Abbott i-STAT 1 System Manual

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Page 1 Section 3 – System Resources 720660-00J (or lower) © 2017 Abbott Point of Care Inc., 100 and 200 Abbott Park Road, Abbott Park, Il 60064 • USA i-STAT is a trademark of the Abbott Group of Companies in various jurisdictions.
Page 3: Quick Reference Guide
Quick Reference Guide for the i-STAT 1 Handheld and ® i-STAT Chemistry Cartridges For use with a CLIA Certificate of Waiver EC4+ Crea CHEM8+...
Page 4 Quick Reference Guide for the i-STAT ® Handheld and i-STAT Chemistry Cartridges For use with a CLIA Certificate of Waiver This Quick Reference Guide is for use with the following CLIA-waived i-STAT cartridges: CHEM8+, 6+, EC4+, E3+, Crea, and G. These cartridges include various subsets of the following tests: sodium, potassium, chloride, total carbon dioxide, ionized calcium, glucose, urea nitrogen, creatinine and hematocrit.
Page 5 Control Testing Procedure Control Testing Frequency • Test one cartridge from each lot in each shipment upon receipt. • Test a single cartridge from the refrigerator monthly. Select cartridge in the following order: CHEM8+, 6+, Crea, EC4+, Glucose, E3+ Prepare Control •...
Page 6 Control Testing Procedure - continued 10. Withdraw the control fluid slowly into a 1 or 3 cc plain syringe until the syringe is half filled. Dispense 3 drops of control fluid onto a gauze pad. Draw fluid 11. Fill the cartridge with the control fluid. Fold the closure over the sample well until it snaps into place.
Page 7 Patient Testing Procedure Prepare the Sample • Mix the sample tube by gently inverting it 2-3 times before filling a cartridge. Do not use a partially filled collection tube. • CHEM8+: Test the sample within 10 minutes after collecting it. •...
Page 8 Review Results mmol/L 1 . 2 2 %PCV mmol/L • See i-STAT 1 System • View results on the handheld. 1 4 . 3 T C O 2 g / d L m m o l / L Manual for Waived Tests...
Page 9 Barcode scanner: do not look into laser beam coming from scanner, or point into eyes of someone else. i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. 06F20-06 Art: 716942-00L Rev. Date: 11-Oct-17 Abbott Point of Care Inc.
Page 11: Table Of Contents
1 System. Contact Information To place an order for cartridges, supplies or equipment, contact Abbott Point of Care Inc. at 800-284-0702 – Option 2, or order through your distributor. Cartridges and controls are shipped Monday through Thursday and delivered within 24 hours.
Page 12 Infrared Communication Window † Laser Barcode Scanner Window Display Battery Compartment Scan Key Page Key Clear Key Numeric Keys (0-9) Enter Key Backlight ON/OFF Key and 0 Key Menu Key Print Key Cartridge Port Art: 720672-00J, Rev. Date: 11-Oct-17...
Page 13: Overview Of The I-Stat System
Overview of the i-STAT System The i-STAT System incorporates components needed to perform blood analysis at the patient’s side. A portable handheld, a cartridge with the required tests, and 1 to 3 drops of blood will allow the caregiver to view quantitative results for tests commonly needed in physician ofﬁces, nursing homes, and clinics.
Page 14 Where unavailability of results while awaiting replacement of handhelds or cartridges is unacceptable, Abbott Point of Care Inc. recommends maintaining both a backup i-STAT System handheld and cartridges from an alternate lot number.
Page 15: Preparing The Handheld
Preparing the Handheld Before using a new or replacement handheld, complete these simple procedures: Install batteries • Check the handheld’s date and time • Check the handheld’s software and status • Customize handheld • Install/Change Batteries The handheld requires two 9-volt lithium batteries. Before using a new handheld, or when battery replacement is indicated, install batteries as follows: 1.
Page 16: Check/Change Date And Time
Check/Change Date and Time 13:26 18MAY10 Administration Menu 1. Press to turn on handheld. 1 - Analyzer Status 2 - Data Review 2. Press to change screen to Administration Menu. 3 - Quality Tests MENU 4 - Customization 5 - Set Clock 6 - Transmit Data 3.
