 Wait for the monitor to analyze the control solution and display the test result 10 Note the test result and whether it falls within the acceptable range The monitor beeps when the sample is accepted The Sample Accepted screen will be displayed Recap the control solution bottle tightly For a detailed description of the test strip target area refer to page 2 2 The test starts automatically as the sample is accepted The monitor counts down 20 seconds then displays the
74. ip and the count down begins do not remove or disturb the test strip Usea new test strip when repeating a patient test e Refer to the instructions for use in the test strip box for specific directions on storage and use of the test strips Questions Refer to Page 10 13 For Customer Care Information eo Collecting Blood Samples How to Obtain a Capillary Blood Sample How to Obtain a Venous Blood Sample Use only fresh whole blood samples Make sure no water remains on the puncture site Collect the capillary blood using a lancing device and an Precision PCx Test Strip Precision PCx Plus Test Strip appr opriate technique For Use with Precision PCx with TrueMeasure Technology v2 0 v2 1 and v2 2 For Use with Precision PCx Avoid squeezing the v2 2 Only puncture site excessively Apply the drop of blood directly to the target area of the test strip covering the entire area If necessary the blood can be collected in a capillary tube coated with sodium heparin lithium heparin or EDTA and then applied to the test strip Use only fresh whole blood samples Collect the venous blood sample in a collection tube precision PCx Test Strip Precision PCx Plus Test Strip d For Use with Precision PCx with TrueMeasure Technology containing sodium v2 0 v2 1 and v2 2 For Use with Precision PCx heparin lithium heparin v2 2 Only or EDTA ensuring that the test tube is
75. ity limits access to the list of certified operators Strip Lot Security test only with approved test strip lots Test Security reports control test as Pass Fail only This is to prevent patient testing from being performed while the monitor is in control test mode The Precision PCx Monitor can store up to 4 000 patient tests and 1 000 control tests All stored data can be automatically uploaded to the MediSense QC Manager Data Management System using the docking station optional or serial cable The QC Manager Data Management System provides a simple and automated way to collect report and send data to the Laboratory Information System LIS or Hospital Information System HIS The monitor uses 2 standard alkaline AA batteries or the rechargeable MediSense battery pack Manual Organization The Precision PCx Point of Care System Operator s Manual provides basic information about the Precision PCx Monitor and contains easy to follow step by step procedures for using it The Precision PCx System operates using menu driven software The software consists of two main menus Test Mode and Menu Mode Test Mode is used to perform Patient Tests and Control Tests Menu Mode is used to set up the monitor s options See page 1 2 The menu portion of the software is set up like a tree with various levels of sub menus branching out from the main trunk The menu diagram on the next page called the Precision PCx Menu Tre
76. l Test History 1 Patient History History menu now appears 2 Control History S Proficiency Data 4 Line arity Data Control History 2 Press 2 Operator ID The monitor will prompt ee ID for the Operator ID to be 3 Outside Range scanned or entered 4 Comment aDate scan or Enter 3 Scan or manually enter The monitor will display Operator ID the Operator ID via the the Operator s most recent ee ee ee een keypad then press control test result Enter OPERATOR Questions Refer to Page 10 13 For Customer Care Information e What You See What You Do Comments on the Display Low SUE 23 38 1058 PH 2m e 1605436 POPUL SS 1 Prewious 2Heat 2 3 mmol L 4 The operator can select one of the following options Press 1 Previous view the previous test result Press 2 Next view the next test result 5 When finished reviewing the data the operator can Press Clear to return to the Operator ID screen Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor The number that appears to the right of 1 Previous and 2 Next on the monitor indicates the number of tests available for review The display also shows the acceptable range for this test and o Operator ID 0 Comment Code Data Review for Control History by Outside Range Results Please refer to page 5 2 of the Data Review section for the step by step instructions to access the Data Review menu No
77. lay shows the Set Time option The display is returned to the Set Time menu The display shows the user selected time The display shows the Date menu What You See on the Display What You Do Comments Date ma dulur 9gr1T 989 lent Z Change Set Date s 1T S8 B riget Date ma dulur 9 18 98 eut zhange Q 6 The administrator will select one of the following options Press 1 Next to return to Change Setup menu Press 2 Change to change the date 7 Enter the current date then press Enter Include leading zeros 09 for 9 8 The administrator will select one of the following options Press 1 Next to return to the Review Change Setup menu Press Menu to return to the Menu Mode Press On Off to turn the monitor off uestions Refer to Page 10 13 For Customer Care Information The display shows the Set Date menu The display is returned to the Date menu Change Setup for Edit Lists The Precision PCx Monitor maintains two lists for the purpose of system security 1 The Operator List contains the ID numbers of operators who are authorized to perform tests When the operator enters an Operator ID the monitor checks the ID against the current list stored in the monitor The monitor can be set to one of the following options Allow Test No checking will occur Warn The monitor displays a warning message but allows the operator to continue testi
78. ll Tests Patient Test Control Test Security and Test Type The System Setup menu defines the look or appearance of the data as it is displayed on the monitor such as language and formats The menu includes language beeper on off date format time format set password and restore defaults The System Status menu allows a review of the current status of the monitor s operating system battery power temperature memory gauge and software version The Date and Time menu displays the current date and time The Edit Lists menu changes the approved Operator ID or Test Strip Lot lists The Precision PCx Menu Tree on the following page will outline the above menus and the sub menus Questions Refer to Page 10 13 For Customer Care Information Precision PCx Menu Tree Menu Mode 1 Patient Test 1 Data Review 1 Patient History All Tests sort by Patient ID Operator ID Action Range Comment Code Date 2 Control Test 2 Control History All Tests sort by Operator ID OutsideRange Comment Code Date 3 Proficiency Data 4 Linearity Data 2 Proficiency Test 3 Linearity Test 4 Review 5 Change 1 Test Setup Setup 1 All Tests Upload Interval Operator ID Format 2 Patient Test Patient ID Format Comment Code Memory Full 3 Control Test Levels Results Format Comment Code Memory Full 4 Security QC Interval Operator ID Strip Lot 5 Test Type Gl
79. llows Overwrite itest 2 Change Memory Full 1 Allow Overwrite Z Prompt for uernwrite Lookout Patient Test Memory Full Lockout 1 Hext z hange 8 18 19 Press 1 Next continue to the next menu 20 The administrator will select one of the following Press 1 Next and continue to next menu Press 2 Change to change Memory Full option 21 The administrator will select one of the following options Press 1 Allow Overwrite Press 2 Prompt for Overwrite Press 3 Lockout 22 The administrator will select one of the following options Press 1 to return to Test Setup menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor The display shows the Memory Full screen The display shows the Memory Full options Once the Patient Test storage bank is full the following can be set by the monitor lockout additional tests prompt for overwrite option or automatically overwrite the oldest stored tests The display is returned to the Patient Test Memory Full screen Review Change Test Setup for Control Tests The options associated with this menu apply to all Control Tests Control levels can be any combination of low normal and high At least one level must be selected The Results Format has the following options Show test results in a Numeric or Pass Fail format Comment Code prompts have the following options
