Abbott i-STAT 1 System Manual

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Abbott i-STAT 1 System Manual

  • System manual (659 pages)
  • User manual (9 pages)
  • Quick reference manual (7 pages)
  • page of 84 Go / 84

Table of Contents

  • Troubleshooting
  • Quick Reference Guide
  • Overview of the I-STAT System
  • Install/Change Batteries
  • Check/Change Date and Time
  • Check Software and Status
  • Entering Information into the Handheld
  • Reviewing Stored Results
  • Printing Results
  • Quality Control
  • Checking Handheld with the Electronic Simulator
  • Cleaning and Decontaminating the Handheld
  • Customizing the Handheld Settings
  • Updating the Handheld Software
  • Thermal Probe Check

Testing Procedures for I-Stat Chemistry Cartridges

  • Precautions
  • Receipt and Storage of Cartridges & Controls
  • Using a Cartridge for Patient or Control Tests
  • Perform a Patient Test
  • Test Ranges
  • Perform a Control Test
  • Factors that Affect Results
  • Components and Supplies
  • New Operator Quiz

System Resources

  • Specifications
  • Laser Caution
  • Test and Administration Menus
  • Customizing the Handheld
  • Highlights of Customization Menu
  • Deleting Results from Handheld
  • Proficiency Testing
  • I-STAT Printer
  • Martel Printer
  • Downloader/Recharger
  • Quality Checks
  • Cartridge and Test Information

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Quick Links

  • 1 Quick Reference Guide
  • 2 Quality Control
  • 3 Cleaning and Decontaminating the Handheld
  • 4 Thermal Probe Check
  • 5 Thermal Probe Check
  • Download this manual
  • Table of Contents 11
  • Testing Procedures for I-Stat Chemistry Cartridges 25
  • System Resources 49

Related Manuals for Abbott i-STAT 1

Measuring Instruments Abbott i-STAT 1 System Manual

Summary of Contents for Abbott i-STAT 1

  • 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

  • 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

  • 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

  • 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

Page 16: check/change date and time, page 17: entering information into the handheld, page 18: reviewing stored results, page 19: printing results, page 20: quality control, page 21: checking handheld with the electronic simulator, page 22: cleaning and decontaminating the handheld, page 23: updating the handheld software.

  • 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

Page 27: receipt and storage of cartridges & controls, page 28: using a cartridge for patient or control tests, page 29: perform a patient test.

  • 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

Page 34: perform a control test.

  • 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

  • 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

Page 42: components and supplies, page 43: new operator quiz.

  • 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

  • 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: [email protected]...

Page 50: Symbols

Page 51: specifications, page 52: laser caution, page 53: test and administration menus, page 54: customizing the handheld, page 55: highlights of customization menu, page 56: proficiency testing, page 57: thermal probe check, page 58: printing results.

  • 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

  • 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

  • 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

  • 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

  • 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

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  • NICE Guidance
  • Health and social care delivery
  • Emergency care

i STAT CG4+ and CHEM8+ cartridges for point-of-care testing in the emergency department

Medtech innovation briefing [MIB38] Published: 09 September 2015

  • Introduction

Technology overview

  • Evidence review
  • Relevance to NICE guidance programmes
  • Search strategy and evidence selection
  • About this briefing

About the technology

Costs and use of the technology, likely place in therapy, specialist commentator comments, equality considerations.

This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of healthcare professionals to check the regulatory status of any intended use of the technology in other indications and settings.

The CG4+ and CHEM8+ cartridges (Abbott) are classified as IVD General in vitro diagnostic medical devices (98/79/EC). The CG4+ cartridge was CE marked in October 2003 and the CHEM8+ cartridge in December 2006.

Description

The i‑STAT is a handheld, in vitro analyser designed to be used at the patient's bedside (point‑of‑care) for testing arterial, venous or capillary whole blood. It takes single‑use cartridges containing chemically sensitive biosensors on a silicon chip that are configured for test‑specific indicators. i‑STAT test cartridges are available for a broad range of diagnostic and treatment indicators including blood gases, electrolytes, metabolites and coagulation markers. Blood samples do not need to be processed before testing and results are available in around 2 minutes.