Page 17: Entering Information Into The Handheld
Entering Information into the Handheld Instructions for performing a patient and control test can be found in the Testing Procedures section for each cartridge type. Information entered into the handheld during the testing process is stored with results in a patient record that can be accessed and printed at any time.
Page 18: Reviewing Stored Results
Reviewing Stored Results A maximum of 1000 test result records are stored by the handheld, and can be reviewed by accessing the Data Review Function: 1. Press to turn on handheld. 13:26 18MAY10 Administration Menu 1 - Analyzer Status 2. Press to change screen to Administration Menu.
Page 19: Printing Results
Printing Results A small thermal printer is available (purchased separately through Abbott Point of Care Inc.) for obtaining printouts of test records. To print a test record shown on the display, point the handheld’s Infrared Communication Window at the printer’s IR LED window (on the left side of the front) and press the on the handheld.
Page 20: Quality Control
Quality Control Quality control procedures are used to ensure the continued accuracy of a test system. The quality control program for the i-STAT System includes: Automatic quality checks: A series of automatic quality checks are performed • during each test cycle. When there is a quality check failure, a message is displayed with the cause and corrective action.
Page 21: Checking Handheld With The Electronic Simulator
Checking Handheld with the Electronic Simulator The external Electronic Simulator is stored at room temperature in its box. When 24 hours has elapsed since the last Electronic Simulator test (internal or external), the internal test will automatically be performed when a cartridge is inserted. If the test passes, the handheld proceeds with the measurement of the patient sample.
Page 22: Cleaning And Decontaminating The Handheld
Cleaning and Decontaminating the Handheld Drying a Wet Handheld If the handheld is placed on a wet surface or if any liquid is spilled on it, dry immediately. The handheld may be damaged if liquid enters the battery compartment, cartridge port or case.
Page 23: Updating The Handheld Software
If Abbott receives notice of such defects during the warranty period, it shall, at its option, either repair or replace products which prove to be defective. With respect to software or ﬁrmware, if Abbott receives notice of defects in these products during the...
Page 24 4. Operating outside of the environmental speciﬁcations of the product. THE WARRANTY SET FORTH ABOVE IS EXCLUSIVE AND NO OTHER WARRANTY, WHETHER WRITTEN OR ORAL, IS EXPRESSED OR IMPLIED. ABBOTT SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
Page 25 New Operator Quiz ....................19–23 Contact Information To place an order for cartridges, supplies or equipment, contact Abbott Point of Care Inc. at 800-284-0702 – Option 2, or order through your distributor. Cartridge and controls are shipped Monday through Thursday and delivered within 24 hours.
Page 26: Precautions
Precautions To protect yourself and others from infection: Potential Sources of Harm to the Operator • Do not perform blood or control fluid testing in areas where food and drink are stored or consumed. • Use gloves and wash hands after handling blood or blood soiled items.
Page 27: Receipt And Storage Of Cartridges & Controls
Receipt and Storage of Cartridges & Controls Required procedure for handling new cartridge or control shipments: 1. Open box marked “Refrigerate Upon Arrival”. Find card with temperature strip attached. Read strip immediately as it will change once it is exposed to room temperature. Follow instructions on card.
Page 28: Using A Cartridge For Patient Or Control Tests
Using a Cartridge for Patient or Control Tests • Prior to using a cartridge, it must be removed from refrigerated storage and kept at room temperature in its protective pouch for at least 5 minutes. An entire box of cartridges must be kept at room temperature for 1 hour before a cartridge is used.
Page 29: Perform A Patient Test
Perform a Patient Test Acceptable Sample Types • Venous whole blood samples collected in evacuated tubes with lithium heparin anticoagulant (green top tube). Tubes with gel for separation of cells and plasma are acceptable. • Fill tubes to capacity. Do not use tubes designed not to fill completely. Sample Collection and Handling Correct sample collection &...
Page 30 Scan Cartridge c. Scan the lot number on the cartridge pouch. Lot Number Position barcode 3 - 9 inches from scanner window on the handheld. _ _ _ _ _ _ _ _ __ _ Press and hold to activate the scanner. Align the red laser SCAN light so it covers the entire barcode as shown in the photo (left).
Page 31 4. Look for any air bubbles in the blood sample. If you see any air bubbles in the sample, discard this syringe and sample and repeat the test beginning with warming a new cartridge and withdrawing a new sample from the green top tube.