80. lts in memory starting with the most recent test result in memory reverse chronological order Operator ID This shows the control test results that were performed by a particular operator starting with the most recent test Outside Range This shows all the control test results that fell outside of the acceptable ranges Comment Code This shows all the control test results by comment code Date This shows the control test results performed on a specific date starting with the most recent test of the day Data Review for Control History for All Tests Please refer to page 5 2 of the Data Review section for the step by step instructions to access the Data Review menu Note If no information is stored for the desired category that was selected the following message will be displayed on the monitor No Stored Tests Note If no tests match the criteria specified this message will be displayed on the monitor No Tests Match Request If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See on the Display What You Do Comments Data Rewiew 1 Press 2 Control The Control History menu 1 Patient History History now appears 2 Control History S Proficiency Data 4 Linearity Data Control History 2 Press 1 All Tests The monitor shows the 1 fll Tests result of the most recent 2 Dperator ID 3 Qutside Range control test 4 Comment Tate Ques
81. me 5 Edit Lists 1 Operator List Add Delete Change Add Delete Change Understanding the Precision PCx Point of Care System The Precision PCx Point of Care System is a portable whole blood testing system which performs tests with quick and accurate results This section is intended to provide an overview of the Precision PCx System s components and basic operations Use product and accessories only as directed Failure to operate the product s in accordance with the manufacturer s documentation may impair the product safety MediSense Precision PCx Point of Care System Components The MediSense Precision PCx Point of Care System includes the following items The Precision PCx Monitor Precision PCx and Precision PCx Plus Blood Glucose Test Strips Accessory Carry Case optional Docking Station optional The Precision PCx Monitor includes Test Strip Port Large LCD Display Barcode Scanner Keypad Data Port e Audible Indicator Precision PCx Blood Glucose Test Strips The Precision PCx and Precision PCx Plus Blood Glucose Test Strips offer the latest advances in biosensor technology Each test strip is wrapped in a foil packet with a barcode label This label holds the calibration information about the test strip including the lot number the expiration date and expected control solution ranges Questions Refer to Page 10 13 For Customer Care Information e Precision PCx Test Strips T
82. n If the option is set to Lockout data must be uploaded before testing starts The room temperature is outside the limits for testing Data Review and Review Change Setup functions are available Questions Refer to Page 10 13 For Customer Care Information How To Respond Perform the control tests indicated in the message Press 1 to Exit or If it appears press 2 to continue patient testing 1 To upload data do one of the following Place the monitor in the docking station if the system has this option Plug the communications cable into the data port and connect to the laptop Refer to QC Manager Manual 2 If the problem persists notify the system administrator Press 1 to exit or If it appears press 2 to continue testing Ensure that the room temperature is within the specified limits Allow time for the monitor to stabilize to room temperature Please refer to test strip instructions for use for appropriate operating temperature range Press 1 to exit Symptom Error Message Test Memory Liou m 1 Continue This screen appears only when Patient Test or Control Test is selected Test Hemory Full 1 Enit z Lontinue This screen appears only when Patient Test or Control Test is selected Explanation Less than 50 test data records are available in test memory for the selected test type The Test Memory Full option for that test type is set to Prompt
83. ng Lockout The monitor will not allow the operator to continue testing The Change Setup for Edit Lists is used to make changes to the Operator ID List When a name is added to the list an expiration date the date the operator s access to the monitor expires must also be entered A single Operator ID or the whole list can be deleted or changed The Expiration Date for operators can also be changed 2 The Strip Lot List contains the strip lot numbers of valid test strip lots in the current inventory When the operator enters a test strip lot number via the barcode scanner or by manually entering the 14 digit lot number the monitor checks the number against the current list stored in the monitor The monitor can be set to one of the following options Allow Test No checking will occur Warn The monitor displays a warning message but allows the operator to continue testing Lockout The monitor will not allow the operator to continue testing The Change Setup for Edit Lists is used to make changes to the Strip Lot List The Strip Lot List can have test strip lots added or deleted The minimum and maximum control values for the test strip lots can be customized to meet tighter default values needed by a facility If you have questions please refer to page 10 13 for Customer Care information Manual entry of strip lots with alpha numeric barcodes is not supported 8 46 C hange Setup for Edit Lists Refer to the
84. nse Produkte Max Planck Ring 2 65205 Wiesbaden Germany Tel 0049 612258 1015 MediSense KA ogc tnc Abbott Laboratories AtebOvuvon A BovAiayp vnc 512 174 56 AAIMOX Tel 01 99 85 220 MediSense Abbott Laboratories Ireland Ltd Dublin Ireland Tel 1 800 77 66 33 Abbott S p A Divisione Diagnostici Prodotti MediSense Roma Italia Tel 800 334 210 Dainabot Tokyo Japan Tel 81 3 3589 9580 Abbott Laborat rios Divis o MediSense Amadora Portugal Tel 0800 200 891 Abbott B V MediSense Nederland Amersfoort Nederland Tel 0 800 0228828 Abbott Norge AS MediSense Products Billingstad Norge Tel 66 98 39 03 Abbott Scandinavia AB MediSense Produkter Solna Sweden Tel 08 546 56700 ABBOTT AG MediSense Products Baar Schweiz Suisse Svizzera Tel 041 768 44 46 Abbott Laboratories MediSense Products Maidenhead UK Toll free 0500 467 466 Abbott Diagnostic Division Johannesburg South Africa Tel 0800 11 69 41 ADD Argentina Buenos Aires Argentina Tel 54 11 4382 8788 Tel 54 11 4383 4286 ADD Brazil S o Paulo Brazil Tel 55 11 536 7215 Tel 0800 164550 ADD Caribe Carolina Puerto Rico Tel 1 787 257 4405 Tel 1 787 257 4444 ADD Chile Santiago Chile Tel 562 557 2126 ADD Colombi Sante F de Bogot Colombia Tel 9800 910353 Abbott Laboratories ADD MediSense Santo Domingo Dominican Rep Tel 809 566 7181 85 e ADD Guatamala Cotio Guatamala Tel 502 5
85. o turn off monitor The monitor beeps when the sample is accepted The Sample Accepted Screen will appear The test starts automatically as the sample is accepted The monitor counts down 20 seconds then displays the test result The display includes the level and test numbers date and time Level indicates Level 1 5 Test indicates replicates 1 4 for that level The monitor will return to the results screen The comment code number that was entered will appear in a box to the left of where the result is displayed The operator can press 2 to perform more tests for the same level return to step 9 or press 1 to perform tests for another level return to step 8 Review Change Setup The Precision PCx Monitor provides setup options to customize the testing procedures and requirements These standards promote good laboratory practices for operators Since the steps to review or change setup options are similar the two sub menus are combined in one section Any operator can review the setup information only an administrator manager with the password can change the setup information The Review Setup feature enables an operator to review only the settings for Test Setup System Setup System Status and Date and Time The Change Setup feature enables an administrator to review or change the settings for Test Setup System Setup System Status Date and Time and Edit Lists The Test Setup menu includes A
86. of contract negligence strict tort or any other legal theory Some states do not allow limitations on warranties or on remedies for breach in certain transactions In such states the limits of this paragraph and the paragraph entitled Disclaimer of Warranty may not apply For Warranty Service purchaser must contact Abbott Laboratories MediSense Products by calling 1 877 529 7185 twenty four hours 24 a day for assistance and or instructions for obtaining repair or replacement of the Precision PCx Monitor Outside the United States contact your local Abbott office or distributor For return of the Precision PCx Monitor Abbott will send a return authorization label that must be affixed to the shipping carton Cartons received without this label will be returned at your expense If you are experiencing difficulties with the Precision PCx Monitor review the troubleshooting information in this section before calling Abbott Abbott will repair or replace returned monitors at its option A postage paid return label will be sent to you to return the defective Precision PCx Monitor Abbott will cover the postage cost of shipping the new or reconditioned replacement unit to you If you fail to return the defective monitor to Abbott within 30 days of shipment of the replacement you will be billed for the balance of the cost for a new Precision PCx Monitor Questions Refer to Page 10 13 For Customer Care Information e Maintenance of the Pr
