Page 1 i-STAT ® System Manual Rev. Date: 07-Mar-13 Art: 714336-01M...
Page 2 Patents: www.abbott.us/patents Symbol Technologies 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. Abbott Point of Care Inc.
Page 3 Technical Bulletin: Reportable Range Customization on the i-STAT 1 Handheld……………………………………………….730009-01B Technical Bulletin: Liquid Quality Control Schedule And Lockout Customization on the i-STAT 1 Handheld…..………….730077-01C Technical Bulletin: Liquid Quality Control Pass/Fail Customization on the i-STAT 1 Handheld…..………………………….730078-01C Technical Bulletin: Positive Patient Identification (PPID) Customization on the i-STAT 1 Handheld……..……………………….730211-01C...
Page 4: Table Of Contents
Hematocrit on the i-STAT System ............. 716240-01D ACT Test Result Options: Prewarmed vs. Non-Prewarmed Result Calibration Modes for the i-STAT 1 Analyzer ......715617-01C Support Services ................716144-01AD April 2008 Update to the Central Data Station Version 5 ....721106-01A April 2009 Update to the Central Data Station Version 5 ....
Page 5 Audible Indicator ..........................2 - 7 Time Out .............................. 2 - 7 Keypad ..............................2 - 8 i-STAT 1 Menu Tree ..........................2 - 9 Test Menu ............................. 2 - 10 Administration Menu ..........................2 - 10 Analyzer Status ............................ 2 - 11 Data Review ............................
Page 6 External Simulator ..........................5 - 1 Operating Characteristics ........................5 - 2 Cleaning the Simulator ......................... 5 - 2 i-STAT 1 DOWNLOADER ..................6 - 1 Function ............................... 6 - 1 Specifications............................6 - 2 Power Supply ............................6 - 2 Downloader/Recharger Indicator LEDs ....................
Page 7 TECHNICAL BULLETIN: LIQUID QC SCHEDULE AND LOCKOUT CUSTOMIZATION ON THE i-STAT 1 HANDHELD TECHNICAL BULLETIN: LIQUID QC PASS/FAIL CUSTOMIZATION ON THE i-STAT 1 HANDHELD TECHNICAL BULLETIN: POSITIVE PATIENT ID CUSTOMIZATION ON THE i-STAT 1 HANDHELD TECHNICAL BULLETIN: OPERATOR COMPETENCY NOTIFICATION ON THE i-STAT 1 HANDHELD PROCEDURES SAMPLE COLLECTION ..................
Page 8 Controls for ACT Cartridges ........................ 14 - 9 Controls for PT/INR Cartridges ......................14 - 11 Controls for i-STAT cTnI, BNP and CK-MB Cartridges ................ 14 - 12 Performing Electronic Simulator Test ....................14 - 14 Procedure for Internal Electronic Simulator ..................14 - 14 Procedure for External Electronic Simulator ..................
Page 9 THEORY THEORY ........................20 - 1 Analyzer Functions ..........................20 - 1 Electrochemical Measurements ......................20 - 3 Determination of Test Results ......................20 - 4 Determination of Cell Concentration ....................20 - 5 CPB ..............................20 - 5 Determination of Coagulation Endpoints ..................... 20 - 7 Quality Control and the i-STAT System ....................
Page 10: Potassium
CARTRIDGE AND TEST INFORMATION Cartridge and Test Information Sodium Potassium Chloride BUN/Urea Glucose Hematocrit/Hemoglobin Ionized Calcium Total Carbon Dioxide/TCO Creatinine Lactate Celite ACT Kaolin ACT Prothrombin Time PT/INR Cardiac Troponin I Creatine Kinase MB/CK-MB B-Type Natriuretic Peptide/BNP Total Beta-Human Chorionic Gonadotropin (ß-hCG) TECHNICAL BULLETIN: THE i-STAT TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (ß-hCG) CARTRIDGE TECHNICAL BULLETINS...
Page 11: This Manual
Related sections are grouped behind tabs. Intended Use The i-STAT 1 Analyzer is intended for use with i-STAT cartridges for the in vitro quantification of various analytes in whole blood. Analyzers and cartridges should be used by healthcare professionals trained and certified to use the system and should be used according to the facility’s policies and procedures.
Page 12: Components
Components The i-STAT System consists of:  i-STAT Cartridges  i-STAT 1 Analyzer  Portable Printer  Quality Assurance Materials • Electronic Simulator • Control Solutions • Calibration Verification Set (for cartridges)  Data Management System • i-STAT 1 Downloader • i-STAT 1 Downloader/Recharger •...
Page 13: Data Management
Where unavailability of results while awaiting replacement of analyzers or cartridges is unacceptable, Abbott Point of Care Inc. recommends maintaining both a backup i-STAT System analyzer and cartridges from an alternate lot number.
Page 14 CAN/CSA C22.2 No. 61010-1 2nd. Ed. i/immuno: Cartridges bearing this symbol must be run on i-STAT analyzers that also bear this symbol. Battery: i-STAT 1 Analyzer low battery icon (flashes on lower left side of display screen). Art: 714363-01W Rev. Date: 21-Mar-14...
Page 15 Regulations, Title 47, Part 15 Subpart B, for Class A devices. (609) 454-9304 christopher.fetters@abbott.com 01 Feb 2010 Symbol The following symbols are used on the i-STAT 1 keypad SCAN Key used to scan information into the analyzer. Key used to enter letters. Key used to enter information.
Page 16 Symbol The following symbols are used on the i-STAT Portable Clinical Analyzer Keypad Key used to activate the display. Key used to enter information. Key used to print a test record. Key used to clear an incorrect entry. Symbol The following symbols are used on i-STAT Value Assignment Sheets Mean Range Symbol...
Page 17: Warranty
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..
Page 18 Art: 714363-01W Rev. Date: 21-Mar-14...
Page 19: I-Stat 1 Analyzer
1 ANALYZER INTRODUCTION The i-STAT 1 Analyzer is used in conjunction with i-STAT cartridges for the simultaneous quantitative determination of specific analytes in whole blood. Refer to the Cartridge and Test Information section of this manual for information on analytes that can be measured using i-STAT cartridges.
Page 20: Specifications
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 635 grams (22.4 oz.) POWER Two 9-volt lithium batteries, or rechargeable battery.
Page 21: Disposable Batteries
Disposable Batteries The analyzer requires two 9-volt lithium batteries. The lifetime for a set of batteries is mainly dependent on the mix of cartridges in use. Cartridges that require thermal control consume more energy because of heating. Coagulation and immunoassay cartridges consume more energy because of the longer test cycle.
Page 22: Cartridge Port
Additional Power A lithium battery inside the analyzer maintains the clock/calendar and customization profile. This battery should last seven years. Cartridge Port Cartridges and the Electronic Simulator are inserted into the analyzer 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).
Page 23: Thermal Control
Infrared The Infrared Communication Window provides the analyzer with two-way Communication communication to the Central Data Station via a Downloader, allows analyzer- Window to-analyzer software updates, and allows analyzer-to-printer communication for printing. Thermal Control The analyzer contains a thermal control subsystem of thermistors and heating contact wires that controls the temperature of the sensors and fluids that come into contact with the sensors to 37°C.
Page 24: Data Entry
Data Entry Data that can be scanned into the analyzer or entered via the keypad include: Operator ID  Patient ID, Proficiency ID, or Simulator ID  Cartridge Lot Number  Control Lot Number  Cal Ver Kit Lot Number ...
Page 25: Lcd Display And Backlight
LCD Display and Test results, operator prompts and other messages are displayed on the analyzer’s Backlight LCD Screen. The backlight for the display is turned on and off by pressing the 0 key for one second. The backlight will automatically turn off after ninety seconds and when the analyzer powers down or is turned off.
Page 26: Keypad
Keypad There are 19 keys located directly below the display. When using the keypad to enter information, the number of dashes in the data entry line will indicate how many characters can be entered on the line. The dash where the next entry will be placed will flash. Function Activates the barcode scanner.
Page 27: I-Stat 1 Menu Tree
1 Menu Tree There are two main menus: The Test Menu and the Administration Menu. Test Menu Administration Menu 1- Last Result 1. Analyzer Status Temp Pressure 2- i-STAT Cartridge Battery Uses Serial CLEW Version Custom Stored Records Total...
Page 28: Test Menu
TEST MENU The Test Menu is displayed when the analyzer is turned on using the On/Off key. The options are: 1 - Last Result 2 - i-STAT Cartridge Option 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.
Page 29: Analyzer Status
Analyzer Status The Analyzer Status screen contains information about the condition or “status” of the analyzer. Fresh readings are made whenever this option is selected. Temp Room temperature. Pressure Barometric pressure. Battery Battery voltage. Uses Total number of cartridge and simulator test cycles, whether or not results reported.
Page 30: Quality Tests
7 - List Records are listed with Cartridge type, date and time of test, patient ID, control lot, proficiency ID, or Cal Ver lot and test level as applicable. Any number of test records can be selected for viewing or printing using the number keys.
Page 31: Customization
Customization Analyzers can be customized for site-specific testing characteristics and requirements. A complete list of customizable parameters and their default values can be found in the Customization section. An analyzer can be customized via the keypad or via the Central Data Station. Items that cannot be customized via the analyzer’s keypad are operator lists, test strip lists, reference and action ranges, sample types and order of items on the Chart page.
Page 32 Viewing the Select 4- Customization from the Administration Menu, select 1- View then select Customization from the Customization Menu: Profile 1 - Analyzer 2 - ID Entry 3 - Patient Tests 4 - QC Tests 5 - Results Select a category to review. Use the ← and → keys to scroll through the preferences for each category and use the ←...
Page 33 Third page Code 39 Check Digit Truncate First Truncate Last Operator List Not Certified Action Not In List Action Fourth page Warn User Print ID 2 – Patient ID First page Minimum Length Maximum Length Repeat ID ID Recall Manual Entry Second page Code I2of5 Code 128...
Page 34 1 - Analyzer First page Language Date Format Sound Auto-transmit Memory Full Second page Batch Mode Timeout Inactivity Timeout Upload Schedule Clock Password Sync Clock Third page Wireless (available with the i-STAT 1 wireless) 2-16 Art: 714364-01O Rev. Date: 26-Feb-16...
Page 35 2 - ID Entry 1 – Operator ID First page Minimum Length Maximum Length Repeat ID Manual Entry Code I2of5 Second page Code 128 EAN-8, EAN-13 Codabar Code 93 Code 39 Third page Code 39, Check Digit Truncate First Truncate Last Print ID 2 –...
Page 36 2 – Cartridge QC Pass/Fail Method Comment Code In Range Comment Code Out of Range Result Format APOC Fluid Lot Scan Only 5 - Results 1 – Units and Ranges 2 – Options First page Decimal Separator Test Selection Hematocrit Base Excess ACT-C Second page...
Page 37: Set Clock
Set Clock If the analyzer is customized with a password, the Set Clock function will be password protected. If a password has not been assigned, pressing the Enter key will display the time and date screen. Use the arrow keys to move the cursor to the digit to be changed.
Page 38: Laser Barcode Scanner
LASER BARCODE SCANNER Laser Barcode The barcode scanner is used to scan barcode information into the analyzer. Scanner Parameters that can be entered into the analyzer via the scanner include: operator and patient IDs, control and cartridge lot numbers, comment codes and patient chart data.
Page 39: Prompts And Messages
Caution Do not open the analyzer. The analyzer may only be opened by factory authorized service personnel. Class 2 laser radiation when open; DO NOT stare into the laser aperture or the laser beam, or point the laser beam at other persons. Use of controls, adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure.
Page 40 Startup Messages When the On/Off key is pressed the analyzer may display one or more startup messages. A startup warning message indicates an action that should be taken in the near future to maintain the analyzer in working condition. If the analyzer is customized to disable testing under certain conditions, a startup lockout message indicates the action that must be taken before testing is re-enabled.
Page 41: I-Stat Cartridge
i-STAT CARTRIDGE Contents The unit-use disposable cartridge contains many of the subassemblies typically found in complex laboratory systems. Microfabricated thin film electrodes or sensors are assembled in unit-use cartridges containing: • calibrant solution in cartridges with sensors for blood gases, electrolytes, chemistries and hematocrit •...
Page 42 Sample Handling Part Function System Sensor Channel The sensor channel directs the sample from the sample chamber to the sensors. An extension of this channel becomes a waste chamber to receive the calibrant Contact solution, if applicable, as it is displaced by the sample. Pads Sensors Air Chamber...
Page 43: Standardization And Calibration
BE AnGap Hb 86ºF days 18ºC 64ºF tage jours giorni días dias dagen dage dagar päivää dager gün 30ºC Abbott Point of Care Inc. 86ºF Abbott Park, IL 60064, USA 18ºC Product of Canada 64ºF Rev. Date: 11-Mar-14 Art: 714365-01G...
Page 44: Storage Conditions
Storage Conditions The main supply of cartridges should be stored at 2-8°C (35-46°F). Cartridges must be at room temperature before removing them from their pouches. Allow 5 minutes for an individual cartridge and one hour for a box of cartridges to come to room temperature.
Page 45: Precision Pcx And Pcx Plus Blood Glucose Test Strips
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 46 Art: 714366-01C Rev. Date: 31-Jan-12...
Page 47: Electronic Simulator
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 on the i-STAT 1 Analyzer.
Page 48: Operating Characteristics
Operating Operating Characteristics Characteristics Dimensions Height 1.9 cm Width 7.0 cm Length 9.0 cm Weight 85 g Operating Same as Analyzer Temperature being tested Operating Ambient 0-90% RH Humidity non-condensing (as shipped) Storage Temperature -20-50˚C (-4-122˚F) Even when the internal Electronic Simulator is enabled, an external Electronic Simulator is needed: •...
Page 49: I-Stat 1 Downloader
1 DOWNLOADER Function The Downloader converts infrared transmissions of test records from the analyzer to electrical form and transmits (uploads) them to the Data Manager. The Downloader also converts electrical signals from the Central Data Station to infrared transmissions, which are transmitted (downloaded) to the analyzer.
Page 50: Specifications
Specifications Specification Downloader Downloader/Recharger Size 5.25in (13.3cm) Wide 4.12in (10.4cm) Wide 6.75in (17.2cm) Long 10.25in (26.cm) Long 2.13in (5.4cm) High 5.00in (12.7cm) High Weight 0.6 lbs (0.27kg) 1.2 lbs (0.55kg) Power AC-DC power adapter AC-DC power adapter or PC/Downloader adapter. or PC/Downloader adapter.* Input 12V Input 12V...
Page 51: Downloader/Recharger Indicator Leds
DR Affect on The operating temperature for an i-STAT 1 Analyzer is 16°C to 30°C. The DR Ambient Operating and Rechargeable Battery may raise the temperature of the i-STAT 1 Analyzer Temperature Range 2°C-3°C relative to the ambient temperature if:...
Page 52: Transmitting Data From Downloader To The Data Manager
Transmitting Data To transmit through a Downloader to the Data Manager, place the analyzer from Downloader to between the arms on the front of the Downloader with the test strip port end the Data Manager touching the Downloader. When properly aligned the red proximity light will turn on and the analyzer will automatically transmit (upload) all unsent results.
Page 53: Troubleshooting
Troubleshooting The analyzer displays “Waiting to Send” until communication is established with the Central Data Station. When communication is established the message changes to “Communication in Progress” and the arrows circle until upload is complete. If the message does not change from “Waiting to Send” or if the Analyzer Status screen reports unsent results after the upload, refer to Support Services in the Troubleshooting section.
Page 54 Charging Placing a rechargeable battery into the recharging compartment will Rechargeable automatically initiate trickle recharging. The indicator light near the recharging Battery in compartment will be green when a rechargeable battery is placed in the External Recharge compartment. Compartment STEP ACTION The battery pack has two labels: one for orientation in the analyzer and one for orientation in the Downloader/Recharger.
Page 55 ® (DRC), which is used to: • convert infrared transmission signals from i-STAT 1 handheld test records to electrical form and transmit them via USB or network cabling to the Data Manager. • convert electrical signals from the Customization Workspace of the Data Management applica- tion to infrared transmissions, and transmit them to the i-STAT 1 handheld.
Page 56 Configuring the CDS Software for Serial Communication IDENTIFICATION OF THE NEW i-STAT 1 DOWNLOADER/RECHARGER Previously, there were two separate versions of the i-STAT 1 Downloader/Recharger; one with serial con- nection capabilities to the Data Manager (DRS) and one with network connection capabilities to the Data Manager (DRN).
Page 57 SPECIFICATIONS OF THE DRC-300 Specification 4.12in (10.4cm) Wide Size 9.60in (24.4cm) Long 5.00in (12.7cm) High Weight 1.2 lbs (0.55kg) AC-DC power adapter Power Input 12Vdc 0 - 40ºC Operating Temperature 32 -104ºF -20 - 50ºC Storage Temperature -4 - 122ºF Pollution Degree (Allowable ambient pollution level) Installation Category (Allowable overvoltage...
Page 58 All i-STAT Cartridges may be run in handhelds that are docked in the DRC. DRC AFFECT ON AMBIENT OPERATING TEMPERATURE RANGE The operating temperature for an i-STAT 1 handheld is 16ºC to 30ºC. The DRC and Rechargeable Battery may raise the temperature of the i-STAT 1 handheld 2ºC-3ºC relative to the ambient temperature •...
Page 59 Note: Do not move handheld until the “Communication in Progress” message disappears. TRANSMITTED INFORMATION The following information is transmitted from the i-STAT 1 handheld with each test record: • Date and time the test was performed •...
Page 60: Charging Rechareable Battery In The External Recharge Compartment
This section includes procedures to configure the i-STAT 1 DRC to transmit data between the i-STAT 1 handheld and the Data Manager PC running the i-STAT Central Data Station (CDS) or i-STAT/DE. Successful programming of the i-STAT 1 DRC for network operation requires the completion of all of the following steps in chronological order.
Page 61 • IP Address of Data Manager 2. Windows 7: Do NOT connect the i-STAT 1 DRC to a PC. Depending on the Domain policies, Windows 7 needs network connectivity in order to access network TCP/IP settings. Windows XP: Connect the i-STAT 1 DRC to a PC using a standard network cable as shown in the figure below.
Page 62 3. Windows 7: Change the PC Network Configuration to detect the DRC. On the PC, click Start → Control Panel → Network and Internet (if shown, skip if not) → Network and Shar- ing Center → View network status and tasks. Windows XP: Change the PC Network Configuration to detect the DRC.
Page 63 Windows XP: Click OK and close all Control Panel windows. Apply power to the DRC. 9. Using Internet Explorer or another browser, navigate to http://192.168.1.10. The Abbott Point of Care Inc. i-STAT login screen should appear. Note 9.1: Internet connectivity is not required. Do not plug the computer into the facility’s net- work.
Page 64 10. At the Configuration Login screen, enter your password and click Login. If a separate password has not been assigned, the default password is “i-STAT” and is case sensitive. Note: Abbott Point of Care Inc. recommends changing the default password. Following a successful login, the home page will appear.
Page 65 11. Under “Current Settings”, click Configure. The Configure Communication Settings page will appear. 12. Determine the following site-specific information for this DRC: • IP Address of the DRC • Subnet Mask • Default Gateway Address • IP Address of the Data Manager •...
Page 66 After completion, the following screen will be displayed. 17. If additional DRCs require configuration, connect the next DRC to the PC per step 2 and apply power to the DRC and repeat steps 9 through 16. Otherwise, proceed to step 18. RESTORING THE PC’S NETWORK CONFIGURATION: Windows 7: Disconnect the Ethernet cable from the DRC and connect to the network.
Page 67 CONNECTING AND WIRING THE DRC FOR NETWORK COMMUNICATION The following diagram shows how to connect the portable printer to the DRC and the DRC to the net- work for communication to the Data Manager. The required parts are: • Printer Interface Cable •...
Page 68 To install the USB drivers for the DRC, it is necessary to be logged into a Windows PC with Administrator rights. Note: If internet access is not available, obtain the i-STAT 1 D/R USB Driver CD-ROM (Abbott L/N 04P75-05) from Abbott Customer Service. After receipt of the CD-ROM, proceed to Option 2, Step 3.
