Itc IRMA TruPoint Blood Analysis System User Manual

User Manual ITC Technical Support: 1-800-631-5945 (Press 2) 1-732-548-5700 (Press 2) ITC Customer Service: 1-800-631-5945 (U.S.) (Press 1) 1-732-548

1.2 SYSTEM COMPONENTS SYSTEM - MAJOR COMPONENTS Figure 1-1 A. IRMA TruPoint analyzer B. Battery charger (PN 442900) and power supply (PN 573400) C.

7.4 5. Enter the Cal code and press next to return to the Lot picklist. Press done to return to TEST SETTINGS. Note: • New product lots that a

7.5 4. If BEb was selected, chose the source of the patient hemoglobin value to be used in the BEb calculation and press next. Highlight the button

7.6 • Selecting a pO2 Temperature Formula: 1. Highlight the button next to the formula to be used in the calculation of patient temperature-correct

7.7 Patient ID There are 3 patient ID options: • Off: No patient ID information may be entered with a test. • Optional: A patient ID may be entered

7.8 Setting up Patient Notes: 1. Turn Patient Notes “on” and press next. 2. Default or established patient notes appear in a picklist. a. Delet

7.9 Collecting Correlation Data: 1. Ensure that the Correlation option is “off” when collecting correlation data. 2. Ensure that the reference ana

7.10 Establishing or changing correlation factors 1. Ensure that Correlation is “on” (see previous section). Press next from Correlation screen. 2.

7.11 BYPASS CORRELATION QA Users can establish correlation factors for samples from patients on cardiopulmonary bypass, to adjust IRMA TruPoint patie

7.12 DISPLAY UNITS QA Users can designate the units of measure for barometric pressure, temperature, and analyte concentration using the Display Unit

7.13 c. Select desired analyte from the picklist. If reference ranges will be entered for multiple analytes, select “All”. Press edit. d. Enter the

1.3 IRMA TRUPOINT BLOOD ANALYZER Figure 1-2 A. Carrying Handle B. On-board Printer: provides hard copies of test results and information. C. Recharg

7.14 REPORTABLE RANGES The default reportable range for each analyte can be found in Appendix B, Table B-8. Due to regulatory requirements, some fac

7.15 QUALITY CONTROL (QC) SETTINGS QA Users can access QC Settings by pressing QC from the SETTING OPTIONS menu. The following options are presented:

7.16 • When NO liquid QC limits have been established, running the designated number of controls will satisfy QC lockout requirements, for all non-s

7.17 Setting up or modifying QC lockout schedule 4. The Analyte Lockout screen displays the current settings for the first analyte/analyte group avai

7.18 QC limits may be entered into the analyzer for each control (optional). These limits are used during quality control testing to verify that the

7.19 Editing an established control 1. Press QC on the SETTING OPTIONS menu. 2. Press Controls on the QC SETTINGS menu. 3. Highlight the product

7.20 > QA Users have access to all analyzer setting and testing functions, including User ID settings. > General Users may perform and recall

7.21 USER ID OPTIONS QA Users can access the User ID Options screen by pressing User ID on the SETTING OPTIONS menu. To access a User ID setting, hig

7.22 DEVICE SETTINGS Device Settings determine the operating functions for the IRMA TruPoint system. • Non-QA Users can access and change the beeper,

7.23 COMMUNICATIONS QA Users can establish the bi-directional IRMA TruPoint communications methods for the transfer of IRMA TruPoint test results to

1.4 IRMA TRUPOINT BATTERY CHARGER AND POWER SUPPLY The IRMA TruPoint analyzer can be operated on battery or AC power. The IRMA TruPoint battery power

7.24 Setting up communications 1. Highlight Communications in the DEVICE SETTINGS picklist. Press edit. 2. Select a data Communications Method. If m

7.25 b3. The Subnet Mask screen displays. This screen defines which bits are significant. The default setting is “255.0.0.0”; other common settings a

7.26 Note: • Selection of “idms” sets the IRMA TruPoint serial data transfer (i.e., direct serial connection, external modem, or connection to a net