87. on PCx Monitor stores up to 4 000 patient tests that can be retrieved by the following categories All Tests This option displays all patient test results starting with the most recent test results reverse chronological order Patient ID This will display the test results for a particular patient starting with the most recent test Operator ID This will show test results performed by a particular operator starting with the most recent test Action Range This will display the test results that fall outside of the action range Comment Code This shows the test results for all tests tagged with a specific comment code Date This will display all the test results for a specific date starting with the most recent test done on that date Questions Refer to Page 10 13 For Customer Care Information e Data Review Follow these steps to access the Data Review menu If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See on the Display What You Do Comments 1 Press the On Off The Abbott logo screen button to turn the will appear for a few monitor on seconds followed by the product name software ABBOTT version and then the Test Mode menu 9 1 28 2 24 PM 2 Press the Menu button The Menu Mode screen will appear next 1 Patient Test 2 Control Test 92 1 28 451 PA 3 Press 1 Data Review The Data Review menu 1 Data Review appears 2 Proficienc
88. ons Refer to Page 10 13 For Customer Care Information Patient Test This section describes the steps to be taken to test patient blood samples using the Precision PCx Monitor Operating Guidelines for All Samples Please follow the recommended guidelines so the most accurate results will be obtained Always wear gloves and follow your facility s biohazard safety policies and procedures when performing tests involving patient blood samples Use only control solutions approved for use on the test strip instructions for use to verify the performance of the Precision PCx and Precision PCx Plus Test Strips and the Precision PCx Monitor Use the test strips before their expiration date Do not use test strips that are wet bent scratched or damaged Use the test strip immediately after opening its foil packet Do not scan a packet s barcode and use a test strip from another packet This may cause incorrect assay results to be generated Cover the entire target area of the test strip with the blood sample The test results will not be affected if the target area has been briefly touched with the patient s finger a capillary tube or pipette e If the test fails to start apply a second drop of blood to the target area within 30 seconds If the test fails to start after the second drop is applied or if more than 30 seconds have passed discard the used test strip and repeat the test After the blood is applied to the test str
89. ons Refer to Page 10 13 For Customer Care Information The display shows the System Setup Language menu The display shows the Language setup options The display returns to the System Setup Language menu The display shows the System Setup Beeper menu The display shows the Beeper option What You See What You Do Comments on the Display Beeper 1 Enabled z Dizahled m Setup Disabled 1 Hext z hange m Setup te Format modu ur ltet zhange Date Format 1 modu ur S o Date Format Separator 1 7 as SIE st n nie 6 The administrator will select one of the following options Press 1 Enabled Press 2 Disabled 7 Press 1 Next 8 The administrator will select one of the following options Press 1 Next to continue to System Setup Time Format menu Skip forward to step 12 Press 2 Change to change the Date Format option 9 The administrator will select one of the following options Press 1 month day year Press 2 day month year Press 3 year month day 10 The administrator will select one of the following options Press 1 slash Press 2 dash Press 3 period Press 4 none The display returns to the System Setup Beeper menu The display shows the System Setup Date Format menu The display shows the Date Format options The date is listed using 2 digits for the month day and year For ex
90. ons for installing the mounting plate are described later in this section The green LED indicates that the docking station is connected to a power supply The yellow LED steady indicates that the monitor has been properly placed into the docking station The yellow LED flashing indicates data transfer upload download is in process Note Use only the AC adapter supplied by MediSense Use of any other adapter might cause serious damage to the docking station and to the Predsion PCx Monitor while it is in the docking station Connecting Cables to the Docking Station The docking station has three ports located on the back an AC adapter port data transfer port and printer port Figure 1 When connected the AC adapter supplies power to the docking station for battery recharge The data transfer port connects the docking station to a variety of transfer options using the RS 232 communications cable supplied by MediSense The printer serial port connects the docking station to a printer Figure 1 AC Adapter Data Port Printer The following network connections can be established Figures 2 4 Figure 2 O Connect the AC adapter to a power source Note For plug connected equipment where protecting earthing is required plug the equipment into a supply outlet that has an earth connection 2 Connect the RS 232 cable to the terminal server and to the docking station data transfer port Questions Refer to Pa
91. ontrol Solution Lot Number m 1 1 1 3 Enter the date the problem occurred 4 Describe the problem and the conditions when it occurred 5 Have the Precision PCx Monitor and testing materials available when calling Questions Refer to Page 10 13 For Customer Care Information e Returning an Instrument The OSHA blood borne pathogen rule requires that contaminated instruments equipment be decontaminated prior to shipping to minimize the risk of exposing those persons involved in handling or transporting this equipment Please perform the following steps before returning an instrument 1 Remove all potentially contaminated accessories such as lancets unused test strips or control solution vials 2 Wipe the surface of the instrument with a detergent solution to remove any soiling 3 Then wipe the unit with a tuberculocidal disinfectant such as 10 chlorine bleach solution Limited Warranty What is Covered by this Warranty Abbott Laboratories Inc Abbott warrants to the original purchaser only that the Precision PCx Blood Glucose Testing Monitor shall be free from defects in material and workmanship for a period of one year from the date of purchase Abbott warrants that the Precision PCx Blood Glucose Testing Monitor is fit for the purposes and indications described in the labeling when used in accordance with the directions for use If the purchaser discovers within one year from
92. or use for assay range of test strips 1 Remove the old test strip 2 Press 1 to continue testing with a new test strip Press 2 to exit to the Test Menu Press 1 to continue testing with a new test strip Press 2 to exit to the Test Menu Symptom Error Message Scan or Enter Operator ID Laser On Time Exceeded Assay Error nnn l Hew Strip z Euit Error codes 112 114 116 118 Assay Error nmn 1 Hew Strip Exit Error codes 113 115 Low Battery Error 115 1 Exuit Explanation If the Scan button is pressed and the laser has been on for a total of 60 seconds in the last 15 minutes the monitor will beep and display Laser on Time Exceeded The test was not successful An error was detected during the analysis sequence The test strip malfunctioned or the blood glucose level is beyond the measuring capabilities of the system During the test battery power was too low for testing How To Respond Turn the monitor off and wait 15 minutes for the laser time to reset Note Remember to release the Scan button before trying to rescan 1 Remove the old test strip 2 Insert a new test strip If the error occurs again record the three digit error code and contact MediSense Customer Care Press 2 to exit to the Test Menu 1 Remove the used test strip 2 Insert a new test strip 3 Press 1 to continue testing with a new test strip 4 If the error a