Page 32 Review Results Pt: 12345 Pt: 12345 16:10 18JUN 16:10 18JUN • The handheld shows the test results by i-STAT CHEM8+ i-STAT CHEM8+ test name, test units, and the numerical mg/dL mmol/L values and units with the results. It also 4 . 2 mmol/L mg/dL shows bar graphs with tic marks...
Page 33: Test Ranges
Test Ranges: • Reportable Range is the lowest to highest values the test system will report. • Reference Range is the normal values for an adult population. Reference ranges may vary according to age, gender and heritage. • Critical Values indicate that a patient may need treatment right away if results are at or below the low value, or at or above the high value.
Page 34: Perform A Control Test
EC4+, G or E3+ i-STAT or TriControls Level 3 Control • 1 cc syringe • Value assignment sheet - available at www.pointofcare.abbott. Note: if your facility does not have internet access, paper copies may be obtained from Technical Support. • Control log sheet •...
Page 35 Prepare the Handheld 1. Press to turn on handheld. 15:26 30SEP Administration Menu 1 - Analyzer Status 2. Press MENU 2 - Data Review 3 - Quality Tests 3. Press for the Quality Tests Menu. 4 - Customization Quality Tests 5 - Set Clock 1 - Control 6 - Transmit Data...
Page 36 Prepare to Test 1. Find a stable surface to perform the test. 2. Remove the cartridge from its pouch and place on a level surface. A level surface includes running the handheld in the downloader/recharger. Only touch the cartridge by its sides to avoid damage or contamination.
Page 37 Fill the Cartridge 1. Fill cartridge with control to the fill mark. a. Place tip of the syringe over cartridge sample well. b. Press plunger so that control enters the cartridge until it reaches the fill mark. c. Confirm that there is control fluid in sample well. If you don’t see control in sample well, continue to press plunger to deliver more control fluid.
Page 38 Target values and ranges are printed on a Value Assignment Sheet (VAS) posted on the APOC website at www.pointofcare.abbott. If your facility does not have internet access, paper copies of the VAS may be obtained from Technical Support. Control test results are shown in numerical values.
Page 39: Troubleshooting
Factors that Affect Results Interfering substances or other events may be encountered which can affect results. Read the summary below and refer to the Cartridge and Test Information (CTI) sheets at www.pointofcare.abbott for the most recent information. Factors that may Factors that may...
Page 40 Factors that may Factors that may Test Increase Results Decrease Results Ionized Calcium (iCa) Bromide Acetaminophen Magnesium Acetylcysteine Hemodilution Lactate Forearm exercise Salicylate Incomplete filling of collection tube Tourniquet left on Delay in testing too long Exposure to air Hemodilution Glucose (Glu) pH above 7.4 Acetylcysteine...
Page 41: Components And Supplies
06F20-03 i-STAT 1 System Manual for Waived Tests: Contains an overview of the i-STAT System and information required to prepare, use and maintain the handheld.
Page 42: Components And Supplies
04P73-04 i-STAT 1 Downloader/Recharger: contains the Downloader/Recharger, power supply, power cord, and cables to be used with the i-STAT 1 Downloader/Recharger. It is needed to perform software updates. Software updates require a PC with Windows 2000 or above. The Downloader/ Recharger allows the use of rechargeable batteries in the handheld.
Page 43: New Operator Quiz
New Operator Quiz Name: Check all that apply. 1. What should you do when you receive a new box of cartridges? a. Read the temperature strip and record b. Test one cartridge from each new lot with liquid control c. Call Technical Support if the first window on the temperature strip is colored d.
Page 44 Check all correct answers. 6. What can damage the handheld? a. Testing a urine sample b. Attempting to remove a cartridge before the “Do Not Remove Cartridge - Cartridge Locked” message is removed or results are displayed c. Using the handheld when the “BATTERY LOW” message is displayed d.
Page 45 Check all correct answers. CHEM8+ Cartridges 1. An acceptable sample type is? a. A full purple top tube (EDTA anticoagulant) b. A green top tube at least half full (lithium heparin anticoagulant) c. A full green top tube (lithium heparin anticoagulant) d.