Page 69 6. Another “Found New Hardware Wizard” will appear automatically. Select the “Yes, this time only” radio button and click Next to continue. 7. Select the “Install a software automatically (Recommended)” radio button as previously illus- trated and click Next. 8. Wait while the “USB Serial Port” driver installs. This may take a few minutes. 9.
Page 70 13. Using the drop down menu, set the “Bits per second” to 38400. Other drop down menus should remain as the default. 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.
Page 71 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) → System to launch the “System Properties” dialog box. Select the Hardware tab, and click “Device Manager”...
Page 72 8. Right click on the “USB Serial Port” device entry and select Properties. A “USB Serial Port Properties” dialog box will open. Select 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.
Page 73 CONNECTING AND WIRING THE i-STAT 1 DRC FOR SERIAL COMMUNICATION Note: For successful data transmission to occur, the USB cable should first be connected between the DRC and the PC prior to installing or opening the CDS or Jammlite applications.
Page 74 2.5 Select the Driver tab. Click Uninstall and then click OK when the warning message appears. CONFIGURING THE CDS SOFTWARE FOR SERIAL COMMUNICATION See the Central Data Station section of the i-STAT 1 System Manual for instructions on configuring the CDS application for receiving serial data transmissions.
Page 75: Portable Printer
PORTABLE PRINTER MARTEL Printer Overview 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. Specifications Dimensions Height: 64mm Width: 135mm...
Page 76: Supplies Provided With Printer
Supplies Provided  Adapter and power cord with Printer  One roll of paper Power The printer is turned on using the switch on its left side. When the printer is on, the Power LED will be green. The plug for the AC adaptor is also on the left side.
Page 77: Printing Directly From The Analyzer
Squeeze cup lid to gain access to paper roll Paper Position of paper roll in printer When removing a printout from the printer, pull the printout toward the front of the printer and tear from one side to the other across the serrated edge. Serrated Edge Paper Using serrated edge...
Page 78: What Is Printed
Use only a rechargeable battery pack purchased from Abbott Point of Care. Rechargeable battery packs not recommended by or purchased from Abbott Point of Care may be susceptible to overheating and could lead to a potential fire or burn hazard.
Page 79: Troubleshooting
Troubleshooting Printer not printing. Power LED on and Status LED off:  check that results are displayed or that results have been selected from List under Data Review.  check that that distance between analyzer and printer, if printing directly from the analyzer, is not too short or too long. ...
Page 80: The I-Stat Printer
OVERVIEW This section describes the instructions for using the new i-STAT Printer, which is used to print 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).
Page 81 SPECIFICATIONS Height: 72.5mm Dimensions Width: 136mm Depth: 120mm Weight 500g (Approx.) 1. 4.8V NiMH rechargeable battery pack Power 2. Power adaptor for AC outlet 1. Infra-red Communication Link 2. RJ12 Paper 5.7cm thermal 1. On/Off Buttons 2. Paper Feed POWER: Green/Orange/Red LED Indicators STATUS: Green/Orange/Red Printing Method...
Page 82 4. Rechargeable Battery 5. One roll of 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...
Page 83 PRINTER PAPER Printer paper may be ordered along with other supplies for the i-STAT System (Abbott List # 06F17-11): The STATUS indicator will illuminate to indicate the print status: Ready: Green  Out of Paper: Orange  Error: ...
Page 84 The i-STAT Printer can be turned on and off by pressing the POWER button. When the printer is on, the POWER indicator will be illuminated: Power OK: Green  Battery Low: Orange  Battery Empty:  If the printer is inactive for >60 seconds, it will automatically enter the power-saving mode. When in the power-saving mode, the POWER indicator will change from a solid color light to pulsed illumination.
Page 85 5. Assure proper connector alignment as shown. 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 compartment. Make sure the wires are not under the battery or projecting out of the opening. The correct positioning is shown below.
Page 86 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 within 1 to 5 inches (2.5 –...
Page 87 6. Press the number key for the test record(s) to be printed. (Press the numbered key again to dese- lect a record.) 7. Align i-STAT 1 handheld and i-STAT Printer IR window or place in the Downloader or Downloader/ Recharger attached to the i-STAT printer. Press the key.
Page 88 Standardization software PRINTER CAUTIONS • Use only a Rechargeable Battery pack purchased from Abbott Point of Care (List Number 04P74-03). Rechargeable battery packs not recommended by or purchased from Abbott Point of Care may be susceptible to overheating and could lead to a potential fire or burn hazard.
Page 89: Printer Troubleshooting
When light from a fluorescent source of sufficient proximity or brightness has a direct path into the IR (Infrared Radiation) window of the i-STAT 1 Printer, the printer may fail to respond when records are sent for printing over a serial (wired) connection to a Downloader or Downloader/Recharger.
Page 90 PRINTER SYMPTOM RECOMMMENDED ACTION(S) Check that the paper is feeding from under the Printer is feeding paper, but nothing is printed. roll. Printer is not printing and POWER indicator is Battery needs to be recharged. red. Printer POWER indicator does not illuminate Battery needs to be recharged.
Page 91 If you have questions regarding the information in this Technical Bulletin or need additional support, please contact your Support Services provider. i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. Abbott Point of Care Inc. • Abbott Park, IL 60064 • USA...
Page 93: Data Management
The instruments may include, but are not limited to: 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.
Page 94: Data Manager
A validated and qualified Data Manager computer system may be purchased The Data Manager 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.
Page 95: Downloader And Downloader/Recharger
(network format) and direct wiring (serial format). The Network Recharger Downloaders convert serial data transmitted from the i-STAT 1 Analyzer via infrared transmission to TCP/IP, which then delivers the data to the Data Manager using the hospital’s ethernet system.
Page 96: Standard Data Management Configuration
Standard Data The figure below shows the standard i-STAT Data Management configuration. Management Downloaders, Downloader/Rechargers, and IR Links are placed in end-user Configuration departments and allow handheld analyzers to transmit results to the Data Manager. The Data Manager then interfaces to the LIS/HIS. Connecting There is only one option available for physically connecting remote Components...
Page 98 1 Analyzer from the CDS. See the "Network Options for Updating the 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.
Page 99 Spring and Fall when clocks are set forward and backward one hour. SYNCHRONIZE Will synchronize or update the real time clock in the i-STAT 1 handheld Not Enabled This eliminates the need to reset the handheld's clock at CLOCK TO CDS to the Central Data Station's clock at the time of each download.
Page 100 NOTIFICATION days) in which the operator will be notified by a message on on the i-STAT 1 Handheld" for full details. the i-STAT 1 handheld display of their competency expiration date. PATIENT ID Minimum and maximum allowed patient ID length (scanned Min = 0 Max = 15 If ID numbers are a fixed length, the min.
Page 101 PREFERENCE WINDOW: ptIons Option Description Default Comments AUTO-CHART If enabled, the Chart Page will be displayed automatically. Not enabled: operator If any information on the Chart Page PRESENTATION must press the → key to is mandatory for the site, Auto-Chart display the Chart Page.
Page 102 1 handheld. 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 the QC run passed or failed.
Page 103 Describes the frequency at which the System Administrator wants the liquid See the Technical Bulletin “Liquid Quality Control Schedule QC run under this schedule. and Lockout Customization on the i-STAT 1 Handheld” for full details. Options are: Off: Disables the selected QC Schedule Daily Weekly: A particular day of the week (e.g.
Page 104 Unit Set Window. CUSTOM REPORTABLE High and low custom Reportable Ranges can be defined for each Disabled See the "Reportable Range Customization on the i-STAT 1 Handheld" Technical Bulletin for full details. RANGES analyte (except ACT). (-99999.9 to 99999.9) PRINT REFERENCE Reference Ranges can be printed with results.
Page 105 "NON-PREWARM" (ambient temperature) types. PREWARMED vs. NON-PREWARMED Result Calibration Modes for the result calibration for both Celite ACT and Kaolin ACT cartridges. i-STAT 1 Analyzer" for full discussion. HEMATOCRIT OPTIONS Reference anticoagulant used to calculate hematocrit result: K3EDTA See Theory section in this manual for explanation of CPB.
Page 106 PREFERENCE WINDOW: arCodes Option Description Default Comments ID BARCODES * The user can select any or all of the following as valid All barcode types Barcode type Code 128 will support USS 128 and UCC/EAN barcode formats for both the operator and patient ID: 128, but not ISBT 128.
Page 107 predefIned unIt sets are avaIlable In the IndoW here Is also a that Can be used to seleCt the name and unIt for eaCh test he default unIt set Is RESULT Na/K/Cl * mmol/L mmol/L mmol/L mmol/L mEq/L mmol/L mmol/L mmol/L mmol/L mmol/L...
Page 109 1 handheld, on printouts, and in the electronic test record sent to the Data Manager. The display ranges on the i-STAT 1 handheld are currently set to factory default values. While system administrators are not able to broaden the display range wider than the default values, this new Custom Reportable Range feature enables them to restrict the display range to custom values to meet clinical and regulatory needs.
Page 110 The minimum handheld and data management requirements for use of the Custom Reportable Range feature are summarized as follows: System Component Minimum Software Requirements ≥ JAMS132 i-STAT 1 handheld ≥ Version 5.26a Central Data Station Version 5.x ≥ Version 2.3 i-STAT/DE Art: 730009-01B Rev.
Page 111: Customization
CUSTOMIzING REPORTAbLE RANGES ON ThE i-STAT 1 hANDhELD USING CDS VERSION 5 1. Click on Main g Open Administration Function g Customization 2. Type in your password and click OK. The default password is the word istat. Note: Abbott Point of Care Inc. recommends changing the default password.
Page 112 -99999.9 or +99999.9 will continue to report the default Reportable Ranges listed in the Cartridge and Test Information Sheet section of the 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.
Page 113 CUSTOMIzING REPORTAbLE RANGES ON ThE i-STAT 1 hANDhELD USING i-STAT/DE 1. Access the Customization Workspace • RALS-Plus Users: RALS-Plus application, pick i-STAT from the drop-down menu. Click on Device Customization. • PrecisionWeb Users:: Enter the DE i-STAT Customization Workspace. 2. Make sure the “Enable Customization” box has a check mark in it.
Page 114 -99999.9 or +99999.9 will continue to report the default Reportable Ranges listed in the Cartridge and Test Information Sheet section of the i-STAT 1 System Manual. Note 5.3: Users may not broaden the displayed Reportable Range beyond the default values.
Page 115 CONFIRMING ThAT 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.
Page 116 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. Art: 730009-01B...
Page 117 This new feature allows a system administrator (e.g. Point of Care Coordinator or Laboratory Administrator) to define a liquid quality control plan for their i-STAT 1 handhelds and enables them to enforce quality control (QC) compliance by invoking automatic lockout of patient and proficiency testing pathways if QC requirements in the plan are not fulfilled.
Page 118 QC test profile is past the set grace period and has not been satisfied. GENERAL NOTES AND CONSIDERATIONS 1. The Liquid QC Schedule and Lockout feature is only available on the i-STAT 1 handheld, and not the i-STAT Portable Clinical Analyzer (i-STAT 200 series model).
Page 119 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 ≥ JAMS132 i-STAT 1 handheld ≥ Version 5.26a Central Data Station Version 5.x ≥ Version 2.3 i-STAT/DE Rev.
Page 120 Customizing Liquid QC Schedules on the i-STAT 1 Handheld Using CDS Version 5 1. Click on Main → Open Administration Function → Customization 2. Type in your password and click OK. The default password is the word istat. Note: Abbott Point of Care Inc. recommends changing the default password.
Page 121 Note 7.1: 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. Press 4 – Customization 3.
Page 122 Note 8.1: Comment Code options can only be selected if one of the Control Pass/Fail Determination methods has been selected (Step 7). Note 8.2: The Control Test Settings 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 123 Scan only: the fluid lot information must be entered by scanning the barcode on the control vial being tested. Note 10.1: 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.
Page 124 14. The Grace Period is the period of time, starting from the Due Time, during which the QC test profile must be completed before the corresponding cartridge set is locked out. Enter the Grace Period in hours: • up to 23 hours for daily schedules, •...
Page 125 17. 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 Note 17.1: Selecting [None] will cease your ability to proceed through the remaining QC Schedule settings.
Page 126 22. Once all schedules have been created and defined, click OK and answer YES to the question about changing the Preferences. 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.
Page 127 Customizing Liquid Quality Schedule and Lockout Features on the i-STAT 1 Handheld Using i-STAT/DE 1. Access the Customization Workspace • RALS-Plus Users: Within the RALS-Plus application, pick i-STAT from the drop-down menu. Click on Device Customization. • PrecisionWeb Users:: Enter the DE i-STAT Customization Workspace.
Page 128 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. Press 4 – Customization 3.
Page 129 Note 7.2: The Control Test Settings 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.
Page 130 Note 9.1: 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.
Page 131 14. The Grace Period is the period of time, starting from the Due Time, during which the QC test profile must be completed before the corresponding cartridge set is locked out. Enter the Grace Period in hours: • up to 23 hours for daily schedules, •...
Page 132 18. In the Fluids section, select up to six (6) types and levels of control fluid that will be required to be run on the handheld during this QC cartridge schedule timeframe and click Update. Note 18.1: All i-STAT control fluid types and levels are listed in the drop-down menu, along with three (3) generic user-defined fluids.
Page 133 New i-STAT 1 Handheld Display Screens for the Liquid QC Schedule and Lockout Customization Features After customizing the i-STAT 1 handheld for the new Liquid QC Schedule and Lockout customization features, users may encounter some new handheld display screens. Test Menu: When the On/Off key is pressed on the handheld, and the Test Menu appears, the handheld will now display one of four messages at the bottom of the screen: “Next i-STAT QC (Date)”: This message will appear if users have been compliant in running...
Page 134 Note 3.1: If this message appears, users can press the listed number on the handheld keypad to display which cartridges are currently inactive. “i-STAT QC Past Due – Cartridge Testing Disabled”: This message will appear if the liquid QC requirements for a schedule were not completed within the grace period, and if the handheld is configured for “non-information-first”...
Page 135 “Automatic via EVAS” Pass/Fail Determination: Examples of handheld display screens when the handheld Control Pass/Fail Determination customization is set to “Automatic via EVAS” can be found in the Technical Bulletin: “Liquid Quality Control Pass/Fail Customization on the i-STAT 1 Handheld”. Rev. Date: 21-Mar-14...
Page 136 APPENDIX: LIQUID CONTROL LOT ABBREVIATIONS The table below lists each i-STAT Control type and corresponding abbreviation used in the Cartridge QC Fluids drop down menus in the Customization Workspace. Control Name Control Customization Abbreviation i-STAT cTnI Control Level 1 APOC cTnI L1 i-STAT cTnI Control Level 2 APOC cTnI L2 i-STAT cTnI Control Level 3...
Page 137 Care (APOC) has released a new Liquid Quality Control Automatic Pass/Fail (QC Auto P/F) customization feature for the i-STAT 1 handheld. This feature can automatically determine if the results of a liquid QC test run on an i-STAT cartridge are within APOC’s published quality control ranges. Since control ranges vary with the handheld’s CLEW software version and with i-STAT cartridge and control lot numbers,...
Page 138 GENERAL NOTES AND CONSIDERATIONS 1. The QC Auto P/F customization 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 order to use the QC Auto P/F customization feature, users must have the i-STAT 1 handheld and either the Central Data Station Version 5 or i-STAT/DE data management applications.
Page 139 However, remember to note the destination directory, as it will need to be accessed later when activating the eVAS, illustrated in section “Customizing the i-STAT 1 Handheld For Liquid QC Auto P/F Using i-STAT/DE”, and Auto QC P/F features. NOTE: It is recommended that older eVAS files be archived in a separate directory or deleted after being uploaded to i-STAT DE.
Page 140 CUSTOMIZING THE i-STAT 1 HANDHELD FOR LIQUID QC P/F USING CDS VERSION 5 1. Click on Main Open Administration Function Customization. 2. Type in your password and click OK. The default password is the word istat. Note: Abbott Point of Care Inc. recommends changing the default password.
Page 141 Note 8.1: The Manual Control Pass/Fail Determination feature is also customizable through the i-STAT 1 handheld keypad. Power on the i-STAT 1 handheld and press MENU to get to the Administration Menu Press 4 – Customization Press 2 – Change Type in your password and press ENT (If no password is set, just press ENT) Note: Abbott Point of Care Inc.
Page 142 Note 9.1: The Control Test Settings 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.
Page 143 APOC liquid QC samples. If testing non-APOC controls, users may scan the barcode from the control vial or 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.
Page 144 CUSTOMIZING THE i-STAT 1 HANDHELD FOR LIQUID QC P/F USING i-STAT/DE 1. Access the Customization Workspace • RALS-Plus Users: Within the RALS-Plus application, pick i-STAT from the drop-down menu. Click on Device Customization. • PrecisionWeb Users: Enter the DE i-STAT Customization Workspace.
Page 145 8. At the bottom of the Default customization profile: column, check the Use eVAS box. 9. 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 the Preferences column for the specific location to which this handheld is assigned.
Page 146 (eVAS) file downloaded into the i-STAT 1 handheld. Note 12.1: 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. Press 4 – Customization 3.
Page 147 APOC liquid QC samples. If testing non-APOC controls, users may scan the barcode from the control vial or enter the control lot number manually. Note 15.2: The APOC Fluid Lot Entry Method is also customizable through the i-STAT 1 handheld keypad.
Page 148 16. Click OK and answer OK to the question about changing the Preferences. 17. Download the handheld(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.
Page 149 CONFIRMING 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.
Page 150 5. Press 2-Cartridge QC. 6. Press the key to view the eVAS Name that has been transferred to the handheld. Art: 730078-01C Rev. Date: 29-Jul-14...
Page 151 NEW i-STAT 1 HANDHELD DISPLAY SCREENS FOR THE LIQUID QC PASS/FAIL CUSTOMIZATION FEATURE After customizing the i-STAT 1 handheld for the new Liquid QC Auto P/F customization feature, users may encounter some new handheld display screens. Quality Tests Menu: 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”...
Page 152 Number. If an APOC fluid has been selected, the user will then be asked to scan the Control Lot Number. Liquid QC Results Screens: If the i-STAT 1 handheld is customized for the QC 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.
Page 153 ) for out-of-range high results, or a down-arrow ( ) for out-of-range low results. HANDHELD DISPLAY MESSAGES The following messages may appear on the i-STAT 1 handheld when it is customized for Auto QC P/F: Message Cause The eVAS file does not exist or is invalid.
Page 154 Art: 730078-01C Rev. Date: 29-Jul-14...
Page 155 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 with the Central Data Station application. It cannot be enabled or disabled through keypad customization.
