Abbott i-STAT 1 System Manual Download Page 243 | Manualshive

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Art: 714377-00K

Rev. Date: 31-Jan-12

15-7

RNA

®

MEDICAL HEMATOCRIT CALIBRATION VERIFICATION CONTROLS

Intended Use

RNA Medical Hematocrit Calibration Verification Control is a quality control
material used for verifying the calibration and linearity of hematocrit sensors in
i-STAT cartridges.

Product Description

Hematocrit Calibration Verification Controls are provided in five (5) levels for
verifying the accuracy of hematocrit measurements throughout the reportable
range. The controls are packaged in sealed glass ampules, each containing 1.7 mL
of solution. Ampules are packaged in kits containing four (4) ampules of each level.

Active Ingredients

This product is a buffered aqueous solution containing electrolytes and non-
conductive ingredients. This control contains no red blood cells, and no human
or biological material.

Storage

RNA Medical Hematocrit Calibration Verification Control is stable until the
expiration date stated on the ampule when stored at temperatures of 2-25 ºC. Do
not freeze or expose ampules to temperatures greater than 30 ºC.

If stored refrigerated, the calibration verification material should be equilibrated
to room temperature for at least four (4) hours prior to testing.

The product may turn slightly yellow in color over its shelf life if stored at
room temperature. This coloration is normal and does not affect product
performance.

Directions For Use

1. Beginning with Level 1, gently invert the ampule to mix the solution.

Tap the ampule to restore the liquid to the bottom of the ampule.

2. Open the ampule by snapping off the tip at the neck. Use gauze, tissue,

gloves, or an appropriate ampule opener (a Snapper is included for this

purpose) to protect fingers from cuts.

3. Fill and seal a cartridge and insert immediately into the analyzer.

i. Note: The CalVer option from the Quality Tests menu must

be used on the i-STAT 1 Analyzer for RNA Medical Hematocrit
Calibration Verification Control.

4. Record the results on the Data Collection and Linearity Worksheet

provided.

5. Test Levels 2, 3, 4, and 5 in the same manner. Record all values on the

worksheet.
i. Note: this product is a buffered aqueous solution containing

electrolytes and non-conductive ingredients. The only value
assigned to this fluid is for hematocrit. All other cartridge analyte
results obtained with this control material should be ignored.

Always ensure that the lot number and software revision on the value
assignment sheet matches the lot number of the vial in use and the software
revision in the analyzer.

Target values are specific to the i-STAT System. Results may differ if used with
other methods.

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Summary of Contents for i-STAT 1

Page 1: ...i STAT 1 System Manual Rev Date 20 Jan 12 Art 714336 00L ...

Page 2: ...nologies Corporation is the owner of US Patent No 5 532 469 Trademarks i STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions Windows is a registered trademark of Microsoft Corporation Art 714336 00L Rev Date 20 Jan 12 Abbott Point of Care Inc Abbott Park IL 60064 USA 2012 Abbott Point of Care Inc All rights reserved Printed in USA For information related to Art...

Page 3: ...n the i STAT 1 Handheld 730077 00B Technical Bulletin Liquid Quality Control Pass Fail Customization on the i STAT 1 Handheld 730078 00A Technical Bulletin Positive Patient Identification PPID Customization on the i STAT 1 Handheld 730211 00B Technical Bulletin Operator Competency Notification on the i STAT 1 Handheld 730292 00A Section 10 714372 00L Section 11 714373 00F Section 12 714374 00J Sec...

Page 4: ...o Other Methods 714261 00E K2EDTA and K3EDTA Customization for Hematocrit on the i STAT System 716240 00D Calibration Verification and the i STAT System 715209 00E ACT Test Result Options Prewarmed vs Non Prewarmed Result Calibration Modes for the i STAT 1 Analyzer 715617 00D i STAT Celite ACT and i STAT Kaolin ACT Heparin Linearity Procedure 714547 00F Support Services 716144 00T October 2007 Upd...

Page 5: ...alyzer 2 1 Specifications 2 2 Software 2 2 Power 2 2 Disposable Batteries 2 3 Rechargeable Battery 2 3 Low Battery Warning 2 3 Cartridge Port 2 4 Infrared Communication Window 2 5 Thermal Control 2 5 Barometric Pressure Sensor 2 5 Cartridge Test Cycle 2 5 Data Entry 2 6 Storage of Results 2 6 LCD Display and Backlight 2 7 Audible Indicator 2 7 Time Out 2 7 Keypad 2 8 i STAT 1 Menu Tree 2 9 Test Me...

Page 6: ...ation 6 4 Troubleshooting 6 5 Charging the Rechargeable Battery 6 5 Charging Rechareable Battery in the External Recharge Compartment 6 6 TECHNICAL BULLETIN THE i STAT DOWNLOADER RECHARGER MODEL NUMBER DRC 300 PORTABLE PRINTER 7 1 MARTEL Printer 7 1 Overview 7 1 Specifications 7 1 Supplies Provided with Printer 7 2 Power 7 2 Loading Paper 7 2 Printing Directly from the Analyzer 7 3 Printing Via a ...

Page 7: ... 10 7 Sample Transfer Devices 10 8 References 10 9 PROCEDURE FOR HANDLING CARTRIDGES 11 1 Preparation for Testing 11 1 Filling and Sealing Cartridge Using Transfer Device 11 2 Filling and Sealing PT INR Cartridges Using Direct Fingerstick Sampling 11 2 Filling and Closing an Immunoassay Cartridge Using a Transfer Device 11 3 Inserting and Removing the Cartridge From the Analyzer 11 4 Incorrect Pro...

Page 8: ...ibration Verification Set 15 2 i STAT CHEM8 Calibration Verification Set 15 3 i STAT Cardiac Marker Calibration Verification Set 15 5 i STAT BNP Calibration Verification Set 15 6 RNA Medical Hematocrit Calibration Verification Controls 15 7 Verification Procedure for Hematocrit 15 8 Verification Procedure for ACT 15 9 Procedure for Cartridges 15 10 Troubleshooting Cartridge Tests 15 10 PROFICIENCY...

Page 9: ... STATION CENTRAL DATA STATION 22 1 i STAT License Agreement and Warranty for Central Data Station Program 22 1 Installation Of The Central Data Station 22 3 General Procedures and Conventions 22 5 Customization of the Central Data Station 22 9 Interface Program Customization 22 15 Overview of the Central Data Station Program 22 17 Administration Tools 22 19 Instrument and Location Workspace 22 19 ...

Page 10: ...on Sodium Potassium Chloride BUN Urea Glucose Hematocrit Hemoglobin Ionized Calcium PO2 pH PCO2 Total Carbon Dioxide TCO2 Creatinine Lactate Celite ACT Kaolin ACT Prothrombin Time PT INR Cardiac Troponin I Creatine Kinase MB CK MB B Type Natriuretic Peptide BNP TECHNICAL BULLETINS PROCEDURE MANUAL ...

Page 11: ...d and transmitted to centralized information systems for record keeping and billing The Central Data Station program provides system management tools including real time monitoring of testing and operator competency FDA Test Categorization With the i STAT 1 System the FDA has categorized the tests included on the i STAT G Crea E3 EC4 6 and CHEM8 cartridges as waived when testing is performed using...

Page 12: ...n sample handling system sensors and reagents The analyzer automatically controls all steps in the testing cycle which may include fluid movement reagent mixing calibration and thermal control Quality checks are performed continuously throughout the test cycle Operator and patient IDs and patient chart information can be entered When the test cycle is completed results are displayed and the test r...

Page 13: ...results in normal operation given the stringency of these specifications If however the analyzer or cartridges have been compromised results may be persistently suppressed and one or the other must be replaced to restore normal operating conditions Where unavailability of results while awaiting replacement of analyzers or cartridges is unacceptable Abbott Point of Care Inc recommends maintaining b...

Page 14: ...ufacturer In vitro diagnostic medical device Authorized Representative for Regulatory Affairs in the European Community Contains sufficient for n tests Direct Current DC Alternating Current AC Class II Construction Consult instructions for use or see System Manual for instructions Control Signifies that the product bearing the ETL Listed mark complies with both U S and Canadian product safety stan...

Page 15: ...product As the Martel Printer is incapable of printing the or symbols this symbol appears on the Martel printout next to results which are outside the action range limits 14 days room temperature storage at 18 30ºC 2 months room temperature storage at 18 30ºC Packaging contains cartridges with barcoded pouches Signifies that the product bearing the Federal Communications Commission FCC logo compli...

Page 16: ...an R Range Symbol TEST Na Sodium K Potassium Cl Chloride Glu Glucose Lac Lactate Crea Creatinine pH pH PCO2 Partial pressure of carbon dioxide PO2 Partial pressure of oxygen iCa Ionized Calcium BUN UREA Urea nitrogen Urea Hct Hematocrit ACTc Celite ACT Activated Clotting Time with Celite activator ACTk Kaolin ACT Activated Clotting Time with Kaolin activator PT INR Prothrombin Time International N...

Page 17: ...e shall be uninterrupted or error free If Abbott Point of Care Inc is unable within a reasonable time to repair or replace any product to a condition as warranted Buyer shall be entitled to a refund of the purchase price upon return of the product to Abbott Point of Care Inc Note Warranty rights may vary from state to state province to province and country to country Limitations of Warranty The fo...

Page 18: ...1 8 Art 714363 00U Rev Date 02 Aug 12 ...

Page 19: ...EW and application software If a different CLEW and or application software is in use in your facility it must be installed in new repaired or replaced analyzers before they are put into use Check the Analyzer Status page for the installed CLEW and application software See under Standardization and Calibration in section 3 of this manual for an explanation of CLEW Customization Analyzers can be cu...

Page 20: ... and a battery carrier Lithium batteries may be ordered from i STAT or obtained locally ULTRALIFE lithium batteries ULTRALIFE Batteries Inc Newark NY USA are recommended Only i STAT rechargeable batteries may be used DESCRIPTION Specifications DIMENSIONS Width 7 68 cm 3 035 in Length 23 48 cm 9 245 in Depth 7 24 cm 2 85 in WEIGHT With rechargeable battery 650 grams 22 9 oz With disposable battery ...

Page 21: ...e rechargeable battery The battery capacity for one full charge is 30 minimum of the capacity of one set of disposable lithium batteries see above If the analyzer is not in use batteries will lose approximately 10 30 of their charge over 30 days if not recharged Store rechargeable batteries in a cool dry place when not in use The battery recharges when the analyzer is placed in a Downloader Rechar...

Page 22: ...nalyzer through the cartridge port on the keypad end of the analyzer Unless the analyzer is customized to require information input before a test inserting a cartridge or Electronic Simulator initiates the test cycle i e the analyzer does not need to be turned on first The cartridge and test strip ports cannot be used simultaneously Infrared Communication Window Battery Compartment Laser Barcode S...

Page 23: ... pressure sensor which determines the ambient atmospheric pressure used for the PO2 sensor calibration Cartridge Test Cycle An operator starts a cartridge test cycle either by inserting a cartridge into the analyzer or by selecting the i STAT Cartridge option from the Test or Quality Tests Menu The analyzer makes electrical contact with the cartridge identifies the cartridge type releases calibrat...

Page 24: ...y barcode scanner or keypad including Operator and Patient IDs Lot numbers for controls and cartridges Chart page data Serial number of the Electronic Simulator the serial number of the analyzer the number of times the analyzer has been used the software and CLEW versions installed in the analyzer the name of the analyzer s customization profile Quality Check Codes which may appear during the test...

Page 25: ...urn off after 15 minutes or after the Inactivity Time Out whichever is greater if there is no response to a mandatory data prompt A mandatory data prompt is a prompt for information that must be entered before pending results are displayed In the case of a missed mandatory data prompt results will not be stored and the test record will state Test Cancelled by Operator Waiting for insertion of cart...

Page 26: ... on data entry screens When the ABC key is pressed the letter A is entered The arrow keys are used to move up and down the alphabet To enter a second letter press the ABC key once to move to the next position and again to enter an A To enter a number after a letter press a numbered key To erase a letter press the ABC key to move to the next position then use the key to backspace and clear the lett...

Page 27: ...TAT Cartridge Pressure Battery Uses Serial CLEW Version Custom Stored Records 2 Data Review 1 Patient 2 Control 3 Proficiency 4 Cal Ver 5 Simulator 6 All 7 List 3 Quality Tests 1 Control 2 Proficiency 3 Cal Ver 4 Simulator 4 Customization 1 View 2 Change 1 Analyzer 2 ID Entry 3 Patient Tests 4 QC Tests 5 Results 6 Password 7 Restore Factory Settings 5 Set Clock 6 Transmit Data 1 Most Recent 2 This...

Page 28: ...tion 2 is used for testing patient samples Note If the handheld is customized to disable testing under certain conditions the disabled option will be listed without its number so that it cannot be selected The Administration Menu is accessed by pressing the Menu key from the Test Menu screen The options are 1 Analyzer Status 2 Data Review 3 Quality Tests 4 Customization 5 Set Clock 6 Transmit Data...

Page 29: ...ic Unsent The number of test records that have not been transmitted to the Central Data Station Analyzer Status Data Review The Data Review function allows the operator to review stored results by the categories listed below The number of test records stored is indicated at the bottom center of the screen as x y where x is the record on the screen and y is the total number of stored records in the...

Page 30: ... To print records select the records and press the Print key Quality Tests Non patient tests can be initiated from the Quality Tests menu Options are 1 Control 2 Proficiency external quality control 3 Cal Ver Calibration Verification for cartridges 4 Simulator cartridge reading function only When testing is initiated from one of these options the handheld prompts the operator to scan or enter the ...

Page 31: ...ypass surgery If an analyzer customized for the CVOR as CPB Automatically Adjust is used for patients who are not on the pump hematocrit results will be reported falsely high If an analyzer customized as CPB Do Not Adjust is used for patients who are on the pump hematocrit results will be reported falsely low For details on the CPB function see the Theory section of this manual It is recommended t...

Page 32: ...eypad select 4 Customization from the Administration Menu then select 2 Change If the handheld has already been customized with a password enter the password If not press the Enter key It is recommended that the Change function be password protected Then make selections from the Customization menu To change a setting select the item by pressing the number key correponding to the item then select t...

Page 33: ...igits 4 Print ID 2 Patient first page 1 Minimum Length 2 Maximum Length 3 Repeat ID 4 ID Recall 5 Manual Entry second page 1 Code I2of5 2 Code 128 3 EAN 8 EAN 13 4 Codabar 5 Code 93 third page 1 Code 39 Full ASCII 2 Code 39 Check Digit 3 Truncate First x Digits 4 Truncate Last x Digits 3 Patient Tests first page 1 Cartridge Auto chart 2 Cartridge Information 3 Cartridge Barcode 4 Cartridge Lot Num...

Page 34: ...tion 2 Cartridge QC 1 Pass Fail Method 2 Comment Code In Range 3 Comment Code Out of Range 4 Result Format 5 APOC Fluid Lot Scan Only 5 Results 1 Units and Ranges 2 Options first page 1 Decimal Separator 2 Test Selection 3 Hematocrit CPB and EDTA 4 Base Excess 5 ACT C Cal Options second page 1 ACT K Cal Options 2 Print Reference Ranges 6 Password 7 Restore Factory Settings ...

Page 35: ...tically transmitted to the Central Data Station when an analyzer is placed in a Downloader or Downloader Recharger In some cases it may be desirable to have the capability to retransmit data The Transmit Data function allows transmission of data in the following manner 1 Most Recent 2 This Month 3 Last Month 4 All 5 Unsent Most Recent is the result from the last cartridge tested The analyzer can b...

Page 36: ...ifications The barcode scan engine is manufactured by Symbol Technologies Corporation The scan engine contains a laser diode that emits laser radiation at a frequency of 650 nm The scan engine outputs power i e the power output of the engine if removed from this product up to 1 9 mW in scanning mode The scanner in this product only operates when the Scan key is pressed Symbol Technologies Corporat...

Page 37: ... analyzer emits a visible red beam 2 Position the analyzer and barcode so the beam forms a red line that spans the entire barcode Increasing distance between the barcode and analyzer lengthens the red line The analyzer does not need to touch the barcode 3 When the analyzer accepts the barcode it will beep in acknowledgement and automatically turn off the beam The beam will also turn off after 3 4 ...

Page 38: ... warning message and Unable to Position Sample is an example of a quality check failure during the testing cycle Note The Cartridge Locked or Simulator Locked prompt is always displayed when a cartridge or Electronic Simulator is inserted into the analyzer Any attempt to remove a cartridge or Electronic Simulator before this prompt is removed from the screen may cause damage to the analyzer When t...

Page 39: ...s for blood gases electrolytes chemistries and hematocrit reagents in cartridges with sensors for coagulation sample handling system waste chamber an array of miniaturized sensors conductive pads to make electrical contact with the analyzer heating elements in cartridges requiring thermal control at 37 C See the Cartridge and Test Information Sheets for test specific details The following diagram ...

Page 40: ...ple remain contained within the cartridge during the testing cycle and subsequent disposal Immunoassay cartridges such as cTnI use a plastic slide enclosure clip Air Vent An air vent on the underside of the cartridge beyond the fluid front allows the calibrant and the sample to flow forward but not out of the cartridge Waste Chamber A waste chamber beneath the cartridge label holds calibrant fluid...

Page 41: ...ffset of the stored calibration curve Next the analyzer automatically moves the sample over the sensors and the signals produced by the sensors responses to the sample are measured While coefficients are used rather than graphic calibration curves the calculation of the result is equivalent to reading the sample s concentration from adjusted calibration curve Packaging Each cartridge is sealed in ...

Page 42: ...ne hour for a box of cartridges to come to room temperature Cartridges in use may be stored at room temperature 18 30 C or 64 86 F for the time frame indicated on the cartridge box The cartridge box and pouch contain a line used to indicate the room temperature expiration date Disposal Although the sample is contained in the cartridge cartridges should be disposed of as biohazardous waste accordin...

Page 43: ...Strip Port functionality will be permanently disabled on all i STAT 1 Handhelds Note The remaining technical information regarding the Glucose Strip Port will be removed from the i STAT 1 System Manual by April 2013 Please contact your Support Services representative for information on transitioning to an Abbott Diabetes Care blood glucose monitoring system ...

Page 44: ......

Page 45: ...l state or national accreditation requirements A reminder message for the operator to run the external simulator can be set by the number of hours on the i STAT Portable Clinical Analyzer and by the hours or tests on the i STAT 1 Analyzer The schedule for the automatic internal Electronic Simulator can be set by the number of hours on the i STAT Portable Clinical Analyzer and by the hours or tests...

Page 46: ...Station Use Use of the Electronic Simulator is described further in the Quality Control section of this manual Operating Characteristics Dimensions Height 1 9 cm Width 7 0 cm Length 9 0 cm Weight 85 g Operating Temperature Same as Analyzer being tested Operating Ambient Humidity 0 90 RH non condensing as shipped Storage Temperature 20 50 C 4 122 F Operating Characteristics Cleaning the Simulator B...

Page 47: ...laced within Both Downloader formats are available for use with direct wiring serial format or ethernet cabling network format Unless indicated otherwise references to the Downloader apply to the Downloader Recharger as well The Downloader Recharger can recharge a rechargeable battery in the analyzer If the analyzer contains a rechargeable battery the battery begins recharging automatically as soo...

Page 48: ...ter Input 12V Operating Temperature 0 to 40 C 32 to 104 F 0 to 40 C 32 to 104 F Storage Temperature 20 to 50 C 4 to 122 F 20 to 50 C 4 to 122 F Pollution Degree Allowable ambient pollution level 2 2 Installation Category Allowable overvoltage specification 2 2 Communication To Central Data Station and other equipment Serial RS232 or Ethernet Serial RS232 or Ethernet Communication Link To and From ...

Page 49: ...e Analyzer while it is in the DR Programming and Connections Details for programming the Network Downloaders can be found in the Downloader Programming and Wiring section of this manual Diagrams and instructions for connecting peripheral components to the Downloader can also be found in the Downloader Programming and Wiring section Cautions The Downloader and Downloader Recharger are not intended ...

Page 50: ... the arms on the front of the Downloader with the test strip port end touching the Downloader When properly aligned the red proximity light will turn on and the analyzer will automatically transmit upload all unsent results The analyzer does not need to be turned on Do not move the analyzer while the message Communication in Progress is displayed on the screen Transmitted Information The following...

Page 51: ...der Recharger to download data until rechargeable battery is ready Keep Battery Charged Fully charged battery if not periodically recharged will self discharge in approximately three months Prevent self discharge by either 1 keeping the rechargeable battery in an Analyzer that is periodically on the Downloader Recharger or 2 store the rechargeable battery separately in the external charging bay on...

Page 52: ...loader facing up and the electrical contact end of the pack facing the contacts in the battery compartment insert the pack into the compartment as shown on the label 2 To remove the battery after it is charged back the pack out of the compartment Full recharge from a discharged state takes approximately 40 hours Caution If you are using rechargeable batteries use only rechargeable batteries and re...

Page 53: ...nvert electrical signals from the Customization Workspace of the Data Management applica tion to infrared transmissions and transmit them to the i STAT 1 handheld recharge the rechargeable battery installed in the i STAT 1 handheld or a rechargeable battery installed in the recharging compartment of the DRC If you have questions regarding the information in this Technical Bulletin please contact A...

Page 54: ...ration 6 Connecting and Wiring the DRC for Network Communication 13 Configuring the i STAT 1 DRC for Serial Operation Option 1 Installation Using Windows Hardware Wizard Option 2 Installation Using a Driver Installer File 14 14 16 Connecting and Wiring the DRC for Serial Communication 19 USB Driver Uninstallation 19 Configuring the CDS Software for Serial Communication 20 IDENTIFICATION OF THE NEW...

Page 55: ...twork Communication Link to and From Handheld Infrared Transceiver Indicator LEDs Power Proximity Charge N A Blue Red Green Configuration By host computer Note This product has been tested to the requirements of CAN CSA C22 2 No 61010 1 second edition including Amendment 1 or a later version of the same standard incorporating the same level of testing requirements POWER SUPPLY SPECIFICATIONS Speci...

Page 56: ...ys The AC power supply adapter plug acts as a disconnect device for the DRC and therefore the socket outlet must be installed or located near the DRC and must be easily accessible Use only the AC power supply provided with the DRC 300 to power the DRC 300 Only APOC provided printers may be connected to the DRC printer port If using a Martel Printer use the power supply that came with the Martel Pr...

Page 57: ...the handheld until communication is estab lished with the Data Manager 2 Once the handheld establishes communication with the Data Manager a Communication in Progress message will then appear on the handheld display and the arrows will circle until the transmission is complete Note Do not move handheld until the Communication in Progress message disappears TRANSMITTED INFORMATION The following inf...

Page 58: ...pending Note No damage will be caused if a handheld with disposable batteries installed is placed in the DRC CHARGING A RECHARGEABLE BATTERY IN THE EXTERNAL RECHARGE COMPARTMENT Placing a rechargeable battery into the external recharging compartment will automatically initiate trickle recharging The indicator light near the recharging compartment will be green when a rechargeable bat tery is place...

Page 59: ...not checked then network communication is not enabled at your facility and these actions do not apply to you 5 At the Maximum number of simultaneous network connections selection box increase the number of connections to 256 6 Click Accept The Central Data Station will then automatically launch with 256 available connections 7 You may now continue uploading as normal Data Exchange DE Customers i S...

Page 60: ...he PC Network Configuration to detect the DRC On the PC click Start Settings Control Panel Network and Internet Connections if listed Network Connections 4 Right click on Local Area Connection and select Properties 5 Select the Internet Protocol TCP IP connection and click the Properties button 6 In the General tab record all Internet Protocol TCP IP Properties for later use 7 Select the Use the f...

Page 61: ...ed Do not plug the computer into the facility s net work Note 9 2 If the webpage doesn t appear check the following Check to make sure the network cable is connected Check to make sure that power has been applied to the DRC Check the proxy settings to make certain they are disabled 1 In Internet Explorer version 6 7 and 8 navigate to Tools Internet Options Connections tab LAN Settings 2 Under Prox...

Page 62: ...gned the default password is i STAT and is case sensitive Following a suc cessful login the home page will appear Note 10 1 The session will terminate after 15 minutes of inactivity after which the user must re enter their password Note 10 2 Should you wish to change the configuration password perform the following steps Under Current Settings click Change Password Enter the existing password and ...

Page 63: ... screen click Configure 15 Scroll to the i STAT Downloader Recharger Network Settings section and select the address type for assigning the IP Address of the DRC being configured 16 To configure for a static IP address follow the instructions in 16A To configure for DCHP follow 16B Note 16 1 Static IP addresses are required when using handheld customization by Download Locations 16A If you want to...

Page 64: ... Internet Connections if listed Network Connections 19 Right click on Local Area Connection and select Properties 20 Select the Internet Protocol TCP IP connection and click the Properties button 21 Restore Internet Protocol TCP IP Properties in the General tab to the network settings recorded in Step 6 22 Click OK and close all Control Panel windows 23 Connect the network cable from the PC to the...

Page 65: ...e Cable Downloader Recharger Power Supply Y Splitter Cable Optional Network Cable Note Once the DRC has been configured and connected to the facility s network you can view the DRC s configuration page by using Internet Explorer and navigating to the DRC s configured IP Address using any computer on the same node of the network NETWORK CABLE If using a Martel Printer use the power supply that came...

Page 66: ...tion Using Windows Hardware Wizard Internet Required This method requires a PC connected to the Internet and to have user permission to receive and install Windows Updates 1 Apply power to the DRC Connect the USB cable from the DRC to the PC A Found New Hardware Wizard box will appear 2 Allow Windows to connect to Windows Update to search for software by selecting the Yes this time only radio butt...

Page 67: ...button as previously illus trated and click Next 8 Wait while the USB Serial Port driver installs This may take a few minutes 9 When the USB Serial Port driver installation is complete click Finish If the DRC USB driver installs successfully you will see a Found New Hardware message appear on the PC Taskbar 10 Select Start Settings Control Panel Performance and Maintenance if listed Sys tem to lau...

Page 68: ...t 14 Click Advance Settings Using the drop down menu change the port number to the lowest available number Determine availability by viewing the existing comports in Device Manager Click OK twice 15 Close all Control Panel windows Option 2 Installation Using a Driver Installer File Note If a CD ROM with the USB driver has been obtained proceed to Step 3 below If not continue with Step 1 1 Using In...

Page 69: ...the on screen instructions to complete the installation If present 4 Connect the DRC to the PC using the USB cable as per the Connecting and Wiring the i STAT 1 DRC for Serial Communication section below 5 Apply power to the DRC The following notifications as shown below should be displayed 6 Select Start Settings Control Panel Performance and Maintenance if listed Sys tem to launch the System Pro...

Page 70: ...ct the Port Settings tab 9 Using the drop down menu set the Bits per second to 38400 Other drop down menus should remain as the default 10 Click Advance Settings Using the drop down menu change the port number to the lowest available number Determine availability by viewing the existing comports in Device Manager Click OK twice 11 Close all Control Panel windows ...

