MediSense PCx manual

Point-of-Care System MediSense, Precision PCx, Precision and QC Manager are trademarks of Abbott Laboratories. © 2002 Abbott Laboratories. 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 th[...]

Questions? Refer to Page 10-13 For Customer Care Information. I Introduction 1. Manual Organization ................................................................... 1-1 Precision PCx Menu T ree .......................................................... 1-2 2. Over view: Understanding the Precision PCx Point-of-Car e System ......................[...]

Questions? Refer to Page 10-13 For Customer Care Information. II 9. Data Upload................................................................................... 9-1 Docking Station (optional) ........................................................ 9-2 10. T roubleshooting ..........................................................................[...]

Questions? Refer to Page 10-13 For Customer Care Information. III Introduction W elcome to the MediSense Precision PCx ™ 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 [...]

IV Accurate Calibration The barcode on each test strip packet label ensures accurate calibration before each test begins. Built-In Security Options 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 [...]

Questions? Refer to Page 10-13 For Customer Care Information. 1-1 The Precision PCx Point-of-Care System Operator's Manual provides basic information about the Precision PCx Monitor and contains easy- to-follo w , step-by-step procedures for using it. The Precision PCx System operates using menu-dri ven softw are. The software consists of two [...]

1-2 T est Mode Patient T est Control Test Menu Mode 1. Data Review 2. Proficiency Test 3. Linearity Test 4. Review / 5.Change Setup Upload Inter val Operator ID Format Patient ID Format Comment Code Memory Full Results For mat Comment Code Memory Full QC Interval Operator ID Strip Lot Glucose Units Sample T ype Action Range 1. Patient History sort [...]

Questions? Refer to Page 10-13 For Customer Care Information. 2-1 Understanding the Precision PCx Point-of-Car e 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 o verview of the Precision PCx System's components a[...]

Precision PCx T est Strips There are no w two types of Precision PCx test strips that may be used for testing with this system. The tar get area of the original Precision PCx biosensor test strip is on the top of the strip. The tar get area of the ne w Precision PCx Plus T est Strip with T rueMeasure™ T echnology is at the end of the strip. Only [...]

Questions? Refer to Page 10-13 For Customer Care Information. 2-3 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 con venient manner . A transparent cov er allows the operator to check the supply status without opening the case. [...]

2-4 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 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 adv antage[...]

Questions? Refer to Page 10-13 For Customer Care Information. 2-5 Numbers The 10-digit ke ypad 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 follo wing functions: • T o back up one space while entering numbers on the ke ypad. • Clear a numerical[...]

2-6 Place the object to be scanned on a flat surface, by itself. This will pre vent other items from being accidentally scanned. Press and hold do wn the Scan button to start the barcode scanner . A visible red beam will be emitted from the monitor . Slowly mo ve this beam ov er the barcode on the item to be scanned. When the monitor accepts the ba[...]

Questions? Refer to Page 10-13 For Customer Care Information. 2-7 Audible Indicator (not visible) The monitor will beep to indicate one of the follo wing: • A successful barcode entry . • Sample detection. • At three seconds before the result is to appear . • When an error occurs. • At thirty seconds before automatic shutof f. Data Port[...]

This section describes the steps to be taken to test patient blood samples using the Precision PCx Monitor . Operating Guidelines for All Samples Please follo w the recommended guidelines so the most accurate results will be obtained. • Al ways wear glov es and follo w your facility’ s biohazard safety policies and procedures when performing te[...]

3-2 Collecting Blood Samples How to Obtain a Capillary Blood Sample: • Use only fresh whole blood samples. • Mak e sure no water remains on the puncture site. • Collect the capillary blood using a lancing de vice and an appropriate technique. • A void squeezing the puncture site excessi vely . • Apply the drop of blood directly to the tar[...]

• Apply a drop of blood directly to the tar get area on the test strip, cov ering 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 MODE for all other samples. How to Obtain an Arterial Blood Sample: • Use only fresh whole blood samples. •[...]

What Y ou See on the Display What Y ou Do Comments 3-4 3. Press Scan to scan the Operator ID barcode, or manually enter the Operator ID via the keypad, then press Enter . The display will prompt for a Patient ID to be entered, if this setting has been enabled. Note: If a Patient ID prompt is not seen, skip down to step 5. 1. Press On/Off to turn on[...]

What Y ou See on the Display What Y ou Do Comments Questions? Refer to Page 10-13 For Customer Support Information. 3-5 4. Press Scan to scan the Patient ID barcode, or manually enter the Patient ID via the keypad, then press Enter . After entering the Patient ID, the test strip lot screen appears next. 5. Press Scan to scan the test strip barcode,[...]