7.27 Automatic device updates occur after IRMA TruPoint results are transferred to idms or another connected system. After results are sent, the ana

7.28 AUTO PRINT There are 3 auto print options: • Off: Test results do not automatically print upon completion of sample analysis. A printout may be

A.1 Appendix A Limitations and Safety Precautions This appendix describes limitations of the IRMA TruPoint system. LIMITATIONS Measurements on the

A.2 • Delayed tourniquet release during venipuncture can result in falsely elevated potassium values or dilution effects. • Hemolysis during sample

A.3 INTERFERENCES Interference studies were based on NCCLS EP7-P. Serum or whole blood was spiked with potentially interfering substances. The concen

A.4 Creatinine Substance (concentration) Expected Effect Acetaminophen (20 mg/dL) Increase creatinine by 0.2 mg/dL at creatinine levels <2 mg/

A.5 Lactate Substance (concentration) Expected Effect Acetaminophen (20 mg/dL) Increase lactate by 40% at lactate levels <18 mg/dL. Acetaminop

1.5 IRMA TRUPOINT AC POWER ADAPTER The IRMA TruPoint analyzer can be operated on AC power using the IRMA TruPoint AC power adapter. • The analyzer

A.6 SAFETY PRECAUTIONS FOR BLOOD HANDLING • Use generally accepted techniques for collecting and handling blood [NCCLS: Standard for the Percutaneou

A.7 5. Oesch et. al., "Ion-Selective Electrodes for Clinical Use", Clinical Chemistry, 1986, vol 32, no 8, p.1448. 6. National Committee f

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B.1 Appendix B System Specifications and Cartridge Information This appendix includes IRMA TruPoint system specifications and IRMA TruPoint cartrid

B.2 General Specifications, continued Table B-1 Category Specification Display: Liquid Crystal Display (LCD) touch screen Power Requirements: Cart

B.3 Environmental Conditions for Vac - Powered Equipment Table B-2 The AC adapter and battery charger are intended for indoor use and operation. The

B.4 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The IRMA TruPoint Blood Analysis System AC adapter is intended for use in th

B.5 Symbol Definitions Definitions for symbols that appear on IRMA TruPoint product labels are shown in Table B-4. Table B-4 Symbols Definition Bat

B.6 CARTRIDGE/ANALYTE CONFIGURATIONS IRMA TruPoint cartridges are available in the following analyte con-figurations: Table B-6 Cartridge Measured

B.7 REPORTABLE RANGES The default reportable ranges for each parameter are shown in Table B-8*: Table B-8 Measured pH 6.000 - 8.000 pH units pCO2

1.6 IRMA TRUPOINT CARTRIDGES Each IRMA TruPoint cartridge contains a sensor array and self-contained calibrant. One patient or liquid QC test is per

B.8 DISPLAY RESOLUTION The display resolution for each parameter is as follows*: Table B-9 Measured Calculated pH 0.001 pH units HCO3- 0.1 mM pCO

B.9 CORRELATION FACTOR LIMITS Refer to Section 7-Correlation for a description of the correlation feature and instructions. Correlation factors must

B.10 REFERENCE VALUES While published values represent the general population, each laboratory should establish its own “normal” values which reflect

B.11 Calculated Reference Range HCO3-: 22-26 mmol/L (arterial) 1; 21-28 mmol/L (venous)3 TCO2: 19-24 mmol/L (arterial) 1; 22-29 mmol/L (venous) 3 BE:

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C.1 Appendix C Principles of Operation This appendix describes the measurement technology of the IRMA TruPoint blood analysis system. MEASUREMENT T

C.2 Potentiometric measurements The IRMA TruPoint potentiometric sensors generate a voltage which is related to ion concentration according to the Ne

C.3 CALCULATED PARAMETERS Other parameters can be calculated by the IRMA TruPoint analyzer based on the measured values of a blood sample. See Append

C.4 Base Excess of Blood 4,12 Base excess of blood, (BEb), also called in vitro or actual base excess, is the difference in concentration of strong b

C.5 Oxygen Saturation6 Oxygen saturation (O2Sat) is the amount of oxyhemoglobin in a solution expressed as a fraction of the total amount of hemoglob

1.7 GETTING STARTED UNPACK AND INSPECT THE SYSTEM • Verify that all components have been received, and inspect components for shipping damage. Immed

C.6 Patient Temperature Correction7, 8, 9, 10 Patient temperature can be entered into the IRMA TruPoint analyzer if it deviates from 37°C. The measur

C.7 REFERENCES 1. Oesch et. al., "Ion-Selective Electrodes for Clinical Use", Clinical Chemistry, 1986, vol 32, no 8, p.1448. 2. Maas et.