Page 71: ...Power Supply Y Splitter Cable Optional PC 1 2 3 Power In RJ12 printer interface USB Y Splitter Cable If using a Martel Printer use the power supply that came with the Martel Printer and not the Y Splitter cable provided with the DRC USB DRIVER UNINSTALLATION 1 USB Driver Uninstallation for Windows XP Caution Disconnect the DRC 300 from the PC before proceeding 1 1 Using Internet Explorer navigate ...

Page 72: ...tem to launch the System Properties dialog box 2 3 Select the Hardware tab and click Device Manager to show the list of devices 2 4 Expand Ports COM LPT to list all the COM Ports Right click on the USB Serial Port device entry associated with the DRC and select Properties A USB Serial Port Properties dialog box will open 2 5 Select the Driver tab Click Uninstall and then click OK when the warning ...

Page 73: ... Green STATUS Amber Printing method Thermal line printing Printing speed 10 lines per second Temperature Operating 0 C to 50 C 32 122 F Storage 20 C to 60 C 4 140 F Charging 10 C to 45 C 50 113 F The printer can receive data directly from the analyzer via IR transmission or through a data cable connected to a Downloader The printer can be recharged from a power adapter connected to an outlet Top v...

Page 74: ...inting again Adapter and power cord One roll of paper Paper Paper may be ordered along with other supplies for the i STAT System or paper with the following specifications can be used Black print thermal paper 2 25 5 7 cm wide by 80 25 m long Paper grade TF50KS E2C The Status light will flash to indicate that the paper has run out To replace the paper open the paper cup lid by squeezing the lid as...

Page 75: ...window on its left side ensure that the results to be printed are displayed and press the Print key on the analyzer The printer must be within 1 to 5in 2 5 to 12 7cm of the analyzer and must not be too close to the analyzer Do not move the analyzer or printer until printing is complete Printing Via a Downloader See the Downloader Wiring and Programming section of this manual for directions to conn...

Page 76: ...s patient or proficiency test Time and Date Time and Date when test was performed Operator ID Operator ID Lot Number Lot number of cartridge Serial Serial number of the analyzer Version Analyzer application software CLEW Standardization software Caution Use only a rechargeable battery pack purchased from Abbott Point of Care Rechargeable battery packs not recommended by or purchased from Abbott Po...

Page 77: ...hat the printout is clear Paper is feeding but nothing is printed check that the paper is feeding from under the roll Printer not printing and Status light on continuously battery needs to be recharged Printer Power LED does not come on when printer turned on battery needs to be recharged The power adapter cannot supply sufficient for printing so the battery needs to be partially charged before pr...

Page 78: ...nt results from all models of the i STAT 1 Analyzer handheld Note This printer cannot be used with the i STAT Portable Clinical Analyzer PCA Power Button Paper Feed Button Power Indicator Status Indicator IR Window Paper Release Lever Power Button Paper Feed Button Power Indicator Status Indicator IR Window Paper Release Lever Data Connection Power Connection ...

Page 79: ...nting Printing Speed Battery Up to 10 lines per second AC Adaptor Up to 2 5 lines per second Temperature Operating 15ºC to 40ºC Storage 20ºC to 50ºC Printer Power Requirements The printer is rated at 12Vdc 1 5A max 18W External Power Supply Unit PSU The external PSU is rated at 100 240Vac 50 60Hz Fuses There are no operator replaceable fuses with the i STAT Printer Note This product has been teste...

Page 80: ...f printer paper not shown below ORDERABLE COMPONENTS The following individual i STAT Printer kit items can be ordered separately from Abbott Customer Service for replacement or supplemental inventory purposes ORDERABLE ITEM ABBOTT LIST NUMBER i STAT Printer 04P74 01 i STAT Combo Power Supply 04P74 02 Rechargeable Battery for the i STAT Printer 04P74 03 Portable Printer Paper 6 rolls per box 06F17 ...

Page 81: ...e of the paper feeding forward from the bottom of the roll 3 Sit the new paper roll in the compartment such that the leading edge is resting outside the compartment on the printer casing 4 Close the lid until it snaps into place Note 1 Should the paper become creased or misaligned simply reload the paper as described above ensuring that the paper has a clean straight edge Note 2 When removing a pr...

Page 82: ...aving mode A full charge takes approximately 3 hours Symptoms Indicating that the Rechargeable Battery Requires Replacement 1 A steady Orange or Red POWER indicator light on the printer even after charging it for the rec ommended 3 hours 2 Loss of battery capacity indicated by a shorter interval between charges Installing or Replacing the Rechargeable Battery in the i STAT Printer 1 Disconnect the...

Page 83: ...own 6 Slide the connector onto the three metal connector pins 7 Once the wires are connected place the battery portion of the pack into the rectangular compart ment Make sure the wires are not under the battery or projecting out of the opening The correct positioning is shown below ...

Page 84: ...to the AC adapter as shown 2 Plug the round connector from the AC adapter into the 12VDC port on the back of the i STAT Printer 3 Plug the power cord into a wall outlet PRINTING DIRECTLY FROM THE i STAT 1 HANDHELD 1 Ensure that the printer is turned on and that the POWER indicator is green 2 Align the handheld s IR communication window with the printer s IR LED window Generally the printer must be...

Page 85: ...Place i STAT 1 handheld in a Downloader or Downloader Recharger that is connected to the i STAT Printer 2 Display the results to be printed on the handheld 3 Press the key on the handheld Do not move handheld or printer until printing is complete 4 If printer is not powered from a wall outlet using the AC adapter turn printer off PRINTING MANY RESULTS 1 Turn the i STAT 1 handheld on 2 Press the Me...

Page 86: ...ncy test Free Fields Information entered into the Free Fields on the Chart Page when sample is patient or profi ciency test Time and Date Time and Date when test was performed Operator ID Operator ID Lot Number Lot number of cartridge Serial Number Serial number of the handheld Version Handheld application software CLEW Standardization software PRINTER CAUTIONS Use only a Rechargeable Battery pack...

Page 87: ...ow the first aid measures outlined in the MSDS Sheet for the Novacell nickel metal hydride battery PRINTER TROUBLESHOOTING PRINTER SYMPTOM RECOMMMENDED ACTION S Printer is not printing The POWER indicator light is green orange and the STATUS indicator light is green Check that the results are displayed on the handheld or that results have been selected from List under Data Review If printing direc...

Page 88: ...ved cleaning agents 10 bleach solution Isopropyl alcohol IPA PDI Super Sani Cloth solution of IPA n Alkyl dimethyl ethylbenzyl and benzyl ammonium chloride Rinse the printer casing using another gauze pad moistened with water and dry DO NOT IMMERSE THE PRINTER IN ANY FLUID AT ANY TIME i STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions ...

Page 89: ...y Check If the battery does not appear to accept charge during regular use follow the instructions below to determine if the i STAT Printer Rechargeable Battery is capable of charging 1 Plug AC adapter into Printer and wall outlet and install i STAT Printer Rechargeable Battery into the i STAT Printer 2 Make sure the Printer is turned off Perform a self test on the i STAT Printer by pressing the P...

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Page 91: ...o i STAT Portable Clinical Analyzer PCA i STAT 1 Analyzer This section describes the information management capabilities of the i STAT System and how the components can be integrated to meet the needs of point of care data management The i STAT 1 Analyzer With each cartridge use the analyzer allows entry of operator identification number patient identification number proficiency identification num...

Page 92: ...s send results automatically or by manual selection to another information system such as an LIS or HIS A validated and qualified Data Manager computer system may be purchased from Abbott Point of Care for use with the Central Data Station 5 software application The end user also has the option to purchase the computer system from another hardware vendor In those cases Abbott Point of Care will pr...

Page 93: ... IR Link and press the star key A single IR Link can be used to collect results from a limitless number of Portable Clinical Analyzers one at a time Transmission time is usually less than 15 seconds LIS HIS Interface The Data Manager typically connects to the Laboratory or Hospital Information System The user can manually select records to send or the Central Data Station application can be config...

Page 94: ...protocol Often no additional wiring needs to be installed but network ports or drops may need to be installed in walls at appropriate locations Also power outlets will need to be available at each location in order to provide power to the Downloaders Downloader Rechargers or terminal servers Using this method allows an unlimited number of Downloaders Downloader Rechargers and IR Links to be connec...

Page 95: ... Menu of the handheld These handhelds must be customized if applicable before being put into use These handhelds will also have the current standard CLEW and application software JAMS If a different version of CLEW or application software is in use it must be downloaded to these handhelds If location specific customization profiles are created analyzers should not be moved from one location to ano...

Page 96: ...e i STAT 1 Handheld Technical Bulletin in the Care and Software Update tabbed section of the i STAT 1 System Manual for full details PREFERENCES WINDOW Options and default settings are listed under six headings Instrument ID Entry Test Cartridge QC Results and Analyte Enable STATNotes Feature allows users to customize the Chart Page on their i STAT 1 Analyzers in order to capture user defined info...

Page 97: ...m the handheld s memory BATCH MODE TIMEOUT Not active at this time DISPLAY PASSWORD FOR CLOCK PAGE The default setting is enabled However it may be useful to disable password protection for the clock page in the Spring and Fall when clocks are set forward and backward one hour Enabled SYNCHRONIZE CLOCK TO CDS Will synchronize or update the real time clock in the i STAT 1 handheld to the Central Da...

Page 98: ...to continue and Lockout block testing until a valid Operator ID is scanned entered Continue without warning This option should not be enabled if the Use Operator List option is disabled Separate Actions can be chosen for Certification Expired or Operator Not On List EXPIRATION NOTIFICATION Allows a System Administrator to define a time period 1 255 days in which the operator will be notified by a ...

Page 99: ...Testing section When not enabled the operator can insert a cartridge and the test cycle will initiate Information is then entered during the test cycle Cartridge lot numbers are mandatory prompts for tests performed under Quality Tests The Scan Cartridge Barcode option is required for i STAT s immunoassays PATIENT TEST COMMENT CODE Options are No prompt or prompt as follows Prompt for Comment Code...

Page 100: ...ecified If the Schedule Option Lockout is selected the analyzer will continue to perform the simulator test and will continue to display FAIL on subsequent cartridges until the test passes If Lockout is not selected the simulator test will not be initiated again until next scheduled time Interval 24 hours Lockout PREFERENCE WINDOW for Cartridge QC Liquid QC Settings Option Description Default Comm...

Page 101: ...the status of previously defined Liquid QC Schedules Off PREFERENCE WINDOW for Cartridge QC Liquid QC Schedule 1 2 or 3 Option Description Default Comments QC FREQUENCY Describes the frequency at which the System Administrator wants the liquid QC run under this schedule Options are Off Disables the selected QC Schedule Daily Weekly A particular day of the week e g every Monday Monthly A particular...

Page 102: ...ages There are no bar graphs for blood gas coagulation and immunoassay tests Ranges are listed in the Cartridge and Test Information sheets Ranges will be displayed on the Customization screen of the handheld under the Administration Menu Only one range is allowed for each test in a particular handheld However different customization profiles can be set up in specific handhelds used for specific p...

Page 103: ...correction every time it runs a cartridge with a hematocrit sensor K3EDTA Prompt CPB See Theory section in this manual for explanation of CPB Analyzers can be customized by location Analyzers customized for CPB Always should not be used for reporting Proficiency Testing results DECIMAL SEPARATOR Select comma or period Period BASE EXCESS CALCULATION Select Base Excess of Extracellular Fluid BEecf o...

Page 104: ...git USS Check Digit CODE 39 OPTIONS Check Digit or No Check Digit Alphanumeric or Full ASCII Check Digit Full ASCII TRUNCATE DIGITS User can select how to truncate digits from a scanned operator and or patient ID First enter number of leading characters to be stripped from the barcode Last enter number of trailing characters to be stripped from the barcode No truncation The analyzer will accept up...

Page 105: ...mol L µmol L µmol L Glu mg dL mmol L mmol L mmol L mg dL mg dL mg dL mmol L mmol L mmol L mmol L Lac mmol L mmol L mmol L mmol L mmol L mmol L mmol L mmol L mmol L mmol L mmol L pH PCO2 PO2 mmHg kPa kPa mmHg mmHg mmHg mmHg kPa mmHg mmHg kPa Hct PCV PCV PCV PCV PCV PCV PCV Hb g dL g L g L g dL g dL g dL g dL mmol L g L g dL g dL HCO3 BE mmol L mmol L mmol L mEq L mmol L mmol L mEq L mmol L mmol L m...

Page 106: ...9 12 Art 714371 00E Rev Date 06 Aug 12 ...

Page 107: ... range to custom values to meet clinical and regulatory needs For example system administrators may wish to limit the display ranges to values that have been verified using calibration verification materials GENERAL NOTES AND CONSIDERATIONS 1 The Custom Reportable Range feature is only available on the i STAT 1 handheld and not the i STAT Portable Clinical Analyzer i STAT 200 series model 2 In ord...

Page 108: ...side the reportable range the dependent test results listed in the second column will be suppressed displayed as Reportable Range Limitations Test Outside the Reportable Range Dependent Suppressed Tests displayed as Na K Cl BUN Anion Gap Hgb Hct Hct Cl BUN Anion Gap Hgb PCO2 TCO2 Anion Gap Base Excess HCO3 sO2 pH TCO2 Anion Gap Base Excess HCO3 sO2 HCO3 TCO2 Anion Gap Base Excess sO2 Cl Anion Gap ...

Page 109: ...on box has a check mark in it Also make certain that the Enable Updates box is checked for the particular location to which the i STAT 1 handheld is assigned 4 If the location where this handheld is assigned has a check mark under Use Default Profile under the Default customization profile column double click the alphanumeric code under Preferences Otherwise double click the alphanumeric code unde...

Page 110: ... i STAT 1 System Manual Note 6 3 Users may not broaden the displayed Reportable Range beyond the default values If a value outside the default Reportable Range is entered the handheld will continue to display the default Reportable Range values for that analyte Note 6 4 Users should enter range values consistent with the resolution of the analyte unit being customized For example since sodium resu...

Page 111: ...ustomization box has a check mark in it Also make certain that the Enabled box is checked for the particular location to which the i STAT 1 handheld is assigned 3 If the location where this handheld is assigned has a check mark under Uses Default under the Default customization profile column double click the alphanumeric code under Preferences Otherwise double click the alphanumeric code under th...

Page 112: ...m Manual Note 5 3 Users may not broaden the displayed Reportable Range beyond the default values If a value outside the default Reportable Range is entered the handheld will continue to display the default Reportable Range values for that analyte Note 5 4 Users should enter range values consistent with the resolution of the analyte unit being customized For example since sodium results are reporte...

Page 113: ... THE CUSTOM REPORTABLE RANGES HAVE BEEN TRANSFERRED TO THE i STAT 1 HANDHELD FROM CDS VERSION 5 OR i STAT DE 1 Power on the i STAT 1 handheld and press MENU once to get to the Administration Menu 2 Press 4 Customization 3 Press 1 View 4 Press 5 Results ...

Page 114: ...oes not appear on the first page of the screen press the g key to find the page containing the analyte which has the customized display range and view the customized values In the example below the sodium Reportable Range has been customized to 110 170 mmol L i STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions ...

Page 115: ...System since no automated liquid QC lockouts were provided With this new customization feature the system administrator can define a customized QC plan that includes which cartridge types and liquid QC fluids must be run which cartridge types are enabled by running the liquid QC and under what schedule the liquid QC is to be performed A QC Profile Using the Customization Workspace in the i STAT CD...

Page 116: ...that the i STAT 1 Patient and Proficiency pathways are disabled until the QC test profile is satisfied A QC test profile is satisfied when at least one of each required QC cycle is run and is determined to have passed Once a given cartridge set is locked out its corresponding QC test cycles can still be run on the QC pathway i e the QC pathway is never locked out The following important lockout ru...

Page 117: ...y Control requirements are not met MINIMUM SOFTWARE REQUIREMENTS______________________________ The minimum handheld and data management requirements for use of the Liquid Quality Control Schedule and Lockout customization features are summarized as follows System Component Minimum Software Requirements i STAT 1 handheld JAMS132 Central Data Station Version 5 x Version 5 26a i STAT DE Version 2 3 ...

Page 118: ...n box has a check mark in it Also make certain that the Enable Updates box is checked for the particular location to which the i STAT 1 handheld is assigned 4 If the location where this handheld is assigned has a check mark under Use Default Profile under the Default customization profile column double click the alphanumeric code under Preferences Otherwise double click the alphanumeric code under...

Page 119: ...1 handheld Please see the Technical Bulletin Liquid Quality Control Pass Fail Customization on the i STAT 1 Handheld for instructions on activating and using this feature Manual the user will manually compare the liquid QC results to a Value Assignment Sheet downloaded or printed from the Abbott Point of Care APOC website at www abbottpointofcare com valsheets and indicate on the handheld whether ...

Page 120: ... If no password is set just press ENT 5 Press 4 QC Tests 6 Press 2 Cartridge QC 7 Press 2 to set Comment Codes for in range results or press 3 to set Comment Codes for out of range results 9 Select the way in which you would like control results to be displayed Numeric liquid QC results are displayed in numeric format Suppressed the following symbol is displayed next to each liquid QC test name in...

Page 121: ... press ENT If no password is set just press ENT 5 Press 4 QC Tests 6 Press 2 Cartridge QC 7 Press 5 to set APOC Fluid Lot Method 11 To set up a Liquid QC Schedule click on the Liquid QC Schedule 1 tab at the bottom of the screen 12 Select the frequency at which you want liquid QC to be run under this schedule Off Disables the selected QC Schedule Daily Weekly A particular day of the week e g every...

Page 122: ...dules up to 167 hours for weekly schedules and up to 255 hours for monthly schedules The minimum Grace Period is one hour for any schedule type 15 Select the months of the year in which you want this schedule to apply All months Selected months Check the box next to the months to which you want this schedule to apply 16 To define the Cartridge QC Profile click Edit to the right of the cartridge an...

Page 123: ... click OK Note 19 1 All i STAT control fluid types and levels are listed in the drop down menu along with three 3 generic user defined fluids For a list of the control fluids and their corresponding drop down menu titles see the Appendix at the end of this Technical Bulletin 20 The Cartridge QC profile will then appear on the Liquid QC 1 tab page Seven 7 additional Cartridge QC profiles can be cre...

Page 124: ...ces 23 Download the handheld s to the CDS from a downloader in the location to which the handheld is assigned This action will upload the chosen customization features into the handheld Repeat step 23 for all handhelds from the same location to be customized To customize handhelds from other locations for the same features return to step 1 of this section ...

Page 125: ...T Customization Workspace 2 Make sure the Enable Customization box has a check mark in it Also make certain that the Enabled box is checked for the particular location to which the i STAT 1 handheld is assigned 3 If the location where this handheld is assigned has a check mark under Uses Default under the Default customization profile column double click the alphanumeric code under Preferences Oth...

Page 126: ... to a Value Assignment Sheet downloaded or printed from the Abbott Point of Care APOC website at www abbottpointofcare com valsheets and indicate on the handheld whether the QC run passed or failed Note 6 1 The Manual Control Pass Fail Determination feature is also customizable through the i STAT 1 handheld keypad 1 Power on the i STAT 1 handheld and press MENU to get to the Administration Menu 2 ...

Page 127: ...antitative numeric results Note 8 1 The Suppressed option should only be chosen if Auto via eVAS is chosen for the liquid QC Pass Fail Determination Note 8 2 The Control Results Display Format feature is also customizable through the i STAT 1 handheld keypad 1 Power on the i STAT 1 handheld and press MENU to get to the Administration Menu 2 Press 4 Customization 3 Press 2 Change 4 Type in your pas...

Page 128: ...id QC to be run under this schedule Off Disables the selected QC Schedule Daily A particular day of the week e g every Monday A particular day of the month e g the second Tuesday of the month 12 Select the months of the year in which you want this schedule to apply All months Selected months Check the box next to the months to which you want this schedule to apply 13 Enter the QC Time The QC Time ...

Page 129: ...e the Cartridge QC Profile click Add a new QC group row at the bottom of the screen The Cartridge QC Profile box will open 16 Select the QC cartridge type from the drop down menu The QC cartridge is the cartridge type to be tested with specified liquid QC fluids during the QC procedure Note16 1 Selecting None will cease your ability to proceed through the remaining QC Schedule settings 17 In the D...

Page 130: ...ofiles for this schedule click Add a new QC Group row and proceed with steps 16 18 above 20 Once all profiles have been created for a Liquid QC Schedule additional Liquid QC Schedules can be created by clicking on the next numbered Liquid QC Schedule tab at the top of the Cartridge QC tab page Follow steps 11 19 above to create the additional schedules Up to three 3 Liquid QC Schedules can be crea...

Page 131: ...ve been compliant in running all liquid QC schedules in this handheld within the customized timeframe It indicates the upcoming date and time when the grace period begins for the next scheduled liquid QC is due 2 i STAT QC Due Complete Before Date This message will appear to remind users that the grace period has begun for one of the liquid QC schedules and the date and time before which all requi...

Page 132: ...led In these scenarios if any cartridge type is locked out all cartridge types are disabled Note When the handheld is customized for multiple liquid QC schedules there is a hierarchy which determines which of the four messages above will appear on the Test Menu display The messages will appear in this order i STAT QC Past Due Cartridge Testing Disabled QC Past Due Not All Cartridges Are Active For...

Page 133: ...y the QC Profile Once the cartridge type is selected the user is taken to a screen to select the fluid type being run Once the fluid type is selected the user proceeds as normal Manual Pass Fail Determination Once the results appear on the screen if the handheld is customized for Manual Control Pass Fail Determination the user will then be prompted to select an outcome as to whether the liquid QC ...

Page 134: ...C CKMB L2 Cliniqa Cardiac Marker Level 3 Control APOC CKMB L3 i STAT Level 1 Control APOC i STAT L1 i STAT Level 2 Control APOC i STAT L2 i STAT Level 3 Control APOC i STAT L3 i STAT CHEM8 Level 1 Control APOC Chem8 L1 i STAT CHEM8 Level 2 Control APOC Chem8 L2 i STAT CHEM8 Level 3 Control APOC Chem8 L3 RNA Medical Hematocrit Level 1 Control APOC Hct L1 RNA Medical Hematocrit Level 2 Control APOC ...

Page 135: ...ue Assignment Sheets VAS posted on the APOC website and comparing each test result value to the corresponding listed control range With the new QC Auto P F feature the system administrator can go to the APOC website and download an electronic value assignment sheet eVAS file an electronic file containing the complete set of the data from the current i STAT QC Value Assignment Sheets By saving the ...

Page 136: ... for the liquid QC test run 5 Unless numerical results have been suppressed through customization when the results of a liquid QC run are printed each analyte value is displayed on the printout along with the corresponding control range The symbol is used to indicate out of range results on the printout 6 When the i STAT 1 handheld is customized for QC Auto P F non APOC controls may be tested in t...

Page 137: ...ll not recognize the eVAS file if it has been renamed CDS Users If using the same computer where CDS resides select C Istat32 VAS as the file destination otherwise save the file to any directory and transfer to the CDS location i STAT DE Users choose any directory on a network which is accessible to i STAT DE However remember to note the destination directory as it will need to be accessed later w...

Page 138: ...mization 2 Type in your password and click OK The default password is the word istat 3 Make sure the Enable Customization box has a check mark in it Also make certain that the Enable Updates box is checked for the particular location to which the i STAT 1 handheld is assigned 4 At the bottom of the Default customization profile column check the Use eVAS box ...

Page 139: ...ol Pass Fail Determination section click the Automatic via EVAS radio button Choosing this option indicates that the handheld will automatically determine whether the liquid QC run passed or failed based upon QC ranges contained on an electronic Value Assignment Sheet eVAS file downloaded into the i STAT 1 handheld Note 8 1 The Manual Control Pass Fail Determination feature is also customizable th...

Page 140: ... Cartridge QC 7 Press 2 to set Comment Codes for in range results or press 3 to set Comment Codes for out of range results 10 Select the way in which you would like control results to be displayed Numeric liquid QC results are displayed in numeric format Suppressed the following symbol is displayed next to each liquid QC test name in place of the quantitative numeric results Note 10 1 The Suppress...

Page 141: ... enter the control lot number manually Note 11 2 The APOC Fluid Lot Entry Method is also customizable through the i STAT 1 handheld keypad 1 Power on the i STAT 1 handheld and press MENU to get to the Administration Menu 2 Press 4 Customization 3 Press 2 Change 4 Type in your password and press ENT If no password is set just press ENT 5 Press 4 QC Tests 6 Press 2 Cartridge QC 7 Press 5 to set APOC...

Page 142: ...Also make certain that the Enabled box is checked for the particular location to which the i STAT 1 handheld is assigned 3 To upload the eVAS file to i STAT DE at the top of the Customization Workspace click Update i STAT DE and select Upload Update File 4 When the Specify file for i STAT DE update box opens Click Browse 5 Navigate to the directory location of where the eVAS file was saved Select ...

Page 143: ... mark under Uses Default under the Default customization profile column double click the alphanumeric code under Preferences Otherwise double click the alphanumeric code under the Preferences column for the specific location to which this handheld is assigned 10 Once the Preferences window opens click on the Cartridge QC tab 11 Click on Liquid QC Settings at the top of the screen ...

Page 144: ...set just press ENT 5 Press 4 QC Tests 6 Press 2 Cartridge QC 7 Press 1 to set Pass Fail Method 13 If you want users to enter a Comment Code when liquid QC results are in range out of range or under both situations check the appropriate box es in the Control Test Settings section and then use the drop down menu to select whether entering the Comment Code is optional Allow no Comment or Required Req...

Page 145: ...method in which control lot number information will be entered into the handheld Scan or Enter allows the user the option of manually entering the liquid QC lot information into the handheld or scanning it from the barcode on the quality control vial being tested Scan only the fluid lot information must be entered by scanning the barcode on the control vial being tested Note 15 1 If customizing ha...

Page 146: ... s to the i STAT DE from a downloader in the location to which the handheld is assigned This action will upload the chosen customization features into the handheld Repeat step 17 for all handhelds from the same location to be customized To customize handhelds from other locations for the same features return to step 1 of this section ...

Page 147: ...IRMING THAT THE eVAS HAS BEEN TRANSFERRED TO THE i STAT 1 HANDHELD FROM CDS VERSION 5 or i STAT DE 1 Power on the i STAT 1 handheld and press MENU once to get to the Administration Menu 2 Press 4 Customization 3 Press 1 View 4 Press 4 QC Tests ...

Page 148: ...Art 730078 00A Rev Date 26 Oct 11 14 5 Press 2 Cartridge QC 6 Press the g key to view the eVAS Name that has been transferred to the handheld ...

Page 149: ...If the QC Auto P F customization feature is being used in conjunction with the Liquid QC Schedule customization feature and the user has selected 1 Control in the Quality Tests Menu on the handheld a new Select QC Event screen will appear on the display If the user selects 1 Unscheduled and then enters scans their operator ID the handheld will display a new screen requesting that they select a Flu...

Page 150: ...C Auto P F feature the Liquid QC results screen appearance will vary depending on whether the handheld is customized to display control results in a Numeric format or whether they are Suppressed along with whether the QC run Passed or Failed Numeric Control Result Display with a Passed QC run Numeric Control Result Display with a Failed QC run The status of individual failed results is displayed o...