Page 156 1. If the lockout override is disabled, a patient test cannot be run unless the entered patient ID is in the handheld’s internal patient list. 2. In order to ensure that the patient list stored in the handheld is current, the i-STAT 1 handhelds must be downloaded regularly in order to obtain patient list updates.
Page 157 Identifier Formats The format for the primary and secondary identifiers displayed on the handheld screen is as follows: Primary Identifier Format Patient ID (e.g. Medical Record Number or Up to 15 characters Account Number) Secondary Identifier Format Last Name Up to 15 characters First Initial Single Character Middle Initial...
Page 158 The operator enters the four digits of the patient’s year of birth to Enter Year of Birth confirm the patient ID. The date of birth is not displayed on the handheld screen. 2. Not On List Action: The system administrator can select the desired behavior when the entered patient ID is not found in the handheld’s patient list.
Page 159 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 160 4. If the location where this handheld is assigned has a check in the Uses Default column, click the button displaying the alphanumeric code under Preferences in the Default customization profile: area. Otherwise, click the button displaying the alphanumeric code in the Preferences column for the specific location to which this handheld is assigned.
Page 161 8. Using the drop down menu, select the Confirmation Method the operator will use to confirm the patient identity: Confirm: The operator confirms the patient ID by selecting “Continue”. • Replicate Year of Birth: The operator enters the four digits of the patient’s year of birth to •...
Page 162 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 163 5. Press 2-Patient ID. 6. Press the key twice to view the Patient List Number that has been transferred to the handheld. Rev. Date: 08-Jul-16 Art: 730211-01C...
Page 165: I-Stat 1 Handheld
(e.g., Point of Care Coordinator or Laboratory Administrator) to define a time period in which the operator will be notified by a message on the i-STAT 1 handheld display of their competency expiration date. By default, the feature is turned off.
Page 166 CUSTOMIZING OPERATOR COMPETENCY NOTIFICATION ON THE i-STAT 1 HANDHELD USING i-STAT / DE 2.3 Note: Abbott Point of Care recommends that customers use the current version of i-STAT / DE software. 1. Access the Customization Workspace. 2. If the location to which this handheld is assigned has a check mark under the Use Default Profile column, double click the alphanumeric code under Preferences in the Default Customization Profile column.
Page 167 CUSTOMIZING OPERATOR COMPETENCY NOTIFICATION ON THE i-STAT 1 HANDHELD USING i-STAT / DE > 2.3 Note: Abbott Point of Care recommends that customers use the current version of i-STAT / DE software. 1. Access the Customization Workspace. 2. If the location to which this handheld is assigned has a check mark under the Use Default Profile column, double click the alphanumeric code under Preferences in the Default Customization Profile column.
Page 168 5. Click OK and then answer YES to the question about changing the Preferences. 6. Download the handheld(s) to i-STAT / DE from a downloader in the location to which the handheld is assigned. This action should upload the chosen customization features into the handheld.
Page 169: Sample Collection
SAMPLE COLLECTION SPECIMEN COLLECTION Overview The specimen used to fill a cartridge must be collected and handled properly to ensure that the results represent the patient’s current status. Specimens should be collected according to the facility’s policies and procedures. The following precautions (taken from the references at the conclusion of this section) can help avoid potential sources of error prior to filling a cartridge or applying sample to a test strip.
Page 170: Venipuncture - Ph, Pco2, Electrolyte, Chemistry, And Hematocrit Tests
Hemolysis Avoid hemolysis (bursting of red cells) by • allowing residual alcohol to dry over the puncture site • discarding a sample from a traumatic draw. Hemolysis will cause an increase in potassium results and a decrease in calcium results. For cTnI, CK-MB, and BNP cartridges, gross hemolysis can also cause a decreased alkaline phosphatase activity and an increased proteolytic activity, resulting in decreased detection of cTnI, CK-MB, or BNP.
Page 171 i-STAT cTnI and CK-MB cartridges require the use of either: 1. heparinized whole blood or plasma samples collected in syringes or evacuated tubes containing lithium or sodium heparin, or 2. non-heparinized whole blood samples tested within one minute of drawing from a patient into a plastic syringe or plastic evacuated tube containing no additives.
Page 172: Venipuncture - Coagulation Tests
Exposure to Air Avoid exposing the sample to air when testing venous samples for ionized calcium, pH, PCO and TCO . Test immediately if the sample is drawn into a blood collection tube. Expel any air bubbles immediately if the sample is drawn into a syringe or leave an air bubble next to the plunger and do not allow it to move through the sample.
Page 173: Arterial Puncture - Blood Gas, Electrolyte, Chemistry, And Hematocrit Tests
ARTERIAL PUNCTURE - BLOOD GAS, ELECTROLYTE, CHEMISTRY, AND HEMATOCRIT TESTS Evacuated Tubes Evacuated or other blood collection tubes are not recommended for blood gas analysis. Syringes and If the sample can be tested in a cartridge immediately, a plain syringe can be used.
Page 174: Arterial Puncture - Act Tests
Mix blood (whether anticoagulated or not) by rolling between the palms for at least 5 seconds, each in two different directions. Then invert the syringe repeatedly for at least 5 seconds. Discard the first 2 drops of blood. Exposure to Air Avoid or remove immediately any air drawn into the syringe and maintain anaerobic conditions.
Page 175: Indwelling Line
INDWELLING LINE Blood Gas, Back flush line with a sufficient amount of blood to remove intravenous Electrolyte, solutions, heparin or medications that may contaminate the sample. Five to Chemistry six times the volume of the catheter, connectors and needle is recommended. Coagulation If blood must be drawn from an indwelling line, possible heparin Cartridges...
Page 176: Sample Transfer Devices
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. Time to Test Test samples collected in capillary tubes immediately to avoid clotting (especially in neonates whose blood may clot more quickly).
Page 177: References
REFERENCES CLSI. H3-A4, Procedure for the Collection of Diagnostic Blood Speci- mens by Venipuncture, 4 ed.; Approved Guideline, CLSI document H3-A4 [ISBN 1-56238-350-7]. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 1998. CLSI. H4-A5, Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens;...
Page 179: Procedure For Handling Cartridges
PROCEDURE FOR HANDLING CARTRIDGES PREPARATION FOR TESTING Select the Cartridge Select the appropriate cartridge for the test or tests required. While the cartridge is not fragile, it should be handled as follows to avoid difficulty in filling and Quality Check failures. Room Temperature Each cartridge is sealed in a foil pouh or clear plastic portion pack for protection during storage.
Page 180: Filling And Sealing Cartridge
FILLING AND SEALING CARTRIDGE Procedure STEP ACTION Place the cartridge on a flat surface. Note the location of the sample well and fill mark indicator, as identified in the images below. Fill Mark Indicator Sample Well Sample Well Mix the sample thoroughly. a.
Page 181 Procedure STEP ACTION Dispense a small amount of sample, ensuring it travels toward the fill mark before applying additional sample. Avoid creating a bubble on the sample well. a. Continue dispensing until the sample reaches the fill mark indicated on the cartridge b.
Page 182 Procedure STEP ACTION Fold the snap closure over the sample well: a. Keeping your thumb or finger on the outside edge of the closure clasp, press the rounded end of the closure until it snaps into place b. Ensure that the cartridge is completely closed before inserting it into the device To close the immunoassay cartridge with the plastic closure clip: a.
Page 183 Examples of Under-filled Cartridges These images display under-filled cartridges. In the images on the left, the sample well is insufficiently filled, and the sample does not reach the fill mark indicator. In the images on the right, the sample well is sufficiently filled, but the sample does not reach the fill mark indicator.
Page 184 FILLING AND SEALING PT/INR (PROTHROMBIN TIME) CARTRIDGES USING DIRECT FINGERSTICK SAMPLING STEP ACTION Remove cartridge from foil pouch and place the cartridge on a flat surface. Prepare lancet device and set aside until needed. Clean and prepare the finger to be sampled using a 70% aqueous solution of isopropanol (70% v/v).
Page 185: Inserting And Removing The Cartridge From The Analyzer
INSERTING AND REMOVING THE CARTRIDGE FROM THE ANALYZER STEP ACTION Inserting Cartridge into Analyzer Align the cartridge with the contact pads facing up and toward the cartridge port. Push the cartridge slowly and smoothly into the cartridge port until it clicks into place.
Page 186: Incorrect Procedure
INCORRECT PROCEDURE Overview The cartridge is designed to fill and seal correctly. However, the conditions described below may occur, especially during the training period. If the condition is not detected by the operator, the analyzer will detect the condition, halt the test cycle and display a cause message followed by the action message “USE ANOTHER CARTRIDGE.”...
Page 187: Procedure For Cartridge Testing
PROCEDURE FOR CARTRIDGE TESTING The following cautions should be taken to prevent damage to the analyzer and Caution to ensure the safety of the operator and the integrity of results. • Never look into the barcode scanner beam or point it toward anyone’s eyes.
Page 188 PERFORMING PATIENT ANALYSIS • DO NOT insert cartridge to start test. • DO NOT open cartridge pouch before scanning the barcode. • If Quality Check Code 69 or 140 appears, see Analyzer Coded Messages Technical Bulletin for Troubleshooting Information. 1. Press to turn on the handheld.
Page 189 INTERPRETATION OF DISPLAYED RESULTS Results Display Test results are displayed with numerical concentration values in the units selected for the Customization profile. For patient test results, bar graphs depicting the values in relation to reference ranges are also displayed. Reference ranges are marked on the bars by tic marks.
Page 190 Flags When the analyzer detects an out-of-range result or an uncharacteristic sensor signal, the condition is indicated by a flag. See table below for flags and symbols used with results. Note: The reportable range flags do not apply when testing is performed under Quality Tests Option 3 – Cal Ver. Action flags do not apply to Option 1 –...
Page 191 TROUBLESHOOTING Warning Message If testing is disabled due to warning message, the condition must be corrected and the analyzer must be turned off and back on again before testing is enabled. Message and Quality See Troubleshooting section. Check Code *** Instead of Results Stars appear in place of results if the analyzer detects that the sensor’s signal is uncharacteristic.
Page 193: Procedures For Glucose Test Strip Testing
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 13-2 Art: 714375-01F Rev. Date: 31-Jan-12...
Page 195: Quality Control
QUALITY CONTROL Overview This section describes the steps to be taken to verify the performance of the analyzer and cartridges. The rationale for the i-STAT cartridge and analyzer quality regimen is described in the Theory section of this manual. Customization The quality control behavior of the analyzer can be customized via the Central Data Station or analyzer Customization Change function to: •...
Page 196 Check Room Verify that the cartridges stored at room temperature are within the expiration date Temperature and that the cartridges have been out of the refrigerator less than the time frame Storage Daily indicated on the cartridge box. If the temperature at which the cartridges are stored is in doubt, use controls to verify that the cartridges are performing properly.
Page 197: Controls For Blood Gas/Electrolyte/Metabolite Cartridges (I-Stat Tricontrols)
CONTROLS FOR BLOOD GAS/ELECTROLYTE/METABOLITE CARTRIDGES Control Solutions Aqueous assayed control fluids are available for verifying the integrity of newly received cartridges. i-STAT Level 1, 2 and 3 Controls are formulated at three clinically relevant levels with known pH and with known concentrations of: Sodium Glucose Potassium...
Page 198 Electronic Simulator test) are printed on a value assignment sheet posted on the APOC website at www.pointofcare.abbott. Always be sure that the lot number printed on the insert matches the lot number on the label of the ampule in use, and that the software revision above the target value table matches the software revision in the analyzer.
Page 199 Ranges The ranges displayed represent the maximum deviation expected when controls and cartridges are performing properly. Should results outside the ranges be obtained, refer to the Troubleshooting section that follows the Procedure for Testing Controls. Target Values are specific to the i-STAT System. Results obtained from these aqueous controls with other methods may differ due to sample matrix effects.
Page 200 CONTROLS FOR BLOOD GAS/ELECTROLYTE/METABOLITE CARTRIDGES (i-STAT TRICONTROLS) Control Solutions Aqueous-based control fluids are available for verifying the integrity of newly received cartridges. i-STAT TriControls Level 1, 2 and 3 are formulated at three clinically relevant levels with defined pH and hematocrit values and with known concentrations of: Sodium Glucose...
Page 201 Before Use i-STAT TriControls solutions require different temperature stabilization times depending on whether or not is to be measured. If PO is to be measured, equilibrate the ampule to room temperature for 4 hours prior to use. If PO is not being measured, equilibrate the ampule for approximately 30 minutes at room temperature.
Page 202 The increase is pronounced at higher levels of indicated hematocrit. Internal testing of non-Abbott aqueous control materials on the i-STAT System which have hematocrit, blood gas and chemistry functionalities exhibit similar precision to that observed for TriControls.
Page 203: Controls For Act Cartridges
The precision data shown below, including results for TriControls solutions, were collected during studies at an Abbott Point of Care facility. SD and %CV are typical of performance; current Value Assignment Sheets should be referenced for applicable mean data. Refer to the value assignment sheets posted on the APOC website at www.pointofcare.abbott.
Page 204 Electronic Simulator test) are printed on a value assignment sheet posted on the APOC website at www.pointofcare.abbott. The ranges displayed represent the maximum deviation expected when controls and cartridges are performing properly. Should results outside the range be obtained, refer to the Troubleshooting portion of this section of the i-STAT System Manual.
Page 205: Controls For Pt/Inr Cartridges
CONTROLS FOR PT/INR CARTRIDGES Intended Use The i-STAT PT Control Level 1 (normal) and PT Control Level 2 (abnormal) are ® used to verify the integrity of newly received PT/INR cartridges. Contents Each level of control is packaged as a box of 5 vials of lyophilized human plasma ±...
Page 206: Controls For I-Stat Ctni, Bnp And Ck-Mb Cartridges
3. Open the vial and transfer a drop of the fluid into the i-STAT cartridge using the dropper tip, a plain capillary tube, plain syringe, or plastic transfer pipette. Tightly recap the control vial and store it at 2-8 ºC (35-46 ºF). 4. Seal the cartridge and immediately insert it into the i-STAT 1 handheld. 14-12 Art: 714376-01P...
Page 207 Control Target Values and Ranges See Value Assignment Sheets posted on the APOC website at www.pointofcare.abbott. The Value Assignment Sheet displays target values and ranges expected when cartridges, controls, and equipment are performing properly. Always ensure that the lot number and software revision on the Value Assignment Sheet match the lot number of the vial in use and the software revision in the handheld.
Page 208: Performing Electronic Simulator Test
PERFORMING ELECTRONIC SIMULATOR TEST Procedure for Internal The internal Electronic Simulator test cycle is automatically activated when a Electronic Simulator cartridge is inserted after the customized interval is reached. If the analyzer passes the simulator test, the cartridge test cycle proceeds. If not, the analyzer displays “ELECTRONIC SIMULATOR FAIL.”...
Page 209: Troubleshooting Failed Electronic Simulator Test
Caution The analyzer will continue to initialize test cycles when the analyzer is customized to warn, but not block testing when a scheduled external Electronic Simulator test is missed, when a FAIL result for the external Electronic Simulator test is ignored, and when the analyzer fails the internal Electronic Simulator test and the lockout feature is not enabled.
Page 210: Checking The Thermal Probes In The I-Stat Analyzers
CHECKING THE THERMAL PROBES IN THE i-STAT ANALYZER Verification for Verify the thermal probe check for the i-STAT 1 Analyzer as follows: Handheld Analyzers • External Electronic Simulator used routinely and results transmitted to a Central Data Station Version 5: On the CDS, click on Data Viewer, then on Simulator.
Page 211: Performing Control Test On Cartridge
PERFORMING CONTROL TEST ON CARTRIDGE Procedure for Testing Initiating control tests from the Quality Test Menu allows results to be stored in Controls separate categories for the purpose of documentation and review. • DO NOT insert cartridge to start test. •...
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Page 225: Calibration Verification
CALIBRATION VERIFICATION NOTE: CALIBRATION VERIFICATION MATERIALS SHIPPED WITH GEL PACKS WILL INCLUDE A FOUR-WINDOW INDICATOR TO MONITOR AND VERIFY TEMPERATURE DURING TRANSIT. CALIBRATION VERIFICATION FOR BLOOD GAS/ELECTROLYTE/METABOLITE CARTRIDGES Purpose Calibration Verification is a procedure intended to verify the accuracy of results over the entire measurement range of a test.
Page 226: I-Stat Calibration Verification Set
i-STAT CALIBRATION VERIFICATION SET i-STAT Calibration Verification solutions require different temperature stabilization Before Use times depending on whether or not oxygen is to be measured. If oxygen is to be measured, equilibrate the ampule to room (ambient) temperature for 4 hours. If not, equilibrate the ampule to room (ambient) temperature for 30 minutes.
Page 227 Electronic Simulator test) are printed on a Value Assignment Sheet posted on the APOC website at www.pointofcare.abbott. Calibration throughout the reportable range of each analyte is verified if each analyte value falls within the corresponding range in the Value Assignment Sheet.
Page 228 Electronic Simulator test) are printed on a Value Assignment Sheet posted on the APOC website at www.pointofcare.abbott. If the result is outside the range published in the Value Assignment Sheet, two additional cartridge runs should be performed on this level and the three results averaged and then compared to the Value Assignment Sheet range.
Page 229: Calibration Verification For Blood Gas/Electrolyte/Metabolite Cartridges (I-Stat Tricontrols)
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 be required by regulatory accreditation bodies.
Page 230 Storage Refrigerated storage at 2-8 ºC (35-46 ºF) should be maintained until the printed 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.
Page 231: Verification Procedure For Hematocrit
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.pointofcare.abbott. Calibration throughout the reportable range of each analyte is verified if each analyte value falls within the corresponding range in the Value Assignment Sheet.
Page 232: Verification Procedure For Act
Interpretation of The i-STAT hematocrit method using blood anticoagulated with lithium heparin is Results calibrated to give results equivalent to the reference microhematocrit method using blood anticoagulated with K EDTA. Since the blood used for the microhematocrit determination here is anticoagulated with lithium heparin, adjustment must be made to the observed i-STAT values to compensate for the anticoagulant difference.
Page 233: Calibration Verification For I-Stat Ctni, Bnp And Ck-Mb Cartridges
Tightly recap the vial and store it at 2-8 ºC (35-46 ºF). 4. Seal the cartridge and immediately insert it into the i-STAT 1 handheld. Acceptable Criteria Target values (determined by testing multiple vials 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.pointofcare.abbott.
Page 234: Procedure For Cartridges
Target values are specific to the i-STAT System. Results may differ if used with other methods. If a result for a level is outside the range published in the Value Assignment Sheet, two additional cartridge runs should be performed on this level and the three results averaged and then compared to the Value Assignment Sheet range.
Page 235: Proficiency Or External Quality Control Testing