What Y ou See on the Display What Y ou Do Comments 3-6 8. W ith the contact bars facing up, insert the test strip into the test strip port until it stops. The Apply Sample screen will appear . 9. Apply a drop of blood directly from the patient’ s finger or from a syringe to the target area on the test strip. The monitor beeps when the sample is a[...]

What Y ou See on the Display What Y ou Do Comments Questions? Refer to Page 10-13 For Customer Support Information. 3-7 For Out-of-Range results, refer to your institution’ s protocol. NO TE: The Outside Action Range screen will appear if the Patient T est Out-of-Range Comment Code is enabled and the following tw o conditions are met: A. The Acti[...]

What Y ou See on the Display What Y ou Do Comments 3-8 13. The operator can select one of the following options: Press 1 – Next Patient. Press 2 – Repeat T est. 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 Ent[...]

Questions? Refer to Page 10-13 For Customer Care Information. 4-1 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 T est Strips. The quality control features of the monitor can be customized to fit the requirements of each [...]

4-2 What Y ou See on the Display What Y ou Do Comments Control T est Procedur e Use the follo wing procedure to perform control 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, T roubleshooting. 1. Press On/Off to turn o[...]

Questions? Refer to Page 10-13 For Customer Care Information. 4-3 7. W ith the contact bars facing up, insert the test strip into the test strip port until it stops. The monitor will prompt the operator to apply the desired control solution to the test strip. What Y ou See on the Display What Y ou Do Comments 5. Scan or manually enter* the test str[...]

4-4 What Y ou See on the Display What Y ou Do Comments 9. W ait for the monitor to analyze the control solution and display the test result. The monitor counts down 20 seconds then displays the test result. The test starts automatically as the sample is accepted. (2.7 mmol/L) 10. Note the test result and whether it falls within the acceptable range[...]

Questions? Refer to Page 10-13 For Customer Care Information. 4-5 14. The operator may select one of the following: Press 1 – Next Lev el. Press 2 – Repeat T est Press Menu to return to the Menu Mode menu. Press On/Off to turn off the monitor . If 1 is selected, the next lev el test will appear . The operator may perform the next le vel control[...]

Patient History The Precision PCx Monitor stores up to 4,000 patient tests that can be retrie ved by the follo wing categories: All T ests: This option displays all patient test results, starting with the most recent test results (re verse chronological order). Patient ID: This will display the test results for a particular patient, starting with t[...]

5-2 What Y ou See on the Display What Y ou Do Comments Data Review: Follo w these steps to access the Data Revie w menu: If the monitor displays a message not indicated in these procedures, please refer to section 10, T r oubleshooting . 1. Press the On/Off button to turn the monitor on. The Abbott logo screen will appear for a few seconds, followe[...]

Questions? Refer to Page 10-13 For Customer Care Information. 5-3 Data Review for Patient History by All T ests: Please refer to page 5-2 of the Data Re vie w section for the step-by-step instructions to access the Data Re vie w menu. Note: If no information is stored for the desired category that was selected, the following message will be display[...]

5-4 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. The number that appears to the right of 1-Previous and 2-Next on the monitor indicates the number of tests av ailable for revie w . The display also shows: p: Patient ID o: Operator ID 12 : C[...]

Questions? Refer to Page 10-13 For Customer Care Information. 5-5 What Y ou See on the Display What Y ou Do Comments Data Review for Patient History by Patient ID: Please refer to page 5-2 of the Data Re vie w section for the step-by-step instructions to access the Data Re vie w menu. Note: If no information is stored for the desired category that [...]

5-6 What Y ou See on the Display What Y ou Do Comments 5. When finished revie wing 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 . 4. The operator can select one of the following options: Press 1 – Pre vious, view the previous test resul[...]

Questions? Refer to Page 10-13 For Customer Care Information. 5-7 What Y ou See on the Display What Y ou Do Comments Data Review for Patient History by Operator ID: Please refer to page 5-2 of the Data Re vie w section for the step-by-step instructions to access the Data Re vie w menu. Note: If no information is stored for the desired category that[...]

5-8 What Y ou See on the Display What Y ou Do Comments 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. The number that appears to the right of 1-Previous and 2-Next on the monitor indicates the number of tests av ailable for revie w . The disp[...]

Questions? Refer to Page 10-13 For Customer Care Information. 5-9 What Y ou See on the Display What Y ou Do Comments Data Review by Patient History for Action Range: Please refer to page 5-2 of the Data Re vie w section for the step-by-step instructions to access the Data Re vie w menu. Note: If no information is stored for the desired category tha[...]

5-10 What Y ou See on the Display What Y ou Do Comments 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. The number that appears to the right of 1-Previous and 2-Next on the monitor indicates the number of tests av ailable for revie w . The dis[...]