93. ou Do Comments Data Review 1 Press 1 Patient The Patient History menu 1 Patient History History now appears Control History S Proficiency Data 4 Linearity Data Patient History 2 Press 6 Date The monitor will now es J ping prompt for the desired 3 perator ID date to be entered 4 Action Kange S Comment Code Date Patient History 3 Enter the desired date The operator will enter in Enter Bate for review then press the date using two digits mo dyyr Enter for month day year pe Aa For example June 8 2001 becomes 06 08 01 Questions Refer to Page 10 13 For Customer Care Information e What You See What You Do Comments on the Display 5 8 mmol L 4 The operator can select one of the following options Press 1 Previous view the previous test result Press 2 Next view the next test result 5 When finished reviewing the data the operator can Press Clear to return to the Enter Date screen Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor The number that appears to the right of 1 Previous and 2 Next on the monitor indicates the number of tests available for review The monitor also shows p Patient ID o Operator ID 12 Comment Code ven Venous Sample Control History The Precision PCx monitor can store up to 1 000 control tests that can be retrieved by the following categories All Tests This shows all control test resu
94. ows the Scan or Enter Operator ID menu Enter the Operator ID The display prompts the operator to verify the delete The ID is deleted from the list and the display returns to the Delete Operator ID menu 8 49 Delete One Operator on the Operator List by Selecting ID What You See What You Do Comments on the Display Delete Operator ID 1 Enter ID 2 Select ID 3S Delete All EeEnter ID zDelete Delete Operator ID 1 Enter ID Select ID 3 Delete All 1 Press 2 Delete 2 Press 2 Select ID 3 The administrator will select one of the following options Press the number of the ID to be deleted Press 6 to see any additional IDs then press the number of the ID to be deleted or Press 6 Exit 4 The administrator will do one of the following options Press 1 ReEnter ID Return back to step 3 Press 2 Delete 5 The administrator will select one of the following options Press Clear to return to the Operator ID List menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor The display shows the Delete Operator ID menu The display shows the list of Operator IDs The display prompts the operator to Verify Delete The ID is deleted from the list and the display returns to the Delete Operator ID menu To delete additional IDs return to step 2 Delete All Operators on the Operator List What You See What
95. p for Patient Test The options set with this menu will apply to all Patient Tests The Patient ID option uses a patient identification number to perform tests Patient ID uses the following options Disable Require or make Optional the entry of a Patient ID Require a minimum and maximum number of digits for the length of the Patient ID Allow any combination of five common barcode formats used in the facility I2 of 5 with or without check digit Code 39 with or without check digit alphanumeric or ASCII format Code 128 Codabar Code 93 Truncate ignore leading and or trailing barcode digits Comment Code option allows the following to be selected Disable the prompt for a Comment Code Prompt for a Comment Code with the option of not requiring it Require a Comment Code for every test result out of range and or in range of the action range See Test Type setup options The Memory Full option will notify the operator that the patient test memory has reached its limit 4000 tests that have not been uploaded Memory Full provides the following options e Lockout additional tests until the data is uploaded Prompt the operator to upload data before overwriting old test results with new ones Automatically overwrite oldest test results with new ones Questions Refer to Page 10 13 For Customer Care Information e Review Change Test Setup for Patient Test Refer to the beginning of the Review or Change Setup
96. ppears again confirm the result by performing a laboratory reference test Contact MediSense Customer Care Do one of the following Install new batteries See Maintenance for more information Place the monitor in the docking station if the system has this option Press 1 to exit Symptom Error Message Temperature Error nnn 1 Exit Error codes 121 122 Explanation During the test the room temperature became unstable or moved outside the limits within which the monitor can perform a test When a Control Test is selected Unenpected Level Low expected High entered 1 ReEnter Lot Z Lontinue This screen shows the level of control test the monitor expected to run Low Normal or High and the level of the lot entered A control solution lot number has been entered for a different level of control test from the one that the monitor expected to run in the usual low to high sequence The user may choose to enter a different lot number usually for the expected level or to run the level of test that matches the lot number entered When a Linearity Test is Selected 9876543210 will replace Old Panel l EeEnter Kit Lot Replace Panel 1 SeT83 u A new linearity kit lot number has been entered different from the one in memory Linearity data has not been uploaded since the last test Only one panel of data is stored The kit lot number may have been entered incorrec
97. r Enter Operator ID OPERATOR 2 3 4 Press On Off to turn on monitor Press Menu Press 3 Linearity Test Press Scan or manually enter the Operator ID via the keypad then press Enter The Abbott logo screen will appear for a few seconds followed by the product name the software version then the Test Mode menu The Menu Mode menu will appear The monitor will prompt for the Operator ID to be scanned or entered The monitor will next prompt for the Linearity Kit lot number to be scanned or entered It is outside the intended use of the PCx QCM system to perform a test in linearity mode on a PCx instrument and change the test result record to a patient result in QCM Data Management System Linearity test results outside the test strip assay range should only be used to set linearity performance on the PCx instrument The performance of the test strips has not been verified outside the assay range listed on the test strip instructions for use Questions Refer to Page 10 13 For Customer Care Information What You See on the Display What You Do Comments Scan or Enter 5 Scan or manually enter If the linearity kit lot Linearity Kit Lot the linearity kit l t number that um entered 1274567290 number via the keypad is different from the then press Enter If the previous one the monitor LIN monitor prompts fora will prompt the operator level to be entered skip to do one of two actions
98. rator ID scanned or entered Action Range S Comment Code amp Date Sean or Enter 3 Scan or manually enter Patient ID the Patient ID via the a are md a keypad then press Enter PATIENT Questions Refer to Page 10 13 For Customer Care Information What You See What You Do Comments on the Display Pl 324 153044 3225 9 2 38 213 PH i 1234567830125 Lal 1 Previous 2Heat 5 8 mmol L d 4 The operator can select one of the following options Press 1 Previous view the previous test result Press 2 Next view the next test result 5 When finished reviewing the data the operator can Press Clear to return to the Patient ID screen Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor The number that appears to the right of 1 Previous and 2 Next on the monitor indicates the number of tests available for review The display also shows p Patient ID o Operator ID 12 Comment Code ven Venous Sample Data Review for Patient History by Operator ID Please refer to page 5 2 of the Data Review section for the step by step instructions to access the Data Review menu Note If no information is stored for the desired category that was selected the following message will be displayed on the monitor No Stored Tests Note If no tests match the criteria specified this message will be displayed on the monitor No Tests Match Request
99. rn to the Patient History menu Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor The number that appears to the right of 1 Previous and 2 Next on the monitor indicates the number of tests available for review The display also shows p Patient ID 0 Operator ID 12 Comment Code ven Venous Sample A Indicates above action range W Indicates below action range Data Review for Patient History by Comment Code Please refer to page 5 2 of the Data Review section for the step by step instructions to access the Data Review menu Note If no information is stored for the desired category that was selected the following message will be displayed on the monitor No Stored Tests Note If no tests match the criteria specified this message will be displayed on the monitor No Tests Match Request If the monitor displays a message not indicated in these procedures please refer to the section 10 Troubleshooting What You See What You Do Comments on the Display Data Rewiew 1 Press 1 Patient The Patient History menu 1 Patient History History now appears Control History S Proficiency Data 4 Linearity Data Patient History 2 Press 5 Comment The monitor will prompt Lir cdg Code for the comment code to 3 perator ID be scanned or entered 4 Action Kange S Comment Code Date Patient History 3 Scan or manually enter The monitor will show the the desired comment most