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D.1 Appendix D Performance Characteristics ACCURACY Accuracy was determined by analyzing human whole blood samples on both the IRMA TruPoint blood

D.2 ACCURACY - CONTINUED Potassium (K+) Number of samples: 137 Range evaluated (mM): 1.5 - 13.8 Slope: 0.961 Intercept: -0.033 Correla

D.3 ACCURACY - CONTINUED Glucose (Glu) Number of samples: 37 Range evaluated (mg/dL): 19 -338 Slope: 0.970 Intercept: 5.47 Correlation

D.4 PRECISION Precision was performed on commercially available liquid control solutions. Typical precision was observed as follows. pH Level 1 Level

D.5 PRECISION - CONTINUED Na+ Level 1 Level 2 Level 3 Level 4 Day 1 Number of samples: 14 16 15 14 Mean (mM): 99.5 120.4 153.1

D.6 PRECISION - CONTINUED Cl- Level 1 Level 2 Level 3 Day 1 Number of samples: 15 15 14 Mean (mM): 30.5 56.9 86.6 SD: 0.7

D.7 PRECISION - CONTINUED Glu Level 1 Level 2 Level 3 Level 4 Day 1 Number of samples: 11 12 12 12 Mean (mg/dL): 48.2 102.7 200.

1.8 UNPACK THE IRMA TRUPOINT CARTRIDGES IRMA TruPoint cartridges are shipped in an insulated shipping container. The shipping temperature range is 0-

D.8 PRECISION - CONTINUED Cr Level 1 Level 2 Day 1 Number of samples: 12 11 Mean (mg/dl): 1.5 8.2 SD: 0.09 0.46 CV (%):

E.1 Appendix E Default Settings This section describes factory default settings for the IRMA TruPoint blood analysis system. DEFAULT SETTINGS: TAB

E.2 Category Default Setting Test Settings • Product and Parameter Setup All products and parameters enabled • Calculations On (HCO3-, TCO2, BEb,

F.1 Appendix F IRMA TruPoint Capillary Collection Device INTENDED USE The IRMA TruPoint Capillary Collection Device is intended for blood collecti

F.2 WARNINGS AND LIMITATIONS OF USE: • Read instructions for the IRMA TruPoint system and capillary device before use. • For in vitro diagnostic u

F.3 INSTRUCTIONS FOR USE 1. The black plunger comes packaged separately from the capillary tube. Samples may be collected with the plunger in or out

F.4 Figure F-3 c. With the index finger of the other hand, dispense the sample by quickly depressing the plunger straight down in one smooth motion

G.1 Appendix G Software Updates ANALYZER SOFTWARE UPDATES Refer to the ITC Device Communications Utility User Manual and the instructions provided w

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H.1 Appendix H Warranty LIMITED WARRANTY International Technidyne Corporation (“the Company”) warrants the IRMA TruPoint Analyzer, Battery Charger,

1.9 CARTRIDGE TEMPERATURE OPERATING RANGE The IRMA TruPoint temperature operating range is 12-30°C (54-86°F). • Room temperature cartridges that ar

H.2 Warranty Disclaimer Every ITC product carries an express, written limited warranty, which is the only warranty, express or implied, of any ITC pr

1.10 ALTERNATE LANGUAGES The IRMA TruPoint analyzer software is available in multiple languages. All available languages are automatically loaded int

1.11 Bypass Status Button displays on the Calibrating and Analyzing screens when available. When “On Bypass” option is selected, Bypass Correlation

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1.12 Note: • The Gluc Strip User privilege is available for users that have purchased the SureStep®Pro Glucose Module, an optional side attachment to