Questions? Refer to Page 10-13 For Customer Care Information. 5-11 What Y ou See on the Display What Y ou Do Comments Data Review for Patient History by Comment Code: Please refer to page 5-2 of the Data Re vie w section for the step-by-step instructions to access the Data Re vie w menu. Note: If no information is stored for the desired category th[...]

5-12 What Y ou See on the Display What Y ou Do Comments 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. The number that appears to the right of 1-Previous and 2-Next on the monitor indicates the number of tests av ailable for revie w . The dis[...]

Questions? Refer to Page 10-13 For Customer Care Information. 5-13 What Y ou See on the Display What Y ou Do Comments Data Review for Patient History by Selected Date: Please refer to page 5-2 of the Data Re vie w section for the step-by-step instructions to access the Data Re vie w menu. Note: If no information is stored for the desired category t[...]

5-14 What Y ou See on the Display What Y ou Do Comments 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. The number that appears to the right of 1-Previous and 2-Next on the monitor indicates the number of tests av ailable for revie w . The mon[...]

Control History The Precision PCx monitor can store up to 1,000 control tests that can be retrie ved by the follo wing categories: All T ests: This shows all control test results in memory starting with the most recent test result in memory (re verse chronological order). Operator ID: This shows the control test results that were performed by a par[...]

5-16 What Y ou See on the Display What Y ou Do Comments 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. The number that appears to the right of 1-Previous and 2-Next on the monitor indicates the number of tests av ailable for revie w . The dis[...]

Data Review for Control History by Operator ID: Please refer to page 5-2 of the Data Re vie w section for the step-by-step instructions to access the Data Re vie w 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 T ests”. Note: If no tests match the[...]

5-18 What Y ou See on the Display What Y ou Do Comments 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. The number that appears to the right of 1-Previous and 2-Next on the monitor indicates the number of tests av ailable for revie w . The dis[...]

Questions? Refer to Page 10-13 For Customer Care Information. 5-19 Data Review for Control History by Outside Range Results: Please refer to page 5-2 of the Data Re vie w section for the step-by-step instructions to access the Data Re vie w menu. Note: If no tests are stored for the desired category that was selected, the following message will be [...]

5-20 What Y ou See on the Display What Y ou Do Comments 4. When finished revie wing 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 . 3. The operator can select one of the following options: Press 1 – Previous, view the previous test re[...]

Questions? Refer to Page 10-13 For Customer Care Information. 5-21 Data Review for Control History by Comment Code: Please refer to page 5-2 of the Data Re vie w section for the step-by-step instructions to access the Data Re vie w menu. Note: If no tests are stored for the desired category that was selected, the following message will be displayed[...]

5-22 What Y ou See on the Display What Y ou Do Comments 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. The number that appears to the right of 1-Previous and 2-Next on the monitor indicates the number of tests av ailable for revie w . The dis[...]

Questions? Refer to Page 10-13 For Customer Care Information. 5-23 Data Review for Control History for Selected Date: Please refer to page 5-2 of the Data Re vie w section for the step-by-step instructions to access the Data Re vie w menu. Note: If no tests are stored for the desired category that was selected, the following message will be display[...]

5-24 What Y ou See on the Display What Y ou Do Comments 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. The number that appears to the right of 1-Previous and 2-Next on the monitor indicates the number of tests av ailable for revie w . The dis[...]

Questions? Refer to Page 10-13 For Customer Care Information. 5-25 What Y ou See on the Display What Y ou Do Comments Data Review for Proficiency Data The monitor stores the last 60 proficienc y test results. Please refer to the beginning of the Data Re view for the step-by-step instructions to access the Data Re vie w menu. Note: If no tests are s[...]

5-26 What Y ou See on the Display What Y ou Do Comments Data Review for Linearity Data The monitor stores the last linearity panel that includes a maximum of 4 replicates for 5 le vels (20 tests).* Please refer to the beginning of the Data Re view section for the step- by-step instructions to access the Data Re vie w menu. Note: If no tests are sto[...]

The Proficienc y T est menu enables the operator to perform unkno wn sample test challenges if required by facility polic y . Use the follo wing procedures to perform a proficienc y test. If the monitor displays a message not indicated in these procedures, please refer to section 10, T r oubleshooting . 6-1 Questions? Refer to Page 10-13 For Custom[...]

What Y ou See on the Display What Y ou Do Comments 6-2 6. Scan or manually enter* the test strip lot number via the keypad, then press Enter . The monitor will prompt the operator to insert the test strip. 7. Open the foil test strip packet at the notch and tear up or down to remov e the test strip. 8. With the contact bars facing up, insert the te[...]