Page 151: ...e display screen above the results Suppressed Control Result Display with a Failed QC run All analyte results will display a symbol and the overall Fail assessment appears at the top of the display screen above the results The status of individual failed results is displayed on the handheld as either an up arrow h for out of range high results or a down arrow i for out of range low results ...

Page 152: ...age Lot Not in eVAS The entered cartridge or control lot number could not be found in eVAS file Download current eVas file from the APOC website Value Assignment Sheet page Does Not Match Selected Level The entered control solution lot number does not match the user selected control level Invalid Length A blank control solution lot number was entered Lot Expired The entered control solution lot nu...

Page 153: ...int Commission National Patient Safety Goal of improving the accuracy of patient identification by obtaining at least two forms of patient identification prior to diagnostic testing GENERAL NOTES AND CONSIDERATIONS 1 The PPID feature is available only through the i STAT 1 handheld and requires the use of the RAL Plus or PrecisionWeb data managers with i STAT DE The PPID feature cannot be utilized ...

Page 154: ...uring subsequent cartridge testing when the operator scans a bar coded wrist band or manually enters a patient ID number the handheld verifies the entered patient ID is found in the handheld s patient list If the patient ID is found in the handheld s patient list the handheld will display the patient s name birth date and gender on the screen The operator can then verify that these identifiers mat...

Page 155: ...a manager the secondary identifiers along with a status flag indicating whether the patient ID was confirmed are included in the transmitted test record C PPID Customization Options There are a number of customization options available to tailor the handheld s PPID behavior to meet the specific needs of the facility Customization options are selected from the Customization Workspace in i STAT DE 1...

Page 156: ...splayed on the handheld N A Warn The operator is warned that the patient ID is not found in the active patient list Lockout Testing cannot be performed using this Patient ID Note 2 1 If Lockout is chosen above the system administrator can choose to enable or disable a lockout override If the override is enabled the operator can override the lockout by entering the patient ID twice Note 2 2 If Year...

Page 157: ... application pick i STAT from the drop down menu o Click on Device Customization PrecisionWeb Users o Double click the Desktop shortcut for the i STAT Customization Workspace 2 Ensure Enable Customization is checked Also ensure Enabled is checked for the particular location to which the i STAT 1 handheld is assigned 3 At the bottom of the Default Customization profile area check Use Patient List ...

Page 158: ... check Action Not on List and select the desired behavior when the entered patient ID is not found in the handheld s patient list Warn The operator is warned that the patient ID is not found in the active patient list Lock Out The operator is locked out from patient testing using the given patient ID Note 6 1 If you do not want the handheld to take any action if the entered patient ID is not found...

Page 159: ...of birth to confirm the patient ID The date of birth is not displayed on the handheld screen 9 Check the box next to Print ID attributes if you want secondary patient identifiers Name DOB Gender printed with test results on the i STAT or Martel printers 10 Once all options have been chosen click OK and answer OK to the question about changing the Preferences 11 If you want to configure the PPID se...

Page 160: ...CONFIRMING THAT THE PATIENT LIST HAS BEEN TRANSFERRED TO THE i STAT 1 HANDHELD FROM i STAT DE 1 Power on the i STAT 1 handheld and press MENU once to get to the Administration Menu 2 Press 4 Customization 3 Press 1 View 4 Press 2 ID Entry ...

Page 161: ...9 Art 730211 00B Rev Date 24 Feb 12 5 Press 2 Patient ID 6 Press the g key twice to view the Patient List Number that has been transferred to the handheld ...

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Page 163: ...ned off Functionality The system administrator will define a time period of notification in the Customization Workspace of the data management system When the operator scans or enters their operator ID in the i STAT 1 handheld if their competency certification will expire within the timeframe set by the system administrator a message will appear on the handheld display alerting them of the expirat...

Page 164: ...nces in the Default Customization Profile column Otherwise double click the alphanumeric code under Preferences for the specific location to which this handheld is assigned 3 Once the Preferences window opens click on the ID Entry tab 4 In the Operator ID section check the Expiration Notification box and type in the number of days between 1 and 255 in which the operator will be notified of their c...

Page 165: ...eld is assigned 3 Once the Preferences window opens click on the Instrument tab 4 In the i STAT Reserved Data section type CE XXX where XXX indicates the number of days between 1 and 255 in which the operator will be notified of their certification expiration 5 Click OK and answer YES to the question about changing the Preferences 6 Download the handheld s to the CDS from a downloader in the locat...

Page 166: ...Art 730292 00A Rev Date 20 Feb 12 4 ...

Page 167: ...balance electrolyte studies metabolic studies coagulation studies hematologic studies Observe the following precautions I V Line Avoid drawing from an arm with an I V line I V solutions will dilute the sample and may interfere with the tests Tourniquet Venous stasis prolonged tourniquet application and forearm exercise may increase ionized calcium due to a decrease in pH caused by localized produc...

Page 168: ... i STAT Glucose and BNP cartridges It may be convenient to collect a single EDTA tube when testing for glucose and glycated hemoglobin HbA1c simultaneously EDTA may not be used with any cartridge type other than the Glucose or BNP cartridges EDTA will cause a clinically significant error in sodium potassium chloride and hematocrit results and may affect other chemistry tests Do not use an EDTA sam...

Page 169: ...ratios which will decrease ionized calcium results and may affect other results Under filling blood collection tubes with and without anticoagulant may also cause decreased PCO2 HCO3 and TCO2 results Partial draw blood collection tubes evacuated tubes that are adjusted to draw less than the tube volume e g a 5 mL tube with enough vacuum to draw only 3 mL with or without anticoagulant are not recom...

Page 170: ...ting should be drawn into a plastic collection device syringe or blood collection tube containing no anticoagulant clot activators or serum plasma separators Any transfer device dispenser capillary tube pipette or syringe must be plastic and must not contain anticoagulant Samples collected into glass tubes or syringes or in tubes containing anticoagulants activators or separators cannot be used wi...

Page 171: ...ma samples collected in plastic syringes or evacuated tubes containing EDTA The use of glass vessels is not recommended because the BNP molecule has been shown to be unstable in glass tubes The use of whole blood or plasma samples containing other anticoagulants such as heparin oxalate and citrate is not recommended i STAT cTnI and CK MB cartridges require the use of either 1 heparinized whole blo...

Page 172: ...t may be difficult to properly remix a sample in a 1 0 cc syringe Sample on Ice Fill the cartridge before icing the sample for transport Icing will increase the potassium and will affect oxygen levels in samples collected in plastic syringes ARTERIAL PUNCTURE ACT TESTS Blood Flow Collection technique resulting in good blood flow must be used Inadequate blood flow may produce erroneous results Plas...

Page 173: ...o vigorous massaging or milking Hemolysis will cause an increase in potassium results and a decrease in calcium results To increase blood flow massage a finger gently from about three inches from the tip to the fleshy portion of the tip Avoid hemolysis by allowing residual alcohol to dry over the puncture site Tissue Fluid For tests other than PT INR cartridges wipe away the first drop of blood as...

Page 174: ...dispensers that would introduce air into the sample when ionized calcium pH or PCO2 are being measured For coagulation testing the dispenser must be plastic and must not contain anticoagulant Anticoagulant Most heparinized capillary tubes are not suitable for electrolyte measurements especially ionized calcium due to the high concentration of heparin 50 U mL or more Use balanced heparin tubes or p...

Page 175: ...400 Wayne Pennsylvania 19087 USA 2004 6 CLSI H18 A2 Procedure for the Handling and Processing of Blood Specimens Approved Guideline Second Edition CLSI document H18 A2 ISBN 1 56238 388 4 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 1999 7 CLSI H21 A3 Collection Transport and Processing of Blood Speci mens for Coagulation Testing and General Performance of Coagulation Assays A...

Page 176: ...10 10 Art 714372 00L Rev Date 30 Jul 12 ...

Page 177: ...ouch prolonged exposure may cause a cartridge to fail a Quality Check If the pouch has been punctured the cartridge should not be used Once cartridges have been brought to room temperature they should not be returned to the refrigerator Cartridges may be stored at room temperature for the time frame indicated on the cartridge box Contact Pads Do not contaminate the contact pads with fingerprints o...

Page 178: ... Remove cartridge from foil pouch and place the cartridge on a flat surface 2 Prepare lancet device and set aside until needed 3 Clean and prepare the finger to be sampled using a 70 aqueous solution of isopropanol 70 v v Allow the finger to dry thoroughly before sampling When disinfecting fingerstick skin puncture sites swabs or solutions containing substances other than isopropanol e g Chlorhexi...

Page 179: ...urface for testing 1 Following thorough mixing of the sample direct the transfer device either syringe tip or pipette tip into the inlet port Apply a single drop of sample to the inlet port If the cartridge fill is incomplete as seen via the fill indicator on the cartridge label apply a second small drop until the sample reaches the fill mark 2 To close the immunoassay cartridge a first anchor the...

Page 180: ... cartridge port until it clicks into place Removing Cartridge from Analyzer 3 Do not attempt to remove the cartridge while the message Cartridge Locked remains on the screen 4 When results are displayed pull the cartridge straight out of the analyzer 5 Dispose of the cartridge in a container for biohazards following local state and national regulatory guidelines INSERTING AND REMOVING THE CARTRIDG...

Page 181: ...UFFICIENT SAMPLE Sample well overfilled If the sample well is so full that sample is seen above the sample well after the sample chamber is filled do not wipe or absorb the excess with a gauze or tissue but draw the excess back into the syringe or a capillary tube If the sample spreads over the outside of the sample well an airtight seal may not form when the cartridge is closed In this case the a...

Page 182: ...11 6 Art 714373 00F Rev Date 17 Jan 11 ...

Page 183: ...dical Laboratories Fourth Edition 1999 or the WHO Laboratory Biosafety Manual Second Edition 2003 To protect from nosocomial infections decontaminate analyzers periodically and whenever blood is spilled or transferred to an analyzer See under Cleaning the Analyzer and Downloader in section 17 of this manual A falling analyzer may cause injury Always place the analyzer and peripherals on a stable s...

Page 184: ...12 2 Art 714374 00J Rev Date 25 Aug 11 ...

Page 185: ...Art 714374 00J Rev Date 25 Aug 11 12 3 ...

Page 186: ...12 4 Art 714374 00J Rev Date 25 Aug 11 ...

Page 187: ...Art 714374 00J Rev Date 25 Aug 11 12 5 ...

Page 188: ...12 6 Art 714374 00J Rev Date 25 Aug 11 for i STAT Cartridge A level surface includes running the handheld in the downloader recharger 7 Review results PERFORMING PATIENT ANALYSIS ...

Page 189: ...he default Customization profile are derived from the literature and are listed in the Cartridge and Test Information section as well as in the Customization option on the analyzer Variables such as sex age heritage and other demographic factors of a population may cause a shift in these ranges Therefore it is usually recommended that each facility determine its own reference ranges Reference rang...

Page 190: ... anion gap base excess and sO2 if the TCO2 is 1 or 80 mmol L Because the values outside this range are essentially non physiological the TCO2 range check is used as an additional quality check on the validity of the underlying pH and PCO2 results If a sodium result is displayed as 180 the calculations for potassium chloride BUN Urea and hematocrit which depend upon the sodium measurement will be f...

Page 191: ...esh sample from the patient and retest If the stars appear in place of results again there may be an interfering substance Refer to the Cartridge and Test Information section for a list of interfering substances Test the sample using another method If the control is out of range or if stars are displayed in place of results there may be a problem with the cartridge lot number Use another lot numbe...

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Page 193: ... Port functionality will be permanently disabled on all i STAT 1 Handhelds Note The remaining technical information regarding the Glucose Strip Port will be removed from the i STAT 1 System Manual by April 2013 Please contact your Support Services representative for information on transitioning to an Abbott Diabetes Care blood glucose monitoring system ...

Page 194: ......

Page 195: ...LITY CONTROL FOR i STAT CARTRIDGES AND THE ANALYZER S CARTRIDGE TEST CYCLE Verify Performance of Analyzers Daily Verify the performance of each analyzer on site using the Electronic Simulator external or internal once a day on the days the analyzers are in use Note that regulatory or accreditation requirements may dictate more frequent intervals Verify Newly Received Cartridges 1 Verify that the t...

Page 196: ...me the external Electronic Simulator is used To complete this check the surface temperature of the external Electronic Simulator must not fluctuate If this condition is not met the thermal probe check is not completed Therefore i STAT recommends that the thermal probe check be verified every six months Check Thermal Control System Every Six Months Check Room Temperature Storage Daily Verify that t...

Page 197: ...Control Level 1 Calibration Verification Level 3 and Control Level 2 Calibration Verification Level 4 and Control Level 3 Calibration Verification Level 5 Na mmol L 108 127 141 169 187 K mmol L 2 3 3 1 4 0 6 8 8 5 Cl mmol L 71 85 100 122 133 Glu mmol L 1 8 2 5 7 3 17 35 Urea mmol L 44 6 18 4 2 7 1 8 iCa mmol L 2 5 1 6 1 3 0 8 0 2 Lac mmol L 19 5 8 4 2 3 1 0 6 Crea μmol L 1486 386 155 46 17 PO2 mmH...

Page 198: ...lutions such as controls lack the buffering capabilities of whole blood the transfer process from ampule to cartridge must be more expedient than with a patient sample Before Use i STAT control solutions require different temperature stabilization times depending on whether or not oxygen is to be measured If oxygen is to be measured equilibrate the ampule for 4 hours If not equilibrate the ampule ...

Page 199: ...the absence of red blood cells containing hemoglobin which binds oxygen molecules This is of practical significance when testing aqueous solutions on blood gas analyzers as there will be a detectable shift in the partial pressure of oxygen in the sample as it equilibrates to the pressure in the flowpath of the analyzer The ranges for i STAT aqueous control solutions are established for the degree ...

Page 200: ... 30 C or 64 to 86 F Prolonged storage at temperatures greater than 30 C 86 F may cause changes in the values of some analytes Do not use beyond the expiration date on the box and ampule labels Best Results For best results ampules cartridges and analyzer should be at the same temperature Ampule Use A separate ampule must be used for each cartridge being tested Do not use the solution left in a syr...

Page 201: ... to the cartridge When using a capillary tube fresh capillary tubes with sufficient fill capacity are recommended fill from the bottom of the ampule to avoid drawing air into the capillary tube Avoid drawing solution from the surface by placing a finger over the far end of the tube as it is inserted into the ampule Once the open end of the tube rests at the bottom of the ampule uncover the other e...

Page 202: ...stable until the expiration date stated on the ampule when stored at temperatures of 2 25 C Do not freeze or expose ampules to temperatures greater than 30 ºC If stored refrigerated the control material should be equilibrated to room temperature for at least four 4 hours prior to testing The product may turn slightly yellow in color over its shelf life if stored at room temperature This coloration...

Page 203: ...andle this product using the same safety precautions used when handling any potentially infectious material The human plasma used in the preparation of this product has been tested by FDA approved test methods and found negative non reactive for HIV 1 HIV 2 HBsAg and HCV However no known test method can offer complete assurance that products derived from human blood will not transmit infectious di...

Page 204: ... do not leak or spill out 3 Allow the vial to sit at room temperature for 1 minute 4 Mix the contents of the vial by swirling gently for 1 m i n u t e t h e n i n v e r t i n g s l o w l y f o r 3 0 s e c o n d s Note To minimize foaming of the control sample avoid vigorous or rapid mixing motion Visually inspect the control vial to ensure that the sample is fully reconstituted If not discard the ...

Page 205: ...constituted If not discard and start over with fresh vials 5 Using a plastic transfer pipette plastic syringe or plastic capillary tube with no anticoagulant immediately transfer the solution from the vial into the PT INR cartridge 6 Immediately seal the cartridge and insert it into an analyzer Note Additional PT INR cartridges may be tested with the remaining fluid if used within 30 seconds of co...

Page 206: ...vial is stable for 4 hours when capped and stored at 2 8o C 35 46 o F Do not re freeze Procedure Step Action 1 Remove vial from freezer and thaw at room temperature 18 30 C for 15 minutes 2 Thoroughly mix by gently swirling the bottle Avoid foaming of the sample 3 Dispense a drop of sample directly from vial into the i STAT cTnI cartridge and seal the cartridge Tightly recap the bottle immediately...

Page 207: ...ring no reconstitution or frozen storage It is stable until the expiration date on the vial label when stored unopened at 2 8 C Once opened CLINIQA Liquid QC Cardiac Marker Control is stable for 30 days when stored tightly capped at 2 8 C Procedure 1 Access the i STAT Cartridge Control option under Quality Tests in the Administration Menu Enter the required information The analyzer allows 15 minut...

Page 208: ...reezer After thawing the opened or unopened vial is stable for 4 hours when capped and stored at 2 8 C 35 46 F Do not re freeze Procedure 1 Remove vial from freezer and thaw at room temperature 18 30 C for 15 minutes 2 Gently invert the vial 10 times then swirl the vial 10 times Inspect the sides of the vial to ensure that no particulate matter is clinging to the sides of the vial If solids are ob...

Page 209: ... Administration Menu Press 3 to select Quality Tests Quality Tests Menu Press 4 to select Simulator Scan or Enter Operator ID Press Scan to scan the Operator ID or manually enter the Operator ID and press Enter If enabled the analyzer will validate ID and or ask for the ID to be repeated Scan or Enter Simulator ID Press Scan to scan the Simulator ID or manually enter the Simulator ID and press Ent...

Page 210: ...est until the specified time has elapsed Verify the analyzer using an external Electronic Simulator With both the internal and external Electronic Simulator an analyzer may occasionally fail a simulator test even though it is in proper operating condition due to the extremely sensitive nature of the test External Simulator Run the test again or try another simulator as it is possible that the test...

Page 211: ...dure below to check the thermal probes on each analyzer every six months Internal Electronic Simulator used routinely Use the procedure below to check the thermal probes on each analyzer twice a year Procedure for Handheld Analyzers Check the thermal probes on the i STAT Portable Clinical Analyzer and i STAT 1 Analyzer as follows 1 If the analyzer and simulator have been stored separately in areas...

Page 212: ...the Manual to record the results PERFORMING CONTROL TEST ON CARTRIDGE Procedure for Testing Controls Initiating control tests from the Quality Test Menu allows results to be stored in separate categories for the purpose of documentation and review NOTE RNA Medical Controls must be tested using this control path and not as a patient sample A level surface includes running the handheld in the downlo...

Page 213: ...rol ampule or vial have not been exceeded Room temperature expiration date for cartridge and control have not been exceeded Cartridge and control have been stored correctly The control has been handled correctly See the directions for use The analyzer being used passes the Electronic Simulator test If the results are still out of range despite meeting the above criteria repeat the test using a new...

Page 214: ...14 20 Art 714376 00M Rev Date 31 Jan 12 ...

Page 215: ...ol Name _____________________________ Level _ _ __________________ Lot No _____________________ Exp Date __________________ TEST TEST TEST TEST TEST TEST TEST TEST RANGE RANGE RANGE RANGE RANGE RANGE RANGE RANGE Control Name _____________________________ Level _ _ __________________ Lot No _____________________ Exp Date __________________ TEST TEST TEST TEST TEST TEST TEST TEST RANGE RANGE RANGE R...

Page 216: ...14 22 Art 714376 00M Rev Date 31 Jan 12 ...

Page 217: ... Jan 12 14 23 i STAT System QC Log Expiration Date and Storage Conditions REFRIGERATED 2 TO 8 C 35 TO 46 F ROOM TEMPERATURE 18 TO 30 C 64 TO 86 F DATE LOCATION CARTRIDGE TYPE LOT QTY EXP DATE TEMP QTY EXP DATE TEMP ACTIONS INSP ...

Page 218: ...14 24 Art 714376 00M Rev Date 31 Jan 12 ...

Page 219: ...Art 714376 00M Rev Date 31 Jan 12 14 25 i STAT Cartridge Quality Control Action Log DATE TIME CONTROL LEVEL CONTROL LOT CARTRIDGE LOT PROBLEM CORRECTIVE ACTION OPERATOR ...

Page 220: ...14 26 Art 714376 00M Rev Date 31 Jan 12 ...

Page 221: ...e 31 Jan 12 14 27 i STAT Electronic Simulator Log for Analyzer Serial Number ________________ Year _________ DATE TIME PASS FAIL SIMULATOR ID OPERATOR TIME PASS FAIL SIMULATOR ID OPERATOR TIME PASS FAIL SIMULATOR ID OPERATOR ...

Page 222: ...14 28 Art 714376 00M Rev Date 31 Jan 12 ...

Page 223: ...Art 714376 00M Rev Date 31 Jan 12 14 29 i STAT Electronic Simulator Action Log DATE TIME ANALYZER FAILURE CODE OR LETTER SIMULATOR ID ACTION OPERATOR ...

Page 224: ...14 30 Art 714376 00M Rev Date 31 Jan 12 ...

Page 225: ...OMMENTS OPERATOR Analyzer Serial No ____________________________ DATE SIMULATOR SERIAL NO THERMAL PROBE DELTA RESULT LIMIT 0 1 C COMMENTS OPERATOR Analyzer Serial No ____________________________ DATE SIMULATOR SERIAL NO THERMAL PROBE DELTA RESULT LIMIT 0 1 C COMMENTS OPERATOR Analyzer Serial No ____________________________ DATE SIMULATOR SERIAL NO THERMAL PROBE DELTA RESULT LIMIT 0 1 C COMMENTS OP...

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Page 227: ...terials that combine the ability to assay hematocrit blood gases electrolytes and chemistries This enables reduced control testing in cases where all of these tests are being evaluated and used Note The additive used to simulate the effect of hematocrit results in reduced precision Refer to the Precision section at the end of this document for additional details Abbott List Number Device Name 05P7...

Page 228: ... Materials Analyte Calibration Verification Level 1 Calibration Verification Level 2 and Control Level 1 Calibration Verification Level 3 and Control Level 2 Calibration Verification Level 4 and Control Level 3 Calibration Verification Level 5 Na mmol L 97 118 124 150 159 K mmol L 2 30 3 00 4 00 6 30 8 20 Cl mmol L 67 76 94 119 134 Glu mg dL 595 285 160 65 53 Urea mg dL 114 44 8 4 4 6 3 0 iCa mmol...

Page 229: ...ON 1 Access the Control option under Quality Tests in the Administration Menu Enter the required information The handheld allows 15 minutes or the customized timeout to insert the cartridge after the last data entry 2 Immediately before use shake the ampule vigorously for 5 to 10 seconds to equilibrate the liquid and gas phases To shake hold the ampule at the tip and bottom with forefinger and thu...

Page 230: ...ore filling the cartridge Target Values Target values determined by testing multiple ampules of each level using multiple lots of cartridges and i STAT handhelds that have passed the Electronic Simulator test are printed on a Value Assignment Sheet posted on the APOC website at www abbottpointofcare com Ensure that the lot number printed on the Value Assignment Sheet matches the lot number on the ...

Page 231: ...creen Approximate change For every decrease of 35 mmHg in pressure from 760 mmHg add 1 mmHg to the observed value CALIBRATION VERIFICATION FOR BLOOD GAS ELECTROLYTE METABOLITE CARTRIDGES i STAT TRICONTROLS Purpose Calibration Verification is a procedure intended to verify the accuracy of results over the entire measurement range of a test The performance of this procedure at defined intervals may ...

Page 232: ...ted expiration date on the box and ampule labels TriControls solutions may also be maintained at room temperature 18 30 ºC 64 86 ºF for up to 5 days Do not use TriControls solutions past the labeled expiration date on the box and ampule labels Ampule Use When using cartridges that contain sensors for pH PCO2 PO2 and ionized calcium a separate ampule must be used for each cartridge being tested Do ...

Page 233: ...e 5 Immediately seal the cartridge and insert it into a handheld it is important not to expose the solution to room air since this will alter the results Note Since aqueous based solutions such as control materials lack the buffering capability of whole blood the transfer process from ampule to cartridge must be more expedient than with a patient sample Transfer with Capillary Tube Plain capillary...

Page 234: ...d If testing at extreme altitude refer to Correction of PO2 at Extreme Altitude paragraph in section CONTROLS FOR BLOOD GAS ELECTROLYTE METABOLITE CARTRIDGES i STAT TriControls above PRECISION The additive used in the aqueous based TriControls to simulate the effect of hematocrit in blood samples results in reduced precision in repeat measurement of electrolytes relative to the precision obtained ...

Page 235: ... abbottpointofcare com Analyte Level 1 Level 3 Mean SD CV Mean SD CV Na mmol L 120 0 46 0 4 158 1 39 0 9 K mmol L 2 85 0 038 1 3 6 15 0 058 0 9 Cl mmol L 72 9 0 63 0 9 113 6 2 30 2 0 Glu mg dL 289 2 4 0 8 41 8 0 68 1 6 Urea mg dL 69 7 0 94 1 3 5 5 0 45 8 2 iCa mmol L 0 84 0 012 1 4 1 51 0 030 2 0 Lac mmol L 6 35 0 08 1 3 0 810 0 03 3 7 Crea mg dL 4 16 0 123 3 0 0 50 0 046 9 1 PCO2 mmHg 63 8 1 57 2...

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Page 237: ...e Potassium PCO2 Lactate Chloride PO2 BUN Urea Ionized Calcium Creatinine There are four 1 7mL glass ampules of each level in the set Storage Refrigerated storage at 2 to 8 C 35 to 46 F should be maintained until the printed expiration date on the box and ampule labels Calibration Verification fluids may also be stored at room temperature for up to 5 days 18 to 30 C or 64 to 86 F Prolonged storage...

Page 238: ...ng capabilities of whole blood the transfer process from ampule to cartridge must be more expedient than with a patient sample Transfer with Capillary Tube Plain capillary tubes are recommended to transfer aqueous calibration verification material from the ampule to the cartridge When using a capillary tube fresh capillary tubes with sufficient fill capacity are recommended fill from the bottom of...

Page 239: ...anual Overview of Procedure i STAT recommends that each sensor type be included in the Calibration Verification procedure using a selection of analyzers that have passed the Electronic Simulator check See the Technical Bulletin Calibration Verfication and the i STAT System for more information Calibration Verification Solutions for CHEM8 Cartridges A five level Calibration Verification Set is avai...

Page 240: ...ransfer aqueous calibration verification material from the ampule to the cartridge When using a capillary tube fresh capillary tubes with sufficient fill capacity are recommended fill from the bottom of the ampule Avoid drawing solution from the surface by placing a finger over the far end of the tube as it is inserted into the ampule Once the open end of the tube rests at the bottom of the ampule...

Page 241: ...utions used when handling any potentially infectious material The human sera used in the preparation of this product have been tested by FDA approved test methods and found negative non reactive for HIV 1 HIV 2 HBsAg HCV HTLV 1 and HTLV 2 However no known test method can offer complete assurance that products derived from human blood will not transmit infectious disease Each vial contains 0 1 sodi...

Page 242: ...in this product may react with lead and copper plumbing to form highly explosive metal azides Flush drain with large amounts of water to prevent azide build up Do not use if the calibration verification materials arrive thawed or uncapped Bacterial contamination of the control can cause an increase in turbidity Do not use the calibration verification material if there is visible evidence of microb...

Page 243: ...ng The product may turn slightly yellow in color over its shelf life if stored at room temperature This coloration is normal and does not affect product performance Directions For Use 1 Beginning with Level 1 gently invert the ampule to mix the solution Tap the ampule to restore the liquid to the bottom of the ampule 2 Open the ampule by snapping off the tip at the neck Use gauze tissue gloves or ...