1.13 • Auto-Print: Enables automatic printing of results immediately upon completion of analysis, or delayed auto-printing after sample and/or oxyge

1.14 • QC Notes: Allows optional entry of up to 3 pre-defined QC notes to be associated with a QC test record. • QC Limits: Allows optional defini

1.15 • User ID: Requires entry of a valid User ID prior to performing select functions. • VueLink: Allows IRMA TruPoint patient test results to be

1.16 Bar Code Scan Symbologies The bar code reader is factory programmed to read the following bar code symbologies: Code 11 EAN/JAN Plessey Code

1.17 2. Connect the bar code reader to the clip. (Figure 1-7) Figure 1-7 Operating the Bar Code Reader-General To scan a bar code, position the b

1.18 1. Enter User ID (optional). If the User ID option is activated, the Enter or Scan ID screen will display. The User ID may be entered using eit

1.19 Transmitting Results to VueLink 1. The patient test results displayed on the Results screen are transmitted to VueLink when done is pressed, on

1.20 DEVICE COMMUNICATION UTILITY (DEVICECOM) Description DeviceCom is a PC software application that handles all communications between the IRMA Tru

1.21 3. a. If the Communications Method setting is User Selects, highlight the button next to the appropriate method and press next and go to step 4

i Table of Contents Section Page 1. The IRMA TruPoint® Blood Analysis System 1.1 Introduction 1.1 Intended Use 1.1 System Overview 1.1 CLIA Comple

1.22 c. Result Transfer setting is “host” and there are unsent results. > Results must be manually transferred to the host system before the upda

2.1 Section 2 Patient Sample Analysis OVERVIEW This section describes the procedure for performing a whole blood patient sample analysis on the IRM

2.2 CAPILLARY REQUIREMENTS Capillary samples must be collected in the IRMA TruPoint Capillary Collection Device. See Appendix F for detailed Capillar

2.3 • Capillary samples must be free-flowing from an “arterialized” site. Avoid excessive squeezing of the puncture site to prevent erroneous result

2.4 SAMPLE INJECTION With each test, the cartridge automatically calibrates before the sample is injected into the cartridge. Following calibration,

2.5 present (Figure 2-3). Bubbles or calibrant should rarely be seen if proper injection technique is being used. The sample path was designed to be

2.6 5. Once the sample path is completely filled with a minimum of 200 uL of sample, press test to begin sample analysis. Leave the syringe attached

2.7 displayed). Go to step 7 if cartridge not yet inserted or step 13 if cartridge has been inserted. 5. b. If the analyzer was powered “on” by car

2.8 Do not touch the cartridge leads after the tape has been removed. Do NOT remove the luer cap from the cartridge. (Figure 2-4). 10. Fully insert

2.9 b2. To enter a new cartridge Lot for the first time, highlight new from the picklist and press edit. › Enter the cartridge Lot using the alph

ii Section Page 2. Patient Sample Analysis 2.1 Overview 2.1 Sample Requirements 2.1 Acceptable Specimens 2.1 Syringe Requirements 2.1 Capillary R

2.10 a. For cartridges that have calibrant gel packaged over the sensors (CC, BG, H3): calibration begins automatically. Proceed to step 17. b.

2.11 Note: • If air bubbles or calibration gel are present in the sample path after the initial sample injection, remove them by injecting additiona

2.12 a. Result outside of reference range: If reference ranges were established by the QA User, and a patient test result falls outside of the define

2.13 TEST INFORMATION ENTRY The Test Information feature allows the user to enter information into the IRMA TruPoint for each patient test. The entry

2.14 Note: • If Patient ID entry is “Required”, and a patient ID was not entered during the Calibrating phase, the Patient ID screen will display i

2.15 Patient Temperature • The Patient Temperature option allows entry of a patient temperature when performing a blood gas test. A default temperatu

2.16 TEST INFORMATION ENTRY – MISCELLANEOUS If test information entry is completed before calibration is complete, the operator is automatically ret

2.17 Patient Status • Highlight the appropriate Patient Status setting. › If Code or Room Air status is selected, press next to accept the selected