Questions? Refer to Page 10-13 For Customer Care Information. What Y ou See on the Display What Y ou Do Comments The test starts automatically , as the sample is accepted. 10. W ait for the monitor to analyze the sample and display the test result. The monitor counts down 20 seconds then displays the test result. 11. If the operator is prompted to [...]

The Linearity T est menu enables the operator to verify method linearity using a Linearity Assessment Kit.* Please use the follo wing procedures to perform a Linearity T est. If the monitor displays a message not indicated in these procedures, please refer to section 10, T r oubleshooting. Questions? Refer to Page 10-13 For Customer Care Informatio[...]

What Y ou See on the Display What Y ou Do Comments 7-2 5. Scan or manually enter the linearity kit lot number via the keypad, then press Enter . If the monitor prompts for a lev el to be entered, skip to step 7. If the linearity kit lot number that was entered is different from the pre vious one, the monitor will prompt the operator to do one of tw[...]

Questions? Refer to Page 10-13 For Customer Care Information. What Y ou See on the Display What Y ou Do Comments 9. Scan or manually enter* the test strip lot number via the keypad, then press Enter . The monitor will prompt for a new test strip to be inserted into the test strip port. 10. Open the foil test strip packet at the notch and tear up or[...]

What Y ou See on the Display What Y ou Do Comments 7-4 15. Press Scan or manually enter the comment code via the keypad then press Enter . 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. 16. The operator can do one of the following options: Pr[...]

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 re vie w or change setup options are similar, the two sub-menus are combined in one section. Any operator can re vie w the setup information; only an administrator[...]

8-2 Precision PCx Menu T ree T est Mode Patient T est Control Test Menu Mode 1. Data Review 2. Proficiency Test 3. Linearity Test 4. Review / 5.Change Setup Upload Inter val Operator ID Format Patient ID Format Comment Code Memory Full Results For mat Comment Code Memory Full QC Interval Operator ID Strip Lot Glucose Units Sample T ype Action Range[...]

Moving Around the Review/Change Setup Menu The Re vie w and Change Setup menu options offer the same additional sub-menus (as sho wn in the Precision PCx Menu T ree). The operators may hav e to select additional options to access the desired change or re vie w option. T o access these sub-menus or options in both the Revie w and Change Setup menus,[...]

What Y ou See on the Display What Y ou Do Comments 8-4 Review Setup: If the monitor displays a message not indicated in these procedures, please refer to section 10, T r oubleshooting. Use the follo wing steps to access the Re view Setup menu: 1. Press On/Off to turn on the monitor . The Abbott logo screen will appear for a few seconds followed by [...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-5 What Y ou See on the Display What Y ou Do Comments Change Setup: If the monitor displays a message not indicated in these procedures, please refer to section 10, T r oubleshooting. Use these steps to access the Change Setup menu: 1. Press On/Off to turn on the monitor . The Abbott lo[...]

What Y ou See on the Display What Y ou Do Comments 8-6 The administrator can change T est Setup, System Setup, System Status, Date and T ime and Edit Lists by following the appropriate steps for these procedures.[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-7 Review/Change Setup for T est Setup The Re vie w/Change Setup menus enable the operator to revie w/change the test settings. Under the T est Setup Menu, the following options can be vie wed or changed: • All T ests • P atient T est • Control T est • Security • T est T ype I[...]

8-8 Review/Change T est Setup for All T ests: The options that are associated with the Re vie w/Change T est Setup for All T ests apply to all test types. Use this menu to re vie w 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 [...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-9 What Y ou See on the Display What Y ou Do Comments 1. Press 1 for T est Setup. The display shows the T est Setup menu. 2. Press 1 for All T ests. The display shows the Upload Interval menu. 3. The administrator will select one of the following options: Press 1 – Next; skip forward [...]

What Y ou See on the Display What Y ou Do Comments 8-10 6. Enter 1-99 hours or 1-99 days then press Enter . The All T ests Upload Interval screen will be displayed. 7. Press 1 to continue to the All T ests Operator ID screen. The display shows the All T ests Operator ID menu. 8. The administrator will select one of the following options: Press 1 ?[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-11 What Y ou See on the Display What Y ou Do Comments 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. Activ ated barcodes appear in bold type . More than one Barcode format can be activ e [...]

8-12 17. Press Enter twice for no truncation of leading or trailing digits; otherwise enter the number of leading and trailing barcode digits to truncate (ignore). The monitor can be set to ignore a specific number of leading and/or trailing barcode digits. The display returns to the All T ests, Operator ID screen. 18. The administrator will select[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-13 Review/Change T est Setup for Patient T est: The options set with this menu will apply to all Patient T ests. The Patient ID option uses a patient identif ication number to perform tests. Patient ID uses the follo wing options: • Disable, Require or make Optional the entry of a Pa[...]