The i‑STAT system has the following components, accessories and consumables:

i‑STAT analyser – a handheld, battery‑operated and fully automated analysis platform, consisting of a LCD screen and keypad. Two versions of the i‑STAT analyser are available: a wireless internet version (the i‑STAT Wireless, which can upload the results wirelessly) and a non‑wireless version (with which test results can be uploaded when the analyser is placed in the i‑STAT downloader/recharger).

i‑STAT cartridges – single‑use, disposable cartridges for whole‑blood testing. They are inserted into the analyser after the blood sample has been applied. A large number of cartridges are available to test the most common test‑specific indicators in different combinations. Cartridges include tests for blood gases, electrolytes, metabolites and coagulation.

i‑STAT downloader/recharger – acts as a cradle for the analyser, automatically uploading data (with the non‑wireless analyser) and recharging its batteries.

Electronic simulator – for checking the performance of the i‑STAT analyser.

TriControls – a set of control solutions at 3 clinically relevant concentrations of test‑specific indicators for verifying each cartridge type.

i‑STAT data manager – data management software for cartridges, where test records can be transmitted to and then be printed or transmitted to the laboratory/hospital information system.

i‑STAT printer – an optional portable printer which enables the operator to print results at the point of care.

This briefing report focuses on 2 i‑STAT cartridges, the CG4+ and CHEM8+, which are most relevant to the NHS ED setting.

The CG4+ cartridge provides the following chemistry test and blood gas measures:

the partial pressure of carbon dioxide ( P CO 2 )

the partial pressure of oxygen ( P O 2 )

total carbon dioxide (TCO 2 ; calculated)

bicarbonate (HCO 3 ; calculated)

base excess (calculated)

oxygen saturation ( s O 2 ; calculated).

The CHEM8+ cartridge provides the following electrolyte and haematology tests:

urea nitrogen/urea

ionised calcium

total carbon dioxide (TCO 2 )

anion gap (calculated)

haematocrit

haemoglobin (calculated).

Detailed information on the cartridges and tests is available on the manufacturer's website, including their intended use, methods and performance data on the tests.

To use a test cartridge, the operator and patient information is entered into the i‑STAT analyser using the keypad. Two or 3 drops of blood (between 65 and 95 microlitres) are applied to the cartridge using a syringe before the cartridge is inserted into the i‑STAT analyser. The test starts automatically once the cartridge is inserted in the analyser. All the tests are run simultaneously and results are available in around 2 minutes for both the CG4+ and CHEM8+ cartridges. Before running a test, each cartridge initiates a series of pre‑set quality control diagnostics, from monitoring the quality of the sample to validating the reagent. Test results are displayed on the LCD screen of the analyser and can be uploaded automatically, either wirelessly with the i‑STAT Wireless or when the analyser is placed in the i‑STAT downloader/recharger. The data can be transmitted from multiple analysers in many patient care areas to the i‑STAT Data Manager, a dedicated desktop computer with the i‑STAT central data application installed. The data can be printed, stored, organised, edited and transferred to a laboratory information system or other computer system such as a hospital information system to aid patient record keeping.

The manufacturer's instruction suggests that an electronic quality control check of the performance of each i‑STAT analyser should be done once on each day of use, or as needed. This is carried out with an electronic simulator (either internal or external), which tests the analyser's cartridge signal‑reading function. When the specified time has passed since the last electronic simulator test the internal test will automatically be performed when a cartridge is inserted and before the sample is tested. This adds about 20 seconds to the testing cycle. The external electronic simulator is a device in a cartridge form. It is inserted into the cartridge port to perform the check. Using the external electronic simulator adds about 60 seconds to the test cycle. The electronic simulator check simulates 2 levels of electrical signals that stress the analyser's cartridge signal detection function both below and above measurement ranges. This provides an independent check of the analyser's ability to take accurate and sensitive measurements of voltage, current and resistance from the cartridge. An analyser will pass or fail this electronic test depending on whether or not it measures these signals within limits specified in the analyser software.

The integrity of i‑STAT cartridges can be verified using 2 of the 3 TriControls, which are control fluids formulated at 3 clinically relevant levels with known concentrations of the test-specific indicators. Cartridges can be verified on 1 representative cartridge from each new batch of cartridges and by comparing the results to the expected values published by the manufacturer in the value assignment sheets. To verify the CG4+ and CHEM8+ cartridges, level 1 (low concentration) and level 3 (high concentration) controls are used.