2.18 • The following information may be entered: › If Venturi, Trach Collar, or High Flow is selected, enter the FIO2 (%) and press next. › If Si

2.19 PATIENT BYPASS STATUS The Bypass Status feature, when established by the QA User, requires the user to select a patient bypass status (“On Bypa

iii Section Page 3. Quality Control Testing 3.1 Overview 3.1 IRMA TruPoint Quality Control 3.2 Quality Control Recommendation 3.3 Run an EQC Test:

2.20 QC LOCKOUT The QC Lockout feature allows the QA User to define the number of successful QC tests (EQC and/or liquid) required to support patien

2.21 • Some, but not all, Product Types are completely locked-out for all analyte groups available on that product. A padlock will display over the

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3.1 Section 3 Quality Control Testing OVERVIEW Quality Assurance (QA) can be defined as the required systems and actions to provide adequate confid

3.2 IRMA TRUPOINT QUALITY CONTROL The IRMA TruPoint Quality Control program consists of the following four elements: 1. Comprehensive, automatic, o

3.3 QUALITY CONTROL RECOMMENDATION Following method verification and establishment of liquid quality control limits, ITC recommends EQC as the primar

3.4 ELECTRONIC QUALITY CONTROL Electronic Quality Control tests may be performed two ways: 1. Manual EQC Test: initiated by user by pressing the EQ

3.5 a. Passed EQC Test: Manual a1. Press view to view quantitative results (optional). Press next from each screen to proceed through results for a

3.6 Note: • When EQC Lockout is on, an EQC test failure at any time (i.e., even if EQC passed earlier on a shift) will lockout patient testing. Foll

3.7 PERFORMING A LIQUID CONTROL TEST Turn IRMA TruPoint Analyzer On 1. Touch the right-hand edge of the screen to turn the analyzer “on”. Do NOT i

iv Section Page 5. Troubleshooting 5.1 Overview 5.1 Troubleshooting General Operational Problems 5.2 Troubleshooting Specific Operating Problems 5.

3.8 Select Product Type 6. Highlight the desired product type and press next. The Insert Cartridge screen displays. Note: • If only one product

3.9 Verify/Enter Cartridge Information 11. a. If the cartridge package bar code was scanned, go to step 13. b. If manual entry, ensure that the pr

3.10 Dispense Calibrant (Cartridges with Cal Cap Only) 13. For cartridges that have a Cal Cap (H4, GL, CR, LA) the Dispense Calibrant screen displa

3.11 17. After cartridge calibration is complete, open the ampule. Immediately draw the sample into a 1-3 mL non-heparinized syringe through an 18-

3.12 22. If a sensor errors during the analysis phase of a liquid QC test, the result for that sensor and any other sensors that are dependent on t

3.13 TEMPERATURE TEST PERFORMING A TEMPERATURE TEST Turn IRMA TruPoint Analyzer On 1. Touch the right-hand edge of the screen to turn the analyzer

3.14 a. If the information displayed matches the information on the Temperature Card, press next. Proceed to step 8. b. If the information displayed

4.1 Section 4 Data Access OVERVIEW This section describes the IRMA TruPoint data storage capabilities, the procedures for patient and QC test resu

4.2 Logs: The error, usage, and transfer logs can be printed. This information may be requested by your service provider to help resolve operating p

4.3 2. Screens that appear are based on search criteria selection: a. Search by Date: a1. The First Date from the previous search or the current dat

v Section Page Correlation 7.8 Bypass Correlation 7.11 Display Units 7.12 Reference Ranges 7.12 Reportable Ranges 7.14 Quality Control (QC) Settin

4.4 a1. print: Presents the Printing Patient Results screen that displays the total number of patient results found and the number of the result c

4.5 QUALITY CONTROL RESULTS From the RECALL menu, press QC to access the QC TEST RESULTS menu. This menu displays the following options: Menu: Retur

4.6 a3. The QC Results Found screen displays a picklist of all the QC tests that meet the search criteria, and the test dates and times. Scroll thr

4.7 b2. The Select Control screen displays a picklist with the control lots and levels available for the selected Product Type. The analytes availabl