100. section 10 Troubleshooting What You See on the Display What You Do Comments ABBOTT 9 1 98 2 24 PM 1 Patient Test 2 Control Test Scan or Enter Operator ID OPERATOR Scan or Enter Low Level Solution Lot High entered ReEnter Lot 2 Continue an N w Press On Off to turn on the monitor Press 2 Control Test Press Scan to scan the Operator ID barcode or manually enter the Operator ID via the keypad then press Enter Scan or manually enter the low control solution lot number via the keypad then press Enter The Abbott logo screen will appear for a few seconds followed by the product name software version and then the Test Mode menu After the control test is selected the Operator ID screen may appear if the setting has been enabled If the Operator ID is not required just press enter After the Operator ID is entered the Low Level Solution Lot screen will appear The Strip Lot screen will appear next If the Unexpected Level screen appears the operator may either 1 Enter 1 to ReEnter the expected level 2 Enter 2 to continue to test the unexpected level What You See on the Display What You Do Comments Scan or Enter 5 Scan or manually After the test strip lot Strip Lot enter the test strip lot number is entered the d number via the keypad monitor will prompt for then press Enter a test strip to be inserted TI m
101. section for step by step instructions to access the appropriate setup menu If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See What You Do Comments on the Display Change Setup Test Setup 2 System Setup AX System States 4 Date and Time S Edit Lists Test Setup 1 All Tests z Fatient Test Control Test 4 Security teTest Type Patient Test Patient ID Disabled L Hext 2 Change Patient ID 1 Disabled Z ptional 3 Requinred 1 Press 1 Test Setup 2 Press 2 Patient Test 3 The administrator will select one of the following options Press 1 Next skip forward to step 14 Press 2 Change to change Patient ID 4 The administrator will select one of the following options Press 1 Disabled returns to the previous screen Press 2 Optional Press 3 Required The display shows the Test Setup menu The display shows the Patient Test Patient ID Barcode screen The display shows the Patient ID options If Disabled is selected the display will not prompt for Patient ID If Optional or Required is selected the operator can enter a minimum and maximum number of digits between 1 15 digits Q What You See What You Do on the Display Patient IU 5 The administrator will 1 15 digits enter minimum and maximum numbers Minimum __ between 1 15 Maximum i Ke
102. ss 2 Warn Press 3 Lockout 12 Press 1 to continue to the Security Strip Lot Not on List screen uestions Refer to Page 10 13 For Customer Care Information the Security QC Interval menu The display shows the Security Operator ID Not Certified screen The display shows the Operator ID Not Certified options The display is returned to the Security Operator ID Not Certified screen The display shows the Security Strip Lot Not on List screen What You See What You Do Comments on the Display Security Strip Lot Hot on List Allow Test 1 Hext z hange Strip Lot Hat on List 1 Allow Test 2 LJarn 3 Lockout Security Strip Lot Hot on List Lockout 1 Hext 2X hange 8 28 13 The administrator will select one of the following options Press 1 Next to return to the Test Setup menu Press 2 Change to change the Strip Lot Not on List options 14 The administrator will select one of the following options Press 1 Allow Test Press 2 Warn Press 3 Lockout 15 The administrator will select one of the following options Press 1 to return to the Test Setup menu Press Menu to return to the Menu Mode Press On Off to turn off the monitor The display shows the Strip Lot Not on List options 1 Allow Test a test strip lot not on the test strip lot list 2 Warn the test strip lot is not on the test strip lot list operator may
103. st Mode In this section the majority of the directions refer specifically to how to change various settings However these same directions can be followed as well for reviewing settings under its own menu option Differentiation is made between the password protected sections in the Change Setup Menu Option where only administrators can access the screens and the non password protected sections in the Review Setup Menu Option where operators and administrators can access the screens Questions Refer to Page 10 13 For Customer Care Information Review Setup If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting Use the following steps to access the Review Setup menu What You See What You Do on the Display Comments 1 Press On Off to turn The Abbott logo screen on the monitor will appear for a few seconds followed by the product name the ABBOTT software version screen and then the Test Mode menu 9 1 28 224 m 2 Press Menu The Menu Mode menu will appear 1 Patient Test 2 Contral Test 9 1 98 451 PA 3 Press 4 for Review The Review Setup Menu 1 Bata Review Setup will appear z Proficiencu Test SLinearity Test 4 Revieur Setup S Change Setup Review Setup The operator can review 1 Test Setup Test Setup System Setup 2Syustem Setup System Status and Date TSustem Status and Time by following the 4Date and Time appropriate steps for these proced
104. t will beep in acknowledgement Without releasing the Scan button look down at the monitor The operator can view the data that was scanned by the monitor Release the Scan button to stop the scan and continue with the next step CAUTION Never look into the barcode scanner beam or point it toward anyone s eyes The beam could cause permanent damage to the eye Class Il and Ila Laser Product Avoid Long Term View ing of Direct Laser Light X Data Port The Data Port is located at the bottom of the monitor This port enables the monitor to automatically transfer the data through a cable connector to a PC laptop Laboratory Information System LIS or Hospital Information System HIS Battery Compartment The monitor holds two AA alkaline batteries to power the monitor A rechargeable battery pack is also available from MediSense The rechargeable battery pack can recharge itself while the monitor is in the optional docking station To prolong the battery life of the monitor the monitor should be turned off when not in use If the monitor is left on and has not been used for 4 minutes it will automatically shut itself off Audible Indicator not visible The monitor will beep to indicate one of the following A successful barcode entry Sample detection e At three seconds before the result is to appear When an error occurs Atthirty seconds before automatic shutoff Barcode Scanner Data Port Questi
105. te If no tests are stored for the desired category that was selected the following message will be displayed on the monitor No Stored Tests Note If no tests match the criteria specified this message will be displayed on the monitor No Tests Match Request If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See on the Display What You Do Comments Data Review 1 Press 2 Control The Control Test History 1 Patient History History menu now appears Z Lontrol History S Proficiency Data 4 Linearity Data Control History 2 Press 3 Outside The monitor shows the 1 fil Tests Range most recent control test 2 perator ID 8e 3 Outside Range result that is outside the 4 Comment Code acceptable range S late Questions Refer to Page 10 13 For Customer Care Information e What You See on the Display What You Do Comments w 0 60 3 The operator can select The number that appears 9 3 98 231 PH one of the following to the right of 1 Previous F X 64 mad options and 2 Next on the monitor c123456T8350 123 indicates the number of Press 1 Previous view 1 the previous test result X3 5 mmol L Press 2 Next view the The display also shows next test result the acceptable range for this test as well as 1 Previous E a tests available for review o Operator ID 2 Comment Code X Outside Range 4 When finished reviewing the
106. test result Control test results can appear as numeric or PASS FAIL depending on how the test is setup The display also shows the control level the control range date and time Q What You See on the Display Loui 3 28 99 12 35 PM PRSS 1 Hext Level z Repeat lest Low 37 6 X67 mata Scan or Enter Comment Code x3 7 mmol L 2 7 mmol L What You Do 11 Note the test result and whether it falls within the acceptable range 1 N If required scan or manually enter the comment code and press Enter The monitor may be enabled to scan or enter a 1 to 2 digit comment code If there is no prompt to enter a comment code skip down to step 13 13 Remove the test strip from the monitor when finished testing 14 The operator may select one of the following Press 1 Next Level Press 2 Repeat Test Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor uestions Refer to Page 10 13 For Customer Care Information Comments The display shows the control level PASS FAIL date and time An X will appear in front of a test result that is Out of Range If 1 is selected the next level test will appear The operator may perform the next level control test by returning to Step 4 If 2 is selected the Scan or Enter Strip Lot screen will appear Return to step 5 to repeat the test Patient History The Precisi