Page 244: ... 3 This plasma should be held in a clean plain tube in case it is needed to make adjustments 6 Gently invert tubes 1 2 and 3 to resuspend the cells 7 Measure the hematocrit of the blood in tubes 1 2 and 3 using one cartridge for each tube Adjust the hematocrit in tube 1 until it reads close to but not less than 10 Adjust the hematocrit in tube 3 until it reads close to but not more than 75 Measure...

Page 245: ...y calibration and reportable range of the i STAT hematocrit However the following requirements apply Blood should be drawn from a fasting donor with a normal hematocrit and a normal MCHC calculated from hemoglobin and hematocrit values determined using reference methods and be free of specific interferences which degrade the accuracy and or precision of the alternative comparative method or the i ...

Page 246: ...RE FOR CARTRIDGES Initiating Calibration Verification tests from the Quality Tests menu allows results to be stored in seperate categories for the purpose of documentation and review Also measurement limits are not applied to results in this test path Therefore results below and above the measurement ranges will be reported A level surface includes running the handheld in the downloader recharger ...

Page 247: ...llows results to be stored in separate categories for the purpose of documentation and review Proficiency samples should be tested in the same way as patient samples The same CLEW is used for the patient test path and the Proficiency test path The Proficiency test path uses K3 EDTA standardization coefficients for Hematocrit and disables the CPB mode It also uses the PREWARM mode for ACT This ensu...

Page 248: ...or other comparative methods Aqueous samples that contain a resistive substance to allow assessment of conductometric hematocrit measurements will cause the i STAT System to extrapolate ambient temperature results to 37 C results for pH and PCO2 as if the sample were whole blood Since extrapolation coefficients for aqueous and whole blood samples differ results on the i STAT System for these sampl...

Page 249: ...s fluids in the seam between the display screen and the case PDI and Sani Cloth are registered trademarks of Sani System Brand Products the Health Care Division of Nice Pak Products Orangeburg NY USA Cleaning the Analyzer and Downloader Caution Exercise universal safety precautions at all times when handling the analyzer cartridges and peripherals to prevent exposure to blood born pathogens The an...

Page 250: ...ompartment door off 2 Tilt the analyzer slightly to slide out the battery carrier which contains the two 9 volt batteries 3 Remove the old batteries from the carrier Pull each battery out to the side and then lift back and out 4 Note the battery orientation symbol molded into the carrier on each side of the center wall Starting with one side orient the new battery so it matches the symbol Slide th...

Page 251: ...de the battery compartment door off 2 Tilt the analyzer slightly to slide out the rechargeable battery pack 3 The battery pack has two labels one for orientation in the analyzer and one for orientation in the Downloader Recharger With the label with the analyzer facing up and the electrical contact end of the pack facing the analyzer insert the pack into the analyzer as shown on the label If the p...

Page 252: ...17 4 Art 714379 00F Rev Date 18 Jul 12 ...

Page 253: ...on updating your i STAT 1 Handheld please refer to the following Technical Bulletins directly following section 18 in your i STAT 1 System Manual 1 Instructions for Updating i STAT 1 Handheld Software Art 725708 00E 2 Network Options for Updating the i STAT 1 Handheld Art 725768 00E ...

Page 254: ......

Page 255: ...acturing process improvements to the i STAT System it is necessary to update standardization values from time to time to maintain long term consistency of performance These updates are equivalent to manually adjusting calibration on a traditional laboratory analyzer New CLEW software delivered twice a year on a CD ROM re establishes these standardization values and incorporates refinements to the ...

Page 256: ...or Abbott Diabetes Care PrecisionWeb who would like to update i STAT 1 Handhelds via the data management software please consult Network Options for Updating the i STAT 1 Handheld i STAT Technical Bulletin 725768 Instructions for Using This Technical Bulletin Color Coded Sections This bulletin contains color coded sections to easily identify the steps associated with the different methods for upda...

Page 257: ...ronic Simulator When using a DS 300 or DRS 300 a computer with a traditional 9 pin serial port is required If the computer does not have one follow your internal technical support procedure i e contact the IT Department or the individual in your office responsible for computer support Indicate that the i STAT 1 software update process requires a 9 pin serial port a CD ROM Drive Need technical supp...

Page 258: ... with the 9 pin null modem serial cable as shown If using a DRC 300 connect the DRC 300 to the USB port on the back of the computer with the USB cable as shown Note These instructions assume that the DRC 300 has already been installed per Art 728690 The i STAT 1 Downloader Recharger model number DRC 300 for serial communications Rechargeable Batteries Disposable Batteries If you have disposable ba...

Page 259: ... power is supplied to the Serial Downloader Recharger or DRC 300 it will look as it did before power was supplied Close all open programs on the computer including i STAT Central Data Station if applicable Before inserting the Software and Documentation CD check that the JAMS application and CLEW match the Product Update Insert the Software and Documentation CD into the CD ROM drive Loading JAMS C...

Page 260: ...ll other users should proceed directly to step 1 11 Double click Double click TRANSFER BAT Next an additional window will open briefly then close Return back to the main CD ROM page and proceed to step 1 11 To open the Software and Documentation CD ROM Double click the following icon Double click CD ROM Drive The following window will appear CD ROM TRANSFER BAT 1 8 1 9 1 10 ...

Page 261: ...rt 725708 00E Rev Date 07 FEB 12 7 To open the JAMMLITE Utility Double click Double click If the JammLite program does not launch or you receive an error message contact APOC Technical Support and tell the support specialist you are unable to complete step 1 of this document In the JammLite utility select the i STAT 300 Analyzer within the Instrument dropdown menu Updating Your i STAT 1 Handheld i...

Page 262: ...ection to that COM port now Art 725708 00E Rev Date 07 FEB 12 8 Check that the Application and CLEW listings match those in the Product Update Note Application and CLEW numbers are for example only The numbers have been replaced with X s in the example above and will change with each software update Click the Update button If an error occurs check the serial connection between the downloader and t...

Page 263: ...mming application block 108 2055 Close The application update was successful The CLEW update was successful Cancel 1 If an analyzer is already in the Downloader remove it 2 Ensure the analyzer to be updated is off 3 Place the analyzer in the Downloader If using the Serial Downloader Recharger a blue light will illuminate when the Handheld is placed correctly within it If using the Serial Downloade...

Page 264: ... are additional Handhelds to update via JammLite Click Close Click Update Repeat Steps through If there are additional handhelds to update with the Handheld to Handheld process Go to on page 11 If your facility uses Central Data Station You must proceed to on page 16 Congratulations The process for updating the first i STAT 1 Handheld is complete Review the options below for additional instruction...

Page 265: ...ld unit to be updated referred to in this section as the Receiving Handheld charged to 7 5 volts or higher Electronic Simulator After updating the first i STAT 1 Handheld follow these steps to update additional Handhelds with the Handheld to Handheld Process Art 725708 00E Rev Date 07 FEB 12 11 For information on checking battery power see page 4 step 2 1 Gathering All Equipment Handheld to Handhe...

Page 266: ... MENU and select 7 Utility If the correct password was not entered the Utility Menu will not appear Check for data entry errors and retry If still unsuccessful call APOC Technical Support and indicate A Handheld to Handheld update has been attempted Password for Utility Menu is unknown When prompted for a password press ENT and continue Sending Handheld Receiving Handheld Make sure the power is of...

Page 267: ...tware update Make sure the Receiving Handheld s power is off When the Sending Handheld displays WAITING TO SEND Keep the infrared windows aligned Without lifting either Handheld off the flat surface move the Receiving Handheld towards the Sending Handheld until the Sending Handheld displays SENDING Sending Handheld Receiving Handheld 2 6 2 7 Updating your i STAT 1 Handheld Handheld to Handheld ...

Page 268: ...ith a bar indicating that the software is being sent The Receiving Handheld will have 1 s and 0 s streaming across the screen signifying that it is receiving the software Do not move the Handhelds until the Sending Handheld goes back to the Utility menu and displays Last Send Successful The update is now complete 2 8 ...

Page 269: ...Simulator attempt fails please contact APOC Technical Support Art 725708 00E Rev Date 07 FEB 12 15 Run the Electronic Simulator in the newly updated Handheld When the simulator finishes PASS will be displayed Congratulations The process for updating an additional i STAT 1 Handheld is complete If there are other i STAT 1 Handhelds to update repeat steps through If there are no other Handhelds to up...

Page 270: ...Open Administration Function Customization Follow these steps to update the Central Data Station Customization Workspace Central Data Station is an optional software component used to collect data from i STAT Handhelds Art 725708 00E Rev Date 07 FEB 12 16 Main System Tools Window Help Open Monitor Open Administration Function Open Data Viewer Open Report Close Exit Alt x Instrument Location Operat...

Page 271: ...all CLEW by going to pages 5 7 of the JammLite Utility section and complete steps through Type istat as the Customization Password and click OK Default customization profile Language English Unit Set UNITSET00 Philips Analyzer CLEW HXX i STAT 1 Software JAMSXXXX BIN Preferences DEFAULT0 STATNotes Use Operator List 09209ATJ i STAT Analyzer CLEW AXX Note CLEW and JAMS numbers are for example only Th...

Page 272: ...yzer CLEW window Select the CLEW version that matches the Product Update and click OK Art 725708 00E Rev Date 07 FEB 12 18 If Use Default Profile is not checked beside any location based customization profile double click the corresponding box under the i STAT Analyzer CLEW column Click YES for the confirmation message The latest CLEW should be displayed in the i STAT Analyzer CLEW window Select t...

Page 273: ...ATNotes Use Operator List 09209ATJ i STAT Analyzer CLEW AXX Art 725708 00E Rev Date 07 FEB 12 19 Underneath the Default customization profile column Double click on the i STAT 1 Software button Select the JAMS version that matches the Product Update Click OK Congratulations You have successfully assigned JAMS CLEW in your Central Data Station 3 7 ...

Page 274: ... to the CDS Customization section pages 16 19 and complete steps through Art 725708 00E Rev Date 07 FEB 12 20 CDS is not installed on the PC used with JammLite i STAT and PrecisionWeb are registered trademarks of the Abbott Group of Companies in various jurisdictions Windows is a registered trademark of Microsoft Corporation RALS Plus is a registered trademark of Medical Automation Systems Inc CDS...

Page 275: ...stomization Workspace and a Network Downloader Downloader Recharger or DRC 300 Before beginning check the Analyzer Status page and verify that the i STAT 1 handheld has enough battery power 7 5 volts or higher WHY DO i STAT HANDHELDS NEED SOFTWARE UPDATES The i STAT System is designed to eliminate operator influence on delivered results Due to continuous manufacturing process improvements to the i...

Page 276: ... the customer s network 2 i STAT 1 handheld 3 The latest i STAT Software and Documentation CD 4 Electronic Simulator List of the IP Address es for the network downloader s to be used for the soft ware update process 1 2 Close all open programs on the computer including i STAT Central Data Station if applicable 1 3 Before inserting the i STAT 1 Software and Documentation CD check that the JAMS appl...

Page 277: ...OM page and proceed to step 1 6 1 6 To open the JammLite Utility Double click and then Double click o If the JammLite program does not launch or you receive an error message con tact APOC Technical Support and tell the support specialist you are unable to complete step 1 6 of this document 1 7 In the JammLite utility select the i STAT 300 Analyzer within the Instrument drop down menu 1 8 Select TC...

Page 278: ...button Note Application and CLEW numbers are for example only 1 11 Follow the onscreen instructions 1 12 When the update is in progress the following screen will appear The handheld will have 1 s and 0 s streaming across the screen signifying that it is receiving the software Do not move the handheld until the success screen is displayed ...

Page 279: ... If there are additional handhelds to update via a different Network Downloader address Click Close Repeat steps 1 9 through 1 13 If your facility uses Central Data Station Proceed to and perform step 2 6 2 UPDATING THE i STAT 1 HANDHELD USING THE CDS VERSION 5 CUSTOMIZATION WORKSPACE WITH A SERIAL OR NETWORK DOWNLOADER OR DOWNLOADER RECHARGER OR DRC 300 2 1 Before starting the process make sure a...

Page 280: ...Drive o The following window will appear 2 5 Transfer the JAMS CLEW Software to the CDS Customization Workspace o Double click on AXX_i STAT_Analyzer_Software o Double click TRANSFER BAT Next an additional window will open briefly then close Close Windows Explorer by clicking on the in the upper right corner 2 6 Update the CLEW and JAMS versions in the CDS Customization Workspace Open the Central ...

Page 281: ...e Customization box is not already checked click the box next to this list ing Under the Location based customization profile section make sure Enable Updates is checked for every location from which you wish to perform software updates on your i STAT 1 Handhelds Under the Default customization profile column double click on the i STAT Analyzer CLEW button The latest CLEW should be displayed in th...

Page 282: ...dheld you wish to update are located or con tact someone at that location who can assist in updating the handheld s Press the On Off button on the handheld Press the Menu key to bring up the Administration Menu Press 7 Utility When prompted for a password press ENT If that did not work a password is needed Enter the password defined by your facility and press ENT From the Utility menu press 3 Rece...

Page 283: ...pdate process is complete 2 8 Run the Electronic Simulator in the handheld When the simulator finishes PASS should be displayed Note If PASS is not displayed re run the Electronic Simulator If the repeated Electronic Simu lator attempt fails contact APOC Technical Support For additional information on running the electronic simulator see Section 14 of the i STAT 1 System Manual Congratulations The...

Page 284: ...lity 3 All supplied downloader cables 4 Electronic Simulator 5 The latest i STAT Software and Documentation CD 3 2 Using the supplied downloader cables connect the i STAT 1 serial Down loader Downloader Recharger or DRC 300 to an accessible port on the back of the computer and the power supply to a wall outlet or power strip 3 3 Close all open programs on the computer 3 4 Before inserting the i ST...

Page 285: ...Wait 30 seconds and close any windows that may appear To access the files on the Software and Documentation CD ROM o Double click the following icon o Double click CD ROM Drive o The following window will appear 3 7 To open the JammLite utility double click and then double click o If the JammLite program does not launch or you receive an error message con tact APOC Technical Support and tell the s...

Page 286: ... list says None make certain the connection from the Serial Downloader to the computer is tight Then reboot the computer and return to step 3 3 3 10 Check that the Application and CLEW listings match those in the Product Update for the current software release If the update is for CLEW only select None for Application 3 11 Click on the Update button Note Application and CLEW numbers are for exampl...

Page 287: ...tronic Simu lator attempt fails contact APOC Technical Support For additional information on running the electronic simulator see Section 14 of the i STAT 1 System Manual Congratulations The process for updating the first i STAT 1 handheld is complete If there are additional handhelds to be updated via JammLite Click Close Repeat steps 3 11 through 3 14 If there are no additional handhelds to upda...

Page 288: ... Documentation CD ROM into the CD ROM drive of the computer you are using Note this computer does not need to be the i STAT DE Server Browse to click on and click Upload Note the XXXXXX is the JAMS and CLEW version that you are updating Immediately after uploading the CLEW JAMS to the i STAT DE server i STAT DE will unpack the files and make them avail able for use in the handheld s Customization ...

Page 289: ...t checked beside any Location based customization profile click the box under the i STAT Analyzer CLEW column Click the new version of CLEW and then click OK Answer OK to the question that appears Under the Default Customization profile column click on the i STAT 1 Software drop down list Select the JAMS version that matches the Product Update and click OK ...

Page 290: ...D check that the JAMS application and CLEW match the Product Update 4 3 Update the CLEW and JAMS versions in the Customization Workspace Transfer the files Access the main Customization Workspace page Click Update i STAT DE Upload Update File Insert the i STAT Software and Documentation CD ROM into the CD ROM drive of the computer you are using Note this computer does not need to be the i STAT DE ...

Page 291: ...tion Workspace Under the Default customization profile column click on the i STAT Analyzer CLEW button Note Customization screens may vary depending upon i STAT DE version in use Check the box next to the new version of CLEW and click OK Answer OK to the question that appears If Uses Default is not checked beside any Location based customization profile click the box under the i STAT Analyzer CLEW...

Page 292: ...ed is checked for every location from which you wish to perform software updates on your i STAT 1 handhelds 4 8 Update the software in the i STAT 1 handheld Go to the location where the i STAT 1 handheld s you wish to update are located or contact someone at that location who can assist in updating the handheld s Press the On Off button on the handheld Press the Menu key to bring up the Administra...

Page 293: ...ss message will then appear on the handheld display After these messages disappear the handheld display will go blank and the update process is complete 4 9 Run the Electronic Simulator in the handheld When the simulator finishes PASS should be displayed Note If PASS is not displayed re run the Electronic Simulator If the repeated Electronic Simu lator attempt fails contact APOC Technical Support ...

Page 294: ...Art 725768 00E Rev Date 04 Jan 12 20 ...

Page 295: ...ality Check Code numbers as well as additional troubleshooting details Caution DO NOT OPEN THE ANALYZER or any other i STAT product or perform any unauthorized procedures Opening any i STAT product including analyzer Electronic Simulator printer or communication device in attempt to repair it or resolve a problem may cause erroneous results If the troubleshooting procedures found in this manual or...

Page 296: ... the analyzer in a Downloader Stored Memory Full The analyzer is customized to alert the operator that the memory for unsent records is full If the operator does not transmit the test records to the Point of Care Central Workstation the analyzer will either block further testing or will overwrite oldest records depending on how the analyzer is customized Place the analyzer in a Downloader Upload R...

Page 297: ...e disposable lithium batteries or recharge the rechargeable battery Temperature Out of Range Check Status Page The analyzer makes a temperature measurement before initiating a test cycle Check the temperature reading on the Analyzer Status screen under the Administration Menu If below the operating range move to a warmer area If above the operating range move to a cooler area Allow time for the an...

Page 298: ...r cartridge If the same code repeats more than twice there may be an analyzer problem Try another analyzer if available Cartridge Preburst Use Another Cartridge This code indicates that the analyzer detected fluid on the sensors before it should have Possible causes Cartridges may have been frozen Calibrant pack may have been burst by operator exerting too much pressure on the center of the cartri...

Page 299: ...opped Try another Simulator If the analyzer passes the Electronic Simulator check continue to use it If not or if the Quality Check Code is recurrent the analyzer may need repair Analyzer Error See Manual These are mechanical or electronic failures from which the analyzer may not be able to recover Use an external Electronic Simulator twice and use a cartridge with sample or control solution If an...

Page 300: ...ended If experiencing an issue contact your support representative and use disposable batteries for continued use of the analyzer Cartridge Locked Not Removed Symptom Possible Cause Action Normally the analyzer will reset and release the cartridge after the testing cycle is completed If the analyzer cannot reset the Cartridge Locked message will remain on the screen Dead batteries Mechanical probl...

Page 301: ... a numeric code associated with the failed quality check Since multiple codes can be associated with a single cause message this is essential information when contacting i STAT Technical Services or your local support organization for further assistance The codes are stored in the analyzer s memory along with other test records and are transmitted to the Central Data Station The code list can be v...

Page 302: ...s are changed after a code 1 has occurred 10 Temperature In Range Ready for Use Temperature is back in range following a code 2 on the Portable Clinical Analyzer 11 Date Invalid Check Clock on Status Page If the date in the real time clock precedes the release date programmed into the application software code 11 is triggered Check the date on the real time clock The accuracy of the clock is check...

Page 303: ...analyzer has been programmed to compensate for these lot to lot differences by maintaining a running average of the Rcal values measured from the most recent cartridge runs Occasionally the difference between the Rcal values for two cartridge lots is large enough to cause the introduction of a new lot to trigger code 24 on the first few cartridge runs The Code 24 errors should disappear as the run...

Page 304: ...sample must reach the fill mark Try another cartridge 30 37 Sample Positioned Beyond Fill Mark Use Another Cartridge The cartridge was overfilled The sample was past the fill mark Try another cartridge 38 39 Insufficient Sample Use Another Cartridge This is most likely due to insufficient sample in the sample well of the cartridge but can also be caused by bubbles in the sample Try another cartrid...

Page 305: ...rtridge This can sometimes be corrected by conditioning the pins in the analyzer using the ceramic conditioning cartridge The specific conditioning procedure is described at the end of this bulletin Note If you do not have a ceramic conditioning cartridge please contact i STAT Technical Support at 1 800 366 8020 option 1 Codes 126 and 128 are sometimes related to electrical connection as well If y...

Page 306: ...STAT 1 Wireless Analyzer If these codes persist contact i STAT Technical Support or your local support organization for further assistance The rate of quality check code 55 can be elevated when cartridges are run without allowing sufficient time for the cartridges to equilibrate to room temperature To minimize the number of quality check codes review i STAT cartridge storage conditions and allow s...

Page 307: ...further assistance Codes in the range of 120 to 138 and 140 to 151 indicate a failure during an immuno or barcoded pouch cartridge cycle In most cases the cartridge is spent and another cartridge must be used Only the i STAT 1 Analyzer produces these codes as the Portable Clinical Analyzer does not support immuno cycles Code Number Cause Action Message on Display Explanation 120 122 124 125 133 14...

Page 308: ...e analyzer detected an air bubble in the sample segment Try another cartridge 140 Lot Expired The analyzer detected an expired cartridge lot Check the expiration date and repeat the test using a non expired cartridge lot 141 Test Canceled by Operator This code will be displayed if the cartridge barcode is not scanned within 60 seconds of cartridge insertion The correct barcode to scan is the barco...

Page 309: ... following conditions are related to the Electronic Simulator Code Explanation How to Respond Numerical Code See under Analyzer Coded Messages See under Analyzer Coded Messages L Potentiometric channel out of limits Can occur if moisture collects on the contact pins inside the analyzer when the analyzer is subjected to ambient temperature change Allow analyzer to equilibrate in new environment for...

Page 310: ...the CCC cycle as you would initiate an external Electronic Simulator cycle The instrument will identify the CCC as an external Electronic Simulator and display a Simulator Failure Code i e rRGL when the cycle is complete Disregard the code as this is expected behavior 3 Update the CCC Usage Log The log is located on page 3 of the Technical Bulletin entitled Instructions for Restoring Analyzers Tha...

Page 311: ...des and messages Microprocessor System The microprocessor control system manages all functions of the analyzer It accesses three types of memory storage devices A FLASH EEPROM module stores the software program in the analyzer The RAM which is backed up by an internal lithium battery is used for temporary storage of sensor signals measured during operation and for storage of test records Another E...

Page 312: ...nalog converter also provides voltages to the motor driver circuit Analog to Digital Conversion An analog to digital converter converts all analog signals into digital form so that the microprocessor can perform mathematical calculations on the signals An analog signal multiplexer makes it possible for the microprocessor to measure eight different types of analog signals The potentiometric signals...

Page 313: ...ependent on the electrode sensor system R is the gas constant T is the absolute temperature F is Faraday s constant n is the valance positive or negative charge for the ion being measured and a is the activity of that ion The Nernst equation can be rewritten as E E S log a ELECTROCHEMICAL MEASUREMENTS Method Measurements are performed on undiluted specimens Undiluted methods are also called direct...

Page 314: ... conductivity of the solution is proportional to the magnitude of the voltage difference In aqueous solutions conductivity is dependent upon the concentration of electrolytes an increase in the electrolyte concentration causes an increase in conductivity Where S replaces the constant term which defines the slope of the sensor The slope is the change in millivolts per tenfold change in the activity...

Page 315: ...nd the result of the direct measurement is adjusted so that normal ranges are in agreement with indirect reference methods at normal levels of total protein and lipids Hematocrit In whole blood plasma conducts electricity while the cellular constituents red and white blood cells and platelets do not For a sample of a given electrolyte concentration as the number of cells per unit volume of plasma ...

Page 316: ...e dilution of the modeled values The algorithm assumes that the pump priming solution has no added albumin or other colloid The algorithm will tend to overcorrect if solutions with added colloids are utilized though the size of the over correction will seldom be more than 1 PCV Other therapies which affect the ratio of total colloids to hemaotcrit administration of colloids packed red blood cells ...

Page 317: ...e of a measurement system to assure the reliability of patient test results As new technologies evolve quality control regimens must match the requirements of the particular analytical system i STAT Corporation recognizes the importance of effective quality control for its analytical medical devices and has developed a program that is tailored to the unique characteristics of the i STAT System The...

Page 318: ...ss the quality of the measurement process by intermittently inserting pseudosamples controls into the stream of samples being tested The approach implicitly assumes that the elements of the measuring system persist from run to run so that the repeatability and accuracy of the measurement of patient samples can be predicted by the repeatability and accuracy of pseudosamples The i STAT regimen uses ...

Page 319: ...for Point of Care Testing The most important quality measure in the i STAT System is that it is designed to reliably deliver quality results in the hands of individuals not trained in laboratory science It addresses those aspects of the design in traditional laboratory based equipment and other point of care devices which detract from robustness in the hands of these individuals 1 In the interest ...

Page 320: ...lt 3 The design of some unit use point of care devices can allow an entire batch of unit use devices to be affected by a single event for example by leaving a tube of paper strips open and exposed to a high humidity environment With the i STAT System each unitized device is sealed in a separate foil pouch and has its own individual history The only external factor which can create a shared history...

Page 321: ... to control the release of calibration ﬂuid over the sensors is functioning properly verify internal element of cartridge that allows the analyzer or module to control the replacement of calibration ﬂuid with sample is functioning properly Every cartridge use Every cartridge use Every cartridge use Handheld Analyzer and Blood Analysis Module Verification When Verified Motorized Mechanical System v...

Page 322: ... regimens prompting various regulatory and accreditation organizations to modify their standards accordingly Many of the newly drafted regulations and accreditation standards recognize the danger of denoting specific methods of achieving an effective quality control regimen Additionally specific methods cannot anticipate future technological changes so many of the regulatory and accreditation orga...

Page 323: ...hat the i STAT System requires only a one point calibration using a calibrant solution packaged in the cartridge to meet the demanding requirements for clinical accuracy As described in the Quality Control section of the i STAT System Manual the calibrant solution is also used to verify the integrity of the sensors as a key component of the quality system For the measurement of ACT and PT the requ...

Page 324: ...eck the amperometric and conductivity circuitry used in the coagulation tests at multiple levels The instrument checks the accuracy of the measurement of elapsed time each time a test is run by comparing the clock rates from two independent clocking circuits The instrument also runs a battery of general instrument checks during each test ...

Page 325: ...ress of the data manager and service port for i STAT 1 Analyzer transmissions default 6004 Preparation Configure a Terminal Session 1 Run a terminal emulation program such as HyperTerminal and choose the following port settings Bits per second 9600 Data bits 8 Parity None Stop Bits 1 Flow Control None Connect to and Program the Downloader 1 Connect one end of a Null Modem Cable to the DB9 Port on ...

Page 326: ...diately to enter the Setup Mode Configure Server Parameters Each network Downloader requires a static IP Address a Gateway Address and if required a Subnet Mask Note Failure to assign a static IP address to the downloader could result in an i STAT 1 Analyzer being programmed with an inappropriate customization profile The following describes how to configure the network Downloader s server paramet...