8-14 Review/Change T est Setup for Patient T est: Refer to the beginning of the Re view 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, T r oubleshooting. What Y ou See on the Display What Y ou Do Comments 1. [...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-15 What Y ou See on the Display What Y ou Do Comments 5. The administrator will enter minimum and maximum numbers between 1-15. Ke y in the minimum number of digits for a Patient ID number then press Enter . Ke y in the maximum number of digits for a Patient ID number then press Enter [...]

8-16 What Y ou See on the Display What Y ou Do Comments 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). The monitor can be set to ignore a specific number of leading and/or trailing barcode digits. The display returns to the Patient T est,[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-17 15. The administrator will select one of the following options: Press 1 – Disabled. Press 2 – Optional. Press 3 – Required. The display is returned to the Patient T est Comment Code If In-Range screen. 16. Press 1 – Next; continue to the next menu. The display shows the Out-[...]

8-18 What Y ou See on the Display What Y ou Do Comments 19. Press 1 – Next; continue to the next menu. The display shows the Memory Full screen. 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. The display shows the Memory Full options. Once the [...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-19 Review/Change T est Setup for Control T ests The options associated with this menu apply to all Control T ests. Control le vels can be an y combination of low , normal, and high. At least one le vel must be selected. The Results Format has the follo wing options: Sho w test results [...]

8-20 Review/Change T est Setup for Control T ests: Refer to the beginning of the Re view 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, T r oubleshooting. What Y ou See on the Display What Y ou Do Comments 1[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-21 What Y ou See on the Display What Y ou Do Comments 5. Press 1 – Next, to continue to the Control T est Result menu. The display shows the Control T est Result option. The control test results can be set to appear as numeric or Pass/F ail. 6. The administrator will select one of th[...]

8-22 What Y ou See on the Display What Y ou Do Comments 10. The administrator will select one of the following options: Press 1 – Disabled. Press 2 – Optional. Press 3 – Required. The display returns to the Control T est Comment Code If In- Range screen. 11. Press 1 to continue to the next option. The display shows the Control T est Comment C[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-23 What Y ou See on the Display What Y ou Do Comments 15. The administrator will select one of the following options: Press 1 – Next, return to the T est Setup menu. Press 2 – Change, change the Memory Full options. Allow Ov erwrite will automatically ov erwrite the existing data. [...]

8-24 Review/Change T est Setup for Security The T est Setup for Security menu enables the monitor to establish that certain criteria be met before a test can be performed. • In all situations, the monitor can be set to Allow T est (allo w the operator to test), W arn (tell the operator about the situation and still test) or Lockout (no testing ca[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-25 Review/Change T est Setup for Security: Refer to the beginning of the Re view 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, T r oublesho[...]

8-26 What Y ou See on the Display What Y ou Do Comments 4. The administrator will select one of the following options: Press 1 – Allow T est. Press 2 – W arn. Press 3 – Lockout. The display shows the QC Interval Security menu. The operator can choose between QC intervals. The settings are: • T ime Interval – QC Interval based on a set num[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-27 What Y ou See on the Display What Y ou Do Comments 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 . The display shows the Operator ID Not Certified options. 11[...]

8-28 What Y ou See on the Display What Y ou Do Comments 15. The administrator will select one of the following options: Press 1 to return to the T est Setup menu. Press Menu to return to the Menu Mode. Press On/Off to turn off the monitor . 14. The administrator will select one of the following options: Press 1 – Allow T est. Press 2 – W arn. P[...]

Review/Change T est Setup for T est T ype The options set with the Re vie w/Change T est Setup for T est T ype apply to dif ferent tests that may be performed, such as glucose. Use this menu to re vie w or change these setups for T est T ype: Units: Display test results in certain measurement units. The options are: • mg/dL • mmol/L Sample T yp[...]

8-30 What Y ou See on the Display What Y ou Do Comments Review/Change T est Setup for T est T ype: Refer to the beginning of the Re view 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, T r oubleshooting. 1[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-31 What Y ou See on the Display What Y ou Do Comments 5. Choose one of the following options: Press 1 – mg/dL. Press 2 – mmol/L. The display is returned to the Glucose Units screen. 6. Press 1 to continue to the next menu. The display shows the Glucose Sample T ype screen. 7. The a[...]

(1.1 mmol/L, -27.8 mmol/L) Precision PCx Plus T est Strip 8-32 What Y ou See on the Display What Y ou Do Comments 10. The administrator will select one of the following options: Press 1 – Next, to return to T est Setup T est T ype. Press 2 – Change, to change action range. If the action range is disabled, the display is returned to the T est Se[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-33 What Y ou See on the Display What Y ou Do Comments 14. The administrator will select one of the following options: Press Clear to return to T est Setup menu. Press Menu to return to the Menu Mode menu. Press On/Off to turn off the monitor .[...]