Page 46 Evaluation For: Date: 1. User demonstrated the procedures required to put a new handheld into use. With ease With help With difficulty Not applicable 2. A patient sample was tested properly. With ease With help With difficulty Not applicable 3. The user understands what to do when ***, < or > , or a quality check message is displayed. With ease With help With difficulty...
Page 47: New Operator Quiz
Answers for New Operator Quiz The following boxes should be checked: a, b, d a, c a, b, c, d b, c, d a, b, c, d b, d a, c, d a, d CHEM8+ Cartridges 6+, EC4+, E3+, Glucose and Creatinine Cartridges Art: 725592-00K, Rev.
Page 49 800-284-0702 – Option 2, or order through your distributor. Cartridge and controls are shipped Monday through Thursday and delivered within 24 hours. For Technical Support, contact Abbott Point of Care Inc. at 800-284-0702 – Option 1, by fax at 609-419-9371, or by e-mail at: techsvc@apoc.abbott.com...
Page 50: Symbols
Symbols The following symbols may be found on components of the i-STAT System. Definition Attention: See instructions for use. Caution: Risk of electrical shock. Laser radiation hazard symbol. Biological Risks. Temperature limitations. The upper and lower limits for storage are adjacent to upper and lower arms.
Page 51: Specifications
Do not reuse. Battery: Low battery icon (flashes on lower left side of display screen). Born On Date: the label BODxxxx-xx defines year and month of manufacture. BODxxxx-xx 14 days room temperature storage at 18-30 °C. 2 months room temperature storage at 18-30 °C. Specifications Dimensions Width 7.68 cm (3.035 in)
Page 52: Laser Caution
Laser Caution Do not open the handheld. The handheld 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 53: Test And Administration Menus
6 - Transmit Data submenus by pressing the appropriate numbered keys. 7 - Utility References to functions can be found in sections of the i-STAT 1 System Manual for Waived Tests as noted below. Function Options Location in Manual Analyzer Status...
Page 54: Customizing The Handheld
Customizing the Handheld The handheld has a variety of settings that can be customized to make data management and compliance with laboratory regulations easier in large hospital settings. Customization options that may be useful to the smaller hospital or physician’s office using the i-STAT System under a CLIA Certificate of Waiver are included below.
Page 55: Highlights Of Customization Menu
Highlights of Customization Menu Of interest to the Menu Item Highlights smaller facility Analyzer Many of these options are Language used by the applicable only in conjunction with handheld can be changed. a data management system. ID Entry Allows you to: If operator and or patient •...
Page 56: Proficiency Testing
Proficiency Testing Proficiency Testing is not a CLIA requirement for waived tests, but may be required by state regulations or if your laboratory is accredited by the College of American Pathologists (CAP). Before participating in a Proficiency Testing program, request a copy of the Technical Bulletin, “Proficiency Testing and the i-STAT System”...
Page 57: Thermal Probe Check
Thermal Probe Check Two thermal probes in the handheld maintain the cartridges at the correct temperature during the testing cycle. This check should be performed every six months. Note: If the handheld and simulator have been stored separately in areas where the ambient temperature differs by more than 3 °C (5 °F), allow simulator and handheld to stand in same place, out of drafts, for 30 minutes before inserting the simulator into the handheld.
Page 58: Printing Results
Printing Results Results can be transmitted from the handheld to either an i-STAT Printer or a Martel Printer. The printer can be recharged from a power adapter connected to an outlet. i-STAT Printer Specifications Height: 72.5 mm Width: 136 mm Depth: 120 mm Weight: 500 g (Approx.) Power...
Page 59 Power There are three options for powering the i-STAT Printer: • Using the AC adapter and power cord only, • Using the Rechargeable Battery only, and • Using the Rechargeable Battery with the AC adapter and power cord. 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...
Page 60 3. If replacing an existing rechargeable battery in the printer, disconnect the existing battery by gently pulling up on the red/white/black wires until the connector releases from the three metal pins. Once the battery is disconnected, remove it completely from the battery compartment. 4.
Page 61 Paper Printer paper may be ordered along with other supplies for the i-STAT System unit Abbott List # 06F17-11. The STATUS indicator will illuminate to indicate the print status: Green Ready:  Out of Paper: Orange  Error:  Paper for the i-STAT Printer can be installed or replaced as follows: 1.