Page 327: ...000 10 000 10 000 12 000 1 Netmask Number of Bits for Host Part 00 8 Note The Netmask is configured as the number of host bits required based on the subnet being used Change telnet config password N N Default Netmasks for Standard IP Networks Subnet Mask Host Bits Network Type 255 0 0 0 24 Class A 255 255 0 0 16 Class B 255 255 255 0 8 Class C Netmasks for Other Networks Subnet Mask Host Bits Subn...

Page 328: ...t value press the Enter key Baudrate 38400 38400 must be set to 38400 I F Mode 4C press Enter key Flow 00 press Enter key Port No 10002 press Enter key ConnectMode C1 C1 must be set to C1 Auto increment source port N N press Enter key Remote IP Address 000 10 000 10 000 12 000 184 Note Set Remote IP Address to the IP Address of the computer where the data manager resides Remote Port 06004 6004 Not...

Page 329: ...ssions from the i STAT 1 Analyzer default 6004 2 At the Your choice prompt Select 1 Channel 1 Configuration 3 At each of the prompts enter the following bold faced value Note If the information to be entered is the same as the default value press the Enter key Baudrate 38400 38400 must be set to 38400 I F Mode 4C press Enter key Flow 00 press Enter key Port No 10001 press Enter key ConnectMode C1 ...

Page 330: ...k Downloader Option 1 The following diagram shows how to connect the portable printer to the network Downloader for communication Parts required are Printer Interface Cable Printer Power Adapter Power In Power Out RJ12 printer interface DB9 RJ45 network Caution Only i STAT provided printers may be connected to the Downloader printer port An ethernet cable and serial DB9 cable may Not be connected ...

Page 331: ...llowing diagram shows how to connect the portable printer to the network Downloader for power and communication Parts required are Printer Interface Cable Printer AC Adapter or Printer Power Cable Power In Power Out RJ12 printer interface DB9 RJ45 network ...

Page 332: ...charging LED lights will be lit The primary recharging LED will blink red and the alternate will be steady green This is typical behavior and does not indicate that any charging is taking place In fact batteries cannot be charged in the Downloader Recharger in this configuration The following diagram shows how to connect a serial downloader locally to the Data Manager Parts required are PC Downloa...

Page 333: ...am shows how to connect a serial downloader to the Data Manager and to connect the portable printer to the Downloader for communication Parts required are DB9 DB9 Null Modem Cable Printer Interface Cable Printer AC Adapter Power In Power Out RJ12 printer interface DB9 ...

Page 334: ... to the Data Manager and to connect the portable printer to the Downloader for power and communication The printer can also be powered by its own AC adpater Parts required are DB9 DB9 Null Modem Cable Printer Interface Cable Printer Power Cable or Printer AC Adapter Power In Power Out RJ12 printer interface DB9 ...

Page 335: ... The i STAT Central Data Station software is licensed to the authorized user by Abbott Point of Care Inc Portions of the software are licensed to you by Abbott Point of Care Inc under sublicense from other original software providers By accepting and using this software the user licensee agrees to the following The user licensee will not make copies of the software programs or any of the program s...

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Page 337: ...lick on the link under CDS Key Generator in the right hand column You can also access this link directly at http www abbottpointofcare com cdslicense In the USA the license key can also be obtained from Technical Support 6 If you are already registered skip to step 8 If you are not registered fill out the required information select Basic Access and click Register 7 Go back to the i STAT web site ...

Page 338: ...wnloader Wiring and Programming section of this manual For assistance in programming the Downloader Downloader Recharger and IR Links contact your i STAT support representative The date displayed with results can be changed to any Short Date format and separator listed in the computer s Control Panel under Regional Options or something similar depending on the version of Microsoft Windows in use I...

Page 339: ...Clicking an item on the menu bar 1 will drop down the menu for that item If any of the items in the drop down menu has a submenu the submenu will open to the right of the symbol next to the item when the item is highlighted 2 1 2 Clicking the beside a toolbar button 3 will drop down a submenu toolbar 4 3 4 Clicking the desired menu option will open the item s window or will perform the item s func...

Page 340: ...ndow 7 or to confirm OK or cancel a function or to manipulate a window All windows can have the following buttons in the upper right hand corner 8 6 8 7 This button causes the window to be maximized This button causes the window to be minimized This button causes the window to be moveable and resizable This button causes the window to close If a window does not have a close button it can be closed...

Page 341: ...ows can be open at the same time The Windows item on the menu bar can be used to select the desired window from the list of open windows and bring it to the forefront Close windows by clicking the Close button at the top right of the window or by selecting Close from the Main menu Column Ordering Columns in the Data Viewers can be placed in any order Use the mouse to grab a column header and drag ...

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Page 343: ...omization screen close the CDS application access the Run dialog box by clicking Start Run Type wcds32 config at the Open prompt then click OK If Run is not on the Start menu double click the Command Prompt shortcut At the C prompt in the window that opens type c istat32 bin wcds32 exe config and press Enter When the Customization screen appears click a tab to display the desired tab page The info...

Page 344: ...nents can be connected to the Central Data Station via serial ports i STAT Series 200 Analyzer IR Link transmits data to and from the i STAT Portable Clinical Analyzer i STAT Series 300 Analyzer Downloader or Downloader Recharger transmits data to and from the i STAT 1 Analyzer Philips Module a local connection to the CDS is needed to transmit software updates and customization profiles to the Blo...

Page 345: ... and ASTM E1394 97 Patient Test Results ONLY Data File Formats the CDS for third party use 1 Test Result 2 Electronic Simulator 3 Control Result 4 Cal Ver Result 5 Proficiency Result HL7 Data transmission conforms to HL7 version 2 4 and is based on the CIC Observation Reporting Interface distributed by the National Committee for Clinical Laboratory Science in the USA under Document POCT 1 A This o...

Page 346: ...reports in the Download and Interface Monitors will be updated after the period of inactivity specified Maximum diagnostic files Diagnostic files contain information that can be useful in troubleshooting cartridge problems The default number is 100 and is changed at the request of a Customer Support representative Data Viewers Selecting Save method selection on exit will cause each Data Viewer to ...

Page 347: ...y features can be activated by performing the following steps 1 Check the box next to Enable Security 2 After enabling security the user also has the option of selecting an inactivity interval after which the CDS will log off the current user Simply click on the Log Off box and use the up down arrows to choose the desired log off interval 3 Click Accept at the bottom of the window 4 A password dia...

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Page 349: ...s Depending on the particular installation one or more of these will be used Procedure Exit the CDS application Access the Run dialog box by clicking Start Run Type c istat32 bin interface32 exe at the Open prompt then click OK If Run is not on the Start menu double click the Command Prompt shortcut At the C prompt in the window that opens type c istat32 bin interface32 exe and press Enter Click F...

Page 350: ...t to the clock in the lower right hand corner of the screen to open the interface program s main screen 3 Click File Options 4 Click the Send Priority tab The other tabs will be available for viewing only 5 Click the Location Method line to prioritize 6 Right click under the Send Priority column and select the priority Normal High Very High from the drop down list 7 Click Accept to finish ...

Page 351: ...d Intervals Monitoring Operator Competence Managing LIS entry exceptions Reviewing Patient and Quality Results These functions are listed under the main menu option in four main groupings monitors viewers workspaces and reports Central Data Station Software Function Overview and Toolbar Buttons Monitor Download Interface Administration Tools Workspaces Instrument Location Operator Database Mainten...

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Page 353: ...k Location Edit Location Name in the menu or click Loc Name in the toolbar Note Interface logic should be considered before editing Add New Download Location Assignment Download locations can be added manually Click Location Add Download Location Assignment in the menu or click the Add Assig in the toolbar Download locations will also be added automatically when a transmission is received from a d...

Page 354: ...program The i STAT method in the Instrument window refers to the i STAT Portable Clinical Analyzer the i STAT 1 Analyzer both i STAT cartridge and MediSense Precision PCx and PCx Plus Glucose Test Strips and the Philips Blood Analysis Module Clicking a Location Method on the left side of the window will list the status of all instruments for that location and method in the right side of the window...

Page 355: ...s in the institution The instrument will be designated Assignment under the Reports column in the Instruments tab page 2 Report location as download location The results from this instrument will appear with the location for the download device that was used to transmit results to the Central Data Station The instrument will be designated Download under the Reports column on the Instruments tab pa...

Page 356: ...ument Toggle In Use from the menu or click the down arrow next to Current Inst and then In Use in the toolbar to check in use or un check out of use the analyzer in the In Use column Instruments that are not checked In Use do not have a download criteria applied to them You would use this for instruments you do not expect to be downloaded When an analyzer that is not marked in use downloads it is ...

Page 357: ...cted to make sense Instrument and Location Summary The Instrument and Location Summary provides a report of the current instrument assignments and the last download for each instrument Click Main Open Report Instrument Summary from the menu or click the down arrow next to Report and then Summary in the toolbar Summaries can be viewed and printed by This method and location only location and method...

Page 358: ...ents can be added to the log by clicking Add Note in the toolbar Date Range Data can be viewed within a user defined default range or by a manually entered range Delete The Delete button allows selected or all entries within the date range selected to be deleted To print the log press the F2 key or select Print from the Main menu or toolbar ...

Page 359: ...on has expired Operators Operators are listed by Department and Method as indicated by the symbol Operators are added to the operator list by department and by method When a record is received with an Operator ID that is not listed in any Department the operator is placed in the Unassigned department Operator list edit in progress When editing the operator list check this box to delay updating i S...

Page 360: ... a department has been added it can be selected for additional operators from the drop down menu Check the Clear Operator data when Add and Remain Open clicked box to specify whether or not the operator information fields should be cleared when the Add and Remain open button s clicked Delete Operator Select the operator or operators Click Operator Delete from the menu or click Delete in the toolba...

Page 361: ...ied for another method without having to complete a new Add Operator form Highlight the operator or operators in the Operator tab window that are to be certified for another method Click Operator Add Certification from the menu or click the Add Cert button on the toolbar Select the other method for which these operators are to be certified then specify the certification dates Add Note Click the op...

Page 362: ...y or Expiration Operator Summary Summaries of operators can be viewed and printed by This method and department only department and method selected with symbol This method all departments method selected with symbol All methods all departments The reports include operator IDs operator names certified from date certified until date comments a checkmark if certification has expired and the operator ...

Page 363: ...rator Log tracks changes made and Add Note entries made in the Operator tab page The Date Range button can be used to specify a time period to be viewed and the Delete button to delete entries To print the log press the F2 key or select Print from the Main menu ...

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Page 365: ...ocess header lines 5 If all operators in the text file containing the list to be imported are to be certified for one method click Assume a test method for all operators and select i STAT for cartridge testing or Precision PCx for the MediSense Precision PCx or PCx Plus Glucose Strip testing on the i STAT1 Analyzer If this option is selected the text file does not need to contain a Method field If...

Page 366: ...n is selected and the text file does contain a Department field its contents will be ignored Example from list to be imported ICU 12345 Smith Judy none 98765 i STAT 2001 08 08 2002 08 08 8 Click Select File and select the name of text file containing the list to be imported 9 Click Import File to import the list from the text file Note operator data that already exits in the CDS5 database takes pr...

Page 367: ...fter the workspace opens click the Archive Test Results tab 3 Click the Backup test results radio button 4 Specify a date range for the function 5 Select a Backup Option Backup Backup and Delete or Delete only 6 If an option that includes Delete is selected then select a Delete Option Delete details data only or Delete details and demographic data Details data includes Original Operator and Patien...

Page 368: ...the Cancel button to stop the operation Once the Cancel button is clicked depending on the amount of data being deleted and the size of the database there may be a significant lag time of a few minutes before a dialog box appears indicating that the deletion has been paused asking you to select one of three options The reason for the lag time is that the program needs to complete whatever portion ...

Page 369: ...kup occurs It creates a complete backup of the database file to the specified drive directory Compact Database File When the backup and delete or delete only functions are executed the deleted data is removed from the database but the disk space the data occupied in the database file is not The compaction function creates a new copy of the database with the excess space removed creating a smaller ...

Page 370: ... result of that type in the database 3 The date and time of the newest result of that type in the database 4 A breakdown of the number of this particular result type that have been sent successfully Yes unsuccessfully or not sent at all No to the LIS HIS Note a listing in this window for Not Available indicates that there are records of this type in the database where the details data have been de...

Page 371: ... displayed information form To delete an item from the Available items list highlight the item then click the Delete button in the tool bar If the item was selected from Chose items from the list the item will be moved from Available items back to this list To edit information under the Available items list click the Edit button in the tool bar Overview The Inventory Workspace is organized under f...

Page 372: ...te the Inventory column 1 Count current stock Go to the Stock tab click on the Edit button in the tool bar and enter the current inventory Lot numbers and Expiration dates will not be tracked for inventory entered by this method 2 Count current stock along with lot numbers expiration dates and loca tions Go to the Order tab and enter and receive the POs for the exist ing stock Go to the Stock tab ...

Page 373: ...e tool bar to adjust the Estimated Inventory Orders To record a new order click on the Add button in the tool bar Select the item from the drop down menu under Item and enter the quantity Click the Add Item button to add another item or the Delete Item button to delete an item To enter information about a received order right away click on the Receive Order button To enter information about a rece...

Page 374: ...se the Delete button on the tool bar to delete an order Use the Find Lot and Find Next buttons on the tool bar to find the PO associated with a received lot Use the Delete Lot button on the tool bar to delete a lot number that has expired or has been used up The Report button on the tool bar is used to view all received items by date range Use the Add Note button on the tool bar to add a note to t...

Page 375: ...o 16 characters can be entered The Distribution tab will list each location with its consumables Define an alert date and click a check mark next to Highlight items expiring within xx days to alert you to transfer stock to a different location where it can be used before its expiration date Use the Delete button on the tool bar to delete a distribution Use the Transfer button in the toolbar to mov...

Page 376: ...nventory Log documents each action taken in the Items Stock Distribution and Orders tabs Click the Date Range button in the toolbar to select the a Default date range or a Start and End date for this report Click the Delete button to delete entries in the log ...

Page 377: ...his assignment in the Instrument workspace will always be updated with the Customization Profile for the instrument s assigned location regardless of the physical location from which it downloads If a location has the Enable Updates option unchecked downloading from that location will result in no customization changes being made to analyzers designated to Report location as download location Anal...

Page 378: ...zation profiles can be created for different locations Uncheck the Use Default Profile box for the location and double click i STAT Analyzer CLEW or BAM CLEW to change the CLEW or double click Preferences to change any of the preferences Alternately select the menu option Profile Change Location Based and the item to be changed Changes in the customization profile can be made for several locations...

Page 379: ...s are made from options in the following ways Select one of the seven main Customization options by double clicking the box for Language Unit Set i STAT Analyzer CLEW Philips BAM CLEW i STAT 1 Software Preferences or Chart Pages After making a selection in the Language Unit Set and CLEW window click the OK button to save the selection or click the Cancel button to return to the previous selection ...

Page 380: ...ails of each unit set are displayed under the Analytes column Details are also listed in the Customization section in this manual To create a unique unit set click UnitSet99 and then the User Settings tab Then select the name and units for each analyte or test ...

Page 381: ...nalysis Module Note Before changing to a new CLEW ensure that all analyzers have been updated to a compatible application software version i STAT 1 Software Window A new JAMS application software is added to the window via the software update process twice a year Click the new JAMS and click OK Selecting the new JAMS aloows users the option of updating their i STAT 1 analyzers remotely or locally ...

Page 382: ...into fields such as for Reference Ranges and Strip Lot Numbers When all information has been entered a button is pressed Default Values will restore the default settings to the open window OK will store the new settings Cancel will ignore any new settings and restore the current settings Each Customization Profile is assigned a unique name by the CDS program This name appears under the Preferences...

Page 383: ...e Customization Technical Bulletin for full details Backup and Restore Profile The current customization profile can be stored by selecting Profile Backup from the menu bar or by clicking the Backup toolbar button selecting the directory where the profile is to be stored typing in a file name for the profile and clicking the Save button To restore a profile to the CDS click Profile Restore or the ...

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Page 385: ...nctions should be available to users at those different security levels Once those decisions have been made the next step is to create the desired security profiles in the User Administration Workspace Please note that an Administrator profile will always exist in the User Administration Workspace It cannot be edited or deleted and allows access for those designated users to all CDS Workspaces and...

Page 386: ... the profile name simply type in the new profile name Then select or deselect the desired listings under the Security Options for Selected Profile window by clicking on the corresponding check box When all edits are complete simply click on Profile Edit and answer Yes to the confirmation message that appears about saving the new changes Adding Users Once all the Security Profiles have been created...

Page 387: ... choosing in the space provided then retype that same password on the New Password Verification line and click OK The password must have a minimum length of 3 alphanumeric characters and a maximum length of 12 alphanumeric characters Once the password is changed the user will then use their new password for all subsequent CDS log ons User Log The User Log tracks the following user activities CDS S...

Page 388: ...tasks they can log off by clicking on System Log Off A box will then appear on the screen indicating that the current user has logged off Automatic Logoff Automatic logoffs are optional and can be enabled in the i STAT CDS Customization screen as described in the Security section above on page 22 13 a Click and highlight this particular user s listing in the User Window b Click on User Emergency P...

Page 389: ...iewed in the Data Viewers alongside the data from the Precision PCx strip To determine which strip type was used on a particular testing run look at the column entitled Panel Precision PCx Plus strip runs will be labeled PCx Plus Glucose while Precision PCx strip runs will be labeled PCx Glucose Information in Data Viewers Data for only one method at a time such as the i STAT cartridges is display...

Page 390: ...ting the record and clicking the Details toolbar button or by selecting Record View Details from the Menu Many of the Extra Data details may be helpful to the Customer Support representative in troubleshooting Example of Details for Results Viewer Customizing the Data Viewers The viewers can be customized for individual preferences The following aspects of the viewers are user configurable Selecti...

Page 391: ...ton To hide a column click the box following the column s name to uncheck it and then click OK To make the column visible again click the empty box following the column s name to check it and click the OK button The Raw Location and the Receive Date Time columns allow users to track the location where particular analyzers are being downloaded plus the time intervals in which users are transmitting...

Page 392: ...drag it back to the left side of the screen under Columns Available For Sorting Editing a Record To edit a record highlight the record to be edited click Record Edit Record in the menu bar or click the Edit toolbar button Different viewers have different editable items Results that have been successfully sent to the LIS or HIS have only an editable Comment Results marked as Pending or In Progress ...

Page 393: ... Analyzer Serial Number or by a selection of records With the Data Viewer open click Record Trend then the trend option from the menu bar or click the arrow beside the Trend toolbar button and click the desired trend option Up to 25 records are presented from oldest to newest data To trend by selection highlight the records to be included in the trend report then perform the Trend function Example...

Page 394: ...ctronic Simulator check click Record View Extended Simulator Report Note that the Simulator ID and Probe Delta columns can be viewed in the screen above by scrolling to the right Unsent Records Viewer This viewer is available only if an external interface installed by i STAT is enabled in the Central Data Station Customization function This data viewer displays records that have not been sent from...

Page 395: ...ystem but has not yet received the Application acknowledgement indicating whether or not the LIS successfully processed the record Yes Yes This value means that the i STAT Interface application successfully processed the record For Data File Protocol Only Yes means that the Data File was successfully created in the c istat32 send directory It does not necessarily mean that the record was processed...

Page 396: ... the Extended Simulator report screen click on the Export data button at the bottom of the report A dialog box will then appear on the screen Choose the file destination location and the type of file you want the exported data saved as from the drop down menus then type in the File Name and click on Save Note Users can be blocked from or allowed access to this data export feature through the User ...

Page 397: ...rument to the CDS is defined under Download Criteria in the Instrument Location workspace The download status of each location is recorded in the Download Monitor The Requires Download column indicates how many of the total number of analyzers reporting to a location have exceeded the Download Criteria Clicking the location will open the Instrument and Location workspace where noncompliant analyze...

Page 398: ...ce monitor for an interface installed by a third party click on the Interface Manager button in the tray at the bottom of the screen The Interface Monitor identifies quickly the status of the Interface to an external computer The number of pending results is shown as well as any exceptions in the last 72 hours Clicking an exception takes you to the Unsent Results viewer to address the exception ...

Page 399: ...eport of cartridge usage by Department or Location Select a date range for the report Data in reports with the exception of Operator can be sorted by clicking on the column headers By Operator data is pre sorted by department Select a report by Reagent Usage by Department Reagent Usage by Location Reagent Usage by Operator or Reagent Usage by Analyzer and then select either All Locations or All De...

Page 400: ...interface to an external computer Select a date range for the report Select a Report by Department Location or Operator then select All Locations or All Departments or select one Location or Department from the list Click on Display operator names if desired When Method Compliance by Operator is selected operators will be listed by department Select the filtering criteria for the report and then c...

Page 401: ...tor names if desired Select the filtering criteria for the report Then click the OK button When Quality Check Codes by Department is selected operators will be listed by Department A legend mapping individual code numbers to their respective quality check code categories is available for viewing To access this legend 1 Create the desired Quality Check Code report 2 With the report still on the scr...

Page 402: ... manually Highlight the records to be sent in the appropriate Data Viewer Results viewer then click Record Send Selected Records If AutoSend is enabled it will be checkmarked under the System option on the menu bar If an external interface is not enabled AutoSend will appear in grey typeface Print Option A Printer Dialog box has been added so that when Print is selected from the menu the user can ...

Page 403: ...German English XP Professional SP2 Italian Italian English XP Professional SP2 Spanish Spanish English XP Professional SP2 Swedish Swedish English During the initial installation or upgrade of the CDS 5 software all U S customers should choose English when the language choice drop down menu appears Failure to do so will result in the following consequences 1 If the wrong language was chosen during...

Page 404: ...22 70 Art 714384 00D Rev Date 07 18 06 ...

Page 405: ...Type Fresh whole blood from arterial venous or skin punctures Note Skin puncture is NOT a recommended sample type for ACT cTnI CK MB or BNP testing cTnI and CK MB cartridges require the use of heparinized whole blood or plasma or non heparinized whole blood tested within one minute of patient draw BNP cartridges require the use of EDTA whole blood or plasma samples Sample Volume 17µL 20µL 40µL 65µ...

Page 406: ...st be filled to capacity Without anticoagulant With balanced heparin anticoagulant Not recommended Not recommended for blood gas analysis arterial specimens are preferred Cartridges which perform ACT Without anticoagulant ONLY Syringes must be plastic Without anticoagulant clot activators or serum separators ONLY Tubes must be plastic Devices used to transfer sample to cartridge must be plastic No...

Page 407: ...lyzer or cartridge does not meet certain internal specifications see Quality Control section in System Manual for detailed information To minimize the probability of delivering a result with medically significant error the internal specifications are very stringent It is typical for the system to suppress a very small percentage of results in normal operation given the stringency of these specific...

Page 408: ...ime CeliteACT seconds 50 1000 74 125 Prewrm 84 139 Nonwrm 74 125 Prewrm 84 139 Nonwrm The range from 80 1000 seconds has been verified through method comparison studies Kaolin Activated Clotting Time KaolinACT seconds 50 1000 74 137 Prewrm 82 152 Nonwrm 74 137 Prewrm 82 152 Nonwrm The range from 77 1000 seconds has been verified through method comparison studies Prothrombin Time PT INR 0 9 8 0 Per...

Page 409: ...al venous Hemoglobin Hb g dL g L mmol L 3 4 25 5 34 255 2 1 15 8 12 17 120 170 7 11 12 17 120 170 7 11 TCO2 on all cartridges but the CHEM8 mmol L mEq L 5 50 23 27 24 29 HCO3 mmol L mEq L 1 0 85 0 22 26 23 28 BE mmol L mEq L 30 30 2 3 2 3 Anion Gap AnGap mmol L mEq L 10 99 10 20 10 20 sO2 N A 95 98 ...

Page 410: ...6 95µL Sodium Na Potassium K Hematocrit Hct pH PCO2 PO2 TCO2 HCO3 BE sO2 Hemoglobin Hb G 3 95µL pH PCO2 PO2 TCO2 HCO3 BE sO2 CG 4 95µL pH PCO2 PO2 Lactate TCO2 HCO3 BE sO2 CG 8 95µL Sodium Na Potassium K Ionized Calcium iCa Glucose Glu Hematocrit Hct pH PCO2 PO2 TCO2 HCO3 BE sO2 Hemoglobin Hb Celite ACT 40µL Celite ACT Kaolin ACT 40µL Kaolin ACT PT INR 20µL Prothrombin Time cTnI 17 µL Troponin I C...

Page 411: ...iguration sensors for the measurement of specific analytes and a buffered aqueous calibrant solution that contains known concentrations of analytes and preservatives For cartridges that contain a sensor for the measurement of sodium a list of reactive ingredients is indicated below Reactive Ingredient Sodium Na Metrological Traceability The i STAT System test for sodium measures sodium amount of s...

Page 412: ...ow Method comparison data were collected using CLSI guideline EP9 A4 Venous blood samples were collected in lithium heparin Vacutainer tubes and analyzed in duplicate on the i STAT System A portion of the specimen was centri fuged and the separated plasma was analyzed in duplicate on comparative methods within 20 minutes of collection Deming regression analysis5 was performed on the first replicat...

Page 413: ...ther than solutions such as normal saline or Ringer s Lactate Test concentrations used were as per the CLSI guidance document 8 unless otherwise indicated The following substances are known to interfere with the i STAT sodium assay Substance Test Concentration mmol L Interference Bromide 37 5 Increased i STAT Sodium results See Note below The following substances are known not to significantly int...

Page 414: ...uideline Second Edition CLSI document EP7 A2 ISBN 1 56238 584 4 Clinical and Laboratory Standards Institute 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 2005 9 Kharasch E D Hankins D Mautz D Thummel K E Identification of the enzyme responsible for oxidative halothane metabolism implications for prevention of halothane hepatitis Lancet 1996 347 1367 71 10 Morrison J E Friesen R...

Page 415: ... analytes and a buffered aqueous calibrant solution that contains known concentrations of analytes and preservatives For cartridges that contain a sensor for the measurement of potassium a list of reactive ingredients is indicated below Reactive Ingredient Potassium K Metrological Traceability The i STAT System test for potassium measures potassium amount of substance concentration in the plasma f...

Page 416: ...e afternoon on five days for a total of 20 replicates The averaged statistics are presented below Method comparison data were collected using CLSI guideline EP9 A4 Venous blood samples were collected in lithium heparin Vacutainer tubes and analyzed in duplicate on the i STAT System A portion of the specimen was centri fuged and the separated plasma was analyzed in duplicate on comparative methods ...

Page 417: ...m values will increase in iced specimens Potassium values from anticoagulated samples are preferred to serum values because 0 1 to 0 7 mmol L potassium can be released from platelets1 and red blood cells during the clotting process Potassium values obtained from skin puncture samples may vary due to hemolysis or an increase in tissue fluid from improper technique during the collection procedure Te...

Page 418: ...leet and N Gochman Incorrect Least Squares Regression Coefficients in Method Comparison Analysis Clinical Chemistry 25 3 432 1979 6 See Reference 7 7 Clinical and Laboratory Standards Institute CLSI Interference Testing in Clinical Chemistry Approved Guideline Second Edition CLSI document EP7 A2 ISBN 1 56238 584 4 Clinical and Laboratory Standards Institute 940 West Valley Road Suite 1400 Wayne Pe...