Both versions of the i‑STAT analyser have the following specifications:

dimensions of 209h x 64w x 52d mm and weight of 520 g

LCD display

keypad with a set of buttons for operating the i‑STAT analyser, including keys to enter information into the analyser and access the analyser's menu

battery‑operated using two 9 volt lithium batteries

communication link: infrared transmitter and receiver.

Both versions also have the same operator features:

Operator and patient information can be entered via a barcode scanner.

Screen prompts provide the user with step‑by‑step instructions during the entire testing process, displaying data in large type for easy reading.

An operator ID code to lock and unlock the i‑STAT analyser. This operator lockout helps prevent unauthorised users from performing or viewing test results.

Setting and intended use

The i‑STAT analyser and cartridges can be used for multiple indications in multiple settings. The focus of this briefing is the intended use of the CG4+ and CHEM8+ cartridges in the ED setting to aid the diagnosis or exclusion of numerous potentially serious diseases and clinical conditions. The CG4+ cartridge is used for the measurement of blood gases and lactate that are indicative of the following conditions:

respiratory disturbances and metabolic and respiratory‑based acid‑base disturbances (blood gases)

hypoxia, shock, heart attack, severe congestive heart failure, renal failure, uncontrolled diabetes, or sepsis (lactate).

The CHEM8+ cartridge is used for tests of blood chemistry, haematology, ionised calcium and total CO 2 to help diagnose:

conditions that manifest electrolyte and acid‑base disorders (blood chemistry and TCO 2 )

anaemia, erythrocytosis, and blood loss related to trauma and surgery (haematocrit and haemoglobin)

parathyroid disease, various bone diseases, chronic renal disease, tetany, and disturbances related to surgical and intensive care (ionised calcium).

The manufacturer stated that the analysers and cartridges should be used by healthcare professionals trained and certified to use the system. Each end‑user should attend an end‑user training class in order to receive certification for the i‑STAT system. The class includes hands‑on demonstration and a competency assessment.

Current NHS options

In the majority of NHS EDs, standard blood tests (such as those available with the CHEM8+ cartridge) are obtained from accredited hospital laboratories, usually on site. Blood gases and lactate measurements are also analysed in hospital laboratories, although a specialist commentator stated that most EDs now have standalone analysers to measure lactate when testing for sepsis. Standalone blood gas analysers are also used in intensive care units where blood gases are measured frequently.

NICE is aware of other CE‑marked point‑of‑care test devices that appear to fulfil a similar function to the i‑STAT CG4+ and CHEM8+ cartridges on an individual test basis. These include handheld devices but also desktop analysers which can be used to provide point‑of‑care tests in the ED. Examples of these devices include:

Radiometer ABL800 FLEX analyser (Radiometer) – desktop blood gas analyser.

HemoCue 201+ meters (HemoCue) – portable systems that are used to measure haemoglobin.

FreeStyle Optium (Abbott) – portable blood glucose monitoring system.

FreeStyle Mini (Abbott) – portable blood glucose monitoring system.

epoc Blood Analysis System (Epocal) – portable blood gas and electrolyte testing.

RAPIDLab 348EX Blood Gas System (Siemens Healthcare Diagnostics) – desktop blood gas analyser.

RAPIDPoint 500 system (Siemens Healthcare Diagnostics) – desktop blood lactate assay.

The list price of the technology and consumables or maintenance required to use the products, excluding VAT, are as follows:

i‑STAT analyser: non‑wireless £5191, i‑STAT Wireless £6191.

i‑STAT downloader/recharger: £1100.

CG4+ cartridge: £12.49 per cartridge (unit size: box of 25 cartridges).

CHEM8+ cartridge: £19.54 per cartridge (unit size: box of 25 cartridges).

electronic simulator: £243.73.

TriControls: £20.31 (box of 10 glass ampules).

i‑STAT printer: £335.

service after 1 year warranty: £1298 per analyser per year.

The unit size for both CG4+ and CHEM8+ cartridges is 25 cartridges. The TriControls are supplied in a box of 10 glass ampules at a single concentration level (level 1, 2 or 3). Each level of TriControls needs to be purchased separately. Each analyser must be verified using a single cartridge. The TriControls used for both the CG4+ CHEM8+ cartridges are not stable, so a separate ampule must be used for each analyser being tested, although up to 3 i‑STAT analysers can be verified if tested simultaneously. Cartridges are verified by analysing level 1 and level 3 of the appropriate control on each new batch of cartridges and by comparing the results with the expected values published by the manufacturer. Verification of cartridges is not a manufacturer's system instruction but a suggestion to comply with quality assurance requirements.