Page 62 6. Press the number key for the test record(s) to be printed. (Press the numbered key again to deselect a record.) 7. Align i-STAT 1 handheld and i-STAT Printer IR window. Press on the handheld. 8. Do not move handheld or printer until printing is complete.
Page 63 Printer. 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 64 IR window. • Relocate the printer or fluorescent lamp to a greater distance from each other. • Turn off fluorescent lights within close proximity of the i-STAT 1 Printer when printing records via a serial connection.
Page 65: Martel Printer
Martel Printer Specifications Height: 64 mm Width: 135 mm Depth: 130 mm Weight: 425g (Approx.) Power 1. 4.8V Nickel Metal Hydride battery pack 2. Power adapter for AC outlet 3. Downloader Communication Link 1. Infra-red 2. RJ12 Paper 5.7cm thermal Switch On/Off LED Indicator Lights...
Page 66 The battery needs to be recharged when the Status LED lights continuously during printing. If the battery becomes exhausted, printing will become faint, erratic, or not possible at all. Should this happen, turn the printer off and allow to recharge for 1 hour before attempting printing again. Paper Paper may be ordered along with other supplies for the i-STAT System: •...
Page 67 6. Press the number key for the test record(s) to be printed. (Press the numbered key again to deselect a record.) 7. Align i-STAT 1 handheld and Martel Printer IR window. Press on the handheld. 8. Do not move handheld or printer until printing is complete.
Page 68 Caution • Use power supply provided with printer. • Use only a rechargeable battery pack purchased from Abbott Point of Care. • Do not operate the printer without paper. • Do not allow the power supply to become a trip hazard.
Page 69: Downloader/Recharger
The Downloader/Recharger is also required if rechargeable batteries are being used. This section will explain how to use the Downloader/ Recharger to recharge rechargeable batteries. Only rechargeable batteries supplied by Abbott Point of Care may be used.
Page 70 Charging Batteries • Put a new or fully discharged rechargeable battery in the Recharging Compartment for 40 hours. Battery will be 100% charged and ready for use. • To keep batteries charged, either keep the handheld on the Downloader/Recharger when not in use, or store a rechargeable battery in the Recharging Compartment.
Page 71: Logs
Logs A variety of logs may be useful for managing the i-STAT System: • Receipt of New Cartridges • Monthly Cartridge Check • Storage Temperature • Quality Check Codes • Thermal Probe Check Reviewing and Recording Control Results The following steps will guide you through recording control results on control logs. You will need: •...
Page 72 Instructions for Receipt of New Cartridges Log 1. Enter the information in the top half of the log. Be sure that: • the lot number printed on the Value Assignment Sheet (VAS) matches the lot number on the label of the control. •...
Page 73 Art: 720660-00K, Rev. Date: 11-Oct-17...
Page 74 Art: 720660-00K, Rev. Date: 11-Oct-17...
Page 75 i-STAT System: Storage Temperature Log (optional) Refrigerator Room Initials Date (2-8 ˚C / 35-46 ˚F) (Up to 30 ˚C / 86 ˚F) Art: 720660-00K, Rev. Date: 11-Oct-17...
Page 76 i-STAT System: Quality Check Codes Date Operator Analyzer SN Code Comment Art: 720660-00K, Rev. Date: 11-Oct-17...
Page 77 i-STAT System: Thermal Probe Check Handheld Serial Result of Date/Time Operator Number Probe Check Art: 720660-00K, Rev. Date: 11-Oct-17...
Page 78 Art: 720660-00K, Rev. Date: 11-Oct-17...
Page 79: Quality Checks
Quality Checks From the time it powers up until the time it powers down, the handheld performs numerous quality checks. The failure of any quality check causes the handheld to halt the test cycle and display a “cause” and “action” message, and a code. The Cause Message: This message describes the likely cause of the failed quality check.
Page 80 Art: 720660-00K, Rev. Date: 11-Oct-17...
Page 81 Art: 720660-00K, Rev. Date: 11-Oct-17...
Page 82 Art: 720660-00K, Rev. Date: 11-Oct-17...
Page 83: Cartridge And Test Information
• References Waived Status Studies for the i-STAT System Abbott Point of Care Inc., in the course of application for Waived Status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), carried out clinical studies intended to demonstrate that users with no laboratory training, after viewing only the manufacturer’s test instructions, can obtain accurate results with the i-STAT System.

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