PROFICIENCY or EXTERNAL QUALITY CONTROL TESTING Samples from external quality control providers can be used to assess consistency of Purpose results for a particular method or system across testing sites. Due to matrix effects and additives, these samples should not be used as an indication of the system’s true accuracy.
Page 236: Troubleshooting
A level surface includes running the handheld in the downloader/recharger. 7. Review results The i-STAT System is designed to measure fresh whole blood samples. Matrix Troubleshooting effects and interfering substances can be expected when measuring non-whole blood samples. The following points should be considered when selecting and testing external quality control samples: •...
Page 237: Routine Care Of The Analyzer And Downloader
ROUTINE CARE of the ANALYZER and DOWNLOADER Drying a Wet Analyzer If the analyzer is placed on a wet surface or if any liquid is spilled onto it, dry the or Downloader analyzer immediately. If liquid enters the following compartments, the analyzer may be damaged:  The electronics compartment  The battery compartment...
Page 238: Removing And Replacing Disposable Batteries
Procedure STEP ACTION Prepare a 1:10 solution of household bleach by mixing one part of bleach with nine parts of tap water. This solution will maintain its germicidal action for a week. Soak a few gauze pads in the bleach solution. Before use, squeeze the pads to remove excess solution.
Page 239: Removing And Replacing The Rechargeable Battery
Removing and Wait until any test in progress is completed, and turn off the analyzer before replacing Replacing the the battery or the most recent set of results may be lost. Stored results will not be Rechargeable Battery lost when replacing the batteries. STEP ACTION Slide the battery compartment door off.
Page 240 17-4 Art: 714379-01G Rev. Date: 07-Mar-17...
Page 241: Updating The Software
For instructions 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: InSTRucTIonS FoR upDATIng i-STAT 1 HAnDHelD SoFTwARe uSIng www.abbottpointofcare.com (Art. 731335-01B) n e T w o R k o p T I o n S F o R u p D AT I n g T H e i - S TAT 1 H A n D H e l D u S I n g www.abbottpointofcare.com (Art.
Page 243 JammLite Process Overview Whether updating one, two, or many i-STAT 1 Handheld(s), the JammLite procedure must be used to update the ﬁrst i-STAT 1 Handheld. This process is noted in the diagram below.
Page 244 Optional Steps Once the ﬁrst i-STAT 1 Handheld has been updated using the JammLite Utility, additional i-STAT 1 Handhelds may be updated the same way or by using the Handheld-to-Handheld method. Additionally, if using Central Data Station (CDS), the new software must be added to the CDS Customization Workspace.
Page 245 (i.e., contact the IT Department or the individual in your ofﬁce Access to: • responsible for computer support). http://www.abbottpointofcare.com/SoftwareUpdate Indicate that the i-STAT 1 software i-STAT System Equipment: update process requires: • (1) Serial Downloader/ Recharger (DRS-300) or DRC-300 • a 9-pin serial port...
Page 246 1 JammLite Utility If using a Serial Downloader or Serial Downloader/Recharger, connect the i-STAT 1 Serial Downloader to the 9-pin serial port on the back of the computer 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.
Page 247 Connect the power supply: When power is supplied to the • to the i-STAT 1 Serial Downloader or Serial Downloader, a green light will illuminate. Serial Downloader/Recharger, and When power is supplied to the Serial Downloader/Recharger or • to a wall outlet or power strip DRC-300, it will look as it did before power was supplied.
Page 248 .1 of this document. 1. 1 1 the icons that appear, double click Updating Your i-STAT 1 Handheld i-STAT 1 JammLite Utility 1. 1 2 In the JammLite utility, select the i-STAT 300 Analyzer within the Instrument dropdown menu.
Page 249 1. 1 3 By default, the lowest numbered COM port will If no ports are displayed, close automatically be selected. all open programs including JammLite, and then re-launch If the downloader is connected to a different COM JammLite. port, change the selection to that COM port now. If JammLite still has no available COM ports listed, call your Support Services representative for assistance.
Page 250 1. 1 5 Follow the onscreen instructions. 1) If an analyzer is already in the Downloader remove it. 2) Ensure the analyzer to be updated is off. Cancel 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.
Page 251 Support Services representative. For additional information on running the electronic simulator, please see: • Section 14 of the i-STAT 1 System Manual, or • The Introduction and Start-up section of the i-STAT System Manual for Waived Tests Congratulations. The process for updating the ﬁrst i-STAT 1 Handheld is complete.
Page 252 After updating the ﬁrst i-STAT 1 Handheld, follow these steps to update additional Handhelds with the Handheld-to-Handheld Process Gathering All Equipment Handheld-to-Handheld Before starting the process make sure all the required equipment is available: • Recently updated i-STAT 1 Handheld (referred to in this section as the Sending Handheld) charged to 7.5 volts or higher*...
Page 253 Utility Menu will not appear. Check for data entry errors and retry. If still unsuccessful, call your Note Abbott Point of Care Inc. Support Services representative recommends changing and indicate: the default password. • A Handheld-to-Handheld update has been attempted •...
Page 254 Updating your i-STAT 1 Handheld Handheld-to-Handheld In the Utility Menu: • Press 1-SEND SOFTWARE • Press 1-JAMSXXX/AXX Note: The “numbers” have been replaced with X’s in the example above and will change with each software update. Make sure the Receiving Handheld’s power is off.
Page 255 When the update is in progress, the Sending Handheld will display SENDING along with 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.
Page 256 System Manual for Waived Tests 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 update, the process is complete.
Page 257 CDS update path: Support Services representative. Are you attempting to update CDS on the PC that was used to update the i-STAT 1 Handhelds with Jammlite? If “Yes,” continue with step If “No,” (CDS is NOT installed on the PC that was used with JammLite) go to page 19.
Page 258 Type istat as the Customization Password and click OK. Note Abbott Point of Care Inc. recommends changing the default password. Password If you are unable to open CDS Customization, please contact your Support Services representative A password is needed to access this workspace.
Page 259 Assigning JAMS/CLEW JAMS/CLEW in Central Data Station The latest CLEW should be displayed in the i-STAT Analyzer CLEW window. Select the CLEW version that matches the Product Update and click OK. CLEW i-STAT Analyzer Philips BAM Section i-STAT Analyzer Name Expiration Date 6/24/2009 Philips BAM...
Page 260 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 Default customization profile: Language: English Unit Set: UNITSET00 i-STAT Analyzer CLEW: Philips Analyzer CLEW: i-STAT 1 Software: JAMSXXXX.BIN...
Page 261 ® ® 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. Art: 731335-01B Rev. Date 13-AUG-13...
Page 263 4. Using the i-STAT/DE Customization 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.
Page 264 Note: These instructions assume that the Network Downloader types used for the update process are already installed and in use on the customer’s network. (2) i-STAT 1 handheld (3) Electronic Simulator • List of the IP Address(es) for the network downloader(s) to be used for the soft- ware update process 1.2:...
Page 265 1.9: In the JammLite utility, select the i-STAT 300 Analyzer within the Instrument dropdown menu. 1.10: Select TCP/IP within the Port dropdown menu. 1.11: Type the IP Address of the Network Downloader being used for the software update in the IP Address box. Note: the address used above is for example only.
Page 266 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 process for updating the first i-STAT 1 Handheld is complete.
Page 267 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 all the required equipment / information is available: • Computer with CDS Version 5 application...
Page 268 A Password box will then appear. • Type in the Password and press Enter. The default password is istat. Note: Abbott Point of Care Inc. recommends changing the default password. Note: If you are unable to open CDS Customization, please contact APOC Technical Support and indicate that your CDS Customization Password is unknown.
Page 269 2.10: Update the software in the i-STAT 1 handheld. • Go to the location where the i-STAT 1 handheld you wish to update is located or contact someone at that location who can assist in updating the handheld(s). • Press the On/Off button on the handheld.
Page 270 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 process for updating the first i-STAT 1 handheld is complete.
Page 271 3. UPDATING THE i-STAT 1 HANDHELD USING A SERIAL DOWNLOADER OR SERIALLY CONNECTED DRC-300 AND THE JammLite PROCESS FOR ACCOUNTS WITH RALS-Plus AND i-STAT/DE 3.1: Before starting the process, make sure all the necessary required equipment is available. • Computer with:...
Page 272 • Record “Host” and “ID” entry. • Uncheck the “Enabled” box. Click OK. • If not enabled, minimize the window and proceed to the next step. 3.5: Navigate to www.abbottpointofcare.com/SoftwareUpdate. • Select Language from the drop-down menu. • Indicate the Data Management type and Version used with the i-STAT System. • When prompted, click on the software file link and save file to Desktop.
Page 273 3.7: In the JammLite utility, select the i-STAT 300 Analyzer within the Instrument drop- down menu. 3.8: Make sure there is at least one port number listed under the Port Drop-Down List. Note: If the Port drop-down list says “None.” make certain the connection from the Serial Downloader to the computer is tight.
Page 274 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 process for updating the first i-STAT 1 handheld is complete.
Page 275 3.15: Update the CLEW version in the Customization Workspace. • Transfer the files. o Access the main Customization Workspace page. o Click Update i-STAT/DE → Upload Update File. o Browse to desktop, click on and click Upload. (Note: the XXX is the CLEW version that you are updating.) o Click Update i-STAT/DE →...
Page 276 • 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 277 4. UPDATING THE i-STAT 1 HANDHELD USING THE i-STAT/DE CUSTOMIZATION WORKSPACE AND A NETWORK DOWNLOADER, DOWNLOADER/RECHARGER, or DRC-300 4.1: Before starting the process, make sure all the required equipment / information is available. • Computer which can access the Customization Workspace • Access to http://abbottpointofcare.com/softwareupdate...
Page 278 • PrecisionWeb Users: o Double click on the desktop shortcut or Internet Explorer Favorites for i-STAT Customization. 4.5: Update the CLEW and JAMS versions in the Customization Workspace. • Under the “Default customization profile:” column, click on the “i-STAT Analyzer CLEW” button.
Page 279 4.7: 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.
Page 280 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 process for updating the first i-STAT 1 handheld is complete.
Page 281: Troubleshooting The Analyzer
TROUBLESHOOTING THE ANALYZER Introduction When the analyzer detects a potential or real problem before the test cycle is initiated or at any time during the test cycle, a Quality Check Code number, the type of problem and the next step to be taken will be displayed. The Code number may be helpful to a technical support representative if a problem cannot be resolved.
Page 282: Startup Messages
STARTUP MESSAGES Overview Whenever the analyzer is turned on using the On/Off key, the analyzer performs self-checks. If a condition that should be corrected in the near future, but that will not affect results is detected, a warning is displayed. The operator presses the 1 key to continue with testing.
Page 283: Test Cycle Messages And Quality Check Codes
TEST CYCLE MESSAGES AND QUALITY CHECK CODES Overview If a problem is detected during a testing cycle, the cycle will be stopped and a message will identify the problem and indicate the next step to be taken. If the problem causes testing to be disabled, the problem must be corrected and the analyzer must be turned off and back on before testing will be enabled.
Page 284 Error in Cartridge or The following conditions usually indicate an error condition relating in some Fluid Movement way to the cartridge or fluid movement within a cartridge. These conditions can be operator or sample related. In most cases a new cartridge must be used. If a condition persists, especially if isolated to one analyzer, there may be an analyzer problem.
Page 285 Error in Cartridge Message on Display Cause Action or Fluid Movement (continued) Insufficient Sample This is most likely due to Try another cartridge. insufficient sample in the sample Use Another Cartridge well of the cartridge, but can also be caused by bubbles in the sample.
Page 286: No Display
If the problem persists, been pressed. the analyzer should be returned for repair. If using the analyzer recharging function of the i-STAT 1 Downloader/Recharger, ensure that the Downloader/Recharger is working as intended. If experiencing an issue, contact your support representative and use disposable batteries for continued use of the analyzer.
Page 287 1 Analyzer, you may want to consider the rechargeable battery system available with the i-STAT 1 Analyzer. Abbott Point of Care Inc. • 100 & 200 Abbott Park Road • Abbott Park, IL 60064 • USA Art: 714260-01R Rev. Date: 30-Mar-17...
Page 288 This message will appear in the stored test records on the Operator i-STAT 1 Analyzer if the analyzer powers down before mandatory information was entered. The following codes are associated with the cartridge or fluid movement within a cartridge. These conditions can be operator or sample related.
Page 289 Code Cause/Action Explanation Number Message on Display 22, 25 Cartridge Error / Use These codes occur only for coagulation cartridges if the mixing Another Cartridge of the sample and reagent is compromised. This can be caused by an insufficient or clotted sample, or by air bubbles in the sample.
Page 290 Code Cause/Action Explanation Number Message on Display Cartridge Preburst / Use This code indicates that the analyzer detected fluid on the Another Cartridge sensors before it should have. Possible causes: mishandling of cartridges (putting pressure in the center of the cartridge), poor storage conditions of cartridges (frozen), or rerunning used cartridges.
Page 291 If testing immunoassay cartridges on an i-STAT 1 Analyzer, this code can be related to poor electrical connection between the i-STAT 1 Analyzer and the cartridge. 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.
Page 292 If this code persists, or if code 86 occurs with the i-STAT 1 Analyzer without a Downloader/Recharger, contact your local support organization for further assistance.
Page 293 Code Cause/Action Explanation Number Message on Display Cartridge Type Not This code could be due to use of a cartridge type that is not Recognized / Use compatible with the version of software in the analyzer, or the use Another Cartridge of expired cartridges.
Page 294 Another Cartridge integrity of the analysis fluid. However, this code can also be related to poor electrical connection between the i-STAT 1 Analyzer and the cartridge. This can sometimes be corrected by conditioning the pins in the analyzer using the ceramic conditioning cartridge.
Page 295 Wait for the sample to reach the fill mark and then close the cartridge. Cartridge Error / Use Overfilled cartridge. Repeat the test. Another Cartridge Analyzer Error / See In order to run an immunoassay cartridge, the i-STAT 1 Analyzer Manual must: • bear the symbol...
Page 296 CCC. If necessary, replace or rotate the ceramic strip so the CCC is ready for future use. 4. Return the analyzer to service. i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. Art: 714260-01R Rev. Date: 30-Mar-17...
Page 297: Theory
THEORY ANALYZER FUNCTIONS Introduction The i-STAT 1 analyzer is a microprocessor-controlled electromechanical instrument designed to: • identify the cartridge type. • control the flow of fluids within the cartridges. • mix sample and reagent (where applicable). • apply electrical signals to certain types of sensors within the cartridges.
Page 298 • A multiplexed potentiometric signal line • A multiplexed amperometric signal line • An AC fluid conductivity signal • A digital identification code to identify the type of cartridge being inserted into the analyzer Mechanical System A single DC gearmotor drives mechanical system components: •...
Page 299: Electrochemical Measurements
ELECTROCHEMICAL MEASUREMENTS Method Measurements are performed on undiluted specimens. Undiluted methods are also called direct methods, while methods requiring dilution of the sample are called indirect methods. Indirect methods measure the total molar concentration of analyte per unit volume of plasma. Direct methods measure the total molar activity of analyte (apparent or free ion activity) per unit volume of plasma water.
Page 300: Determination Of Test Results
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 of the analyte. For a positively-charged monovalent ion, the theoretical slope would be 59.1 mV at 25°C. Activity Versus Ion-selective electrodes measure activity rather than concentration.
Page 301: Determination Of Cell Concentration
It is known that direct methods read up to 7% higher than indirect methods in measuring the concentration of electrolytes. This is because there is an excluded volume occupied by plasma protein and lipids that is not considered in indirect measurements. Typically, however, the elevation of results is less than the full 7% because some of the analyte is bound to protein and other ions, and is not assayed by direct methods.
Page 302 For example: • uncompensated Hct = 21 %PCV • 21 %PCV = 0.50 of 42 % • inferred total protein = 7.0g/dL x 0.50 = 3.5 g/dL • 21 %PCV + 3 g/dL = 24 %PCV (CPB) Limitations of the The CPB algorithm is based upon a series of inferences: CPB Algorithm •...
Page 303: Determination Of Coagulation Endpoints
As new technologies evolve, quality control regimens must match the requirements of the particular analytical system. Abbott Point of Care 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.
Page 304 The use of unit-use cartridges frees the i-STAT System from these skilled maintenance and calibration procedures. It also allows for the design of a quality control system which automatically monitors those aspects of the measurement process which are the most likely to impact quality, including the characteristics of the individual sensors and the operator’s actions.
Page 305 Comparison of this regimen to laboratory quality control procedures can seem confusing because it does not employ liquid control solutions. However, the principle is the same in that the traditional intermittent quality control measurements are applied to the persistent part of the system. In the case of the i-STAT System, only the instrumentation is persistent so only this portion is tested with an external challenge.
Page 306 • putting in too much sample • putting in too little sample • rerunning the same cartridge • introducing an air segment into the fluid segment, etc. The analyzer will flag these conditions and not deliver a result. 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.
Page 307 Handheld Analyzer Verification When Verified Motorized Mechanical System • verify electrical contact is made with sensors on cartridge Every cartridge use • verify ability to properly move calibration fluid, if Every cartridge use applicable Every cartridge use • verify ability to properly move sample Electrical Measurement System •...
Page 308: Quality Control And The I-Stat Coagulation Tests
Validating the Until recently, regulations and laboratory accreditation standards specified the Performance of the use of traditional quality control regimens, including the daily use of liquid i-STAT System “control” materials. As new technologies such as the i-STAT System have become available, the community has recognized the limitations of relying upon traditional regimens, prompting various regulatory and accreditation organizations to modify their standards accordingly.
Page 309 The system quantitatively confirms the accuracy of the mixing step by monitoring the key parameters of mix uniformity, magnitude and timing. These quality tests are performed on each coagulation cartridge. i-STAT’s microfabrication production processes are inherently capable of creating sensors with highly reproducible characteristics. For the measurement of blood gases, electrolytes and chemistries, this means that the i-STAT System requires only a one-point calibration, using a calibrant solution...
Page 311: Downloader Programming And Wiring
Preparation 1. Determine for each Downloader: IP Address, Gateway Address, and Subnet Mask. 2. Determine the IP Address of the data manager and service port for i-STAT 1 Analyzer transmissions (default 6004). Configure a Terminal 1. Run a terminal emulation program, such as HyperTerminal, and choose the...
Page 312 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 parameters.