The data management software is an optional component of the i‑STAT. It can be purchased from a third‑party vendor if an open system is needed to connect multiple devices. The software is typically installed in a server but could be installed on a computer with the correct specifications.

The i‑STAT analyser with the CG4+ and CHEM8+ cartridges could be used in emergency departments to reduce the time taken for results compared with the same tests done in the hospital laboratory.

One specialist commentator stated that because the i‑STAT system is a compact and relatively simple machine to use, it can be a valuable addition to an ED if a blood gas analyser is not available, or if the time taken to get results from the laboratory regularly delays decision‑making. It could also be of benefit in minor injury units without access to on‑site laboratory services.

One commentator mentioned that almost all EDs have point‑of‑care blood gas machines already, so the benefits of these cartridges in reducing time to discharge are overstated. Another commentator stated that if on‑site laboratory services are available and results are generally ready in a reasonable timescale, the i‑STAT does not confer a huge advantage to the speed of decision‑making or total length of ED stay.

Two specialist commentators stated that the CHEM8+ and CG4+ cartridges do not include some of the additional tests that are used to help decide if a patient can be sent home safely, such as d‑dimer, troponin and white cell count, although cardiac troponin I is available on another i‑STAT cartridge. Therefore, even with the i‑STAT, other tests may be needed in some instances. One specialist commentator was of the opinion that the i‑STAT analyser may also take up clinical time to carry out quality control checks and to test the sample, rather than leaving this to laboratory staff outside the ED.

Another specialist commentator stated that from a financial point of view, the cost per test when using the i‑STAT is much higher than an on‑site laboratory analysis.

NICE is committed to promoting equality and eliminating unlawful discrimination. In producing guidance, NICE aims to comply fully with all legal obligations to:

promote race and disability equality and equality of opportunity between men and women

eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010).

Young children, older people and people with chronic conditions are more likely to need the services of an ED. These groups in particular will benefit from improvements in the quality of ED care. Using point‑of‑care tests could contribute to quality of care if outcomes such as time to a clinical decision improve. Age is a protected characteristic under the 2010 Equality Act.

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  • Diagnostics
  • About Abbott
  • i-STAT Registration
  • i-STAT Entry
  • Unity States
  • Czechoslovak Republic
  • Netherlands
  • New Zealand
  • Philippines
  • United Kingdom

Abbott

VALUE ASSIGNMENT SHEETS

Use Value Order Sheets to locate the valid target values and ranges for your i-STAT  test cartridge controls and calibration verification materials. You can also access  electronic Value Assignment Sheets (eVAS) .  Content go this page was updated in 11-May-2023.

FIND YOUR VALUE ASSIGNMENT SHEET

To detect that right Value Assignment Sheet, you must have:

  • CLEW revision (found within the handheld’s Status Page)
  • Control/Calibration Verification lot number found on the box (not this unique site for each level located on the vials from the Standardisation Authentication kits) Intended Use: To i-STAT 1 Analyzer is intended for use with i-STAT cassette ... the Value Assignment Covers up verify the integrity of the cartridges.
  • Cartridge your or lot number (found on cartridge pouch or cartridge box)

To locate an correct ranges for your controls:

  • Select the CLEW revision below that corresponds with the handheld’s current CLEW.
  • Locate and select the Control/Calibration Verification game the type below the corresponds with your lot number.
  • Search cartridge type and lot prefix buchstabe WITHIN aforementioned value sheet that equal with get cartridge.