Page 419: ...lectrode when potentiometric sensors are included in the cartridge configuration sensors for the measurement of specific analytes and a buffered aqueous calibrant solution that contains known concentrations of analytes and preservatives For cartridges that contain a sensor for the measurement of chloride a list of reactive ingredients is indicated below Reactive Ingredient Chloride Cl Metrological...

Page 420: ...orning and in the afternoon on five days for a total of 20 replicates The averaged statistics are presented below Method comparison data were collected using CLSI guideline EP9 A4 Venous blood samples were collected in lithium heparin Vacutainer tubes and analyzed in duplicate on the i STAT System A portion of the specimen was centri fuged and the separated plasma was analyzed in duplicate on comp...

Page 421: ...such as Normosol R Abbott Laboratories Plasma Lyte A Baxter Healthcare Corporation and Isolyte S B Braun Medical rather than solutions such as normal saline or Ringer s Lactate Test concentrations used were as per the CLSI guidance document 7 unless otherwise indicated The following substances are known to interfere with the i STAT chloride assay Substance Test Concentration mmol L Interference Ac...

Page 422: ... 1 N W Tietz E L Pruden O Siggaard Andersen Electrolytes in Tietz Textbook of Clinical Chemistry Second Edition C A Burtis and E R Ashwood eds Philadelphia W B Saunders Company 1994 2 D S Young Effects of Drugs on Clinical Laboratory Tests 3rd ed Washington DC American Association of Clinical Chemistry 1990 3 B E Statland Clinical Decision Levels for Lab Tests Oradell NJ Medical Economic Books 198...

Page 423: ...Matthew Partington John Burn Robert Wilson and Helen M Arthur Therapeutic levels of aspirin and salicylate directly inhibit a model of angiogenesis through a Cox independent mechanism The FASEB Journal 2006 20 2009 2016 i STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions Vacutainer is a registered trademark of Becton Dickinson and Company Franklin Lakes NJ US...

Page 424: ...bbott Park IL 60064 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299 2011 Abbott Point of Care Inc All rights reserved Printed in USA Rev Date 12 Jul 11 Art 714175 00K CL 6 ...

Page 425: ...es and a buffered aqueous calibrant solution that contains known concentrations of analytes and preservatives For cartridges that contain a sensor for the measurement of urea nitrogen a list of reactive ingredients is indicated below Reactive Ingredient Biological Source Urea N A Urease Canavalia ensiformis Metrological Traceability The i STAT System test for blood urea nitrogen urea measures bloo...

Page 426: ...uplicates of each control fluid were tested in the morning and in the afternoon on five days for a total of 20 replicates The averaged statistics are presented below Method comparison data were collected using CLSI guideline EP9 A3 Venous blood samples were collected in lithium heparin Vacutainer tubes and analyzed in duplicate on the i STAT System A portion of the specimen was centri fuged and th...

Page 427: ...dL range the average difference was 1 13 In the 60 140 mg dL range the average difference was 0 77 Factors Affecting Results Endogenous ammonium ions will not affect results Test concentrations used were as per the CLSI guidance document 6 unless otherwise indicated The following substances were shown not to significantly interfere with the i STAT BUN assay at the stated test concentrations Substa...

Page 428: ...ct Least Squares Regression Coefficients in Method Comparison Analysis Clinical Chemistry 25 3 432 1979 5 See Reference 6 6 Clinical and Laboratory Standards Institute CLSI Interference Testing in Clinical Chemistry Ap proved Guideline Second Edition CLSI document EP7 A2 ISBN 1 56238 584 4 Clinical and Laboratory Standards Institute 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA...

Page 429: ...creatic islet cell carcinoma Contents Each i STAT cartridge contains one reference electrode when potentiometric sensors are included in the cartridge configuration sensors for the measurement of specific analytes and a buffered aqueous calibrant solution that contains known concentrations of analytes and preservatives For cartridges that contain a sensor for the measurement of glucose a list of r...

Page 430: ...w was collected in health care facilities by health care professionals trained in the use of the i STAT System and comparative methods Precision data were collected at multiple sites as follows Duplicates of each control fluid were tested in the morning and in the afternoon on five days for a total of 20 replicates The averaged statistics are presented below Method comparison data were collected u...

Page 431: ... a result of tissue utilization 6 Test concentrations used were as per the CLSI guidance document 7 unless otherwise indicated The following substances are known to interfere with the i STAT glucose assay Substance Test Concentration mmol L Interference Acetaminophen 1 32 Increased i STAT Glucose results See Note Below Acetylcysteine 10 2 Decreased i STAT Glucose results See Note below Bromide 37 ...

Page 432: ... which bromide is released APOC has not identified a therapeutic condition that would lead to levels consistent with the CLSI recommended level Bromide at a concentration of 37 5 mmol L sig nificantly decreased i STAT glucose results Bromide at a concentration of 2 5 mmol L decreased i STAT glucose results by approximately 5 mg dL on cartridges heated to 37 C CG8 CHEM8 and at higher levels on cart...

Page 433: ... urine by ion chromatography J of Chromatography B 692 1997 413 418 9 Kharasch E D Hankins D Mautz D Thummel K E Identification of the enzyme responsible for oxi dative halothane metabolism implications for prevention of halothane hepatitis Lancet 1996 347 1367 71 10 Morrison J E Friesen R H Elevated serum bromide concentrations following repeated halothane anaesthesia in a child Can J Asaesth 199...

Page 434: ...bott Park IL 60064 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299 2012 Abbott Point of Care Inc All rights reserved Printed in USA Rev Date 03 Aug 12 Art 714177 00N Glu 6 ...

Page 435: ...erence electrode when potentiometric sensors are included in the cartridge configuration sensors for the measurement of specific analytes and a buffered aqueous calibrant solution of known conductance that contains known concentrations of analytes and preservatives Metrological Traceability The i STAT System test for hematocrit measures packed red blood cell volume fraction in arterial venous or c...

Page 436: ... polycythemia vera and impaired ventilation Performance Characteristics The typical performance data summarized below was collected in health care facilities by health care professionals trained in the use of the i STAT System and comparative methods Precision data were collected in multiple sites as follows Duplicates of each control fluid were tested in the morning and in the afternoon on five d...

Page 437: ...decreased in patients undergoing cardiopulmonary bypass CPB or ECMO and with patients receiving large volumes of saline based IV fluids Care should be taken when using hematocrit results from patients with total protein levels below the adult reference range 6 5 to 8 g dL The CPB sample type can be used to correct the hematocrit result for the dilutional affect of the pump prime in cardiovascular ...

Page 438: ...of blood from a syringe before filling a cartridge n Low hematocrit results can be caused by contamination of flush solutions in an arterial or venous line o Back flush a line with a sufficient amount of blood to remove intravenous solutions heparin or medications that may contaminate the sample Five to six times the volume of the catheter connectors and needle is recommended Cartridge Comparison ...

Page 439: ...man Incorrect Least Squares Regression Coefficients in Method Comparison Analysis Clinical Chemistry 25 3 432 1979 6 CLSI Interference Testing in Clinical Chemistry Proposed Guideline CLSI document EP7 P ISBN 1 56238 020 6 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 1986 7 J D Bower P G Ackerman and G Toto eds Evaluation of Formed Elements of Blood in Clinical Laboratory...

Page 440: ...bbott Park IL 60064 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299 2011 Abbott Point of Care Inc All rights reserved Printed in USA Rev Date 01 Aug 11 Art 714178 00L HB 6 ...

Page 441: ...idge configuration sensors for the measurement of specific analytes and a buffered aqueous calibrant solution that contains known concentrations of analytes and preservatives For cartridges that contain a sensor for the measurement of ionized calcium a list of reactive ingredients is indicated below Reactive Ingredient Calcium Ca2 Metrological Traceability The i STAT System test for ionized calciu...

Page 442: ...ics The typical performance data summarized below was collected in health care facilities by health care professionals trained in the use of the i STAT System and comparative methods Precision data were collected in multiple sites as follows Duplicates of each control fluid were tested in the morning and in the afternoon on five days for a total of 20 replicates The averaged statistics are present...

Page 443: ...erials Hemodilution of the plasma by more than 20 associated with priming cardiopulmonary bypass pumps plasma volume expansion or other fluid administration therapies using certain solutions may cause clinically significant error on sodium chloride ionized calcium and pH results These errors are associated with solutions that do not match the ionic characteristics of plasma To avoid these errors w...

Page 444: ...t a concentration of 10 2 mmol L decreased i STAT ionized calcium results while acetylcysteine at a concentration of 0 3 mmol L did not significantly interfere with ionized calcium results 3 Bromide has been tested at two levels the CLSI recommended level and a therapeutic plasma con centration level of 2 5 mmol L The latter is the peak plasma concentration associated with halothane anesthesia in ...

Page 445: ...ine Reduces Homocysteine Plasma Levels After Single Intravenous Adminstration by Increasing Thiols Urinary Excretion Pharmacological Research Volume 40 Issue 4 October 1999 Pages 345 350 10 Gillian M Borthwick A Sarah Johnson Matthew Partington John Burn Robert Wilson and Helen M Arthur Therapeutic levels of aspirin and salicylate directly inhibit a model of angiogenesis through a Cox independent ...

Page 446: ...bott Park IL 60064 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299 2011 Abbott Point of Care Inc All rights reserved Printed in USA Rev Date 01 Aug 11 Art 714179 00L iCa 6 ...

Page 447: ... electrode when potentiometric sensors are included in the cartridge configuration sensors for the measurement of specific analytes and a buffered aqueous calibrant solution that contains known concentrations of analytes and preservatives Metrological Traceability The i STAT System test for oxygen partial pressure measures oxygen partial pressure in arterial venous or capillary whole blood dimensi...

Page 448: ... also does not take into account the effects of fetal hemoglobin or dysfunctional hemoglobins carboxy met and sulfhemoglobin Clinically significant errors can result from incorporation of such an estimated sO2 value for oxygen saturation in further calculations such as shunt fraction or by assuming the value obtained is equivalent to fractional oxyhemoglobin Temperature Correction Algorithm PO2 is...

Page 449: ...ge in overcoming this problem As a guide the range of data can be considered adequate if r 0 975 Precision Data mmHg Aqueous Control Mean SD CV Level 1 65 1 3 12 4 79 Level 3 146 5 6 00 4 10 Method Comparison mmHg Radiometer ABL500 Radiometer ABL700 Bayer 845 n 45 29 30 Sxx 3 70 2 04 3 03 Syy 2 78 2 64 3 28 Slope 1 023 0 962 1 033 Int t 2 6 1 2 2 9 Sy x 2 52 3 53 3 44 Xmin 39 31 Xmax 163 185 r 0 9...

Page 450: ...ley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 2001 4 CLSI Method Comparison and Bias Estimation Using Patient Samples Approved Guideline CLSI document EP9 A ISBN 1 56238 283 7 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 1995 5 P J Cornbleet and N Gochman Incorrect Least Squares Regression Coefficients in Method Comparison Analysis Clinical Chemistry 25 3 432 1979...

Page 451: ... concentrations of analytes and preservatives For cartridges that contain a sensor for the measurement of pH a list of reactive ingredients is indicated below Reactive Ingredient Hydrogen Ion H Metrological Traceability The i STAT System test for pH measures the hydrogen ion amount of substance concentration in the plasma fraction of arterial venous or capillary whole blood expressed as the negati...

Page 452: ... sites as follows Duplicates of each control fluid were tested in the morning and in the afternoon on five days for a total of 20 replicates The averaged statistics are presented below Method comparison data were collected using CLSI guideline EP9 A5 Venous blood samples were collected in evacuated tubes and arterial samples were collected in blood gas syringes with lithium heparin anticoagulant A...

Page 453: ...r 3 Hemodilution of the plasma by more than 20 associated with priming cardiopulmonary bypass pumps plasma volume expansion or other fluid administration therapies using certain solutions may cause clinically significant error on sodium chloride ionized calcium and pH results These errors are associated with solutions that do not match the ionic characteristics of plasma To avoid these errors when...

Page 454: ...eline CLSI document C46 A ISBN 1 56238 444 9 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 2001 5 CLSI Method Comparison and Bias Estimation Using Patient Samples Approved Guideline CLSI document EP9 A ISBN 1 56238 283 7 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 1995 6 P J Cornbleet and N Gochman Incorrect Least Squares Regression Coefficients ...

Page 455: ... use in the in vitro quantification of carbon dioxide partial pressure in arterial venous or capillary whole blood PCO2 measurements are used in the diagnosis monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid base disturbances Bicarbonate is used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid...

Page 456: ...y respiratory alkalosis decreased PCO2 are hypoxia resulting in hyperventilation due to chronic heart failure edema and neurologic disorders and mechanical hyperventilation HCO3 bicarbonate the most abundant buffer in the blood plasma is an indicator of the buffering capacity of blood Regulated primarily by the kidneys HCO3 is the metabolic component of acid base balance Causes of primary metaboli...

Page 457: ...deline EP9 A5 Venous blood samples were collected in blood gas syringes All samples were analyzed in duplicate on the i STAT System and on the comparative methods within 10 minutes of each other Arterial blood samples were collected from hospital patients in 3cc blood gas syringes and were analyzed in duplicate on the i STAT System and the comparative method within 5 minutes of each other Deming r...

Page 458: ...le with a pipette when filling a cartridge to avoid the loss of CO2 in the blood Allowing blood to stand without exposure to air before testing allows PCO2 to increase and pH to decrease which will cause HCO3 and TCO2 to be over estimated due to metabolic processes For patients administered propofol Diprivan or thiopental sodium syn thiomebumal sodium penthiobarbital sodium thiopentone sodium thio...

Page 459: ...d Comparison and Bias Estimation Using Patient Samples Approved Guideline CLSI document EP9 A ISBN 1 56238 283 7 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 1995 6 P J Cornbleet and N Gochman Incorrect Least Squares Regression Coefficients in Method Comparison Analysis Clinical Chemistry 25 3 432 1979 7 The Merck Index Eleventh Edition Merck Co Inc NJ 1989 i STAT is a re...

Page 460: ...bott Park IL 60064 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299 2011 Abbott Point of Care Inc All rights reserved Printed in USA Rev Date 02 Aug 11 Art 714182 00R PCO2 6 ...

Page 461: ... that contains sensors for the measurement of TCO2 a list of reactive ingredients is indicated below Reactive Ingredient Carbon Dioxide CO2 Metrological Traceability The i STAT System test for total carbon dioxide TCO2 measures the amount of substance total concentration of all forms of carbon dioxide in the plasma fraction of arterial venous or capillary whole blood dimension mmol L 1 for in vitr...

Page 462: ...rological traceability of the CHEM8 TCO2 measurement the traceable TCO2 is considered to be a measured analyte Performance Characteristics Precision data were collected in multiple sites following the protocol recommended by Abbott Point of Care The means SDs and CVs from 20 replicates at each site were averaged The average statistics are presented below Method comparison data were collected using...

Page 463: ...T CHEM8 and i STAT EC8 cartridges In the 14 30 mmol L range the average difference was 0 7 mmol L Factors Affecting Results Exposing the sample to air allows CO2 to escape which causes TCO2 to be under estimated The use of partial draw tubes evacuated tubes that are adjusted to draw less than the tube volume e g a 5 mL tube with enough vacuum to draw only 3 mL is not recommended for use with the i...

Page 464: ...ment C46 A ISBN 1 56238 444 9 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 2001 4 CLSI Method Comparison and Bias Estimation Using Patient Samples Approved Guideline CLSI document EP9 A ISBN 1 56238 283 7 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 1995 5 P J Cornbleet and N Gochman Incorrect Least Squares Regression Coefficients in Method Compa...

Page 465: ...cal assessment the patient sample should be retested using another cartridge INTENDED USE The test for creatinine as part of the i STAT System is for the quantitative determination of creatinine in whole blood on the i STAT handheld Creatinine measurements are used in the diagnosis and treatment of renal diseases in monitoring renal dialysis and as a calculation basis for measuring other urine ana...

Page 466: ...entration of creatinine is a better indicator of renal function than urea or uric acid because it is not affected by diet exercise or hormones The creatinine level has been used in combination with BUN to differentiate between prerenal and renal causes of an elevated urea BUN Performance Characteristics The typical performance data summarized below were collected in health care facilities by profe...

Page 467: ...7 0 5 0 5 Xmax 10 3 20 0 7 2 5 7 r 0 997 0 996 0 991 0 986 Cartridge Comparison The performance characteristics of the sensors are equivalent in all cartridge configurations System difference analysis was performed on 39 patient samples using the i STAT CHEM8 and i STAT Crea cartridges In the 0 42 2 50 mg dL range the average difference was 0 01 In the 2 50 9 08 mg dL range the average difference ...

Page 468: ... treat malignancies including melanoma metastatic ovar ian cancer and chronic myelogenous leukemia It is also used in the treatment of polycythemia vera thrombocythemia and psoriasis At typical doses ranging from 500 mg to 2 g day concentrations of hydroxyurea in patients blood may be sustained at approximately 100 to 500 µmol L Higher concentra tions may be observed soon after dosing or at higher...

Page 469: ...rfere with i STAT creatinine results 6 The dependence of the i STAT creatinine with respect to Carbon Dioxide CO2 is as follows For Crea values below 2 mg dL For PCO2 values above 40 mmHg the values are increased by 6 9 for every 10 mmHg For PCO2 values below 40 mmHg the values are decreased by 6 9 for every 10 mmHg Cr corrected Cr istat X 1 0 069 X PCO2 40 10 For Crea values above 2 mg dL For PCO...

Page 470: ... Chapman B Kuchel PW Role of N acetylcysteine and cystine in glutathione synthesis in human erythrocytes Redox Rep 2009 14 3 115 24 9 Paolo Ventura Rossana Panini Maria CristinaPasini Gabriella Scarpetta and Gianfranco Salvioli N Acetyl Cysteine Reduces Homocysteine Plasma Levels After Single Intravenous Adminstration by Increasing Thiols Urinary Excretion Pharmacological Research Volume 40 Issue ...

Page 471: ...asurements of blood acid base status 2 monitoring tissue hypoxia and strenuous physical exertion and 3 diagnosis of hyperlactatemia Contents Each i STAT cartridge contains one reference electrode when potentiometric sensors are included in the cartridge configuration sensors for the measurement of specific analytes and a buffered aqueous calibrant solution that contains known concentrations of ana...

Page 472: ...5 but also in trauma6 8 and surgical9 11 settings Performance Characteristics The typical performance data summarized below was collected in health care facilities by health care professionals trained in the use of the i STAT System and comparative methods Precision data were collected using CLSI guideline EP5 A12 Duplicates of each level of control were tested on three lots of cartridges over 20 ...

Page 473: ...ected into heparinized syringes Samples for lactate should be analyzed immediately on drawing as lactate increases by as much as 70 within 30 minutes at 25 ºC as a result of glycolysis 2 Test concentrations used were as per the CLSI guidance document 16 unless otherwise indicated The following substances are known to interfere with the i STAT lactate assay Substance Test Concentration mmol L Inter...

Page 474: ...ethylene glycol ingestion as the cause of an otherwise unknown high anion gap metabolic acidosis 22 23 In a study of 35 patients who had ingested eth ylene glycol initial glycolic acid concentrations of 0 to 38 mmol L corresponded to ethylene glycol levels of 0 97 130 6 mmol L 23 3 Bromide has been tested at two levels the CLSI recommended level and a therapeutic plasma con centration level of 2 5...

Page 475: ... signal in surgical practice Crit Care 2004 8 96 98 10 Husain FA Martin MJ Mullenix PS et al Serum lactate and base deficit as predictors of mortality and morbidity Am J Surg 2003 185 485 491 11 Rossi AF Khan DM Hannan R et al Goal directed medical therapy and point of care testing improve outcomes after congenital heart surgery Intensive Care Med 2005 31 98 104 12 CLSI Evaluation of Precision Per...

Page 476: ...the emergency department Singapore Med J 2007 48 11 986 22 Morgan TJ Clark C Clague A Artifactual elevation of measured plasma L lactate concentration in the presence of glycolate Crit Care Med 1999 27 2177 2179 23 Porter WH Crellin M Rutter PW Oeltgen P Interference by Glycolic Acid in the Beckman Synchron Method for Lactate A Useful Clue for Unsuspected Ethylene Glycol Intoxication Clin Chem 200...

Page 477: ...d amperometrically and the time of detection is measured in seconds The test reports the Activated Clotting Time ACT as a whole blood time WBT in seconds The i STAT Celite ACT test is calibrated to match the Hemochron Celite FTCA510 using prewarmed tubes However users of the i STAT 1 analyzer may choose to customize their individual i STAT locations to report ACT results as calibrated against the ...

Page 478: ... and assigned values may not be commutable with other methods Further information regarding metrological traceability is available from Abbott Point of Care Inc Expected Values Test Abbreviation Units Reportable Range Reference Range PREWRM Reference Range NONWRM Activated Clotting Time ACT seconds 50 1000 74 125 84 139 The range from 80 1000 seconds has been verified through method comparison stu...

Page 479: ...ate of each sample In the method comparison table n is the number of specimens in the data set Sxx and Syy refer to estimates of the imprecision based on the duplicates of the comparative and i STAT methods respectively Sy x is the standard error of the estimate and r is the correlation coefficient Method comparisons will vary from site to site due to differences in the sample handling reagent and...

Page 480: ...results may differ somewhat due to test to test variation The degree of interference at concentrations other than those listed might not be predictable Heparin sensitivity was demonstrated using whole blood samples to which varying concentrations of heparin were added in vitro The five graphs below each indicate the response of a different donor with respect to heparin concentration ...

Page 481: ...Rev Date 30 Jan 12 Art 714185 00N Celite ACT 5 The graphs below indicate the response of the same five donors with respect to the ACT result on the Medtronic HR ACT and the Hemochron Celite FTCA 510 ...

Page 482: ...esults Poor technique in sample collection may also compromise the results Samples drawn from insufficiently flushed catheters or from traumatic venipunctures may be contaminated with interfering substances Samples should be collected into plastic syringes or tubes Collection into glass may prematurely activate coagulation resulting in accelerated clotting times The i STAT ACT test uses Celite bra...

Page 483: ...agulants such as heparin EDTA oxalate or citrate The collection device cannot contain clot activators or serum separators The sample should be immediately dispensed into the sample well of a cartridge If a second measurement is required a fresh sample must be obtained Note Some experts recommend drawing and discarding a sample of at least 1 mL prior to drawing sample for coagulation testing 5 Indw...

Page 484: ...087 1995 3 P J Cornbleet and N Gochman Incorrect Least Squares Regression Coefficients in Method Comparison Analysis Clinical Chemistry 25 3 432 1979 4 Wang JS Lin CY Hung WT Thisted RA Carp RB In vitro effects of aprotinin on activated clotting time measured with different activators Journal of Thoracic Cardiovascular Surgery 104 4 1135 40 1992 5 Corriveau Donna Fritsma George ed Hemostasis and T...

Page 485: ...ctive compound NH3 C6 H4 NH C6 H4 OCH3 The formation of the electroactive compound is detected amperometrically and the time of detection is measured in seconds The test reports the Activated Clotting Time ACT in seconds The i STAT Kaolin ACT test is calibrated to match the Hemochron Celite FTCA510 using prewarmed reagent tubes However users of the i STAT 1 analyzer may choose to customize their i...

Page 486: ... i STAT System controls are validated for use only with the i STAT System and assigned values may not be commutable with other methods Further information regarding metrological traceability is available from Abbott Point of Care Inc Expected Values Test Abbreviation Units Reportable Range Reference Range PREWRM Reference Range NONWRM Activated Clotting Time ACT seconds 50 1000 74 137 82 152 The r...

Page 487: ...thods respectively Sy x is the standard error of the estimate and r is the correlation coefficient Method comparisons will vary from site to site due to differences in the sample handling reagent and instrument systems in use and other site specific variables Hemochron FTK ACT CVOR Site 1 Site 2 Site 3 n 104 118 106 Sxx 9 1 6 8 7 6 Syy 3 6 4 0 3 6 Slope 0 96 1 05 0 96 Intercept 12 38 39 Xmin 68 11...

Page 488: ...Kaolin ACT 4 Art 715878 00M Rev Date 31 Jan 12 ...

Page 489: ...v Date 31 Jan 12 Art 715878 00M Kaolin ACT 5 The following two graphs indicate the response of the same three donors with respect to the ACT result on the Medtronic HR ACT and the Hemochron Kaolin FTK ACT ...

Page 490: ...main on a level surface with the display facing up during testing If the analyzer is not level the ACT result may be affected by more than 10 A level surface includes running the handheld in the downloader recharger Hemodilution may affect test results Platelet dysfunction hereditary or acquired may affect the results of this test This includes the administration of pharmacological compounds known...

Page 491: ...e discontinued If blood must be drawn from an indwelling line possible heparin contamination and specimen dilution should be considered The line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded Withdraw the sample for testing into a fresh plastic syringe The collection syringe cannot contain anticoagulants such as heparin EDTA oxalate ...

Page 492: ...e CLSI document EP9 A ISBN 1 56238 283 7 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1995 3 P J Cornbleet and N Gochman Incorrect Least Squares Regression Coefficients in Method Comparison Analysis Clinical Chemistry 25 3 432 1979 4 Corriveau Donna Fritsma George ed Hemostasis and Thrombosis in the Clinical Laboratory Ed J B Lippinncott Company Philadelphia 1988 pp 70 71 i STAT i...

Page 493: ...enoted by the two dashes because the bond structurally resembles the thrombin cleaved amide linkage in fibrinogen The product of the thrombin substrate reaction is the electrochemically inert tripeptide Phenylalanyl Pipecolyl Arginine and the electroactive compound NH3 C6 H4 NH C6 H4 OCH3 A formation of the electroactive compound is detected amperometrically and the time of detection is measured T...

Page 494: ...d Health Organization WHO international reference measurement procedures and the International Reference Preparation recommended by the WHO 2 i STAT System controls are validated for use only with the i STAT System and assigned values may not be commutable with other methods Further information regarding metrological traceability is available from Abbott Point of Care Inc Expected Values Test Abbr...

Page 495: ...ethod comparison data were collected at the Hemostasis Reference Laboratory Hamilton Ontario Canada Venous samples from outpatients undergoing routine oral anticoagulation therapy were collected in plastic tubes and analyzed in duplicate on multiple lots of cartridges on the i STAT System plasma from tubes containing a citrate anticoagulant were analyzed in duplicate on the comparative instruments...

Page 496: ...PT INR 4 Art 715236 00N Rev Date 01 Mar 12 i STAT PT INR Siemens System CA 1500 PT INR i STAT PT INR STA Compact PT INR Siemens Sysmex CA 1500 PT INR ...

Page 497: ...ne clinical site comparing data from capillary samples to data from venous samples analyzed on the i STAT System Statistic Capillary vs Venous n 39 Mean INR 2 4 Range INR 1 3 5 4 Sx INR 0 960 Slope 1 049 Intercept INR 0 098 Sy x 0 128 r 0 978 IL ACL 7000 PT INR i STAT PT INR ...

Page 498: ...udes running the handheld in the downloader recharger The i STAT PT INR test is not affected by fibrinogen concentrations between 70 and 541 mg dL The i STAT PT INR test is not affected by unfractionated heparin concentrations up to 1 0 U mL Hematocrits in the range of 24 54 PCV have been demonstrated not to affect results Cubicin daptomycin for injection has been found to cause a concentration de...