Page 313 1. Determine the following site specific information for this Downloader: • IP Address (Example: 10.10.12.142 used below) • Gateway Address (Example: 10.10.12.1 used below) • Netmask (Example: 8 for 255.255.255.0 used below) 2. At the Your choice? prompt, Select 0 for Server Configuration and enter the information required for this Downloader.
Page 314 Configure for Channel 2 provides network access for the i-STAT 1 Analyzer data transmissions i-STAT 1 Data to a data manager. This section describes how to set up parameters for Channel Transfer via IR Port 1. Determine the following information: •...
Page 315 Configure for Channel 1 provides network access for the i-STAT 1 Analyzer data transmissions i-STAT 1 Serial to a data manager. This section describes how to set up parameters for Channel...
Page 316: Wiring The Downloaders
WIRING thE DOWNLOADERs Overview This section includes diagrams to make a connection between the Downloaders and the Data Manager and to connect a printer to the Downloaders. 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 to the Downloader at the same time.
Page 317 Option 2: The following 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 ...
Page 318 Connecting the Serial Option 1: The following option is for downloading/uploading only and Port Downloader can be used when there is no power outlet available for the Downloader or Downloader/Recharger. In this particular configuration, both recharging LED lights will be lit.
Page 319 Option 2: The following diagram 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 ...
Page 320 Option 3: The following diagram shows how to connect a serial downloader 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: •...
Page 321: Central Data Station 5
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: •...
Page 322 22-2 Art: 714384-01F Rev. Date: 16-Apr-15...
Page 323: Installation Of The Central Data Station
INSTALLATION OF THE CENTRAL DATA STATION Hardware The PC on which the CDS software resides must meet specifications provided by Abbott Point of Care Inc. and should be installed following the PC manufacturer’s directions. Install the printer if applicable. Software A license key is required to install the Central Data Station software.
Page 324 22-4 Art: 714384-01F Rev. Date: 16-Apr-15...
Page 325: General Procedures And Conventions
GENERAL PROCEDURES AND CONVENTIONS Overview The CDS software follows typical Microsoft Windows conventions and procedures. The illustrations below are used to point out the use of the menu bar, toolbars, tabs and buttons. Selecting Menu Options 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).
Page 326 Selecting Functions Tabs: A window may have several functional groupings that are contained in a Window in tabs (6) with multiple pages. Clicking the text on the tab will display the corresponding page. Buttons: Use to activate a function within a window (7) or to confirm (OK) or cancel a function or to manipulate a window.
Page 327 Sorting Data in In most cases, when data is presented in a table, clicking a column header will a Window sort the display based on the data in that column. In the Data Viewers, repeating values, such as a patient ID, will be sorted in descending Date/Time order. Clicking the header again will reverse the order of the sort.
Page 328 22-8 Art: 714384-01F Rev. Date: 16-Apr-15...
Page 329: Customization Of The Central Data Station
CUSTOMIZATION OF THE CENTRAL DATA STATION Overview The Customization options are: Site Information Institution name and technical support phone number Serial Ports Enables/Disables serial communications and allows individual ports to be selected and configured Network Enables/Disables network communications and allows specification of TCP port numbers Interface Enables/Disables external interfacing and allows protocol to...
Page 330 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 Blood Analysis Module.
Page 331 Indicates no primary protocol in use. Select when no external interface is used and PCx glucose test strip data is to be uploaded to QC Manager 3 Automatic Manual Entry – Installed by Abbott Point of Care Inc. Test Result...
Page 332 When MediSense Precision PCx glucose test strips are being run on the i-STAT 1 Analyzer, the glucose test strip data can be made available to QC Manager data management program. Click the Upload PCx Strip Data to QC Manager 2.2 box to enable this function.
Page 333 Then click on OK. 5. Another dialog box will appear prompting you to change your password. Note: Abbott Point of Care Inc. recommends changing the default password. 6. Type in a New Password of your choosing in the space provided. Then retype that same password on the New Password Verification line and click OK.
Page 334 22-14 Art: 714384-01F Rev. Date: 16-Apr-15...
Page 335: Interface Program Customization
LIS or HIS. The Central Data Station also provides a function that, when enabled, will also transmit all of the Precision PCx results generated on the i-STAT 1 Analyzer to QC Manager so they can be managed as part of the overall Blood Glucose Testing program.
Page 336 Procedure 1. The CDS program must be running and the external interface must be enabled. 2. Double click the i-STAT interface icon in the system tray (next to the clock in the lower right hand corner of the screen) to open the interface program’s main screen.
Page 337: Overview Of The Central Data Station Program
OVERVIEW OF THE CENTRAL DATA STATION PROGRAM The Central Data Station (CDS) software includes the following point-of-care testing process management functions: • Managing Instruments • Managing Analyzer Customization Profiles • Managing Operators • Maintaining Database Contents and Size • Managing Inventory •...
Page 338 22-18 Art: 714384-01F Rev. Date: 16-Apr-15...
Page 339: Administration Tools
ADMINISTRATION TOOLS Overview Administration Tools include Workspaces for Instruments and Locations, Operators, Database Maintenance, Inventory, Customization, and User Administration. INSTRUMENT AND LOCATION WORKSPACE Overview This workspace is used to: • assign names to download locations, • assign instruments to locations, •...
Page 340 Instrument  Add… from the menu or click Add Inst. in the toolbar. Select a method from the drop down list. Note: If using the i-STAT 1 Analyzer for cartridge and/or test strip runs, select i-STAT as the method. 22-20 Art: 714384-01F Rev.
Page 341 17 characters can be used. There are two options for Download Result Reporting, both of which apply to the i-STAT PCA, i-STAT 1 Analyzer, and the Philips Blood Analysis Module: 1. Always report location as this assignment: The results from this instrument will appear with the location of the instrument’s assignment...
Page 342 Delete Instrument  Click the Location/Method for the instrument to be deleted and then the serial number of the instrument to be deleted. Click Instrument  Delete... from the menu or click Delete Inst. in the toolbar. Move Instrument  Click the Location/Method for the instrument to be moved and then on the serial number of the instrument to be moved.
Page 343 Note: The i-STAT 1 Analyzer can also be customized either to warn the end users that a download is required or to lockout end users if the time for a download has been reached or exceeded. The download criteria for analyzers and for the CDS monitor should be selected to make sense.
Page 344 Instrument Log The Instrument Log tracks all changes made in the Instruments tab page. Additional comments 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.
Page 345: Operator Workspace
Assign operators to departments • Add comments When the i-STAT 1 Analyzer is customized to use the operator list created here, the analyzer can be customized to warn or lockout operators if they are not on the list or their certification has expired.
Page 346 Add Operator  This function is used to add new operators to the list of operators. Alternatively, operator lists can be imported (see Operator List Import at the end of this section). Click Operator  Add... from menu or Click on Add in the toolbar. Enter the ID number that the operator will enter into the analyzer on the Operator ID line.
Page 347 Update Certifications  Select the operator or operators. Click Operator  Update Certification... from the menu or click Update Cert. in the toolbar and complete the Update Certification form.  Add Certification The Add Certification button allows operators who are certified for one method to be certified for another method without having to complete a new Add Operator form.
Page 348 Edit Department Name  Click the department name to edit. Click Operator  Edit Department Name from the menu or click Dept. Name in the toolbar. The Unassigned designation cannot be changed. Operator and Certification Reports  Click on the down arrow next to Report in the Operator Workspace toolbar and click on Summary or Expiration.
Page 349 Operator Log The Operator 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.
Page 350 22-30 Art: 714384-01F Rev. Date: 16-Apr-15...
Page 351: Operator List Import
OPERATOR LIST IMPORT This function in the Operator Workspace on the CDS5 allows an operator list to be imported from a text file. To access this function, click on Main  Open Administration Function  Operator from the main menu to open the Operator Workspace.
Page 352 7. If all operators are to be assigned to the same department, such as Nursing or Perfusion, click on Assume a single department for all operators and enter or select the department from the drop down list. If this option is selected, the text file does not need to contain a Department field.
Page 353: Database Maintenance
DATABASE MAINTENANCE Overview This workspace allows the database to be backed up, deleted and restored. A "Statistics" tab page also allows users to view a summary page of Result Types contained in the database. Archive Test Backup test results: This function allows test results to be backed up onto a Results disk, CD or other directory.
Page 354 • Location • Comment • Interface comment • Serial number • Department 7. Select a Directory. 8. Select a method or methods to back up or click Select all methods. 9. Click the button marked Backup or Backup and Delete and follow the prompts.
Page 355 Restore test results: This function allows test results that have been deleted from the CDS but backed up elsewhere to be restored to the database. 1. Click on Main  Open Administration Functions  Database Maintenance. 2. Insert disk or CD where files are located. 3.
Page 356 Selecting an individual Result Type and then clicking on Details allows you to view a similar statistical breakdown for that particular Result Type: 1. The total number of that particular Result Type in the database, 2. The date and time of the oldest result of that type in the database, 3.
Page 357: Inventory Workspace
INVENTORY WORKSPACE Overview The Inventory Workspace is organized under five tabs with the following functions: • Stock: define reorder triggers, view and edit inventory • Distribution: track items distributed from central stock to different locations • Orders: track pending and received orders, view reports on received items •...
Page 358 Stock The Stock tab includes both Inventory and Estimated Inventory statistics. Inventory: The number of given items as counted and entered by the user. The inventory is automatically updated when new orders are received under the Orders tab. Estimated Inventory: The number of i-STAT cartridges and MediSense PCx and/or PCx Plus glucose test strips as estimated by the workspace software.
Page 359 The Estimated Inventory for i-STAT cartridges and MediSense PCx glucose test strips will automatically begin updating with the next analyzer transmission. Click the Refresh button to update the workspace for transmitted data. Both the Inventory and the Estimated Inventory are updated automatically when orders are received under the Orders tab.
Page 360 Click the Add Button to add another item or the Delete Button to delete an item. Click the Receive All Button to automatically enter items and quantities, as they were ordered. Use 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.
Page 361 Distribution Use the Add button in the tool bar to record the distribution of consumables. The Item drop down menu includes all consumables entered in the Items tab. The Location drop down menu includes all locations entered in the Instrument and Location Workspace.
Page 362 Inventory Log The Inventory 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 363: Customization Workspace
CDS application logon password. To change the password, select Tools and Change Password from the menu bar. A password from 3 to 8 characters can be used. Note: Abbott Point of Care Inc. recommends changing the default password.
Page 364 Default The first step in customization is to create a default customization profile. This Customization is the profile initially assigned to every new location. To change the default Profile profile, use the directions under Making Selections or click the menu option Profile ...
Page 365 OK button to save the selection or click the Cancel button to return to the previous selection. Language Window Note: Russian is available only on the i-STAT Portable Clinical Analyzer and Portuguese, Danish, and Finnish are available only on the i-STAT 1 Analyzer. 22-45 Rev. Date: 16-Apr-15...
Page 366 Unit Set Window Details 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. 22-46 Art: 714384-01F Rev.
Page 367 Window 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 using the Customization Workspace. Please see the Technical Bulletin "Updating Analyzer Software" for full details on performing this procedure.
Page 368 Each Customization Profile is assigned a unique name by the CDS program. This name appears under the Preferences column in the Customization Workspace window, on the Customization screen on the i-STAT 1 Analyzer, on the Analyzer Status screen on the i-STAT Portable Clinical Analyzer and on the Blood Analysis Setup screen of the Blood Analysis Module.
Page 369 The Chart Page selection box is part of a feature allowing users to customize the Selection Box Chart Page on their i-STAT 1 analyzers in order to capture user-defined information such as ventillator settings. See the "i-STAT 1 Analyzer Chart Page Customization"...
Page 370 22-50 Art: 714384-01F Rev. Date: 16-Apr-15...
Page 371: User Administration Workspace
USER ADMINISTRATION WORKSPACE Overview The User Administration Workspace is designed as a tool for system administrators. It allows administrators to manage security profiles (a set of security settings determining the access to different CDS screens and functions), manage users, and assign users to security profiles. Access Only users designated as administrators can access the User Administration Workspace in the CDS by clicking on Main ...
Page 372 Type in the name of the new Security Profile, then check off the different workspaces and functions users assigned to that security level will be allowed to access, and then click OK. The newly created security profile will then be added to the Available Security Profile list.
Page 373: Password Management
User Log The User Log tracks the following user activities: CDS Startup and Shutdown, User Logon, Manual and Automatic User Logoff, and Disabling of the Security feature via the Customization Screen. PASSWORD MANAGEMENT Passwords Once all the Security Profiles are created, and all CDS users are assigned to the appropriate Profiles, the Administrator should provide the users with their assigned User Names.
Page 374 a. Click and highlight this particular user’s listing in the User Window. b. Click on User  Emergency Password. A box will appear with an Emergency Password that this particular user can use. Note: Once this user uses the Emergency Password to log in, they will be immediately prompted to change their password for future CDS log- ins.
Page 375: Data Viewers
Overview Data from instruments downloaded to the CDS are viewed in the Data Viewers. Data downloaded from the i-STAT 1 Analyzers can be viewed in separate Data Viewers for Results, QC Codes, Simulator, Unsent Results, Control Results, Calibration Verification (or Linearity) Results and Proficiency Results (external quality control).
Page 376 Refreshing the Data is received continuously by the CDS. Updating the viewers with the Data continuous incoming stream of data would make viewing the data difficult. Therefore, new data is not added to a viewer until the Refresh button is pressed.
Page 377 The selection of a shorter date range enhances the system performance by limiting the amount of information needing to be presented. It is always possible to expand the range to view results from earlier and then reset to a more limited default period.
Page 378 A two-sided Sort dialog will then appear, listing Columns Available for Sorting on the left, and Sort Columns on the right. Simply click the listing under Columns Available for Sorting that you wish to sort your data by, and then drag that column title to the right hand side of the screen under the Sort Columns section.
Page 379 Printing Selected With a Data Viewer open, highlight the records to be printed, click Record  Print Records Selected Records or click the Print toolbar button. Send Selected With a Data Viewer open, highlight the records to be sent, click Record  Send Records Selected Records or click the Send toolbar button.
Page 380 Electronic All Electronic Simulator results, both external and internal, are listed in Simulator Viewer chronological order with the newest result at the top of the screen. To view all simulator results together for each analyzer, click the Serial Number column header to sort the analyzers by serial number or use the Find...
Page 381 Sent Column Values Sent Column Definition Can the record Value be resent? This is the initial value when a data record is entered into the database. Pending This value means that the record is in the queue waiting to be processed by the Interface.
Page 382: Data Export
DATA EXPORT A data export option is available in the following areas of the Central Data Station application: a. Data Viewers b. Reports c. Trend report, and d. the Extended Simulator report screen To access this option from any of the Data Viewers or Reports, click on Window ...
Page 383: Monitors
MONITORS Download Monitor The download monitor quickly identifies the download status of all locations and any locations that have instruments out of download compliance. The upper portion of the monitor shows the last time an analyzer from the listed locations was downloaded. These columns can be sorted by clicking the column heading.
Page 384 The Interface Monitor accessed via the menu bar functions with an interface installed by Abbott Point of Care Inc. To access the the interface monitor for an interface installed by a third party, click on the Interface Manager button in the tray at the bottom of the screen.
Page 385: Reports
REPORTS Overview Reports for managing the point-of-care testing process are available from the CDS program. Three reports can be generated: Reagent Management, Method Competency and Method Compliance. These show information summarized by operator, location, department, or analyzer. Reports can be printed. Reagent This is a report of cartridge usage by Department or Location.
Page 386 Method This is a report of exceptions of policy and procedure for cartridge testing by Compliance Department, Location or Operator. This information is available when there is an 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.
Page 387 Method This is a report of Quality Check Code occurrence for cartridges by Department, Competence Operator, Location or Analyzer. Select a date range for the report. Select a Report by Department, Location, Operator, or Analyzer and then select All Locations or All Departments or select one or more Locations or Departments from the list.
Page 388: System
SYSTEM Customization: Configuration of the CDS can be viewed. Central Data Station Settings Customization: Customization profiles of the i-STAT analyzers can be viewed. i-STAT Analyzer Settings AutoSend When enabled, data will be transmitted automatically from the CDS to the LIS or other information management system when received by the CDS.
Page 389: Windows Operating System And Language Support
HELP Technical Support Phone number for your Customer Support Representative. About… Software version of the Central Data Station. WINDOWS OPERATING SYSTEM AND LANGUAGE SUPPORT Windows Version/ Windows Supported CDS Language(s) Service Pack Language NT 4.0, SP6a English English 2000 Professional, SP4 English English, German, Italian, Spanish, Swedish...
Page 390 22-70 Art: 714384-01F Rev. Date: 16-Apr-15...
Page 391 Sensors are contained in cartridges with microfluidic components and, in some cartridges, calibration solution. i-STAT cartridges are used with the i-STAT 1 Analyzer* for the simultaneous quantitative determination of specific analytes and coagulation parameters in whole blood.
Page 392 * The cTnI, CK-MB, ß-hCG and BNP cartridges can only be used with the i-STAT 1 analyzer bearing the symbol. Analysis Time: • ACT cartridge: to detection of end point - up to 1000 sec (16.7 min) • PT/INR cartridge: to detection of end point – up to 300 sec (5 min) •...