107. that fall in the action range What You See What You Do Comments Q on the Display Comment Cade If IneRange 1 Disabled 2 Optional o Required Patient Test Patient Test Comment Code If ut of Eanae Disabled 1 Hext 2 Chanae Comment Cade Tt Qut of Range 1 Disabled 2 Optional 3 Reauired 15 The administrator will select one of the following options Press 1 Disabled Press 2 Optional Press 3 Required 16 Press 1 Next continue to the next menu 17 The administrator will select one of the following options Press 1 Next and continue to step 20 Press 2 Change to change the Out of Range Comment Code 18 The administrator will select one of the following options Press 1 Disabled Press 2 Optional Press 3 Required uestions Refer to Page 10 13 For Customer Care Information The display is returned to the Patient Test Comment Code If In Range screen The display shows the Out of Range Comment Code menu The comment code options can be set to Disabled Optional or Required for test results that fall outside the action range The display shows the Out of Range Comment Code options The display shows the Patient Test Comment Code If Out of Range screen What You See What You Do Comments on the Display Patient Test Comment Code If ut of EFanae Optional 1 Hext zChange Patient Test Memory Full A
108. the date of purchase a defect in the material and workmanship the purchaser must promptly notify Abbott in writing In no event shall such notification be received by Abbott later than 13 months from the date of purchase Abbott s sole obligation as a result of the breach of any warranty and the purchaser s exclusive remedy for the breach of any warranty shall be limited to at Abbott s option the repair or replacement with a new or reconditioned unit of the Precision PCx Blood Glucose Testing Monitor What is not Covered by this Warranty The warranty granted by Abbott extends only to defects in material and workmanship discovered within one year from the date of purchase In addition Abbott does not warrant a damage caused by use of the Precision PCx Monitor for purposes other than those for which it was designed b any products components or parts not manufactured by Abbott including without limitation any auxiliary equipment or disposable accessories or c any damage caused by any other abuse or misuse by the purchaser e Disclaimer of Warranty THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Limitation of Remedies In no case shall Abbott Laboratories Inc Abbott be liable for any proximate special incidental or consequential damages based upon breach of warranties breach
109. the maximum number of digits for an operator ID then press Enter The All Tests Upload Interval screen will be displayed The display shows the All Tests Operator ID menu The display shows the Operator ID options If Disabled is selected the display will not prompt for Operator ID If Optional or Required is selected the administrator can enter a minimum and maximum number of digits between 1 15 digits The display shows the Operator ID Barcode options What You See What You Do Comments Q on the Display Operator DD Barcode Tots i Ho Check Digit 2455 Check Digit SOPLE Check Digit Operator ID Operator IU Barcode Code 35 1 Ho Check Digit fee Check Digit Operator IU Barcode Code 39 i Alphanumeric z Full ASCII 11 The administrator may customize I2 of 5 by pressing 1 if I2 of 5 is bolded enabled Press 1 again to access the Operator ID Barcode screen 12 The administrator will select one of the following 1 No Check Digit 2 USS Check Digit 3 OPCC Check Digit 13 The administrator may customize Code 39 by pressing 2 if Code 39 is bolded enabled Press 2 again to access the Operator ID Barcode screen 14 The administrator will select one of the following 1 No Check Digit 2 Use Check Digit 15 The administrator will select one of the following 1 Alphanumeric 2 Full ASCII uestions Refer to Page 10 13 For Customer Care Information
110. the monitor Data Review by Patient History for Action Range Please refer to page 5 2 of the Data Review section for the step by step instructions to access the Data Review menu Note If no information is stored for the desired category that was selected the following message will be displayed on the monitor No Stored Tests Note If no tests match the criteria specified this message will be displayed on the monitor No Tests Match Request If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See on the Display What You Do Comments Data Rewiew 1 Press 1 Patient The Patient History menu 1 Patient History History now appears 2 Control History S Proficiency Data 4 Linearity Data Patient History 2 Press 4 Action Range The monitor displays the Lir cdg most recent test result that 3 Operator ID is outside the action 4 fiction Range range Comment Code 6Date Questions Refer to Page 10 13 For Customer Care Information What You See What You Do Comments on the Display Pl 324 153044 3223 acai 216 wl 23456790125 1 Previous Tout A 20 1 mmol L FH mafdL ven Rit 3 The operator can select one of the following options Press 1 Previous view the previous test result Press 2 Next view the next test result 4 When finished reviewing the data the operator can Press Clear to retu
111. tions Refer to Page 10 13 For Customer Care Information e What You See What You Do Comments on the Display Low 20 6 0 Bi29 9B 12 58 PH 2m v 125196 re30123 1 Previous Zeit 2 3 mmol L 3 The operator can select one of the following options Press 1 Previous view the previous test result Press 2 Next view the next test result 4 When finished reviewing the data the operator can Press Clear to return to the Control History menu Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor The number that appears to the right of 1 Previous and 2 Next on the monitor indicates the number of tests available for review The display also shows the acceptable range for this test and o Operator ID 0 Comment Code Data Review for Control History by Operator ID Please refer to page 5 2 of the Data Review section for the step by step instructions to access the Data Review menu Note If no tests are stored for the desired category that was selected the following message will be displayed on the monitor No Stored Tests Note If no tests match the criteria specified this message will be displayed on the monitor No Tests Match Request If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See on the Display What You Do Comments Data Review 1 Press 2 Control The Contro
112. tly or the user may choose to replace the earlier data Questions Refer to Page 10 13 For Customer Care Information How To Respond Ensure that the room temperature is within the specified limits Allow the monitor time to stabilize to room temperature Please refer to the test strip instructions for use for appropriate operating temperature range Press 1 to exit Press 1 to ReEnter the lot or Press 2 to run the level of test that matches the lot number already entered Press 1 to enter a different linearity kit lot number typically the number of the previous kit or Press 2 to proceed using the new kit lot number The existing linearity data will be replaced by data from the new lot Symptom Error Message Explanation When a Data Review is Selected Control History Ho Stored Tests 1 Exit The requested type of results is shown at the top of the screen Patient History Ho Tests Match quest 1 Enit The requested type of results is shown at the top of the screen There are no stored test results for the type of data requested There are no stored test results that match the selected criteria During Data Transfer Please Wait for Data U d Last Upload Inc lete Redock Meter e An error has occurred during data transfer This screen will only appear for three seconds An error has occurred during last data transfer This screen will appear when you turn on
113. to step 7 either re enter the existing linearity kit lot number or replace the existing linearity kit lot number with the new linearity kit lot number Heu Panel 6 The operator can If 1 is pressed the Re aacra perform one of the monitor will return to the Panel following actions previous screen so the Letter Blot Press 1 ReEnter HE can Ms or enter TEE ari Kit Lot e linearity kit lot 6543210 number Press 2 Replace Panel The monitor will prompt the operator to select a level Select Level 7 Enter the number of There can be up to 4 Fin E the level of the next test replicates per level The ZLovel X n to be run number in the parenthesis Level 4 0 indicates the number of SLevel 5 0 replicates already run for that level When a level is full the menu item 1 Level 1 will no longer appear Select Level 8 If the operator presses i Lewel 1 C2 6 for a new panel the pee m monitor will again d4 Level 4 0 prompt the operator to Pee on select a level Ghee The monitor will prompt the operator to scan or manually enter the test strip lot number What You See on the Display What You Do Comments Sean a 9 Scan or manually The monitor will prompt enter the test strip lot for a new test strip to be number via the keypad inserted into the test strip then press Enter port 10 Open the foil test strip packet at the notch and tear up or down to open the packet then remove the test s