8-34 Review/Change Setup for System Setup System Setup enables the look or appearance of the data sho wn on the display to be customized. The monitor can be formatted to present information in a way that is more comfortable or familiar to w ork with. Use this menu to re vie w or change the setup for these features: Language This option presents the[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-35 What Y ou See on the Display What Y ou Do Comments Review/Change Setup for System Setup: Refer to the beginning of the Re view 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 pro[...]

8-36 What Y ou See on the Display What Y ou Do Comments 6. The administrator will select one of the following options: Press 1 – Enabled. Press 2 – Disabled. The display returns to the System Setup Beeper menu. 7. Press 1 – Next. The display shows the System Setup Date Format menu. 8. The administrator will select one of the following options[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-37 What Y ou See on the Display What Y ou Do Comments 11. Press 1 to continue to System Setup T ime Format menu. The display shows the System Setup T ime Format menu. 12. The administrator will select one of the following options: Press 1 – Next, to continue to System Setup Password;[...]

8-38 What Y ou See on the Display What Y ou Do Comments 18. Press 1 to continue to System Setup Passwo rd. The display shows the System Setup Password screen. 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 [...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-39 21. Enter the New Password, then press Enter . The display asks the operator to re-enter the password to conf irm the New P assword, then press Enter . 22. Re-enter New Password; press Enter to confirm. The display returns to the System Setup Password menu. 23. Press 1 to continue t[...]

8-40 Review/Change Setup for System Status The Re vie w/Change Setup menu allows the operator or administrator to re vie w important information about the monitor operating status. The operator scrolls through the v arious screens, in the order they are listed belo w , by pressing 1 – Next. Battery Po wer This option checks the amount of battery [...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-41 What Y ou See on the Display What Y ou Do Comments Review/Change Setup for System Status: Refer to the beginning of the Re view 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 proce[...]

8-42 What Y ou See on the Display What Y ou Do Comments 5. The administrator will select one of the following options: Press 1 – to return to Revie w/Change Setup menu. Press Menu – to return to Menu Mode. Press On/Off – to turn off the monitor .[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-43 Review/Change Setup for Date and Time The Re vie w/Change Setup menu allows the date and time to be re vie wed or changed. Depending on the format selected for date and time (this function is performed in T est Setup/System Setup/Date Format and Time F ormat menu), the instructions [...]

8-44 What Y ou See on the Display What Y ou Do Comments Review/Change Setup for Date and Time: Refer to the beginning of the Re view 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, T r oubleshooting. 1. Press[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-45 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. The display shows the Set Date menu. 7. Enter the current date, then press Enter . Include leading zeros: 09 for 9. The display is[...]

8-46 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 [...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-47 What Y ou See on the Display What Y ou Do Comments Change Setup for Edit Lists: 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 sect[...]

8-48 What Y ou See on the Display What Y ou Do Comments Add an Operator to the Operator List: 1. Press 1 – Add. The display shows the Scan or Enter Operator ID screen. 2. Press Scan or manually enter the Operator ID via the keypad and press Enter . The display shows the Operator ID Expiration Date menu. Enter a certification Expiration Date for t[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-49 What Y ou See on the Display What Y ou Do Comments Delete One Operator on the Operator List by Entering ID: 1. Press 2 – Delete. The display shows the Delete Operator ID menu. 2. Press 1 – Enter ID. The display shows the Scan or Enter Operator ID menu. Enter the Operator ID. 3. [...]

8-50 What Y ou See on the Display What Y ou Do Comments 1. Press 2 – Delete. The display shows the Delete Operator ID menu. 2. Press 2 – Select ID. The display shows the list of Operator IDs. 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[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-51 What Y ou See on the Display What Y ou Do Comments 1. Press 2 – Delete. The display shows the Delete Operator ID menu. 2. Press 3 – Delete All. The display prompts the operator to verify the delete. Delete All Operators on the Operator List: 3. The administrator will do one of t[...]

8-52 What Y ou See on the Display What Y ou Do Comments Change One Operator on the Operator List by Entering ID: 1. Press 3 – Change. The display shows the Change Operator ID menu. 2. Press 1 – Enter ID. The display shows the Scan or Enter Operator ID menu. 3. Press Scan or manually enter the Operator ID via the keypad and press Enter . The dis[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-53 What Y ou See on the Display What Y ou Do Comments Change One Operator on the List by Selecting ID: 1. Press 3 – Change. The display shows the Change Operator ID menu. 2. Press 2 – Select ID. The display shows a list of Operator IDs. 3. The administrator will select one of the f[...]