Page 393 Collection Options Cartridges Directly from Syringes Evacuated Tubes Capillary Tubes Skin Puncture • With sodium or • With sodium or lithium • Not recommended • Not recommended lithium anticoagulant heparin anticoagulant (syringe must be filled (tubes must be filled to labeled capacity) to capacity) Cartridges which...
Page 394 EXPECTED VALUES Measured: REPORTABLE REFERENCE TEST UNITS RANGE RANGE (arterial) (venous) Sodium/Na mmol/L (mEq/L) 100 – 180 138 – 146 138 – 146 Potassium/K mmol/L (mEq/L) 2.0 – 9.0 3.5 – 4.9 3.5 – 4.9 Chloride/Cl mmol/L (mEq/L) 65 – 140 98 –...
Page 395 EXPECTED VALUES (C Measured: (C REPORTABLE REFERENCE TEST UNITS RANGE RANGE (arterial) (venous) B-Type Natriuretic pg/mL (ng/L) 15 – 5000 <15 – 50# Peptide / BNP # Represents the 0 to 95% range of results. Total Beta-Human IU/L 5.0 – 2000.0 <5.0 Chorionic Gonadotropin...
Page 396 CARTRIDGE CONFIGURATIONS AND SAMPLE VOLUME (65µL) (95µL) (95µL) Sodium (Na) Sodium (Na) Sodium (Na) Potassium (K) Potassium (K) Potassium (K) Chloride (Cl) Ionized Calcium (iCa) Ionized Calcium (iCa) Hematocrit (Hct) Glucose (Glu) PCO 2 Hematocrit (Hct) Urea Nitrogen (BUN)/Urea PCO 2 Glucose (Glu) PO 2 PCO 2...
Page 397 System controls and calibration verification materials 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...
Page 398 The i-STAT reference range for whole blood listed above is similar to reference ranges derived from serum or plasma measurements with standard laboratory methods. The reference range programmed into the analyzer and shown above is intended to be used as a guide for the interpretation of results.
Page 399 Slope 1.00 0.98 0.95 Int’t -0.11 3.57 5.26 Sy.x 1.17 1.04 1.53 Xmin Xmax 0.865 0.937 0.838 Cartridge Comparison The performance characteristics of the sensors are equivalent in all cartridge configurations. System difference analysis was performed on 40 patient samples using the i-STAT 6+ and i-STAT EC4+ cartridges.
Page 400 Note: 1) Bromide has been tested at two levels: the CLSI recommended level and a therapeutic plasma concentration level of 2.5 mmol/L. The latter is the peak plasma concentration associated with halothane anesthesia, in which bromide is released. APOC has not identified a therapeutic condition that would lead to levels consistent with the CLSI recommended level.
Page 401 James C. Boyd, and David E. Bruns. Falsely increased chloride and missed anion gap elevation during treatment with sodium thiosulfate. Clinica Chimica Acta 2014; 431: 77–79. 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 USA. CX 3 is a registered trademark of Beckman Coulter Incorporated, Fullerton CA USA.
Page 403 System controls and calibration verification materials 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...
Page 404 The i-STAT reference range for whole blood listed above is similar to reference ranges derived from serum or plasma measurements with standard laboratory methods. The reference range programmed into the analyzer and shown above is intended to be used as a guide for the interpretation of results.
Page 405 Method Comparison (mmol/L or mEq/L) Beckman Nova Synchron Kodak STAT Ektachem™ 700 Profile ® ® 0.060 0.031 0.065 0.055 0.059 0.055 Slope 0.97 1.06 0.99 Int't 0.02 -0.15 -0.01 Sy.x 0.076 0.060 0.112 Xmin Xmax 0.978 0.993 0.948 Cartridge Comparison The performance characteristics of the sensors are equivalent in all cartridge configurations.
Page 406 anesthesia, in 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 increased i-STAT potassium results and the rate of potassium star (***) outs, while a therapeutic range of bromide (2.5 mmol/L) did not significantly interfere with i-STAT potassium results.
Page 407 Clinica Chimica Acta 2014; 431: 77–79. 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 USA. CX 3 is a registered trademark of Beckman Coulter Incorporated, Fullerton, CA USA. Ektachem was a trademark of Kodak Clinical Diagnostics.
Page 409 System controls and calibration verification materials 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...
Page 410 The i-STAT reference range for whole blood listed above is similar to reference ranges derived from serum or plasma measurements with standard laboratory methods. The reference range programmed into the analyzer and shown above is intended to be used as a guide for the interpretation of results.
Page 411 Method Comparison (mmol/L or mEq/L) Beckman Synchron CX Kodak Ektachem 700 Nova STAT Profile ® ® 1.27 0.41 0.89 0.88 0.90 0.88 Slope 0.99 0.88 0.93 Int’t -0.82 14.6 Sy.x 1.65 1.84 2.33 Xmin Xmax 0.817 0.914 0.752 Factors Affecting Results* 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.
Page 412 Notes: 1) Acetylcysteine has been tested at two levels: the CLSI recommended level and a concentration of 0.30 mmol/L. The latter is 3 times the peak plasma therapeutic concentration associated with treatment to reverse acetaminophen poisoning. APOC has not identified a therapeutic condition that would lead to levels consistent with the CLSI recommended level.
Page 413 James C. Boyd, and David E. Bruns. Falsely increased chloride and missed anion gap elevation during treatment with sodium thiosulfate. Clinica Chimica Acta 2014; 431: 77–79. 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 USA. CX 3 is a registered trademark of Beckman Coulter Incorporated, Fullerton CA USA.
Page 414 100 and 200 Abbott Park Road Abbott Park, IL 60064 • USA Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands ©2016 Abbott Point of Care Inc. All rights reserved. Printed in USA. CL - 6 Rev. Date: 15-Jul-16 Art: 714175-01O...
Page 415 SRM909. i-STAT System controls and calibration verification materials 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...
Page 416 To convert a BUN result in mg/dL to a urea result in mmol/L, multiply the BUN result by 0.357. To convert a urea result in mmol/L to a urea result in mg/dL, multiply the mmol/L result by 6. To convert a urea result in mg/dL to a urea result in g/L, divide the mg/dL result by 100.
Page 417 Method Comparison (mg/dL) Beckman Coulter Dade Dimension Beckman Coulter LX20 RxL-Xpand ® ® ® 0.36 0.48 0.39 0.67 0.34 0.60 Slope 1.03 1.05 1.00 Int’t 1.39 -0.28 -0.38 Sy.x 0.99 0.31 0.85 Xmin Xmax 0.997 0.998 0.997 Cartridge Comparison The performance characteristics of the sensors are equivalent in all cartridge configurations. System difference analysis was performed on 40 patient samples using the i-STAT 6+ and i-STAT EC8+ cartridges.
Page 418 Thiocyanate Notes: Bromide has been tested at two levels: the CLSI recommended level and a therapeutic plasma concentration of 2.5 mmol/L. The latter is the peak plasma concentration associated with halothane anesthesia, in which bromide is released. APOC has not identified a therapeutic condition that would lead to levels consistent with the CLSI recommended level.
Page 419 Clinica Chimica Acta 2014; 431: 77–79. 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 USA. LX20 and CX9 are registered trademarks of Beckman Coulter Incorporated, Fullerton, CA USA. Dimension RxL- Xpand is a registered trademark of Dade Behring Inc., Deerfield, IL USA.
Page 420 100 and 200 Abbott Park Road Abbott Park, IL 60064 • USA Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands ©2016 Abbott Point of Care Inc. All rights reserved. Printed in USA. BUN - 6 Art: 714176-01Q Rev. Date: 15-Jul-16...
Page 421 System controls and calibration verification materials 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. Rev. Date: 15-Jul-16...
Page 422 Expected Values Reportable Reference Test/Abbreviation Units* Range Range Glucose/Glu mg/dL 20 – 700 70 – 105 (fasting) mmol/L 1.1 – 38.9 3.9 – 5.8 0.20 – 7.00 0.70 – 1.05 * The i-STAT System can be configured with the preferred units. To convert a result from mg/dL to mmol/L, multiply the mg/dL value by 0.055.
Page 423 Precision Data (mg/dL) Aqueous Control Mean Level 1 41.8 0.68 Level 3 Method Comparison (mg/dL) Beckman Coulter Bayer 860 Dade Dimension LX20 RxL-Xpand 2.21 4.71 0.98 0.69 0.96 0.59 Slope 1.03 0.99 1.01 Int’t -3.39 -1.67 -0.85 Sy.x 0.91 0.70 1.57 Xmin Xmax...
Page 424: Lactate
Dopamine 0.006 Formaldehyde 0.133 β–Hydroxybutyrate Lactate Maltose 13.3 Pyruvate 0.31 Salicylate 4.34 Thiocyanate (therapeutic) Uric Acid Notes: 1) Acetaminophen has been shown to interfere with glucose results in the i-STAT 6+, EC8+, EC4+ and G products, at a concentration prescribed by the CLSI guideline, 1.32 mmol/L, which represents a toxic concentration of acetaminophen.
Page 425 1024. 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 USA. LX20 is a registered trademark of Beckman Coulter Incorporated, Fullerton, CA USA. The Bayer 860 analyzer is manufactured by Bayer Diagnostics, Tarrytown, NY USA.
Page 426 100 and 200 Abbott Park Road Abbott Park, IL 60064 • USA Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands ©2016 Abbott Point of Care Inc. All rights reserved. Printed in USA. Glu - 6 Rev. Date: 15-Jul-16 Art: 714177-01R...
Page 427 Clinical and Laboratory Standards Institute (CLSI) H7-A3 procedure for determining packed cell volume by the microhematocrit method. Further information regarding metrological traceability is available from Abbott Point of Care Inc. Expected Values...
Page 428 To convert a result from %PCV to fraction packed cell volume, divide the %PCV result by 100. For the measurement of hematocrit, the i-STAT System can be customized to agree with methods calibrated by the microhematocrit reference method using either K EDTA or K EDTA anticoagulant.
Page 429 Method Comparison (%PCV) Coulter S Plus Nova STAT Profile Abbott Sysmex SE9500 ® ® Cell-Dyn 4000 0.50 0.46 0.41 0.53 1.09 1.31 0.77 0.76 Slope 0.98 1.06 1.06 1.11 Int’t 1.78 -3.98 -1.42 -4.19 Sy.x 2.03 2.063 1.13 0.98 Xmin Xmax 0.952...
Page 430 Sodium The sample electrolyte concentration is used to correct the measured conductivity prior to reporting hematocrit results. Factors that affect sodium will therefore also affect hematocrit. Bromide Bromide (37.5 mmol/L) is known to result in an increased rate of star (***) outs. Bromide has been tested at two levels: the CLSI recommended level and a therapeutic plasma concentration level of 2.5 mmol/L.
Page 431 Laboratory Methods (St. Louis: The C.V. Mosby Company, 1974). 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 USA. Coulter S Plus is a registered trademark of Beckman Coulter Incorporated, Fullerton, CA USA. Cell-Dyn is a registered trademark of Abbott Laboratories, Abbott Park, IL USA.
Page 432 100 and 200 Abbott Park Road Abbott Park, IL 60064 • USA Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands ©2016 Abbott Point of Care Inc. All rights reserved. Printed in USA. Hct - 6 Art: 714178-01O Rev. Date: 15-Aug-16...
Page 433 SRM956. i-STAT System controls and calibration verification materials 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 Care Inc. Expected Values...
Page 434 *The i-STAT System can be configured with the preferred units. To convert a result from mmol/L to mg/dL, multiply the mmol/L value by 4. To convert mmol/L to mEq/L multiply the mmol/L value by 2. The reference range programmed into the analyzer and shown above is intended to be used as a guide for the interpretation of results.
Page 435 Method Comparison (mmol/L) Radiometer ICA1 Nova STAT Profile 0.009 0.017 0.017 0.017 Slope 0.925 0.960 Int’t 0.113 0.062 Sy.x 0.035 0.029 Xmin 0.46 0.53 Xmax 2.05 2.05 0.982 0.982 Cartridge Comparison The performance characteristics of the sensors are equivalent in all cartridge configurations. System difference analysis was performed on 24 patient samples using i-STAT CHEM8+ and i-STAT CG8+ cartridges.
Page 436 Interference studies were based on CLSI guideline EP7-A2. Test concentrations used were as per the CLSI guideline unless otherwise indicated. When added to a plasma pool, the following substances (at the concentration indicated) were found to interfere with the i-STAT Ionized Calcium assay: Test Concentration Substance Interference...
Page 437 decrease ionized calcium results by approximately 0.03 mmol/L. 5) Nithiodote (sodium thiosulfate) is indicated for the treatment of acute cyanide poisoning. The journal article titled “Falsely increased chloride and missed anion gap elevation during treatment with sodium thiosulfate” indicated that sodium thiosulfate could be used in the treatment of calciphylaxis indicating that “the highest concentration likely to be seen in plasma [is] after infusion of a 12.5 g dose of sodium thiosulfate pentahydrate.
Page 438 Clinica Chimica Acta 2014; 431: 77–79. 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 USA. ICA 1 is a trademark of Radiometer Medical A/S, Copenhagen, Denmark. Stat Profile is a registered trademark of Nova Biomedical, Waltham, MA USA.
Page 439 System controls and calibration verification materials 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...
Page 440 37°C can be ‘corrected’ by entering the patient’s temperature on the chart page of the analyzer. See section 12 ‘Procedure for Cartridge Testing’ in the i-STAT 1 System Manual or section 11 ‘Patient and Control Sample Testing’ in the i-STAT System Manual for details. In this case, blood gas results will be displayed at both 37°C and the patient’s temperature.
Page 441 Method comparison data were collected using CLSI guideline EP9-A. Arterial blood samples were collected from hospital patients in 3 cc blood gas syringes and were analyzed in duplicate on the i-STAT System and the comparative method within 5 minutes of each other. Deming regression analysis was performed on the first replicate of each sample.
Page 442 Chemistry—Second Edition, C.A. Burtis and E.R. Ashwood, eds. (Philadelphia: W.B. Saunders Company, 1994). i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. ABL is a registered trademark of Radiometer Medical A/S, Copenhagen,Denmark. Bayer 845 is manufactured by Bayer Diagnostics, Tarrytown, NY USA.
Page 443 (NIST) standard reference materials SRMs 186-I, 186-II, 185, and 187. i-STAT System controls and calibration verification materials 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 Reportable...
Page 444 37°C can be ‘corrected’ by entering the patient’s temperature on the chart page of the analyzer. See section 12 ‘Procedure for Cartridge Testing’ in the i-STAT 1 System Manual or section 11 ‘Patient and Control Sample Testing’ in the i-STAT System Manual for details. In this case, blood gas results will be displayed at both 37°C and the patient’s temperature.
Page 445 Precision Data Aqueous Control Mean Level 1 7.165 0.005 0.08 Level 3 7.656 0.003 0.04 Method Comparison Radiometer Nova Radiometer IL BGE ICA 1 STAT Profile 5 ABL500 0.005 0.011 0.006 0.004 0.009 0.008 0.008 0.008 Slope 0.974 1.065 1.058 1.0265 Int't 0.196...
Page 446 Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979). i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. BGE is a registered trademark of Instumentation Laboratory, Lexington MA. ICA 1 is a trademark of Radiometer Medical A/S, Copenhagen, Denmark. Stat Profile is a registered trademark of Nova Biomedical, Waltham MA USA.
Page 447 System controls and calibration verification materials 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.
Page 448 Expected Values Reportable Reference Test/Abbreviation Units* Range Range (arterial) (venous) Partial Pressure mmHg 5 – 130 35 – 45 41 – 51 Carbon Dioxide/PCO 0.67 – 17.33 4.67 – 6.00 5.47 – 6.80 Bicarbonate/HCO mmol/L 1.0 – 85.0 22 – 26** 23 –...
Page 449 37°C can be ‘corrected’ by entering the patient’s temperature on the chart page of the analyzer. See section 12 ‘Procedure for Cartridge Testing’ in the i-STAT 1 System Manual or section 11 ‘Patient and Control Sample Testing’ in the i-STAT System Manual for details. In this case, blood gas results will be displayed at both 37°C and the patient’s temperature.
Page 450 Method Comparison (mmHg) IL BGE Radiometer ABL500 0.69 0.74 1.24 0.53 Slope 1.003 1.016 Int’t -0.8 Sy.x 1.65 0.32 Xmin 30.4 Xmax 99.0 0.989 0.999 Factors Affecting Results* to escape which causes PCO Exposing the sample to air allows CO to decrease and pH to increase and HCO and TCO...
Page 451 7. The Merck Index, Eleventh Edition, Merck & Co., Inc., NJ 1989. i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. Diprivan is a registered trademark of the AstraZeneca group of companies. Pentothal Sodium is a registered trademark of Abbott Labs., USA. Nesdonal Sodium is a registered trademark of Specia, France. Intraval Sodium is a registered trademark of May and Baker, Ltd., England.
Page 452 Abbott Park, IL 60064 • USA Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands Tel: (31)70 345 8570 Fax: (31)70 346 7299 ©2013 Abbott Point of Care Inc. All rights reserved. Printed in USA. PCO2 - 6 Rev. Date: 01-Jul-13 Art: 714182-01R...
Page 453 System controls and calibration verification materials 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...
Page 454 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.
Page 455 Precision Data (mmol/L) Aqueous Control Mean Level 1 17.4 0.62 Level 3 34.6 0.62 Method Comparison (mmol/L) (Calculated) (Measured) (Calculated) Beckman Coulter Beckman Coulter IL BGE ® ® 0.40 0.55 0.48 0.84 0.55 0.60 Slope 1.136 1.155 1.152 Int’t -4.1 -2.6 -1.5 Sy.x...
Page 456 7. M.G. Scott, J. Heusel, V.A. LeGrys, and O. Siggard-Andersen, Electrolytes and Blood Gases, in Tietz Textbook of Clinical Chemistry, Third Edition, ed. C.A. Burtis and E.R. Ashwood. (Philadelphia: W.B. Saunders Company, 1999). i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. ® ®...
Page 457 CREATININE/CREA Creatinine is measured amperometrically. Creatinine is hydrolyzed to creatine in a reaction catalyzed by the enzyme creatinine amidohydrolase. Creatine is then hydrolyzed to sarcosine in a reaction catalyzed by the enzyme creatine amidinohydrolase. The oxidation of sarcosine, catalyzed by the enzyme sarcosine oxidase, produces hydrogen peroxide (H ).
Page 458 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.
Page 459 *The usual warning relating to the use of regression analysis is summarized here as a reminder. For any analyte, “if the data are collected over a narrow range, the estimate of the regression parameters is relatively imprecise and may be biased. Therefore, predictions made from these estimates may be invalid.”...
Page 460 The following substances are known not to significantly interfere with the i‑STAT Creatinine assay at the stated test concentrations: Test Concentration Substance (mmol/L) Acetaldehyde 0.045 Acetaminophen (therapeutic) 0.132 Acetylcysteine (therapeutic) 10,11 Bicarbonate 35.0 Bilirubin 0.342 Calcium Chloride Dopamine 0.006 Formaldehyde 0.133 β–Hydroxybutyrate Lactate...
Page 461 5) Bromide has been tested at two levels: the CLSI recommended level and a therapeutic plasma concentration level of 2.5 mmol/L. The latter is the peak plasma concentration associated with halothane anesthesia, in which bromide is released. APOC has not identified a therapeutic condition that would lead to levels consistent with the CLSI recommended level.
Page 462 Clinica Chimica Acta 2014; 431: 77–79. 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 USA. Vitros is a registered trademark of Ortho-Clinical Diagnostics, Rochester, NY. Droxia and Hydrea are registered trademarks of Bristol-Myers Squibb Company, Princeton, NJ.
Page 463 LACTATE/LAC Lactate is measured amperometrically. The enzyme lactate oxidase, immobilized in the lactate biosensor, selectively converts lactate to pyruvate and hydrogen peroxide (H ). The liberated hydrogen peroxide is oxidized at a platinum electrode to produce a current which is proportional to the sample lactate concentration.
Page 464 Fluka, >99 % purity). i-STAT System controls and calibration verification materials 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...
Page 465 Precision Data Aqueous Control Mean (mmol/L) Level 1 6.35 0.08 1.21 Level 3 0.81 0.03 3.27 Method Comparison Radiometer ABL 725 Hitachi 917 (mmol/L) (whole blood vs. (i-STAT whole blood vs. whole blood) Hitachi plasma) 0.123 0.084 0.136 0.079 Slope 1.02 1.06 Int't...
Page 466 Notes: 1) Hydroxyurea is a DNA synthesis inhibitor used in the treatment of various forms of cancer, sickle cell anemia, and HIV infection. This drug is used to 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.
Page 467 References D.S. Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington, DC: American Association of Clinical Chemistry, 1990). D.B. Sacks, Carbohydrates, in Tietz Textbook of Clinical Chemistry, Second Edition, ed. C.A. Burtis and E.R. Ashwood, (Philadelphia: W.B. Saunders Company, 1994). Jones AE, Puskarich MA.
Page 468 Clin Chem 2000; 46:874-875. 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 USA. ABL is a registered trademark of Radiometer Medical A/S, Copenhagen, Denmark. Droxia and Hydrea are registered trademarks of Bristol-Myers Squibb Company, Princeton, NJ.
Page 469: Celite Act
CELITE ACTIVATED CLOTTING TIME/ ACT) CELITE The i-STAT Celite Activated Clotting Time test, ACT, is a measure of the time required for complete ® ® Celite activation of the coagulation cascade. In traditional ACT tests, coagulation is initiated by mixing a whole blood sample with a particulate activator, and complete activation is indicated when extensive or localized clots form as activated thrombin converts fibrinogen to fibrin.