Page 499: ...d will be drawn into the cartridge 7 Apply sample until it reaches the fill mark indicated on the cartridge 8 Fold the sample closure over the sample well 9 Press the rounded end of the closure until it snaps into place Note To further simplify the sample application into the test cartridge it is possible to bring the cartridge to the finger for easier application Do ensure that the instrument rem...

Page 500: ...uares Regression Coefficients in Method Comparison Analysis Clinical Chemistry 25 3 432 1979 5 CLSI Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens Approved Standard Sixth Edition CLSI document H4 A6 ISBN 1 56238 677 8 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 USA 2008 6 Corriveau Donna Fritsma George ed Hemostasis and Thrombosis in the Clinica...

Page 501: ...s allowing the enzyme conjugate to dissolve into the sample The cTnI within the sample becomes labeled with alkaline phosphatase and is captured onto the surface of the electrochemical sensor during an incubation period of approximately seven minutes The sample as well as excess enzyme conjugate is washed off the sensors Within the wash fluid is a substrate for the alkaline phosphatase enzyme The ...

Page 502: ...diagnostic time window 1 The cardiac specific troponins troponin I cTnI and troponin T cTnT are considered the biochemical markers of choice in the evaluation of acute coronary syndromes ACS including ST elevation myocardial infarction non ST elevation myocardial infarction and unstable angina 2 3 Elevated levels of cardiac specific troponins convey prognostic information beyond that supplied by t...

Page 503: ...esults Where there are inconsistencies in the clinical information or where diagnostic criteria are not fully satisfied the possibility of biased results should be recognized see Test Limitations Performance Characteristics Precision data were collected in multiple sites as follows Duplicates of each control were tested daily for a period of 20 days resulting in a total of 40 replicates The averag...

Page 504: ...he analytical sensitivity is defined as the concentration at two standard deviations from a sample at 0 00 ng mL Another characteristic of an analytical measurement is the functional sensitivity which is defined as the cTnI level at which the test method displays a particular percent coefficient of variation CV Estimates of the 20 and 10 functional sensitivity for the cTnI method were determined f...

Page 505: ...ree cTnI positive whole blood samples that were then assayed in duplicate for each of three separate i STAT cTnI cartridge lots These whole blood samples were then diluted using an equal mass of the original unspiked whole blood and assayed in duplicate From this whole blood data the cTnI recovery was calculated The plasma derived from these three donors was combined in equal masses and all pairwi...

Page 506: ...ment 14 Cardiac troponin may not appear in circulation for 4 6 hours following the onset of symptoms of MI Consequently a single negative result is insufficient to rule out MI The use of a serial sampling protocol is recommended practice 11 The results of different troponin assays are not generally comparable cTnI and cTnT are distinct molecules and results are not interchangeable nor comparable I...

Page 507: ... indicated Acetaminophen 1660 Allopurinol 294 Ascorbic Acid 227 Acetyl Salicylic Acid 3330 Atenolol 37 6 Caffeine 308 Captopril 23 Chloramphenicol 155 Diclofenac 169 Digoxin 6 15 Dopamine 5 87 Enalaprilat 0 86 Erythromycin 81 6 Furosemide 181 Sodium Heparin 36 U mL Ibuprofen 2425 Isosorbide dinitrate 636 Methyldopa 71 Nicotine 6 2 Nifedipine 1 156 Phenytoin 198 Propanolol 7 71 Salicylic Acid 4340 ...

Page 508: ...c peptide Circulation 2002 105 1760 1763 8 Cannon CP Weintraub WS Demopoulos LA et al Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb IIIa inhibitor tirofiban NEJM 2001 344 25 1879 1887 9 Morrow DA Antman EM Tanasijevic MJ et al Cardiac troponin I for stratification of early outcomes and the efficacy of enoxapr...

Page 509: ...murine immunoglobulin responses in patients receiving monoclonal antibody therapy Cancer Res 1985 45 879 22 Primus et al Sandwich type immunoassay of carcinoembryonic antigen in patients receiving murine monoclonal antibodies for diagnosis and therapy Clin Chem 1988 34 261 23 Nahm et al Heteroantibody phantom of the immunoassay Clin Chem 1990 36 829 24 Boscato et al Heterophilic antibodies a probl...

Page 510: ...ott Park IL 60064 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299 2012 Abbott Point of Care Inc All rights reserved Printed in USA Rev Date 23 May 12 Art 715595 00R cTnI 10 ...

Page 511: ...nto contact with the sensors allowing the enzyme conjugate to dissolve into the sample The CK MB within the sample becomes labeled with alkaline phosphatase and is captured onto the surface of the electrochemical sensor during an incubation period of approximately three minutes The sample is washed off the sensors as well as excess enzyme conjugate Within the wash fluid is a substrate for the alka...

Page 512: ...soforms of creatine kinase BB MM and MB BB is found primarily in the brain Skeletal muscles primarily contain the MM isoform with traces of MB estimates of 1 4 of CK activity Cardiac muscles also contain primarily the MM isoform but higher amounts of MB typically around 20 of CK activity 2 Serum from healthy individuals typically contains the MM isoform and a small amount of the MB isoform CK MB c...

Page 513: ...g CLSI guideline EP9 A2 10 Venous blood samples were collected in heparinized evacuated tubes and analyzed in duplicate on the i STAT System A portion of the specimen was centrifuged and the separated plasma was analyzed in duplicate on the i STAT System and on the comparative method within 1 hour of collection Deming regression analysis11 was performed on the first replicate of each sample In the...

Page 514: ... CK MB Crossreactant Concentration Percent Crossreactivity CK MM skeletal 10000 ng mL Not Detectable CK BB brain 100 ng mL Not Detectable Recovery The dilution linearity of the i STAT CK MB test was investigated using heparinized whole blood and plasma samples derived from 3 separate donors For each donor the original CK MB negative sample and a CK MB spiked sample were prepared This process yield...

Page 515: ...has been reported 13 While this product contains reagents that minimize the effect of these interferents and QC algorithms designed to detect their effects the possibility of interference causing erroneous results should be evaluated carefully in cases where there are inconsistencies in the clinical information Partially clotted samples can result in elevated CK MB readings above the reference ran...

Page 516: ...nd Test Level μmol L unless otherwise indicated Acetaminophen 1660 Allopurinol 294 Ampicillin 152 Ascorbic Acid 227 Acetyl Salicylic Acid 3330 Atenolol 37 6 Caffeine 308 Captopril 23 Chloramphenicol 155 Diclofenac 169 Digoxin 6 15 Dopamine 5 87 Enalaprilat 0 86 Erythromycin 81 6 Furosemide 181 Sodium Heparin 90 U mL Ibuprofen 2425 Isosorbide dinitrate 636 Methyldopa 71 Nicotine 6 2 Nifedipine 1156...

Page 517: ...himica Acta 1998 272 59 67 9 A S Maisel Point of Care Diagnosis and Management of Myocardial Infarction and Congestive Heart Failure in Principles Practice of Point of Care Testing G J Kost ed Philadelphia Lippincott Williams Wilkins 2002 10 Clinical and Laboratory Standards Institute CLSI Method Comparison and Bias Estimation Using Patient Samples Approved Guideline Second Edition CLSI document E...

Page 518: ...ott Park IL 60064 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299 2012 Abbott Point of Care Inc All rights reserved Printed in USA Rev Date 03 Aug 12 Art 716675 00L CK MB 8 ...

Page 519: ...sample The BNP within the sample becomes labeled with alkaline phosphatase and is captured onto the surface of the electrochemical sensor during an incubation period of approximately seven minutes The sample is washed off the sensors as well as excess enzyme conjugate Within the wash fluid is a substrate for the alkaline phosphatase enzyme The enzyme bound to the antibody antigen antibody sandwich...

Page 520: ...a dyspnea on exertion DOE nocturnal cough and peripheral edema 2 Clinical signs include elevated jugular venous pressure rales on lung auscultation the presence of a third heart sound and peripheral edema 2 Unfortunately these signs and symptoms are variable and when present non specific as other clinical entities such as chronic obstructive pulmonary disease can produce a similar clinical picture...

Page 521: ...t ventricular EF in identifying patients with CHF regardless of the threshold value 16 Two dimensional echocardiography was less sensitive than a single determination of BNP in diagnosing CHF However the two variables have marked additive diagnostic value and when combined have a much improved accuracy compared to either method alone This strongly suggests that where applicable they should be used...

Page 522: ...tudy are summarized in the following table Non Heart Failure Population All Age Group All 45 Years 45 54 Years 55 64 Years 65 74 Years 75 Years Sample Size N 890 205 146 171 248 120 Median pg mL 21 17 9 24 23 31 Mean pg mL 39 28 21 37 47 63 SD pg mL 66 36 30 48 80 109 95th Percentile 135 85 87 119 160 254 Percentage 100 pg mL 91 5 96 6 95 2 94 2 87 1 83 3 Minimum pg mL 0 0 0 0 0 0 Maximum pg mL 90...

Page 523: ...gnosed heart failure 231 females 462 males were tested with the AxSYM BNP assay All patients in this population were categorized according to the functional classification system published by the New York Heart Association NYHA 22 This system divides heart failure patients into one of four categories of increasing disease progression classes I to IV based upon a subjective assessment of the patien...

Page 524: ...70 7 76 0 96 9 Minimum pg mL 0 3 0 0 14 Maximum pg mL 4000 1408 3782 4000 4000 Heart Failure Population Females NYHA Functional Class All I II III IV Sample Size N 231 30 104 69 28 Median pg mL 385 174 298 466 1408 Mean pg mL 685 341 481 760 1623 SD pg mL 858 388 641 870 1186 5th Percentile 16 14 21 12 244 95th Percentile 2593 1022 2031 2718 4000 Percentage 100 pg mL 80 5 63 3 77 9 84 1 100 0 Mini...

Page 525: ...es in NYHA classifications This analysis indicates that BNP measurements provide objective information for use in the assessment of the severity of heart failure Data from the above clinical study were used to generate the Receiver Operating Characteristic ROC curve of BNP decision thresholds versus clinical sensitivity and clinical specificity as shown in the following graph At a decision thresho...

Page 526: ...62 9 to 77 4 79 5 to 91 2 Specificity 94 8 403 425 97 2 104 107 100 0 71 71 97 9 92 94 88 7 102 115 89 5 34 38 95 Confidence Interval 92 3 to 96 7 92 0 to 99 4 94 9 to 100 0 92 5 to 99 7 81 5 to 93 8 75 2 to 97 1 Females Age Group All 45 Years 45 54 Years 55 64 Years 65 74 Years 75 Years Sensitivity 80 5 186 231 44 4 4 9 73 3 11 15 50 0 13 26 80 6 58 72 91 7 100 109 95 Confidence Interval 74 8 to ...

Page 527: ... plasma obtained via centrifugation were first run simultaneously in duplicate i STAT BNP test cartridges A whole blood sample was then spiked with BNP and following a short equilibration period a plasma sample was prepared by centrifugation and the whole blood and plasma samples were run simultaneously in duplicate Three lots of i STAT BNP test cartridges were employed with a single lot being use...

Page 528: ...tectable crossreactivity for BNP ANP CNP and N terminal pro BNP Recovery The dilution linearity of the i STAT BNP test was investigated using EDTA whole blood and plasma samples derived from 3 separate donors For each donor the original BNP negative sample and a BNP spiked sample were prepared This process yielded three BNP positive whole blood samples that were then assayed in duplicate for each ...

Page 529: ...3 4222 102 Whole Blood 1 44 41 93 Whole Blood 2 88 88 100 Whole Blood 3 269 287 107 Whole Blood 4 537 554 103 Whole Blood 5 725 720 99 Whole Blood 6 1450 1367 94 Whole Blood 7 3042 2826 93 Whole Blood 8 4056 3856 95 Test Limitations The frequency of suppressed results is affected by atmospheric pressure Suppressed result rates may increase with higher elevations decreased barometric pressure and m...

Page 530: ...etection of BNP increased assay backgrounds and or quality check codes Hematocrits in the range of 0 60 PCV have been demonstrated not to affect results Samples with hematocrit levels above this range have demonstrated increases in the test imprecision and quality check codes The analyzer must remain on a flat surface with the display facing up during testing Motion of the analyzer during testing ...

Page 531: ...SI guideline EP7 A 36 Compound Test Level μmol L unless otherwise indicated Acetaminophen 1660 Allopurinol 294 Ampicillin 152 Ascorbic Acid 227 Acetyl Salicylic Acid 3330 Atenolol 37 6 Caffeine 308 Captopril 23 Chloramphenicol 155 Diclofenac 169 Digoxin 6 15 Dopamine 5 87 Enalaprilat 0 86 Erythromycin 81 6 Furosemide 181 Sodium Heparin 90 U mL Ibuprofen 2425 Isosorbide dinitrate 636 Methyldopa 71 ...

Page 532: ...waiblmair M Vogeser M Cremer P von Scheidt W Role of Brain Natri uretic Peptide in Risk Stratification of Patients with Congestive Heart Failure J Am Coll Cardiol 2001 Dec 38 7 1934 41 10 Richards AM Lainchbury JG Nicholls MG Troughton RW Yandle TG BNP in hormone guided treatment of heart failure Trends Endocrinol Metab 2002 May Jun 13 4 151 5 11 Troughton RW Frampton CM Yandle TG Espiner EA Nicho...

Page 533: ...arison and Bias Estimation Using Pa tient Samples Approved Guideline Second Edition CLSI document EP9 A2 ISBN 1 56238 472 4 Clinical and Laboratory Standards Institute 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 2002 27 P J Cornbleet and N Gochman Incorrect Least Squares Regression Coefficients in Method Compari son Analysis Clinical Chemistry 25 3 432 1979 28 Clinical and La...

Page 534: ...bott Park IL 60064 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299 2012 Abbott Point of Care Inc All rights reserved Printed in USA Rev Date 23 May 12 Art 716969 00J BNP 16 ...

Page 535: ... feature that provides protection preventing the i STAT handheld from overheating due to component failure within the analyzer circuitry 2 GENERAL NOTES AND CONSIDERATIONS 1 The new Ultralife 9 volt lithium battery has the same Abbott List Number as the current battery 06F21 26 The new battery will also be packaged the same as the current battery with each box containing 6 batteries 2 The new batt...

Page 536: ......

Page 537: ...as defined by the criteria defined in Subpart I Proficiency Testing Programs A primary testing system is defined as the only method or the primary method for performing and reporting tests under a CLIA certificate The i STAT System may be a primary testing system when A hospital has separate CLIA certificates for the main laboratory and point of care testing A hospital owns a clinic same day surge...

Page 538: ... not available make your selection based upon the cartridge type and lot number Note 3 When reporting results with the or symbol you must record the lowest or highest reportable value Make sure the symbol is legible and cannot be interpreted as a number Follow the proficiency testing survey instructions for reporting results Double check the coding as well as the CLIA number test results and any a...

Page 539: ...t is important to record the cartridge type and lot numbers used to test samples Note the CLEW software prevents manufacturing changes from affecting results when testing patient samples Proficiency Testing Survey Providers Note 1 This list may not include all providers and is not intended as an endorsement of any particular provider Abbott Point of Care no longer evaluates surveys and assumes tha...

Page 540: ...te the samples i STAT Protime INR Catalog 216 5 samples Calcium Chloride is included to reconstitute the samples Cardiac Markers CM Catalog 140 five samples Catalog 920 two samples For use with i STAT cTnI CK MB and BNP cartridges If additional sample is required for testing multiple cartridge types please add on 165 WSLH PT WSLH Proficiency Testing WSLH PT 465 Henry Mall Room 402 Madison WI 53706...

Page 541: ...PBGA432 2 samples for waived testing Includes pH PCO2 PO2 Na K Cl Glu Lac and iCa Hematocrit HCRT435 and Hematocrit POC PHCR432 Hematocrit by conductivity methods survey only For waived tests use survey PHCR432 Urea Creatinine URCR435 5 samples Urea Creatinine POC PUCR432 2 samples For waived tests use survey PUCR432 Chemistry Electrolytes Urea Creat Glu Lac BCHE435 CHEM463 Canada Only Cardiac Tro...

Page 542: ...ut with 2 samples per shipment Blood Gases Catalog 847 Includes Cl iCa PCO2 pH PO2 K and Na i STAT Protrombin Time INR Catalog 328 American Academy of Family Physicians Proficiency Testing Program AAFP PT American Academy of Family Physicians Proficiency Testing Program AAFP PT 11400 Tomahawk Creek Parkway Leawood Kansas 66211 2672 800 274 7911 www aafp org pt email pt aafp org Module 700 i STAT C...

Page 543: ...battery by gently pulling up on the red black wires until the connector releases from the two metal pins Once the battery is disconnected remove it completely from the battery compartment 4 Remove the new rechargeable battery from its packaging With the thumb and index finger of one hand grasp the connector at the end of the red black battery wires 5 Assure proper connector alignment as shown See ...

Page 544: ...or a minimum of 9 hours before use fast charging occurs only when the printer is turned off Symptoms Indicating that the NiMH Rechargeable Battery Requires Replacement 1 A steady yellow Status Light on the printer even after charging it for the recommended 9 hours 2 Loss of battery capacity indicated by a shorter interval between charges 3 The printer Power LED does not come on when the printer is...

Page 545: ... If the analyzer is configured with the Internal Electronic Simulator enabled run an external Electronic Simulator Running the external Electronic Simulator ensures the Internal Simulator cycle will not execute during the restoration cycle which could lead to the premature termination of restoration cycle 2 Run the CCC two times Initiate the CCC cycle as you would initiate an external Electronic S...

Page 546: ...Flip the strip over so the bottom side is now up Check one box for each time the ceramic cartridge is run in the analyzer Typically this means two boxes are checked each time an analyzer is restored with the ceramic cartridge serial number shown above There are 50 boxes If the strip is damaged2 replace the strip start a new log After all the boxes immediately below are checked rotate the strip as ...

Page 547: ... the ceramic strip for damage Replace if cracked or chipped CRACKED STRIPS MUST BE REPLACED BEFORE USING THE CERAMIC CARTRIDGE IN AN ANALYZER 4 Inspect the aluminum base Clean if necessary with isopropyl alcohol and soft lint free cloth Avoid using paper that might leave fibers on the ceramic cartridge which might be carried into the analyzer 5 Rotate the ceramic strip to the next orientation eith...

Page 548: ...Art 721215 00B Rev Date 10 Jun 11 4 PROCEDURE FOR REPLACING THE STRIP Follow the same procedure as rotating the strip except discard the old strip and insert a new strip in its place ...

Page 549: ...mally expressed as a decimal fraction Abbott Point of Care Inc has retained the term hematocrit for the measured quantity and according to common practice expresses hematocrit as a percentage in units of Percent Packed Cell Volume PCV A hematocrit of 0 45 PCV is expressed as 45 PCV THE METHODS The Microhematocrit Method Microhematocrit is the standard method for hematocrit determination1 An antico...

Page 550: ...amples collected in K2 EDTA for the purpose of calibrating their systems to reference methods Therefore for best agreement between these analyzers and the i STAT System the K2 EDTA customization setting should be selected Note The default setting on the i STAT System is K3 EDTA Automated Hematology Analyzer Methods Automated hematology analyzers do not directly measure hematocrit but rather calcul...

Page 551: ...h red blood cells from other non conducting elements such as proteins lipids and white blood cells which occupy volume in the sample The i STAT System is calibrated to read hematocrit accurately when these other elements are at normal levels Total Protein At hematocrit levels less than 40 PCV the reading will increase by approximately 1 PCV for each g dL 10 g L the protein level is increased outsi...

Page 552: ...obin Concentration 11 15 Red blood cells can deform under the pressure experienced when being sent through the measuring orifice This is particularly true for electrical impedance methods Cells with lower hemoglobin concentrations will deform to a greater degree This can create errors as large as 3 PCV Early authors attributed the discrepancy between automated hematology determinations and referen...

Page 553: ...er TF Adair RM Comparison of hematocrit determinations by micro hematocrit and electronic particle counter Am J Clin Pathol 72 71 74 1979 9 Fairbanks VF Nonequivalence of automated and manual hematocrit and erythrocyte indices Am J Clin Pathol 73 55 62 1980 10a Pearson TC Guthrie DL Trapped plasma in the microhematocrit Am J Clin Pathol 78 770 772 1982 10b Bull B Hay K Is the Packed Cell Volume PC...

Page 554: ... different automatic cell counters Annals Clin Lab Science 15 286 291 1985 27 Bock HA Fluckiger R Berger G Real and artefactual erythrocyte swelling in hyperglycemia Dia betologia 28 335 338 1985 Cold Agglutinin Interference on Automated Hematology Analyzers 28 Brittin GM Brecher G Jonsom CA et al Spurious macrocytosis of antibody coated red cells Amer J Clin Pathol 52 237 241 1969 29 Hattersley P...

Page 555: ... ed Norbert W Tietz W B Saunders Co Philadelphia 1986 TB 93 2 October 1993 Interference on Co oximetry Methods 41 Performance characteristics In ABL700 series RM Ed H Brønshøj Radiometer Medical A S 2002 Chapter 5 46 47 Code no 989 312 42 Jacobs DS Kasten BL Jr Demott WR et al Laboratory Test Handbook Second ed Hudson Cleveland Lexicomp Inc 1990 490 91 43 Zwart A Buursma A Oeseburg B Zijistra Dete...

Page 556: ...Art 714261 00E Rev Date 10 Jan 11 8 ...

Page 557: ...EDTA report lower hematocrit results than analyzers calibrated to MH K2 EDTA Selection of the K2 EDTA or K3 EDTA Customization Settings on the i STAT System i STAT provides two customization settings for reporting hematocrit results The K3 EDTA customization reports hematocrit results traceable to MH K3 EDTA The K2 EDTA customization reports hematocrit results traceable to MH K2 EDTA For best agre...

Page 558: ...s will be equivalent This is because the osmotically balanced diluent reverses the red blood cell shrinkage caused by the anticoagulant 5 It should be clear that results from K2 EDTA and K3 EDTA tubes will be equivalent but lower on an analyzer calibrated to MH K3 EDTA than on an analyzer calibrated to MH K2 EDTA i STAT has become aware that some customers have selected their i STAT hematocrit cus...

Page 559: ...413 9 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 1908 1898 USA 2000 4 Gotch F Torres L Evans M Keen M Metzner K Westpal D Polascegg H Comparison of Conductivity Measured Hematocrit to Microhematocrit ASAIO Transactions 37 M138 139 1991 5 Parikh M Evaluation of BD Vacutainer Plus Plastic 4 0mL K2 EDTA 2 0mL K2 EDTA and Glass 5 0mL K3 EDTA Tubes for CBC WBC Differential Count and Reticu...

Page 560: ...Art 716240 00D Rev Date 03 Mar 10 4 ...

Page 561: ...ification procedure be performed and documented at least once every six months The information presented below supports Abbott Point of Care Inc s position that it is the cartridges or more specifically the sensors rather than the analyzers that should be subject to the six month check on the accuracy of the reportable range and supports Abbott Point of Care Inc s claim that all analyzers that pas...

Page 562: ...the reportable ranges Injecting signals directly into the analyzer allows very tight control limits to be set Control limits for liquid controls are set wide enough to allow for sensor to sensor variation All analyzers that pass the Electronic Simulator test are equivalent and any variations in results are caused by within and between lot variations in the cartridges The combination of unit use ca...

Page 563: ... Calibration verification solutions can be used to verify that the calibration or slope of the measuring system has not been affected by the maintenance or repair procedure The user cannot perform any maintenance procedures on the i STAT System However the software in the analyzer is updated periodically a procedure that potentially could cause a change in results In fact software updates are rele...

Page 564: ...fication Controls BNP BNP 1 2 and 3 When performing the calibration verification procedure to meet a six month calibration verification requirement include each sensor and a representative selection of analyzers Notes Calibration Verification or a linearity check for hematocrit can also be performed by a manual method using blood collected in lithium heparin tubes and manipulated to create three l...

Page 565: ...ridges or cards instead of tubes and all have incorporated an automatic test cycle prewarming step that brings the ACT testing chamber to 37 C prior to initiating the clotting reaction As blood clotting is an enzymatic process the temperature at which the clotting cycle takes place has a marked impact on the rate at which the blood clot forms The ACT tests that incorporate a prewarming step allow ...

Page 566: ...ous ACT method and the i STAT ACT may require changing familiar clotting time target values In order to ease the changeover to the i STAT ACT method under these circumstances i STAT now provides a choice between the current 37ºC result calibration and a new non prewarm or ambient temperature result calibration The additional calibration mode allows an i STAT ACT cartridge to deliver results that w...

Page 567: ... Art 715617 00D Rev Date 06 11 08 REPRESENTATIVE DATA Effect of Sample Tube Temperature on Hemochron ACT Results using Paired Samples Prewarmed sample tubes vs Non prewarmed sample tubes ...

Page 568: ...Art 715617 00D Rev Date 06 11 08 i STAT Celite ACT vs Room Temperature Hemochron FTCA510 Prewarmed PREWRM vs Non prewarmed NONWRM calibration modes ...

Page 569: ...ow The i STAT PCA and BAM are NOT capable of offering the new ACT result calibration option All PCA and BAM ACT results continue to use the original ACT calibration PREWRM To clearly identify this calibration ACT results reported on the i STAT PCA will show PREWRM on the result screen The ACT test results that will be displayed on the i STAT 1 analyzer now show the calibration setting that was use...

Page 570: ...mization ACT K 1 PREWRM 2 NONWRM Page Celite ACT handheld customization Results Customization Decimal Separator Period 1 2 Test Selection Disabled 3 Hematocrit Prompt CPB K3 EDTA 4 Base Excess ecf 5 Page ACT C PREWRM Change Customization ACT C 1 PREWRM 2 NONWRM For i STAT 1 analyzers used in conjunction with CDS version 5 the new ACT customization options are located on the RESULTS tab of the Pref...

Page 571: ...ifferent locations within a given hospital may utilize different calibration modes customization profiles Prior to testing patient samples ensure the appropriate calibration mode is employed i STAT is registered trademark of Abbot Laboratories Actalyke is a registered trademark of Helena Laboratories Hemochron is a registered trademark of International Technidyne Corporation Hemotec is registered ...

Page 572: ...Art 715617 00D Rev Date 06 11 08 ...

Page 573: ...minal coronary angioplasty PTCA The i STAT Kaolin ACT is used for heparin anticoagulation monitoring during cardiopulminary bypass CPB surgery and can be used in the presence of aprotinin The i STAT ACT tests can be performed using the i STAT Portable Clinical Analyzer or i STAT 1 Analyzer The reportable range of the i STAT ACT test is from 50 1000 seconds The i STAT ACT tests have demonstrated li...

Page 574: ...no additives 1 1 000 units mL USP Heparin beef lung or porcine Isotonic Saline 9 0 mL 0 025M Calcium Chloride Precision pipettes 1 000 μL 3 2 or 3 8 Sodium Citrate evacuated blood collection tubes blue top for 9mL collection i e 2 x 4 5mL tubes Procedure Note Although clinical testing utilizes fresh whole blood exclusively for the purposes of the linearity assessment citrated whole blood can be su...