8-54 What Y ou See on the Display What Y ou Do Comments Change Setup for Edit T est 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, T r oubleshooting . 1. Press 5 – Edit[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-55 What Y ou See on the Display What Y ou Do Comments Add a T est Strip Lot to the Strip Lot List: 1. Press 1 – Add. The display sho ws the Scan or Enter Strip Code screen. 2. Press Scan or manually enter* the test strip lot number via the keypad and press Enter . The display shows t[...]

8-56 6. Key in the minimum and maximum values for the high control, press Enter after each value entered. The display returns to the Strip Lot List menu. 7. 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 . What Y ou[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-57 What Y ou See on the Display What Y ou Do Comments Delete T est Strip Lots from the Strip Lot List: 1. Press 2 – Delete. The display sho ws the Delete list where test strip lot codes can be viewed. 2. Press the number of the test strip lot to be deleted. Press 6 – Exit. 3. The a[...]

8-58 What Y ou See on the Display What Y ou Do Comments Change T est Strip Lot on the Strip Lot List: 1. Press 3 – Change. 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. 3. Key in the minimum and maximum values for the low control, press En[...]

Questions? Refer to Page 10-13 For Customer Care Information. 8-59 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 . What Y ou See on the Display What [...]

Questions? Refer to Page 10-13 For Customer Care Information. 9-1 Once the test results hav e 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 w ay to collect, report and transfer data to a persona[...]

9-2 Docking Station The Precision PCx System of fers an optional docking station that provides a means for hands-free, automatic data transfer (upload/do wnload) between the Precision PCx Monitor and a PC running the QC Manager application software. The QC Manager program will allo w messages to be monitored and managed from a v ariety of MediSense[...]

The green LED indicates that the docking station is connected to a po wer supply . The yello w LED (steady) indicates that the monitor has been properly placed into the docking station. The yello w LED (flashing) indicates data transfer (upload/do wnload) is in process. Note: Use only the AC adapter supplied by MediSense. Use of any other adapter m[...]

9-4 3. Connect the network cable to the RJ-45 netw ork jack and to the serial port of the terminal server . Figure 3 1. Connect the A C adapter to a po wer source. 2. Connect the RS-232 cable to a serial port on a network ed PC at the nurses’ station and to the docking station data transfer port. 3. Connect the network cable to the RJ-45 netw ork[...]

Mounting Instructions 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 scre ws. 3. Align the two holes in the dock station with the two mounting anchors. 4. After aligning the holes, press in and then down t[...]

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T roubleshooting: Patient T est Results This section describes conditions that can cause out-of-range patient test results. Refer to the Precision PCx or Precision PCx Plus T est Strip instructions for use for test strip specification information. Reasons Glucose Results May Be Higher than Expected: • Hematocrit is lower than the acceptable limit[...]

10-2 • Use a new test strip for each test. • Use only Precision PCx or Precision PCx Plus T est Strips. If test results are out of range despite meeting the abov e criteria, please repeat the test using a ne w 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 Un[...]

Questions? Refer to Page 10-13 For Customer Care Information. The monitor has little or no power . V erify proper battery 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[...]

10-4 Symptom/Error Message Explanation How T o Respond When Y ou T urn on the Monitor , or During Use: The monitor has a problem that prev ents it from operating. 1. T urn of f the monitor . T urn it on and repeat the function. 2. If the problem persists, record the three-digit error code and contact Customer Care. There may be a problem in the sto[...]

Questions? Refer to Page 10-13 For Customer Care Information. 10-5 Symptom/Error Message Explanation How T o Respond When a T est is Selected: The QC Interval Controls Expired option is set to W arn or Lockout, and one or more control tests is past due. (The menu item 2 – Continue appears only if this option is set to W arn). If the option is set[...]

10-6 Symptom/Error Message Explanation How T o Respond Less than 50 test data records are av ailable in test memory for the selected test type. The T est Memory Full option for that test type is set to Prompt for Overwrite or Lockout. The number of test records av ailable is displayed. Data should be uploaded as soon as possible. For data upload: 1[...]

Questions? Refer to Page 10-13 For Customer Care Information. 10-7 During Any T est: Symptom/Error Message Explanation How T o Respond 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 w as not held between 3 and 12 inches from the barcode. [...]

10-8 Symptom/Error Message Explanation How T o Respond 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 W arn. 1. V erify and re-enter the ID using the barcode scanner . [...]