Page 470 System and comparative methods. All data use the PREWRM calibration, unless otherwise noted. Precision data were collected at Abbott Point of Care Inc. and during clinical trials following a protocol recommended by i-STAT and using plasma control material. Similar results can be expected in future performance studies provided the same experimental design and data analysis procedures are followed.
Page 471 Method comparison data were collected using a modification of the CLSI guideline EP9-A. Venous or arterial blood samples were collected in plastic syringes and analyzed in duplicate on the i-STAT System and in duplicate using the comparative methods. All samples were analyzed immediately upon collection. The patient populations in the studies were those in which ACT is routinely used.
Page 472 Factors Affecting Results* *It is possible that other interfering substances may be encountered. These results are representative and your 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.
Page 473 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. Celite ACT - 5 Rev. Date: 01-Jul-13 Art: 714185-01P...
Page 474 Performance of the i-STAT Celite ACT at lower levels of heparin is shown below with two “Low Range” ACT methods included for comparison: Medtronic LR-ACT, s Test Limitations The i-STAT ACT test is to be used with fresh venous or arterial whole blood samples. The presence Celite of exogenously added heparin, citrate, oxalate, or EDTA will interfere with test results.
Page 475 The analyzer should remain 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.
Page 476 J.B. Lippinncott Company, Philadelphia, 1988, pp 70-71. i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. Celite is a registered trademark of Celite Corporation, Santa Barbara, CA, for its diatomaceous earth products. Hemochron is a registered trademark of International Technidyne Corporation, Edison, NJ Abbott Point of Care Inc.
Page 477: Kaolin Act
® ® 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 Hemochron Celite ACT using non-prewarmed (ambient temperature) tubes. This customization affects the Patient path only, and will not be applied to the Control or the Proficiency Testing pathway.
Page 478 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...
Page 479 Method comparison data were collected using a modification of the CLSI guideline EP9-A. Venous or arterial blood samples were collected in plastic syringes and analyzed in duplicate on the i-STAT System and in duplicate using the comparative methods. All samples were analyzed immediately upon collection. The patient populations in the studies were those in which ACT is routinely used and included both aprotinin and non-aprotinin receiving patients.
Page 480 Kaolin ACT - 4 Art: 715878-01M Rev. Date: 01-Jul-13...
Page 481 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. Kaolin ACT - 5 Rev. Date: 01-Jul-13 Art: 715878-01M...
Page 482 Test Limitations The i-STAT ACT test is to be used with fresh venous or arterial whole blood samples. The presence Kaolin of exogenously added heparin, citrate, oxalate, or EDTA will interfere with test results. 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.
Page 483 J.B. Lippinncott Company, Philadelphia, 1988, pp 70-71. i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. Celite is a registered trademark of Celite Corporation, Santa Barbara, CA, for its diatomaceous earth products. Hemochron is a registered trademark of International Technidyne Corporation, Edison, NJ.
Page 484 Abbott Park, IL 60064 • USA Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands Tel: (31)70 345 8570 Fax: (31)70 346 7299 ©2013 Abbott Point of Care Inc. All rights reserved. Printed in USA. Kaolin ACT - 8 Rev. Date: 01-Jul-13 Art: 715878-01M...
Page 485: Prothrombin Time Pt/Inr
PROTHROMBIN TIME/ (PT/INR) The i-STAT PT/INR test is a whole blood determination of the prothrombin time used for monitoring oral ® anticoagulant (Coumadin or warfarin) therapy. The test determines the time required for complete activation of the extrinsic pathway of the coagulation cascade when initiated (activated) with a thromboplastin. In a prothrombin time test, coagulation is initiated by mixing the sample with tissue thromboplastin.
Page 486 Preparation recommended by the WHO. 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...
Page 487 The below imprecision data for lyophilized plasma control material were collected during studies at an Abbott Point of Care facility and during clinical trials. SD and %CV are typical of current performance. Current Value Assignment Sheets should be referenced for applicable plasma control mean data.
Page 488 Siemens System Siemens Sysmex CA 1500 PT (INR) CA 1500 PT (INR) ® ® STA Compact PT (INR) ® PT/INR - 4 Art: 715236-01M Rev. Date: 01-Jul-13...
Page 489 IL ACL 7000 PT (INR) Data is presented below from one clinical site comparing data from capillary samples to data from venous samples analyzed on the i-STAT System. Statistic Capillary vs. Venous Mean (INR) Range (INR) 1.3 – 5.4 Sx (INR) 0.960 Slope 1.049...
Page 490 PT/INR results may be affected by commonly administered drugs. • Abbott Point of Care has not characterized the i-STAT PT/INR test with patients that have lupus anticoagulant antibodies. If the presence of lupus anticoagulant antibodies is known or suspected, consider using a prothrombin time laboratory assay using a reagent that is known to be insensitive to lupus anticoagulant antibodies or an alternate laboratory method.
Page 491 Specimen Collection and Preparation Caution: The i-STAT PT/INR cartridge is designed to accept a sample between 20 and 45 microliters. A single drop of blood from either a finger puncture or as formed at the tip of a syringe will typically be within this range.
Page 492 6. Corriveau, Donna: Fritsma, George (ed.): Hemostasis and Thrombosis in the Clinical Laboratory. Ed, J.B. Lippinncott Company, Philadelphia, 1988, pp 70-71. i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. Dade Innovin, and BCS are registered trademarks of Dade Behring Inc., Deerfield, IL.
Page 493: Cardiac Troponin I
CARDIAC TROPONIN I/ (cTnI) Intended Use The i-STAT cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitative measurement of ® cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Page 494 Ltd., Turku, Finland, catalogue #8T62). i-STAT System controls and calibration verification materials 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.
Page 495 exam) and ECG should be used in conjunction with troponin in the diagnostic evaluation of suspected myocardial infarction. A serial sampling protocol is recommended to facilitate the identification of temporal changes in troponin levels characteristic of MI. 2,3,11 Since cTnI is not unequivocably detectable by commercial assays in samples from healthy persons, measurements beyond the upper limit of the reference range have a significant probability of being associated with ischemia or necrosis;...
Page 496 Method Comparison (ng/mL) Dade Behring Stratus ® 0.28 0.31 Slope 0.883 Int’t 0.029 Sy.x 1.40 Xmin 0.00 Xmax 46.27 0.975 Analytical and Functional Sensitivities The analytical sensitivity of the cTnI method is 0.02 ng/mL, which is the lowest cTnI level that can be distinguished from zero.
Page 497 Analytical Specificity The cTnI method is specific for cardiac troponin I. The following muscle proteins were tested and found to have an insignificant effect on the measured cTnI. Crossreactant Concentration Percent Crossreactivity Troponin C (cardiac) 1000 ng/mL <0.002% Troponin T (cardiac) 1000 ng/mL 0.65% Troponin I (skeletal)
Page 498 Samples from patients who have been exposed to animals or who have received therapeutic or diagnostic procedures employing immunoglobulins or reagents derived from immunoglobulins may contain antibodies, e.g., HAMA or other heterophile antibodies, which may interfere with immunoassays and produce erroneous results.
Page 499 Interference Testing The following substances were found to have no significant effect (less than 10%) on the cTnI method, when added to a plasma pool containing approximately 2 ng/mL of cardiac troponin I, at the concentrations indicated: Test Level Compound (μmol/L unless otherwise indicated) Acetaminophen 1660...
Page 500 References 1. Braunwald, E, et al. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients with Unstable Angina). 2002. Available at: http:// content.onlinejacc.org/article.aspx?articleid=1130417.
Page 501 23. Nahm et al. Heteroantibody: phantom of the immunoassay. Clin. Chem. 1990; 36:829. 24. Boscato et al. Heterophilic antibodies: a problem for all immunoassays. Clin. Chem. 1988; 34:27. i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. cTnI - 9 Rev.
Page 502 Abbott Park, IL 60064 • USA Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands Tel: (31)70 345 8570 Fax: (31)70 346 7299 ©2013 Abbott Point of Care Inc. All rights reserved. Printed in USA. cTnI - 10 Rev. Date: 01-Jul-13 Art: 715595-01R...
Page 503: Creatine Kinase Mb / Ck-Mb
CREATINE KINASE MB/ (CK-MB) Intended Use The i-STAT CK-MB test is an in vitro diagnostic test for the quantitative measurement of creatine kinase ® MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).
Page 504 System and assigned values may not be commutable with other methods. Further information regarding metrological traceability is available from Abbott Point of Care Inc. Reportable Range The i-STAT CK-MB test will report 0.0 to 150.0 ng/mL (µg/L). Samples above the reportable range will yield “>150.0 ng/mL”...
Page 505 The European Society of Cardiology / American College of Cardiology consensus document notes that in the clinical setting of a reinfarction, CK-MB may be more useful for monitoring for MI than cardiac troponin I (cTnI) or cardiac troponin T (cTnT) because CK-MB remains increased for only 2-4 days following an MI, in contrast to up to 5 days for cTnI or 10 days for cTnT.
Page 506 The analytical sensitivity was estimated using a control material with <1 ng/mL CK-MB during a 20-day precision study in which three separate lots of CK-MB test cartridges were tested in duplicate using a pool of six i-STAT 1 analyzers for a total of 120 test results. Analytical Specificity The CK-MB method is specific for the creatine kinase MB isoenzyme.
Page 507 Whole Blood Sample Concentration Diluted Concentration % Recovery (ng/mL) (ng/mL) 73.24 40.73 108.7% 8.90 6.07 101.5% 47.74 26.91 109.3% Plasma Sample Concentration Diluted Concentration % Recovery (ng/mL) (ng/mL) 73.24 — — 8.90 — — 47.74 — — — 42.17 102.7% —...
Page 508 Interference Testing When added to a plasma pool containing approximately 20 ng/mL of creatine kinase MB isoenzyme, the following substances were found to have no significant effect (less than 10%) on the CK-MB method at the concentrations indicated Test Level Compound (μmol/L unless otherwise indicated) Acetaminophen...
Page 509 18. Nahm et al. Heteroantibody: phantom of the immunoassay. Clin. Chem. 1990; 36:829. 19. Boscato et al. Heterphilic antibodies: a problem for all immunoassays. Clin Chem. 1988; 34:27. i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. CK-MB - 7 Rev.
Page 510 Abbott Park, IL 60064 • USA Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands Tel: (31)70 345 8570 Fax: (31)70 346 7299 ©2013 Abbott Point of Care Inc. All rights reserved. Printed in USA. CK-MB - 8 Rev. Date: 01-Jul-13 Art: 716675-01L...
Page 511: B-Type Natriuretic Peptide/Bnp
B-TYPE NATRIURETIC PEPTIDE/ (BNP) Intended Use The i-STAT BNP test is an in vitro diagnostic test for the quantitative measurement of B-type natriuretic ® peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
Page 512 Metrological Traceability The i-STAT System test for B-type natriuretic peptide (BNP) measures BNP amount-of-substance concentration in plasma or the plasma fraction of EDTA anticoagulated whole blood (units of measure: pg/mL or ng/L) for in vitro diagnostic use. BNP values assigned to i-STAT’s controls and calibration verification materials are traceable to i-STAT’s working calibrator prepared from synthetic BNP (Peptide International, Louisville, KY, Cat# 4212v).
Page 513 included the use of natriuretic peptide (e.g., BNP) testing along with electrocardiography and chest x-rays in their guidelines for the diagnosis or rule out of HF. The Breathing Not Properly study, a 1586 patient multinational prospective study, validated the clinical utility of rapid measurement of BNP, used in conjunction with other clinical information, for the diagnosis or exclusion of CHF in the emergency department .
Page 514 EXPECTED VALUES Non-heart Failure Population Plasma samples from 890 individuals (465 females, 425 males) who had not been diagnosed with heart failure were tested with the AxSYM BNP assay. This population included non-hospitalized patients with ® renal disease (not on dialysis), diabetes, hypertension and chronic obstructive pulmonary disease. BNP levels for the patients with renal disease, diabetes, hypertension and chronic obstructive pulmonary disease were not statistically different from the population of apparently healthy individuals.
Page 515 Non-Heart Failure Population - Females (Age Group) <45 45-54 55-64 65-74 Years Years Years Years Years Sample Size (N=) Median (pg/mL) Mean (pg/mL) SD (pg/mL) 95th Percentile Percentage < 100 pg/mL 88.4% 95.9% 90.7% 89.6% 85.7% 80.5% Minimum (pg/mL) Maximum (pg/mL) * Representative data, results in individual laboratories may vary from these data.
Page 516 Heart Failure Population - Males NYHA Functional Class Sample Size (N=) 1645 Median (pg/mL) 1646 Mean (pg/mL) 1032 SD (pg/mL) 5th Percentile 1976 1281 1356 2288 3654 95th Percentile 71.0% 56.4% 70.7% 76.0% 96.9% Percentage ≥ 100 pg/mL Minimum (pg/mL) >4000 1408 3782...
Page 517 A box and whiskers plot of the clinical study population, broken down by NYHA classification, is presented in the following graph. The dashed line represents 100 pg/mL, the suggested decision threshold for the AxSYM BNP assay. In support of previous literature reports, these data show a progressive increase in BNP concentrations with increases in NYHA classifications.
Page 518 The i-STAT BNP Calibrators are traceable to an internal reference standard that has been prepared gravimetrically with synthetic BNP. The internal reference standard underwent a one-time value assignment to align with the ARCHITECT BNP assay with a decision threshold of 100 pg/mL. An age-matched analysis of the heart failure and non-heart failure populations was performed based on the data published by the American Heart Association in the 2000 Heart and Stroke Statistical Update according to the age structure of the United States population.
Page 519 As a guide, the range of data can be considered adequate if r>0.975. Precision Data (pg/mL) Aqueous Control Mean %CV (within-run) %CV (total) Level 1 11.1 Level 2 1551 Level 3 3337 Method Comparison Abbott ARCHITECT Mean (pg/mL) 482.1 Sxx (pg/mL) 38.1 Syy (pg/mL) 97.6 Slope 0.971 Intercept -14.4 Sy.x 198.0...
Page 520 The limit of blank (commonly termed analytical sensitivity) was estimated at 14 pg/mL by calculating two times the total imprecision determined using a BNP-depleted plasma material (measured to be <5 pg/mL BNP) over a 20-day imprecision study using three separate lots of BNP cartridges and 6 i-STAT 1 analyzers. Analytical Specificity The BNP method is specific for the B-type natriuretic peptide.
Page 521 Plasma Blood Concentration Diluted Concentration % Recovery Sample pg/mL) (pg/mL) — — 2764 — — 5123 — — — 1570 — 3992 101% — 2734 A plasma sample was spiked with BNP to a value of approximately 5000 pg/mL and the concentration was determined by duplicate measurements with i-STAT BNP test cartridges;...
Page 522 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 BNP readings above the reference range, as well as quality check codes.
Page 523 Interference Testing The following substances were found to have no significant effect (less than 10%) on the BNP method, when added to a plasma pool containing approximately 1000 pg/mL of B-type natriuretic peptide at the concentrations indicated: Interference studies were based on CLSI guideline EP7-A. Test Level Compound (μmol/L unless otherwise indicated)
Page 524 References 1. Maisel A, Mehra MR. Understanding B-Type Natriuretic Peptide and Its Role in Diagnosing and Monitoring Congestive Heart Failure, Clin Cornerstone 2005, 7 Suppl 1: S7-17. 2. Senni M, Tribouilloy CM, Rodeheffer RJ, et al. Congestive Heart Failure in the Community. A Study of All Incident Cases in Olmsted County, Minnesota, in 1991.
Page 525 17. Rodeheffer RJ. Measuring Plasma B-Type Natriuretic Peptide in Heart Failure: Good to Go in 2004? J Am Coll Cardiol. 2004 Aug 18; 44(4): 740-9. 18. Doust JA, Petrzak E, Dobson A, Glasziou P. How Well Does B-Type Natriuretic Peptide Predict Death and Cardiac Events in Patients With Heart Failure: Systematic Review.
Page 526 Approved Guideline. CLSI document EP7-A [ISBN 1-56238-480-5]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2002. i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. Abbott Point of Care Inc. Abbott Park, IL 60064 • USA...
Page 527: Total Beta-Human Chorionic Gonadotropin (Β-Hcg)
TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (β-hCG) Intended Use The i-STAT Total Beta-Human Chorionic Gonadotropin (β-hCG) assay is an in vitro diagnostic test for the ® quantitative and qualitative determination of beta-human chorionic gonadotropin in whole blood or plasma samples. β-hCG can be used for the detection of early pregnancy. Method Explanation The i-STAT β-hCG test cartridge uses a two-site enzyme-linked immunosorbant assay (ELISA) method.
Page 528 (dimension IU/L) for in vitro diagnostic use. β-hCG values assigned to Abbott Point of Care’s controls and calibration verification materials are traceable to Abbott Point of Care’s working calibrators that are traceable to the World Health Organization’s 5 International Standard (07/364), prepared from pooled plasma and hCG antigen obtained from 3 party sources.
Page 529 then decrease and plateau. β-hCG circulates as the intact molecule in the serum of women who have an uncomplicated pregnancy. The subunits are cleaved rapidly and cleared by the kidneys. With the availability of sensitive quantitative assays for the measurement of β-hCG, it has been shown that hCG levels can be useful in prediction of spontaneous abortions, aiding in the detection of ectopic pregnancy...
Page 530 Method Comparison: i-STAT vs Abbott Architect (IU/L) i-STAT (Whole Blood) vs i-STAT (Fresh Plasma) vs Architect (Fresh Plasma) Architect (Fresh Plasma) Slope 1.01 1.00 Intercept 2.40 -3.21 Sy.x 0.0084 0.0044 5.7% 4.0% 2.4% 0.990 0.997 Xmin Xmax 2024.8 1983.6 Analytical Specificity The β-hCG method is specific for the beta subunit (free and intact) of human chorionic gonadotropin.
Page 531 Whole blood Concentration Diluted Concentration Sample % Recovery (IU/L) IU/L 104.1 52.9 101.8% 288.9 132.0 91.4% 899.8 467.2 103.8% Plasma Concentration Diluted Concentration Sample % Recovery (IU/L) IU/L 88.8 298.0 971.6 203.4 105.2% 655.3 103.2% 532.2 100.4% Test Limitations This assay is capable of detecting whole molecule (intact) hCG as well as free β-hCG subunits. The i-STAT Total β-hCG assay is intended for use in the early detection of pregnancy only and should not be performed for any other purpose.
Page 532 7500 feet (2286 meters) above sea level. Where unavailability of results is unacceptable, Abbott Point of Care recommends having an alternate test method available. Prior to filling the i-STAT β-hCG cartridge, invert the blood collection tube and inspect for red cell sedimentation.
Page 533 Interference Testing Interference studies were based on CLSI guideline EP7-A2. The following substances were found to have no significant effect (less than 10%) on the β-hCG method when added to a plasma pool containing approximately IU/L of β-hCG at the concentrations indicated: Compound Test Level (µmol/L unless otherwise indicated) Acetyl Salicylic Acid...
Page 534 References 1. Braunstein GD, Vaitukaitis JL, Carbone PP, Ross GT. Ectopic Production of Human Chorionic Gonadotropin by Neoplasms. Ann Intern Med 1973; 78:39-45. 2. Tietz NW, Clinical Guide to Laboratory Tests, 4th Ed. 2006. p. 2160-2161. 3. Lenton EA, Neal LM, Sulaiman R. Plasma Concentrations of Human Chorionic Gonadotropin from the Time of Implantation until the Second Week of Pregnancy.
Page 535 29. N.R. vand den Brock et al. Pregnancy and the erythrocyte sedimentation rate. British Journal of Obstetrics and Gynaecology November 2001; 108: 1164-1167. 30. Hamilton GM. The Erythrocyte Sedimentation Rate in Pregnancy. BJOG: An International Journal of Obstetrics and Gynaecology June 1953; 60: 409-415. i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. β-hCG Rev. Date: 24-Jan-17 Art: 730474-01D...
Page 536 Abbott Point of Care Inc. 100 and 200 Abbott Park Road Abbott Park, IL 60064 • USA Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands ©2017 Abbott Point of Care Inc. All rights reserved. Printed in USA. β-hCG - 10 Art: 730474-01D Rev. Date: 24-Jan-17...
Page 537: Gonadotropin (Β-Hcg) Cartridge