Page 575: ...heparin sensitivity high levels may yield out of range high results An intermediate amount of heparin can be used to perform linearity e g 35 μL The actual values obtained for a given heparin level will vary among donors The heparin type beef or porcine manufacturer source and lot number of the heparin preparation will also affect results The maximum concentration of heparin at which a donor s blo...

Page 576: ...F and G Note Before testing tubes B G mix gently by inversion 10 Record the clotting times and graph the results using Avg ACT seconds on the y axis and Heparin Concentration units mL on the x axis Result Interpretation Inspection of the dose response curve will identify a linear sensitivity response Linearity is defined statistically by the correlation coefficient r value of the assay which shoul...

Page 577: ... Whole Blood Date Facility Name Analyzer Serial Number i STAT ACT Lot Hep Conc U ml Clotting Time sec ACT 1 sec ACT 2 sec Average sec 0 1 2 3 4 5 6 i STAT is a registered trademark of Abbott Laboratories East Windsor NJ Celite is a registered trademark of Celite Corporation Santa Barbara CA for its diatomaceous earth products ...

Page 578: ...Art 714547 00F Rev Date 06 11 08 ...

Page 579: ...USA 08540 Tel 800 366 8020 option 1 Tel 877 529 7185 Email techsvc apoc abbott com AFRICA ANGOLA Magnamed Rua Prof Francisco Gentil n 22F 2620 097 Póvoa de Santo Adrião Portugal Tel No 351 21 938 32 40 BOTSWANA Adcock Ingram Scientific Group Ltd Scientific Group House Cosmo Business Park 15621 Cosmo City Randburg South Africa Tel No 27 87 35 35 600 COMORES Adcock Ingram Scientific Group Ltd Scient...

Page 580: ...ica Tel No 27 87 35 35 600 ZAMBIA Adcock Ingram Scientific Group Ltd Scientific Group House Cosmo Business Park 15621 Cosmo City Randburg South Africa Tel No 27 87 35 35 600 ZIMBABWE Adcock Ingram Scientific Group Ltd Scientific Group House Cosmo Business Park 15621 Cosmo City Randburg South Africa Tel No 27 87 35 35 600 ASIA PACIFIC EXCLUDING CHINA AUSTRALIA Abbott Point of Care P O Box 394 North...

Page 581: ...ict Beijing 100111 P R China Tel No 010 57621837 010 57621838 Beijing Beiyi Pharmaceuticals Co Ltd 706 7th floor Zhongxin Building No 52 West Road North 4 Ring Road HaiDian District Beijing China 100080 Tel No 86 10 51721328 Hangzhou Mulin Medical Equipment Co Ltd Room 3102 No 98 Zun Bao Mansion Cheng Xing Road Hangzhou Zhejiang China Tel No 86 571 88932385 Shanghai Runda Medical Technology Co Ltd...

Page 582: ...n 32 20090 ASSAGO MI Italy Tel No 39 02 457 13 663 NETHERLANDS Abbott Point of Care Wegalaan 9 NL 2132 JD Hoofddopr Netherlands Tel No 31 235 544 500 NORWAY Algol Kivex Kivex A S Hammervej 2 DK 2970 Hoersholm Tel 45 45170600 POLAND Dutchmed PL Sp z o o Ul Szajnochy 14 85 738 Bydgoszcz Poland Tel No 48 52 345 31 15 PORTUGAL Magnamed Rua Prof Francisco Gentil n 22F 2620 097 Póvoa de Santo Adrião Por...

Page 583: ...ta Rica 75 Oeste de la Cruz Roja costarricense Cs 16 a 18 Av 8 Edificio 1628 San Jose Costa Rica Tel 506 2257 7676 DOMINICAN REPUBLIC Caribbean Consolidation AHS American Hospital Supply 1060 Maitland Center Commons Maitland FL USA 32751 Tel 1 407 475 1168 ECUADOR M R U Fortune Plaza Medical Business Centre Av Eloy Alfaro N29 235 Entre Italia y Alemania Piso 4 to Of 403 Ecuador Tel 593 2 3801 533 ...

Page 584: ...ikh Khalid Building Gulf Street P O Box 4349 Doha Qatar Tel 974 432 5198 441 7471 442 7784 431 2233 SAUDI ARABIA Medical Supplies Services Co Ltd MEDISERV P O Box 17550 Riyadh 11494 Kingdom of Saudi Arabia Tel No 966 1 478 0555 U A E Gulf and World Traders LLc P O Box 5527 Al Garhoud Area Opposite DHL Office Dubai U A E Tel No 971 4 2821717 YEMEN Griffin Ltd Villa No 8 Street 16 Diplomatic Area Sa...

Page 585: ...tial release activates a set of alarms related to analyzers not being able to update CLEWs software binaries or customization preferences To access this new Monitor click on Main Open Monitor Alarm from the menu bar or Alarm Monitor from the Monitor submenu toolbar A window will open listing the currently enabled alarm categories and how many total alarms have been detected from each category A da...

Page 586: ...e printed by clicking the Print button at the bottom of the window The default setting for the Alarm Monitor is to have all Alarm Categories and the individual detailed alarms contained in those categories enabled To disable alarm reporting alarm categories or specific alarms contained in those categories 1 Close the CDS application if open 2 Click Start Run 3 Type wcds32 config at the Open prompt...

Page 587: ...Alarm Category containing the alarm to be disabled and then uncheck the Enabled box next to the alarm you wish to disable 8 Once all Alarm Categories and specific alarms you do not wish to view are disabled click Accept Reports 1 The Precision PCx method can now be selected on the Reagent Usage and Method Competence reports 2 Monthly subtotals may now be included in the Reagent Usage and Method Co...

Page 588: ... 4 When the i STAT Central Data Station Customization window appears click on the Options tab 5 Uncheck the Show Patient Name in Trend view print box and click Accept B Enabling the Precision PCx Method The Precision PCx method may now be enabled disabled from the i STAT Central Data Station Customization screen The default is to have the Precision PCx method disabled To enable the Precision PCx m...

Page 589: ... using a drag drop technique Instruments may now also be deleted in groups Simply highlight all of the instruments to be deleted and click on Instrument Delete from the menu bar or the Delete Instrument in the toolbar Operator Workspace The i STAT and Precision PCx certifications for operators may now be updated at the same time 1 Highlight the operator to be updated and click on Operator Update C...

Page 590: ...Art 720735 00B Rev Date 06 11 08 ...

Page 591: ... 06 11 08 Technical Bulletin i STAT APRIL 2008 UPDATE TO THE i STAT CENTRAL DATA STATION VERSION 5 QUALITY CHECK CODES VIEWER A new column has been added to the Quality Check Codes Viewer indicating the Quality Code Category corresponding to the individual quality check code ...

Page 592: ...Art 721106 00B Rev Date 06 11 08 ...

Page 593: ...Unused Preferences in the menu The Delete Preferences window will then open 2 Users may either Delete selected unused preferences or Delete all unused preferences by clicking the appropriate radio button a To delete selected unused preferences Click the Delete selected unused preferences radio button In the Available Preferences section click on the Name of the Preferences you wish to delete If yo...

Page 594: ...iew print Reference Ranges for a particular result record Double click on the record to be viewed printed The Details window will appear Check the Show Reference Ranges box in the lower left corner of the Details window Two options will appear for viewing the Reference Ranges with the results o With Results the References Ranges will appear directly below the Test Results o Separately the Referenc...

Page 595: ...tion Workspace screen Those customers already using STATNotes should review the information below for new use options Those not currently using the STATNotes feature are encouraged to read the Overview section and contact their Abbott Point of Care Sales Representative for more information regarding this special customization feature Overview The i STAT 1 Handheld Chart Page was originally develop...

Page 596: ...tion click on the Name of the STATNotes you wish to apply If you wish to view the contents of the selected STATNotes before applying it click on View STATNotes Click Apply A confirmation message will appear asking if you want to want to proceed in changing the STATNotes Click Yes to apply the STATNotes b To apply a particular STATNotes to location based customization profile s Click the Selected l...

Page 597: ...To delete selected unused STATNotes Click the Delete selected unused STATNotes radio button In the Available STATNotes section click on the Name of the STATNotes you wish to delete If you wish to view the contents of the selected STATNotes before deleting it click View STATNotes Otherwise click Delete A confirmation message will appear asking if you want to want to delete the STATNotes Click Yes t...

Page 598: ...Art 722831 00A Rev Date 19 Feb 09 ...

Page 599: ...with their system This can take some time after Abbott Point of Care releases a new version of i STAT DE 2 Restart of their systems may be required to resume processing data after an update to i STAT DE 3 DO NOT upload the i STAT DE update file to the i STAT DE server if you do not wish to immediately update i STAT DE Abbott Diabetes Care PrecisionWeb Users Please contact ADC Technical Support ADC...

Page 600: ... All pages have been modified in appearance to provide a more uniform look and feel CUSTOMIZATION WORKSPACE A new feature has been added allowing users to delete unused Preferences so that they no longer appear on the Apply Preferences web page Note the Default0 Preferences may not be deleted To delete unused Preferences 1 Click Preferences Delete Preferences in the menu The Delete Preferences web...

Page 601: ...ed to read the Overview section and contact their Abbott Point of Care Sales Representative for more information regarding purchase of this special customization feature Overview The i STAT 1 Handheld Chart Page was originally developed to allow a user to enter relevant patient information at the time of a patient test Through a series of prompts users may enter data in Field 1 Field 2 and Field 3...

Page 602: ...aining the STATNotes you wish to apply If you wish to view the contents of the selected STATNotes before applying it click View STATNotes Click OK A confirmation message will appear asking if you want to proceed in changing the STATNotes Click Yes to apply the STATNotes b To apply a particular STATNotes to a location based customization profile Click the Selected location based customization profi...

Page 603: ...es Delete STATNotes in the menu The Delete STATNotes web page will then open 2 To delete selected unused STATNotes Check the box next to the Name s of the STATNotes you wish to delete If you wish to view the contents of the selected STATNotes before deleting it click on the STATNotes name Click Delete A confirmation message will appear asking if you want to want to delete the selected STATNotes Cl...

Page 604: ... the i STAT Software update CD and named as SUXXXXXX exe where XXXXXX is the JAMS and CLEW version that you are updating b Immediately after uploading the CLEW JAMS to the i STAT DE server i STAT DE will unpack the files and make them available for use in the handheld s customization workspace UPLOADING NEW VERSIONS OF i STAT DE 1 Click Update i STAT DE Upload Update File in the menu The i STAT DE...

Page 605: ...sing the analyzer keypad and Barcode scanning using the laser barcode scanner As with any user operated system ID entry errors can occur using either of the above options These generally occur in two ways 1 Incorrectly entering an ID Mistyping an ID Incorrectly reading an ID from a patient s wrist band Entering no ID at all 2 Entering an ID that represents the wrong person Patient or Operator Scan...

Page 606: ...erator ID entry 2 Use an Operator List How does this feature work Using an Operator List allows the Point of Care Coordinator POCC to maintain a list of up to 4000 operators Each operator in the list can be certified for i STAT and or PCx Glucose Strip testing for a set time period defined by the POCC Once the operator list is created it is then uploaded to each analyzer What benefits does using a...

Page 607: ...cation Rev 1 4 Please contact your LIS HIS or IT departments to help determine if your facility uses Check Digits in the creation of operator and or patient ID numbers and if so what algorithm is used What benefits does using Manual Entry Check Digits provide It helps prevent users from making the following ID entry errors Interchanging adjacent digits i e 67 becomes 76 Doubling the wrong digit i ...

Page 608: ... enter the password If not press the Enter key Select 2 ID Entry then make selections from the Customization menu After all items have been set turn the analyzer off to save and activate the settings 2 The individual features available on the i STAT PCA are only available through The i STAT CDS Customization Workspace or Through i STAT DE 3 Figure 1 illustrates the i STAT Analyzer ID Entry prefere...

Page 609: ... CDS Customization Workspace main page The Use Operator List feature discussed in this Technical Bulletin is marked by the numbered circle 2 indicating the section of the Bulletin where this feature is described 2 Figure 2 i STAT is a registered trademark of Abbott Laboratories ...

Page 610: ...Art 720654 00B Rev Date 06 11 08 ...

Page 611: ...ITY SYSTEM INSTRUCTIONS The list below defines the i STAT System MQSI components Number MQSI Description 1 Perform Daily Quality Control with Electronic Simulator Check each Handheld reader with the Electronic Simulator using either the internal or external simulator once on each day of use 2 Check New or Replacement Handheld Readers with the Electronic Simulator Use the Electronic Simulator inter...

Page 612: ...ed by Abbott Point of Care APOC Check the handheld with the external Electrical Simulator after software updates The thermal probe reading can also be taken from this check ADDITIONAL FDA REQUIRED ACTIVITIES FOR i STAT WAIVED TESTS For the i STAT waived test cartridges in addition to the MQSI above the activities listed below must be conducted These activities were required by the Food and Drug Ad...

Page 613: ...located on the Abbott Point of Care website www abbottpointofcare com Customer Info Center Cartridge and Test Info Sheets aspx 2 Train Staff on Backup System Measures Ensure that users are trained on the backup provisions for testing should they be unable to utilize the i STAT System in their area Backup provisions in many facilities include the use of a spare handheld reader backup lot of cartrid...

Page 614: ...Art 721317 00D Rev Date 13 Aug 12 4 ...

Page 615: ...to our Downloader Recharger products as described below Note these changes do not impact the configuration or transmission instructions for the devices CHANGE DESCRIPTION Current Downloader Recharger New Downloader Recharger The side walls have been raised to prevent the insertion of a handheld at an angle or from the side A The color of the recharge pins has been changed to silver and their diame...

Page 616: ...Art 725703 00A Rev Date 08 Mar 10 2 ...

Page 617: ...ssories i STAT Portable Clinical Analyzer The exterior parts of the i STAT Portable Clinical Analyzer are latex free No natural or synthetic latex is used anywhere on the exterior of this product the product packaging or accessories i STAT Cartridges The i STAT cartridges contain natural latex in the areas indicated below The Sample Entry Well Gasket contains natural latex and is used on the follo...

Page 618: ...Art 721296 00A Rev Date 07 16 08 ...

Page 619: ...te for the Procedure Manual required by CLIA and laboratory accreditation bodies This Procedure Manual should be customized for site specific policies and procedures This Procedure Manual is not intended to replace the System Manual i STAT is a registered trademark of the Abbott group of companies in various jurisdictions ...

Page 620: ...REV DATE 16 Oct 12 ART 714446 00L ...

Page 621: ...ng Specimen Collection and Handling Criteria for Specimen Rejection Precautions Procedure for Analysis 5 10 Preparation for Use Procedure for Cartridge Testing Alternative Procedure Results 11 17 Calculations Displayed Results Suppressed Results Printing and Transmitting Results Reference Ranges and Reportable Ranges Critical Results Interferences Quality Control 18 24 Daily Procedures Monthly Pro...

Page 622: ...oximately 1 to 3 drops is dispensed into the cartridge sample well and the sample well is sealed before inserting it into the analyzer Central Data Station or Data Manager A dedicated desktop computer with the i STAT Central Data application provides the primary information management capabilities for the i STAT System IR Links for Portable Clinical Analyzers and Downloaders and Downloader Recharg...

Page 623: ...stored refrigerated the control material should be equilibrated to room temperature for at least 4 hours prior to testing Electronic Simulator Store at room temperature and protect contact pads from contamination by replacing the plastic cap and placing the Electronic Simulator in its protective case after use BLOOD SPECIMENS Blood Collection Equipment Cartridges for Blood Gas Electrolytes Chemist...

Page 624: ...ringe or in a blood gas syringe labeled for the assays to be performed Fill syringes for correct blood to heparin ratio Suitable Specimens for ACT Fresh whole blood without anticoagulant collected in a plastic syringe If from an indwelling line flush the line with 5mL saline and discard the first 5mL of blood or six dead space volumes of the catheter Fresh whole blood collected in a plastic tube w...

Page 625: ...card the first two drops of blood For blood gas testing avoid or remove immediately any air drawn into syringe to maintain anaerobic conditions Test samples collected without anticoagulant immediately Test samples for ACT and lactate immediately For pH blood gases TCO2 and ionized calcium test within 10 minutes of collection If not tested immediately remix the sample and discard the first two drop...

Page 626: ...nd BNP Criteria For Specimen Rejection Evidence of clotting Specimens collected in vacuum tubes with anticoagulant other than lithium or sodium heparin or EDTA for BNP or glucose cartridges Specimens for ACT or PT INR collected in glass syringes or tubes or with anticoagulant of any kind Syringe for pH PCO2 PO2 and TCO2 with air bubbles in sample Incompletely filled vacuum tube for the measurement...

Page 627: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 6 REV DATE 16 Oct 12 ART 714446 00L ...

Page 628: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 7 REV DATE 16 Oct 12 ART 714446 00L ...

Page 629: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 8 REV DATE 16 Oct 12 ART 714446 00L ...

Page 630: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 9 REV DATE 16 Oct 12 ART 714446 00L ...

Page 631: ... includes running the handheld in the downloader recharger 7 Review results Alternative Procedure Should the i STAT System become inoperable for any reason specimens should be collected and submitted to the laboratory in accordance with the Laboratory Procedure Manual 10 REV DATE 16 Oct 12 ART 714446 00L ...

Page 632: ...1 System Manual s Troubleshooting section or the Analyzer Coded Messages Technical Bulletin if necessary Printing and Transmitting Results Printing Results from the i STAT Portable Clinical Analyzer to the HP Portable Printer 1 Place the handheld in the cradle of an IR Link or align the IR windows of the handheld and printer Turn the printer on printer light red or press the paper advance switch t...

Page 633: ...ed key for the test record s Press the numbered key again to deselect a record 7 Align handheld and printer IR window or place in Downloader or Downloader Recharger attached to printer Press the Print key 8 Do not move handheld or printer until printing is complete 9 If printer is not powered from a wall unit using the AC adapter turn printer off Transmitting Results from the i STAT Portable Clini...

Page 634: ... L x 1 mEq L Chloride mmol L mEq L 98 109 98 109 65 140 mmol L x 1 mEq L BUN UREA mg dL mmol L 8 26 8 26 2 9 9 4 2 9 9 4 3 140 1 50 mg dL BUN x 0 357 mmol urea L Example 20 mg dL BUN 7 1 mmol urea L Glucose mg dL g L mmol L 70 105 70 105 0 70 1 05 0 70 1 05 3 9 5 8 3 9 5 8 20 700 0 20 7 00 1 1 38 9 mg dL x 0 055 mmol L Example 100 mg dL 5 55 mmol L g L x 5 556 mmol L Creatinine mg dL µmol L 0 6 1 ...

Page 635: ...conds 74 125 PREWRM 74 125 PREWRM 84 139 NONWRM 84 139 NONWRM 50 1000 Kaolin ACT seconds 74 137 PREWRM 74 137 PREWRM 82 152 NONWRM 82 152 NONWRM 50 1000 Prothrombin Time PT INR 0 9 8 0 Troponin I cTnI ng mL µg L 0 00 0 03 0 00 0 08 0 00 50 00 ng mL x 1 µg L Creatine Kinase MB CK MB ng mL µg L 0 0 3 5 0 0 150 0 ng mL x 1 µg L B Type Natriuretic Peptide BNP pg mL ng L 15 50 15 5000 pg mL x 1 ng L Ca...

Page 636: ...physician or nurse ANALYTE units ADULT CHILDREN NEONATES Sodium mmol L low high 120 158 low high 121 156 low high 121 156 Potassium mmol L 2 8 6 2 2 8 6 4 2 8 6 5 Chloride mmol L 75 126 77 121 77 121 TCO2 mmol L 11 40 11 39 Ionized Calcium mmol L 0 78 1 58 0 74 1 57 pH 7 21 7 59 7 21 7 59 PCO2 mmHg 19 67 21 66 PO2 mmHg 43 45 124 37 92 BUN mg dL 104 55 55 Glucose mg dL 46 484 46 445 32 328 Creatini...

Page 637: ... mmol L 1 0 mmol L 10 2 mmol L 37 5 mmol L 6 6 mmol L 0 5 mmol L 4 34 mmol L Decrease iCa Increase iCa by 0 04 mmol L Decrease iCa Increase iCa Decrease iCa by 0 07 mmol L Decrease iCa by approx 0 03 mmol L Decrease iCa Glucose Cartridge Acetominophen Acetylcysteine Bromide Bromide therapeutic pH Oxygen Hydroxyurea Thiocyanate 1 32 mmol L 10 2 mmol L 37 5 mmol L 2 5 mmol L pH per 0 1 pH units belo...

Page 638: ...ematocrit White Blood Count WBC Total Protein Lipids Greater than 50 000 WBC L For measured Hct 40 For each g dL below 6 5 For each g dL above 8 0 For measured Hct 40 For each g dL below 6 5 For each g dL above 8 0 Abnormally high May Increase hematocrit Decrease Hct by 1 PCV Increase Hct by 1 PCV Decrease Hct by 0 75 PCV Increase Hct by 0 75 PCV Increase Hct Celite ACT Aprotinin Falsely extends C...

Page 639: ... required If FAIL is displayed repeat the procedure with a different external Electronic Simulator If PASS is displayed with the second external Electronic Simulator Use the handheld as required Deliver the questionable external Electronic Simulator to the i STAT System Coordinator If FAIL is displayed with the second external Electronic Simulator DO NOT analyze patient samples with the handheld T...

Page 640: ...ersion lower than 5 Click on System and Electronic Simulator CDS version 5 and above Click on the Simulator Viewer Print Control Fluid Analysis Results Print results for any control fluids analyzed from the Central Data Station Include the report in the i STAT QC Log CDS version lower than 5 Use the Trend function CDS version 5 and above Click on the Control Results Viewer Periodic Procedures for ...

Page 641: ...nsert it into a handheld It is important not to expose the solution to room air since this will alter the results When using a capillary tube fill from the bottom of the ampule Avoid drawing solution from the surface by covering the far end of the tube as it is inserted into the ampule Once the open end of the tube rests at the bottom of the ampule uncover the other end to allow filling by capilla...

Page 642: ...temperature 2 Immediately before use shake the ampule vigorously for 5 10 seconds to equilibrate the liquid and gas phases To shake hold the ampule at the tip and bottom with forefinger and thumb to minimize increasing the temperature of the solution If necessary tap the tip of the ampule to send solution back into the bottom section of the ampule 3 Protect fingers with gauze tissue or glove or us...

Page 643: ...rting slowly for 30 seconds 4 Use a plastic pipette syringe or capillary tube without anticoagulant to transfer the solution to an ACT cartridge 5 Immediately seal the cartridge and insert it into a handheld This process must be completed within 30 seconds of the complete reconstitution of the control sample 6 Compare results to the value assignment sheet ranges If results are within the expected ...

Page 644: ... number and software revision on the Value Assignment Sheet matches the lot number of the vial in use and the software revision in the handheld Should results fall outside the range refer to the Troubleshooting section of i STAT 1 System Manual section 14 Quality Control 6 If available transmit results to the Central Data Station Remedial Action If any results are outside the published expected ra...

Page 645: ...rom the suspect lot Quarantine the suspect lot Notify the i STAT System Coordinator immediately Record the QC failure in the i STAT QC Action Log along with the action taken CALIBRATION For cartridges calibration is automatically performed as part of the test cycle on each cartridge type except coagulation and immunoassay cartridges Operator intervention is not necessary ...

Page 646: ...yperparathyroidism Dehydration Prolonged vomiting Burns Salt losing renal disease Overhydration Thiazide therapy Ionized Calcium Dehydration Hyperparathyroidism Malignancies Immobilization Thiazide diuretics Vitamin D intoxication Hypoparathyroidism Early neonatal hypocalcemia Chronic renal disease Pancreatitis Massive blood transfusions Severe malnutrition BUN Impaired renal function Prerenal azo...

Page 647: ...ders Inadequate mechanical ventilation Chronic respiratory acidosis Decreased alveolar ventilation Hypoventilation Compensation in metabolic alkalosis Respiratory alkalosis Increased stimulation of respirator center Hypermetabolic states Mechanical hyperventilation Compensation in metabolic acidosis PO2 Breathing oxygen enriched air Carbon monoxide exposure Pulmonary disorders Myocardial infarctio...

Page 648: ... Pulmonary hypertension Chronic renal insufficiency Sepsis Strenuous exercise Certain drug ingestions Rare antibodies to troponin or its circulating complexes CK MB Myocardial Infarction Coronary vasospasm Cardiac contusion trauma Myocarditis pericarditis Infiltrative diseases ex Amyloidosis sarcoidosis hemochromatosis connective tissue disease Cardiac procedures PTCA DC cardioversion Intracranial...

Page 649: ...ide is oxidized at the platinum electrode to produce a current which is proportional to the lactate concentration PO2 is measured amperometrically The oxygen sensor is similar to a conventional Clark electrode Oxygen permeates through a gas permeable membrane from the blood sample into an internal electrolyte solution where it is reduced at the cathode The oxygen reduction current is proportional ...

Page 650: ...sensors allowing the enzyme conjugate to dissolve into the sample The CK MB within the sample becomes labeled with alkaline phosphatase and is captured onto the surface of the electrochemical sensor during an incubation period of approximately three minutes The sample is washed off the sensors as well as excess enzyme conjugate Within the wash fluid is a substrate for the alkaline phosphatase enzy...

Page 651: ..._____________________________________________ Date _______________________________________ Adopted ___________________________________________________________ Date _______________________________________ Reviewed ___________________________________________________________ Date _______________________________________ Reviewed ___________________________________________________________ Date ________...

Page 652: ...__ CLEW _______________ Test Range Results Results Control Name ___________________ Lot No __________________ Level _____________ Exp Date _______________ CLEW _______________ Test Range Results Results Control Name ___________________ Lot No __________________ Level _____________ Exp Date _______________ CLEW _______________ Test Range Results Results Lot Shipment accepted by ____________________...

Page 653: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM i STAT QC Action Log Date Cartridge Type Cartridge Lot No Date Rec d Quantity Test s Out of Range Corrective Action Operator ii REV DATE 16 Oct 12 ART 714446 00L ...

Page 654: ...URE MANUAL FOR THE i STAT SYSTEM i STAT QC Log Expiration Date and Storage Conditions Refrigerated Date Location Cartridge Type Lot Exp Date Quantity Temp Action Operator iii REV DATE 16 Oct 12 ART 714446 00L ...

Page 655: ...E MANUAL FOR THE i STAT SYSTEM i STAT QC Log Expiration Date and Storage Conditions Room Temperature Date Location Cartridge Type Lot Exp Date Quantity Temp Action Operator iv REV DATE 16 Oct 12 ART 714446 00L ...

Page 656: ...ronic Simulator Log for Analyzer Serial Number _______________________ Year _________________________ Date Time Pass Fail Simulator ID Operator Time Pass Fail Simulator ID Operator Time Pass Fail Simulator ID Operator v REV DATE 16 Oct 12 ART 714446 00L ...

Page 657: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM vi REV DATE 16 Oct 12 ART 714446 00L i STAT Electronic Simulator Action Log Date Time Analyzer Failure Code or Letter Simulator ID Action Pass Fail Operator ...

Page 658: ......

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