114. tor may have a problem that prevents it from operating properly The monitor may have a problem that prevents it from operating properly How To Respond Do one of the following Install new batteries See Maintenance for further information Place the monitor into the docking station to recharge the battery pack if the system has this option 1 Turn off the monitor Turn it on and repeat the function 2 If the problem persists record the three digit error code and contact Customer Care Contact Customer Care Contact Customer Care 1 Turn off the monitor Turn it on and repeat the function 2 If the problem persists record the three digit error code and contact Customer Care When a Test is Selected Symptom Error Message Low High Control Tests Required 1 Enit Test Memory Upload Required 1 Enit 2 Continue Temperature Outside Range 4g 56 Testing Disabled 1 Exit 119 3 Explanation The QC Interval Controls Expired option is set to Warn or Lockout and one or more control tests is past due The menu item 2 Continue appears only if this option is set to Warn If the option is set to Lockout each control test shown on the screen must be performed before the patient tests start The Upload Interval option is set to Warn or Lockout and the specified interval has been exceeded The menu item 2 Continue appears only if this option is set to War
115. trip M ZR 11 With the contact bars The monitor will prompt Insert 4 facing up insert the the operator to apply the Strip test strip into the test sample to the test strip strip port until it stops Precision PCx Test Strip Precision PCx Plus Test Strip For Use with Precision PCx with TrueMeasure Technology v2 0 v2 1 and v2 2 For Use with Precision PCx v2 2 Only Manual entry of strip lots with alpha numeric barcodes is not supported Questions Refer to Page 10 13 For Customer Care Information o What You See What You Do Comments on the Display Rpplu Level 2 Sample Sample hooep ted 4 Analyzing Sample Result in seconds Level Z Test 1 Siz 9B D235 PH i 2640 1 Heu Level Zame Level 14 6 mmol L Level Z lest 1 254 Soan or Enter Comment Code 14 6 mmol L 14 6 mmol L 12 Gently invert the sample 3 4 times then apply a drop of the sample to the target area on the test strip 13 Wait for the monitor to analyze the sample and display the test result 14 Note the result If the operator is prompted to enter a comment code continue to step 15 otherwise skip to step 16 15 Press Scan or manually enter the comment code via the keypad then press Enter 16 The operator can do one of the following options Press 1 Next Level Press 2 Same Level Press the Menu button to return to the Menu Mode Press On Off t
116. ttings to Factory Defaults menu The display shows the Confirm options The display is returned to the System Setup Change all settings to Factory Defaults menu Review Change Setup for System Status The Review Change Setup menu allows the operator or administrator to review important information about the monitor operating status The operator scrolls through the various screens in the order they are listed below by pressing 1 Next Battery Power This option checks the amount of battery power available for a rechargeable or disposable battery Temperature This option measures the current temperature of the area where the monitor is Memory This option indicates the percentages of memory available for Patient Test results and Control Test results Software Version This option displays the software version in the monitor Review Change Setup for System Status Refer to the beginning of the Review or Change Setup section for step by step instructions to access the appropriate setup menu If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See on the Display What You Do Comments Change Setup 1 Press 3 to review The display shows the 1 Test Setup System Status Battery Power menu The 2 System Setup black bar in the battery System Status image drops as the battery 4 Date and Time power drains When the 5 Edit Lists power drains below a
117. u place a drop you place a drop of blood at the of blood on top of the test strip end of the strip You can apply blood to the edge of the strip or on the top of the strip within this white area Contact bars At the opposite end of both test strips are three black contact bars to be inserted into the test strip port of the monitor Accessory Carry Case optional The light yet rugged accessory carry case holds the hand held monitor test strips glucose control solutions and other supplies in a convenient manner A transparent cover allows the operator to check the supply status without opening the case The overall form is compact allowing the convenient storage of many cases in a small area The case holds the Precision PCx Monitor and the following items Precision PCx or Precision PCx Plus Test Strips Single use Lancing Devices Gauze Pads Glucose Control Solutions Quick Reference Guide Docking Station optional The optional docking station will automatically upload the data from the monitor into a central computer via the MediSense QC Manager Data Management System To start the upload of data simply place the Precision PCx Monitor into the Precision PCx Docking Station Questions Refer to Page 10 13 For Customer Care Information The monitor will automatically upload data to the MediSense QC Manager Program Please refer to the QC Manager Operator s Manual for more information The
118. ucose Units SampleType Action Range 2 System Setup Language Beeper On Off Date Format Time Format Password Factory Settings Battery Power Temperature Memory Gauge Software Version 3 System Status 4 Date and Time Add Delete Change 5 Edit Lists 1 Operator List 2 Strip Lot List Add Delete Change Moving Around the Review Change Setup Menu The Review and Change Setup menu options offer the same additional sub menus as shown in the Precision PCx Menu Tree The operators may have to select additional options to access the desired change or review option To access these sub menus or options in both the Review and Change Setup menus the message 1 Next appears at the bottom of the display The operator presses 1 to move to the next option The monitor also allows the operator to go back to the previous option by pressing Clear The current status or selection for the option appears in bold type on the display To change an option the administrator must access the Change Setup menu this is password protected In addition to the 1 Next message that appears at the bottom of the option screen there is the 2 Change message The administrator presses 2 to change the option The active selection for the option now appears in bold type When finished reviewing or changing the options the operator or administrator can press Menu once to return to the beginning of Menu Mode or press Menu twice to go to Te
119. ures Change Setup If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting Use these steps to access the Change Setup menu What You See What You Do Comments on the Display 1 Press On Off to turn on The Abbott logo screen the monitor will appear for a few seconds followed by the product name the ABBOTT software version screen and then the Test Mode menu 9 1 28 2 24 PH 2 Press Menu The Menu Mode menu will appear 1 Patient Test Z Lontroel Test 3 1 98 451 PA 3 Press 5 for Change The display prompts the 1 Data Review Setup operator to enter a 2 Proficiency lest password of up to 8 J Linearity Test characters The password eres ities is displayed as asterisks nge Setup on the monitor Enter 4 Key in the password The factory set password Password then press Enter If the is 123 Once in the password is entered Change Setup Mode it incorrectly the monitor is suggested that the displays error message administrator change Incorrect Password the password This can Press Clear twice be done in the System verify the password Setup Set Password then re enter the correct option password and press Enter Questions Refer to Page 10 13 For Customer Care Information Q What You See on the Display Change Setup 1 Tlest Setup Z System Setup System States 4 Date and Time 5eEdit Lists What You Do The administrator can chan