Values for hCG generally peak during the first trimester and decline slowly throughout the remainder of the pregnancy. Abbott Point of Care Inc. • 100 & 200 Abbott Park Road • Abbott Park, IL 60064 • USA Rev. Date: 14-Mar-16 Art: 730475-01F...
Page 538 E. Sample Volume Requirement The i-STAT Total β-hCG cartridge requires a minimum sample volume of 17 µL to fill. Excess amounts beyond this requirement will not impair the results. However, excess blood or plasma will be present at the inlet of the cartridge and caution should be observed in handling the cartridge to minimize biohazard exposure.
Page 539 • Detection of very low levels of hCG does not rule out pregnancy. Low levels of hCG can occur in apparently healthy, nonpregnant subjects. Because hCG 11,12 values double approximately every 48 hours in a normal pregnancy, patients with very low levels of hCG should be resampled and retested after 48 hours. •...
Page 540 From each lot of cartridges received, use a representative number of cartridges to analyze multiple levels of i-STAT Total b-hCG Controls for use on the i-STAT System using any verified i-STAT 1 handheld.* These controls should also be used to verify cartridge performance when storage conditions are in question.
Page 541 Tightly recap the control vial and store it at 2-8 °C (35-46 °F). 4. Seal the cartridge and immediately insert it into the i-STAT 1 handheld. E. Target Value and Ranges Target values (determined by testing multiple vials of each level using multiple...
Page 542 E. Target Value and Ranges Target values (determined by testing multiple vials of each level using multiple lots of cartridges and i-STAT 1 handhelds that pass the Electronic Simulator test) are printed on a Value Assignment Sheet posted on the APOC website at www.abbottpointofcare.com.
Page 543 Target values are specific to the i-STAT System. Results may differ if used with other methods. Always remember to analyze the Calibration Verification material in the Cal Ver pathway under the Quality Tests option of the i-STAT 1 Handheld Administration Menu. Customizing the Handheld to Display a Qualitative β-hCG Result The default setting on the handheld displays a quantitative β-hCG value as well as a...
Page 544 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 this i-STAT 1 handheld is assigned. Art: 730475-01F Rev. Date: 14-Mar-16...
Page 545 4. If the location to which this handheld is assigned has a check mark under the Use Default Profile column, double click on the alphanumeric code under Preferences in the Default Customization Profile column. Otherwise, double click on the alphanumeric code under Preferences for the specific location to which this handheld is assigned.
Page 546 Enter the DE i-STAT 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. Art: 730475-01F Rev. Date: 14-Mar-16...
Page 547 3. If the location to which 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 the Preferences column for the specific location to which this handheld is assigned.
Page 548 7. Download the handheld(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 7 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 549 References Braunstein GD, Vaitukaitis JL, Carbone PP, Ross GT. Ectopic Production of Human Chorionic Gonadotropin by Neoplasms. Ann Intern Med 1973; 78:39-45. Tietz NW, Clinical Guide to Laboratory Tests, 3rd Ed. 1995. p. 134-136. Cole LA. Background Human Chorionic Gonadotropin in Healthy, Nonpregnant Women.
Page 550 British Journal of Obstetrics and Gynaecology November 2001; 108:1164-1167. 21. Hamilton GM. The Erythrocyte Sedimentation Rate in Pregnancy. BJOG: An International Journal of Obstetrics and Gynaecology June 1953; 60:409-415. i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. Art: 730475-01F Rev. Date: 14-Mar-16...
Page 551: New Ultralife 9-Volt Lithium Battery For Use With The I-Stat System
1. OVERVIEW Ultralife Battery and Energy Products, the manufacturer of the current 9-volt lithium battery (Part No. U9VL-J) sold by Abbott Point of Care (APOC) for use with the i-STAT System is releasing a new 9-volt lithium battery (Part No. U9VL-J-P), which will replace the current U9VL-J battery for shipment to i-STAT customers.
Page 553: Replacing The Nimh Rechargeable Battery In The Martel Printer
REPLACING THE NiMH RECHARGEABLE BATTERY IN THE ® MARTEL PRINTER USED WITH THE i-STAT 1 ANALYZER Prior to starting, assure the printer is disconnected from the AC Power Adapter. Installing the Battery Pack Connector backwards can cause the printer to overheat. Follow the instructions in this Bulletin to prevent damage.
Page 554 Procedure for Ordering a Replacement NiMH Rechargeable Battery To order a replacement NiMH rechargeable battery, call Abbott Customer Service at 1-800-323-9100. The Abbott list number for the NiMH rechargeable battery is 06F21-35.
Page 555: Instructions For Restoring Analyzers That Produce *** For Hematocrit And Quality Check Code 23
i-STAT ® TECHNICAL BULLETIN Instructions For Restoring Analyzers That Produce *** For Hematocrit and Quality Check Code 23 Hematocrit star-out (***) results and Quality Check Code 23 may be reduced by restoring an analyzer with the reusable i-STAT Ceramic Conditioning Cartridge. This technical bulletin contains instructions for this restoration process.
Page 556 Ceramic Conditioning Cartridge Usage Log Ceramic Cartridge Serial Number _______________________ NEW STRIP 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.
Page 557 MAINTAINING THE CERAMIC CONDITIONING CARTRIDGE The Ceramic Conditioning Cartridge consists of an aluminum base that supports a ceramic “strip.” The strip is a white strip of Alumina that is held down by a brass retainer and retainer screw. The ceramic cartridge may be used up to 50 times before the strip is worn and needs to be rotated or up to 200 times before the strip must be replaced as described below.
Page 558 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. Art: 714962-01D Rev. Date: 10-Jun-11...
Page 559: Hematocrit Determination In The I-Stat System
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.
Page 560 Conductivity Methods Systems using the conductivity method, such as the i-STAT System, measure the electrical conductance of a whole blood sample. Plasma conducts electrical current, and blood cells act as insulators. A sample with a relatively high hematocrit has, by definition, a larger proportion of its volume filled by the non-conductive red blood cells.
Page 561 System see the Theory section of the i-STAT or i-STAT 1 System Manual. It is also important to be aware that the total protein level in premature neonates can be in the range of 3.6 g/dL to 6.0 g/dL (36 g/L to 60 g/L).
Page 562 White Blood Cells Interference from white blood cells depends upon the size of the cell. As an example, the hematocrit reading will be increased by 1 %PCV when the white cell count is 50,000 per microliter, assuming the average white blood cell occupies twice the volume of an average red blood cell.
Page 563 BIBLIOGRAPHY Standards for Microhematocrit Determination CLSI. Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard - Third Edition. CLSI document H7-A3 [ISBN 1-56238-413-9]. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2000. Effect of K EDTA on Cell Size Sears D, Charache S, Perlstein M: Electronic blood cell counters: Faulty calibration due to type and amount of anticoagulant in collection tubes.
Page 564 Strauchen J, Alston W, Anderson J, Gustafson Z, Fajardo L: Inaccuracy in automated measure- ment of hematocrit and corpuscular indices in the presence of severe hyperglycemia. Blood 57:1065-1067, 1981. Morse EE, Kalache G, Germino W, Stockwell R: Increased electronic mean corpuscular volume induced by marked hyperglycemia.
Page 565 282 Co-Oximeter as Compared with a Manual Spectrophotometric Five-Wavelength Method. Clin Chem 27(11):1903-1907, 1981. Locke R, Francke K, Nötzil B. The whole blood sampling handbook. Brønshøj: Radiometer Medi- cal A/S 2000. i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. Art: 714261-01D Rev. Date: 10-Jan-11...
Page 566 Art: 714261-01D Rev. Date: 10-Jan-11...
Page 567 (MH-K EDTA or MH-K EDTA). (Note: The default setting on the i-STAT System is K EDTA.) Abbott Point of Care Inc. • 100 & 200 Abbott Park Road • Abbott Park, IL 60064 • USA Art: 716240-01D Rev. Date: 26-Feb-16...
Page 568 If the calibration of a comparative method is uncertain, determine the customization setting by minimizing the average bias between methods as follows: • Check that the results from hematocrit controls for both i-STAT and comparative methods are acceptable. • If i-STAT hematocrit results obtained using the “K EDTA”...
Page 569 EDTA Tubes for CBC, WBC Differential Count and Reticulocyte Count. (Technical Literature). Becton, Dickenson and Company, 2003. i-STAT is a registered trademark of the Abbott Group of Companies in Various Jurisdictions. Advia is a registered trademark of Siemens Healthcare Diagnostics, Tarrytown, NY Cell-Dyn is a registered trademark of Abbott Laboratories, Abbott Park, IL Coulter is a registered trademark of Beckman Coulter, Inc., Fullerton, CA...
Page 570 Art: 716240-01D Rev. Date: 26-Feb-16...
Page 571 i-STAT ® Technical BulleTin ACT Test Result Calibration Options: PREWARMED vs. NON-PREWARMED Result Calibration Modes for the i-STAT 1 Analyzer ® BACKGROUND The Activated Clotting Time (ACT) test has been in existence for over 30 years. It is the most popular test for measuring the effect of heparin administered during an interventional procedure. By placing an activator in the test chamber, the blood sample is “activated” to promote clotting. When heparin is present in the sample, the clotting is delayed in proportion to the amount of “anticlotting” effect of the heparin.
Page 572 i-STAT ACT CALIBRATION Currently, the i-STAT Celite ACT and i-STAT Kaolin ACT tests are factory calibrated by mathematically ® ® ® adjusting the raw i-STAT “clot time” to match the Hemochron Celite tube result. This calibration is ® performed by testing cartridges and Hemochron Celite tubes side by side, using a range of heparinized, non-hemodiluted whole blood samples, and using Hemochron tubes prewarmed to 37ºC.
Page 573 REPRESENTATIVE DATA Effect of Sample Tube Temperature on Hemochron ACT Results using Paired Samples: Prewarmed sample tubes vs. Non-prewarmed sample tubes. Art: 715617-01C Rev. Date: 08/23/06...
Page 574 i-STAT Celite ACT vs. Room Temperature Hemochron FTCA510: Prewarmed (PREWRM) vs. Non- prewarmed (NONWRM) calibration modes. Art: 715617-01C Rev. Date: 08/23/06...
Page 575 ANALyzER DISPLAy AND CDS CHANGES Due to the new ACT result calibration option, there are several changes to the analyzer display as well as to the Central Data Station (CDS). Major changes are noted below: • 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 used to perform the ACT calculations.
Page 576 • The i-STAT 1 analyzer is capable of offering both the NONWRM and PREWRM ACT customization settings. These customizations can be viewed, selected and changed via the RESULTS CUSTOMIZATION section on the i-STAT 1 analyzer Results Results Customization Customization Change Change Customization Customization Decimal Separator ACT-K (.) Period PREWRM ACT-C...
Page 577 LIMITATIONS AND WARNINGS • The NONWRM calibration mode applies to the Patient Path only, and will not be applied to the Control or Proficiency Testing pathway. Control or Proficiency samples run in the Patient Pathway may produce erroneous results. • Different locations within a given hospital may utilize different calibration modes/customization profiles. Prior to testing patient samples, ensure the appropriate calibration mode is employed.
Page 578 Art: 715617-01C Rev. Date: 08/23/06...
Page 579: Support Services
Cairo, Egypt Accra, Ghana Burkina Faso Tel.No.: 201111117828 Tel.No.: +233 2670 891 94 Tel. No.: +226 70193555 Abbott Point of Care Inc. • 100 & 200 Abbott Park Road • Abbott Park, IL 60064 • USA Art: 716144-01AD Rev. Date: 16-Jan-17...
Page 580 Randburg, South Africa 2188 Tel. No.: +263778401114 Tel.No.: +27 87 3535600 ASIA/PACIFIC (EXCLUDING CHINA) AUSTRALIA BRUNEI HONG KONG Abbott Australia Transmedic Pte Ltd. Bio-Asia Diagnostics Company Ltd. 299 Lane Cove Road 5, Jalan Kilang Barat Unit 1-3, 20F Macquarie Park...
Page 581 Tel: 7-7112-500-480 Tel.: 00996 312 93 50 05 Tel: +65 6 7371 945 NEW ZEALAND PAKISTAN PHILIPPINES Abbott New Zealand Hospital Supply Corporation Transmedic Pte Ltd. Building D, 4 Pacific Rise 42 Darul Aman Society 5, Jalan Kilang Barat Mt. Wellington...
Page 582 Building 1, Unit 3, Floor A3-5 Wuhan, Hubei 430060 China Tel. No: 027-88925558 EUROPE ARMENIA AUSTRIA AZERBAIJAN Advanced Medical Technologies & Service Abbott Austria Advanced Medical Technologies & (AMTS) Perfektastr., 84A A-1230 Service (AMTS) Saburtalo Str. 7, Flat 13 Wien, Austria Tbilisi 0159 A 1230 Saburtalo Str.
Page 583 Tel.No.: +39 0481 21711 Tel.No.: +39 0481 21711 DENMARK FINLAND FRANCE Abbott Denmark Abbott Finland Abbott France ADD Denmark Abbott Laboratories A/S ADD Finland Abbott Oy Diagnostic Division Emdrupvej 28C Pihatörmä 1 B 12 Rue de la Couture DK-2100 ESPOO, Finland 2240...
Page 584 Tel.No.: +39 0481 21711 Tel.No.: +351 21 938 32 40 Trzin, Ljubijana, Slovenia SI-1236 Tel.No.: +386 1 831 47 78 SWEDEN SWITZERLAND SWITZERLAND Abbott Sweden-Diagnostic Division Axonlab AG Abbott Switzerland Hemvärnsgatan 9 Taefernstrasse 15 ADD Switzerland Box 1498 Neuhofstrasse 23...
Page 585 Tel.: +1 55 11 95557-6345 Tel.: +1 55 21 7818-0462 BRAZIL BRAZIL BRAZIL PMH Produtos Medicos Hospitalares LTDA Abbott Brazil Provomendo Rua Michigan 735 - Brooklin Rua Ruy Porto 50 loja G SIA Trecho Sao Paulo, Brazil 04566-905 Barra da Tijuca...
Page 586 Opposite DHL Office Opposite Mineral Circles Dubai Bearing Free St. U.A.E. Jebel Ali, 732 UAE Tel.No.: +971 4 2821717 Tel. No.: +967 1 441 907 i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. Art: 716144-01AD Rev. Date: 16-Jan-17...
Page 587 i-STAT ® Technical BulleTin April 2008 UPDATE TO THE i-STAT CENTRAL DATA STATION VERSION 5 Monitors A new Alarm Monitor has been added which displays real time alerts and conditions of the system that require attention. This initial 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 date/time stamp indicating when the monitor was last updated is also visible to the lower left corner of the list.
Page 588 Clicking on an individual alarm category opens a window displaying specific details of the alarms detected in that category, the date/time they occurred, and in what location. Selected Alarm details or all Alarm details may be deleted by clicking the Acknowledge button at the bottom of the window. A report of selected Alarm details or all Alarm details may be 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.
Page 589 6. To disable an entire Alarm Category, uncheck the “Enabled” box next to the Alarm Category you wish to disable. 7. To disable a specific alarm contained in an Alarm Category, click the 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.
Page 590 i-stAt CentrAl DAtA stAtion CustoMizAtion A. Results Viewer Users now have the option to include/exclude the patient name from the trend display or printout in the Results Viewer. The default setting is to have the patient name included in the trend report. To exclude the patient name from the trend display and printout: 1. Close the CDS application, if open. 2. Click start → run… 3. Type wcds32 config at the open: prompt and click oK. 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.
Page 591 inventory WorKspACe In the Items tab page, items can now be moved to the “Available items:” list using a drag/drop technique. instruMent /loCAtion WorKspACe Instead of highlighting an instrument serial number and clicking on instrument → Move… from the menu bar or Move inst. in the toolbar, instruments can now be moved singly or in groups to new locations 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 Certification… from the menu bar or update Cert. in the toolbar. 2. Check the box next to the method(s) for which the operator is being certified, enter the certification dates, and click oK.
Page 592 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. Art: 721106-01A Rev. Date: 03/03/08...
Page 593 i-STAT ® Technical BulleTin APRIL 2009 UPDATE TO THE i-STAT CENTRAL DATA STATION VERSION 5 CUSTOMIZATION WORKSPACE A new feature has been added allowing users to delete unused Preferences so that they no longer appear in the Apply Preferences window. Note: the DeFAult0 Preferences may not be deleted. to delete unused Preferences: 1. Click Profile → Delete 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.
Page 594 b. to delete all unused preferences: • Click the Delete all unused preferences radio button. • Click Delete. • A confirmation message will appear asking if you want to delete the preferences. Click Yes to delete the Preferences. DATA VIEWER 1. A new feature has been added to the Results and Proficiency Viewers allowing the ability to display/print Reference Ranges with individual results. Note: the Preferences associated with an individual record must be present in the Customization Workspace for this option to appear. to view/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...
Page 595 For example, if a user wants to see a trend display or obtain a multi-result printout for a particular patient ID number, and this patient ID number has records attached with ionized calcium values in both mmol/l and mg/dl, a message will appear indicating that the display/printout will not be allowed. Art: 722831-01A Rev. Date: 19-Feb-09...
Page 596 Art: 722831-01A Rev. Date: 19-Feb-09...
Page 597: Using I-Stat Analyzer Customization Features To Minimize Id Entry Errors
i-STAT ® Technical BulleTin Using i-STAT Analyzer Customization Features to ® Minimize ID Entry Errors IntroductIon This Technical Bulletin describes seven i-STAT Analyzer Customization features that can help minimize ® Patient and Operator ID entry errors. ID Entry on the i-STAT System and Sources of Error The i-STAT System offers the following options for entering Patient and Operator IDs: •...
Page 598 1. Barcode Scanning How does this feature work? Instead of users entering Operator and Patient IDs manually using the analyzer keypad, the i-STAT 1 Analyzer also accepts scanned Operator and Patient ID information from 6 valid barcode formats. What benefits does using barcode scanning provide? •...
Page 599 How does this feature work? If a facility makes use of a supported Check Digit algorithm when creating Operator or Patient IDs, the i-STAT 1 Analyzer can verify the entered ID format by calculating the check digit and comparing it to the entered ID number. If the Check Digits don’t match, the ID is rejected.
Page 600 4-customization from the Administration Menu. • select 2-change. If the analyzer has already been customized with a password, enter the password. If not, press the Enter key. Note: Abbott Point of Care Inc. recommends changing the default password. •...
Page 601 4. Figure 2 illustrates the i-STAT CDS Customization Workspace main page. The Use Operator List feature, discussed in this Technical Bulletin, is marked by the numbered circle indicating the section of the Bulletin where this feature is described. Figure 2 i-STAT is a registered trademark of Abbott Laboratories. Art: 720654-01B Rev. Date: 09-Aug-13...
Page 602 Art: 720654-01B Rev. Date: 09-Aug-13...
Page 603: The I-Stat System Manufacturer's Quality System Instructions
i-STAT ® TECHNICAL BULLETIN The i-STAT System Manufacturer’s Quality System Instructions OVERVIEW The Manufacturer’s Quality System Instructions (MQSI) represent what are necessary to ensure quality results (accurate, precise and reliable) based upon the specific characteristics of the i‑STAT System. Three key technological characteristics of the i‑STAT System underlie the MQSI: 1.
Page 604 (results reporting and communication). Update Software then Check with External Simulator Update the i‑STAT System software as provided 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.
Page 605: Updates To The I-Stat 1 Downloader/Recharger
CHARGERS OVERVIEW Abbott Point of Care continuously seeks to improve the reliability of our product lines. As such, we have made three (3) changes to our Downloader/Recharger products as described below. Note: these changes do not impact the configuration or transmission instructions for the devices.
Page 606 Art: 725703-01A Rev. Date: 08-Mar-10...

Abbott i-STAT 1 System Manual

Introduction

I-STAT 1 ANALYZER

I-STAT CARTRIDGE

PRECISION Pcx and Pcx PLUS BLOOD GLUCOSE TEST STRIPS

Electronic Simulator

I-STAT 1 DOWNLOADER

(Model Number Drc-300)

Portable Printer

MARTEL Printer

The I-STAT Printer

TECHNICAL BULLETIN: I-STAT PRINTER RECHARGEABLE BATTERY NOTICE

Data Management

Customization

Technical Bulletin: Liquid Qc Schedule and Lockout Customization on the

I-STAT 1 HANDHELD

Sample Collection

Procedure for Handling Cartridges

Procedure for Cartridge Testing

Procedures for Glucose Test Strip Testing

Quality Control

Calibration Verification

PROFICIENCY or EXTERNAL QUALITY CONTROL TESTING

ROUTINE CARE of the ANALYZER and DOWNLOADER

Updating the Software

Troubleshooting the Analyzer

Theory

Downloader Programming and Wiring

Central Data Station 5

Technical Bulletins

Quick Links

Troubleshooting

Related Manuals for Abbott i-STAT 1

Summary of Contents for Abbott i-STAT 1