4.8 › back: Returns to the Output Type screen. 3. If no results for the criteria entered are found, the Unable to Recall - No Results found for

4.9 RESULTS TRANSFER The Results Transfer feature allows IRMA TruPoint patient and QC test results and associated test information to be transferre

4.10 c. IRMA TruPoint LAN 10/100 transfer: Connect one end of a CAT5e patch cable to the LAN port on the back of the IRMA TruPoint (labeled “LAN 10/

4.11 2. The Automatic Results Transfer option is configured “on”. 3. The IRMA TruPoint analyzer is operated with the AC adapter. Automatic Results T

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5.1 Section 5 Troubleshooting OVERVIEW The IRMA TruPoint Blood Analysis System troubleshooting information is organized to address both general and

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5.2 TROUBLESHOOTING GENERAL OPERATIONAL PROBLEMS Corrective actions are listed to help resolve each problem noted in this section. If necessary, call

5.3 PROBLEM CORRECTIVE ACTION(S) PRINTER PROBLEMS • Poor print quality 1. Only use paper supplied by your service provider. 2. Try a new roll of p

5.4 PROBLEM CORRECTIVE ACTION(S) EQC FAILURES 1. Clean edge connector and IR probe. See Section 6- Maintenance. 2. Repeat EQC test. 3. Call your se

5.5 SCREEN MESSAGE REASON FOR MESSAGE CORRECTIVE ACTION PROCEDURAL ERRORS “Cartridge removed prematurely” Cartridge was removed during a test or

5.6 SCREEN MESSAGE REASON FOR MESSAGE CORRECTIVE ACTION TEMPERATURE ERRORS “Cartridge out of temperature range” Cartridge temperature was outsid

5.7 SCREEN MESSAGE REASON FOR MESSAGE CORRECTIVE ACTION ANALYZER MEMORY “Attention! Approaching result capacity” Patient, EQC, LQC, or Temperatu

5.8 SCREEN MESSAGE REASON FOR MESSAGE CORRECTIVE ACTION DATA TRANSFER “Unable to Transfer - No test results to upload” A. send was pressed when

5.9 SCREEN MESSAGE REASON FOR MESSAGE CORRECTIVE ACTION MISCELLANEOUS “Unable to Add - Maximum number have been entered” Displays when adding a

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6.1 Section 6 Maintenance OVERVIEW This chapter describes the routine and preventative maintenance procedures that can be performed on the IRMA Tru

1.1 Section 1 The IRMA TruPoint® Blood Analysis System INTRODUCTION This section outlines general information about the IRMA TruPoint Blood Analysi

6.2 • Perform a conditioning charge monthly, or more frequently as the schedule allows. A conditioning charge will help ensure optimal battery pe

6.3 REMOVING THE BATTERY Remove the depleted battery from the analyzer by pressing on the clips located on the sides of the battery. Recharge the bat

6.4 CONDITIONING THE BATTERY For optimal battery performance, perform a conditioning charge: • Prior to initial use; • Monthly, or more frequentl

6.5 4. Place the spindle into the cradle in the paper compartment. 5. Feed paper into printer. Insert the paper into the feed slot ensuring that t

6.6 CLEANING THE BATTERY CHARGER, POWER SUPPLY, AND ANALYZER SURFACES Immediately wipe any spilled blood or other contaminant from the component s

6.7 CLEANING THE EDGE CONNECTOR Clean the edge connector only if it is accidentally contaminated with blood or other contaminants, or when EQC, Temp

6.8 REPLACING THE EDGE CONNECTOR Replace the edge connector if instructed to do so by your service provider or if it has been contaminated and cleani

7.1 Section 7 System Settings OVERVIEW This chapter provides setup instructions for all IRMA TruPoint system settings. SETTING OPTIONS MENU System

7.2 TEST SETTINGS QA Users can access Test Settings by pressing Test from the SETTING OPTIONS menu. A TEST SETTINGS picklist displays. Current test

7.3 3. Highlight the button next to the analyte groupings to be displayed for selection with each CC test. In the example shown, the user would have