120. uring Any Test Symptom Error Message Sean or Enter Patient I 18306522444244 Invalid ID Barcode Sean or Enter Operator ID Invalid ID Too Short The reason may also be Too Long Strip Lot 192165 Is Hot on the Strip Lot List EeEnter Lot z Lontinue Explanation The barcode just scanned was not read correctly Possible reasons are The red scanner beam did not pass across all the bars of the code The scanner was not held between 3 and 12 inches from the barcode The barcode was damaged or poorly printed The barcode was not of the type specified for this ID or lot number The ID or lot number just scanned or entered is too long or too short according to format defined during the setup of this monitor The ID or lot number just scanned or entered is not on the list of acceptable IDs or lot numbers defined for this monitor How To Respond 1 Rescan the barcode or manually enter the ID or lot number 2 Notify the system administrator The problem may be the printing of the barcode or the setup 1 Verify and re enter the ID or lot number using the barcode scanner 2 Manually enter the ID or lot number 3 If the problem persists notify the system administrator j Verify and re enter the ID or lot number using the barcode scanner 2 Manually enter the ID or lot number 3 If the problem persists notify the system administrator Manu
121. using a new test strip Results that are incorrect may have serious medical consequences Consult your healthcare professional before making any changes to diabetes medication plans if The blood glucose results are not consistent with the physical symptoms AND you have ruled out common errors in technique The blood glucose result is less than 50 mg dL 2 8 mmol L or greater than 300 mg dL 16 7 mmol L Control Test This section describes the steps to be taken to test Control Solutions in order to verify the performance of the Precision PCx Monitor and Precision PCx and Precision PCx Plus Test Strips The quality control features of the monitor can be customized to fit the requirements of each facility The monitor can be set to require Tests of Low Normal and High Control Solutions or any variation of this depending on the facility s policy Tests of Control Solutions at regular times or time intervals or by number of patient tests Control test results will appear as Numeric or Pass Fail These quality control features can be set through the Menu Mode menu Change Setup Test Setup Menu Operating Guidelines for Control Solution Testing Observe the following guidelines to obtain optimal quality control results using the Precision PCx System Useonly control solutions approved for use on the test strip instructions for use to verify the performance of the Precision PCx and Precision PCx Plus Test Strips and t
122. ver Voltages 1 5V Rated Pollution Degree 2 Other Information There are special symbols that appear on the Precision PCx Monitor Precision PCx and Precision PCx Plus Test Strips and Docking Station The complete list of symbols and an explanation are listed below Please note Some of the symbols listed below will not appear on your Precision PCx Monitor and Docking Station due to differences in local regulatory requirements Symbols e Refers to Type B Equipment Per EN60601 1 X M The double arrow symbol indicates the connector to be used gt for data transfer The double arrow symbol also appears on the front panel of the docking station beneath the LED display If the LED is steady this indicates that the monitor is properly placed in the docking station If the LED is flashing this indicates that data transfer is in process refer to Data Upload Section 9 The CSA mark means that an evaluation of samples of SP Equipment has been performed by CSA to determine compliance with specific requirements CSA CS22 2 No 601 1 op Classification marking for U S This symbol indicates the hazards with respect to which the product has been classified by identifying the Particular Collateral Standards used in evaluation UL2601 1 A Laser Radiation Do Not Stare Into Beam Class 2 Laser product Wavelength 670 nm Max Output lt 1 0 mW This product meets the requirements of European Standard EN 60825 1 1994 This s
123. ws the Alphanumeric Full ASCII screen What You See What You Do Comments on the Display Patient ID Barcode Code 39 1 f lphanumeric ll ASCII z Fu Fatient ID Barcode Truncate Digits a mi First Last Patient Test Patient ID is i ts din lent zXhange Patient Test 10 Select one of the following 1 Alphanumeric 2 Full ASCII 11 To access the Truncate Digits screen press 6 and continue forward to step 12 12 Press Enter twice for no truncation of leading or trailing digits otherwise enter the number of leading and trailing barcode digits to truncate ignore 13 Press 1 Next continue to the next menu 14 The administrator will select one of the following options Press 1 Next and continue to step 17 Press 2 Change to change the In Range Comment Code The display returns to the Patient ID Barcode screen C will appear after the format if Check Digit is selected F will appear if Full ASCII is selected The display shows the Patient ID Barcode Truncate Digits screen The monitor can be set to ignore a specific number of leading and or trailing barcode digits The display returns to the Patient Test Patient ID Barcode screen The display shows the In Range Comment Code screen The display shows the In Range Comment Code options The Comment Code options can be set to Disabled Optional or Required for test results
124. y Test SLinearity Test 4 Revieur Setup S Change Setup Data Review At this point Patient 1 Patient History History Control History Control History Proficiency Data as well S Froficiencu Data as Linearity Data can be 4 Line arity Data viewed Data Review for Patient History by All Tests Please refer to page 5 2 of the Data Review section for the step by step instructions to access the Data Review menu Note If no information is stored for the desired category that was selected the following message will be displayed on the monitor No Stored Tests Note If no tests match the criteria specified this message will be displayed on the monitor No Tests Match Request If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting What You See on the Display What You Do Comments Data Rewiew 1 Press 1 Patient The Patient History menu 1 Patient History History now appears Control History S Proficiency Data 4 Linearity Data Patient History 2 Press 1 All Tests The monitor shows the oo most recent patient test 3 Operator ID result 4 H ction Range 2 Comment Code amp Date Questions Refer to Page 10 13 For Customer Care Information What You See What You Do Comments on the Display lZ3 3 The operator can select The number that appears makil one of the following to the right of 1 Previous 5 wen options and 2 Next on the monitor c123
125. y in the minimum number of digits for a Patient ID number then press Enter Key in the maximum number of digits for a Patient ID number then press Enter Fatient ID 6 The administrator may LI2o ee customize I2 of 5 by 2 Lode 39c pressing 1 if I2 of 5 is X Cade 178 bolded enabled Press 4 Codabar 1 again to access the Code 9 3 gt Patient ID Barcode screen Patient ID 7 The administrator will Bar code select one of the I2of5 following 1 Ho Check Digit d 2 USS Check Digit 1 No Check Ines 3 PCC Check Digit 2 USS Check Digit 3 OPCC Check Digit Patient ID mi B ie 8 The administrator may 1 I2efSuss customize Code 39 by Code Xc pressing 2 if Code 39 is Sode 128 bolded enabled Press 4 Codabar Code 93 2 again to access the am ai Patient ID Barcode screen Patient 1D 9 The administrator will ar Code 39 select one of the following 1 Ho Check Digit 1 No Check Digit 2 Use Check Digit eee De 2 Use Check Digit uestions Refer to Page 10 13 For Customer Care Information Comments The display returns to the Patient Test Patient ID Barcode Menu Activated barcodes appear in bold type More than one Barcode format can be active at one time Any Barcode can be deactivated by selecting the corresponding number Note Only Barcodes 1 and 2 can be customized The display returns to the Patient ID Barcode screen USS or OPCC will appear after the format if selected The display sho
126. ymbol indicates that this product affords electrical protection as Class II equipment as described in IEC 601 1 Part 1 This Way Up Represents the limitations of temperature for storage Lot Number Expiration Date EJ gs CE CE mark applies to the Medical Device Directive 0088 93 42 EEC The product meets the requirements of 93 42 EEC VAN Attention Refer to manual Q Discard after single use Use only once Re order Number wl Date of Manufacture GR Do not drink Legal Manufacturer under n Vitro Diagnostic Medical Devices Directive 98 79 EC MediSense UK Limited Questions Refer to Page 10 13 For Customer Care Information e jeg STERILE p Power Supply Refer to manual Recyclable For in vitro diagnostic use only Method of sterility for Lancets only Sterilized using irradiation Lancets only WARNING Potential Biohazard Consider all clinical specimens reagents controls etc that contain human blood or serum as potentially infectious Always wear gloves and follow your facility s biohazard safety policies and procedures 1 The Precision PCx Monitor requires two 2 AA alkaline batteries or a rechargeable battery pack N The docking station optional requires an AC adapter to be connected from the docking station to a power supply The docking station also acts as a recharge station for the MediSense rechargeable battery pack 3 The compl

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