Questions? Refer to Page 10-13 For Customer Care Information. 10-9 Symptom/Error Message Explanation How T o Respond The lot number or test strip code is in valid. 1. V erify the lot number or test strip code. 2. If the problem persists, notify the system administrator . The test result is below the measuring limit of the system. Press 2 – Repeat[...]

10-10 Symptom/Error Message Explanation How T o Respond The test was not successful. An error was detected during the analysis sequence. 1. Remov e 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 T est Menu. The test strip malfu[...]

Questions? Refer to Page 10-13 For Customer Care Information. 10-11 Symptom/Error Message Explanation How T o Respond During the test, the room temperature became unstable or mov ed outside the limits within which the monitor can perform a test. Ensure that the room temperature is within the specified limits. Allow the monitor time to stabilize to [...]

10-12 Symptom/Error Message Explanation How T o Respond There are no stored test results for the type of data requested. Press 1 to return to the Data Revie w Menu. There are no stored test results that match the selected criteria. Press 1 to return to the previous screen. When a Data Review is Selected: The requested type of results is shown at th[...]

Contacting Abbott Laboratories, MediSense Products for Service Abbott Laboratories, MediSense Products is committed to helping you resolve an y 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 of[...]

10-14 Abbott Scandinavia AB MediSense Produkter Solna, Sweden T el: 08 546 56700 ABBO TT A G MediSense Products Baar , Schweiz/Suisse/Svizzera T el: 041 768 44 46 Abbott Laboratories MediSense Products Maidenhead, UK T oll free: 0500 467 466 Abbott Diagnostic Division Johannesbur g, South Africa T el: 0800 11 69 41 ADD Argentina Buenos Aires, Argen[...]

Questions? Refer to Page 10-13 For Customer Care Information. 10-15 A MediSense representati ve 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 recei ve authorization from a MediSense representati ve. T o help ensure eff icient resolution of [...]

10-16 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 in volved in handling or transporting this equipment. Please perform the follo wing steps before returning an instrument: 1. Remov e all potentially cont[...]

Questions? Refer to Page 10-13 For Customer Care Information. 10-17 Disclaimer of W arranty THE FOREGOING W ARRANTIES ARE IN LIEU OF ALL O THER W ARRANTIES, EXPRESSED OR IMPLIED, INCLUDING BUT NO T LIMITED TO THE IMPLIED W ARRANTIES OF MERCHANT ABILITY AND FITNESS FOR A P AR TICULAR PURPOSE. Limitation of Remedies In no case shall Abbott Laboratori[...]

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 surf ace of the monitor . – Replacing the batteries. It is a good idea to rec[...]

11-2 Replacing the Batteries Use the follo wing procedure to install ne w batteries in the Precision PCx Monitor . The Precision PCx Monitor requires two (2) AA alkaline batteries or use the rechargeable battery pack which is a vailable from Abbott Laboratories, MediSense Products. 1. T urn the PCx Monitor of f by pressing the On/Of f button on the[...]

Questions? Refer to Page 10-13 For Customer Care Information. 11-3 Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Precision PCx Blood Glucose Monitor Six-Month Maintenance Log from___________ to___________ As Required: Replace the Batteries Daily: Clean the Exterior Surfaces Date Operator ID[...]

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Precision PCx T est Strips The follo wing information regarding the Precision PCx and Precision PCx Plus T est Strip can be found in the test strip instructions for use: • System Operating Ranges • Storage and Handling • Quality Control • Limitations of the Procedure • Performance Characteristics Precision PCx Monitor Dimensions: Length: [...]

12-2 The Precision PCx Point-of-Care System's performance has been e v aluated in clinical studies at seven independent sites. In all the studies, the Precision PCx Monitor was calibrated and used according to the labeling. En vironmental Specif ications Product is intended for indoor use Monitor Operating T emperature: 32°F to 115°F (0°C t[...]

Classification marking for U.S. This symbol indicates the hazards with respect to which the product has been classified by identifying the P articular Collateral Standards used in e v aluation UL2601-1. Laser Radiation. Do Not Stare Into Beam. Class 2 Laser product. W av elength 670 nm, Max. Output <1.0 mW . This product meets the requirements o[...]

12-4 Refer to manual Recyclable For in vitr o diagnostic use only . Method of sterility for Lancets only . Sterilized using irradiation (Lancets only). W ARNING: Potential Biohazard. Consider all clinical specimens, reagents, controls, etc., that contain human blood or serum as potentially infectious. Always wear glov es and follo w your facility?[...]

Questions? Refer to Page 10-13 For Customer Care Information. 12-5 Signal Output and Signal Input Parts The follo wing is recommended by UL for the “Intended signal input and signal output connections complying with this requirement. ” (UL 2601.1) The use of A CCESSOR Y equipment not complying with the equiv alent safety requirements of this eq[...]