ACT LEVEL 1 CONTROL

  • Land 261149, with CLEW A45
  • Lot 261156, in CLEW A45
  • Lot 261158, for CLEW A45

ACT LEVEL 2 CONTROL

  • Lot 271149, for CLEW A45
  • Lot 271156, fork CLEW A45
  • Lot 271158, for CLEW A45

B-HCG CAMERA VERIFICATION SET

  • Piece 210340, for CLEW A45
  • Lot 220117,  for CLEW A45
  • Lot 220237, by CLEW A45
  • Lots 230039, for SEGEL A45

B-HCG RANK 1 CONTROL

  • Lot 351155, for CLEW A45
  • Lot 351159, for CLUE A45
  • Lot 351163, by CLEW A45
  • Lot 351169, for CLEW A45

B-HCG SELECT 2 POWER

  • Lot 361155, for CLEMP A45
  • Lot 361159, used CLEW A45
  • Lot 361163, by CLEW A45
  • Lot 361169, for CLEW A45

B-HCG LEVEL 3 CONTROL

  • Batch 371155, for CLEW A45
  • Lot 371159, on CLEAV A45
  • Lot 371163, with CLEW A45
  • Lot 371169, with LUFF A45

BNP CALIBRATION VERIFICATION SET

  • Lot 210320, for CLEW A45
  • Lots 220083, for CLEW A45

BNP LEVEL 1 CONTROL

  • Lot 041150, for CLEW A45
  • Lot 041154, for CLEW A45
  • Lot 041158, for CLEW A45

BNP LEVEL 2 CONTROL

  • Lot 051150, for CLEW A45
  • Lot 051154, for CLEW A45
  • Lot 051158, for CLEARANCE A45

BNP LEVEL 3 CONTROL

  • Parcel 061150, for CLEW A45
  • Lot 061154, for KIELSCHWEIN A45
  • Lot 061158, for KLATSCHE A45

CHEM8+ CALIBRATION VERIFICATION LEVEL 1B

  • Lot 181149, for CLEW A45
  • Lot 181152, for CLEW A45

CK-MB CALIBRATION VERIFICATION SET

  • Lot 210341, required CLEW A45
  • Lot 220115, for CLEW A45
  • Lot 220257, for CLEW A45
  • Lot 230055, on CLEW A45

CK-MB LEVEL 1 CONTROL

  • Lot 071155, for CLEW A45
  • Lot 071159, for LUFF A45
  • Plenty 071164, in CLEW A45
  • Lot 071169, for CLEW A45

CK-MB LEVEL 2 TAKE

  • Lot 081155, for CLEW A45
  • Lot 081159, on CLEW A45
  • Land 081164, for CLEFF A45
  • Lot 081169, for CLEW A45

CK-MB LEVEL 3 CONTROL

  • Lot 091155, for CLEW A45
  • Lot 091159, for CLEW A45
  • Lot 091164, required CLEW A45
  • Plot 091169, by CLEW A45

CTNI CALIBRATION VERIFICATION SET

  • Lot 210218, for CLEW A45
  • Plot 210348, for CLEW A45
  • Lot 220137, with CLEW A45
  • Land 220262, for CLEW A45

CTNI LEVEL 1 STEERING

  • Lot 011151, for CLEW A45
  • Lot 011155, available CLEW A45
  • Lot 011160, for KIELSCHWERT A45
  • Abundance 011164, for CLEW A45

CTNI LEVEL 2 CONTROLLING

  • Lot 021151, with CLEW A45
  • Lot 021155, for CLEW A45
  • Lot 021160, for CLEW A45
  • Lot 021164, fork CLEW A45

CTNI LEVEL 3 RULE

  • Property 031151, for CLEW A45
  • Parcel 031155, for CLEW A45
  • Lot 031160, by SCHLEPPNETZ A45
  • Abundance 031164, for CLEW A45

i-STAT CALIBRATION VERIFICATION PLACE

  • Lot 22081, for SEIL A45
  • Lot 22244, for CLEW A45

i-STAT LEVEL 1 GOVERN

  • Lot 101152, since CLEW A45
  • Lot 101156, for CLEW A45

i-STAT LEVEL 2 CONTROL

  • Lot 111149, for CLEW A45
  • Lot 111152, for CLEW A45
  • Lot 111156, for SCHLEPPLEINE A45

i-STAT LEVEL 3 CONTROL

  • Lot 121152, for CLEFT A45
  • Lot 121156, for CLEW A45

PT STEP 1 CONTROL

  • Lot 281149, for CLEW A45
  • Lot 281151, for CLEW A45
  • Lot 281156, for CLEW A45

PT LEVEL 2 CONTROL

  • Lot 291149, for SCHLEIER A45
  • Lot 291151, for PINNE A45
  • Lot 291156, in CLEW A45

TRICONTROLS CALIBRATION VERIFICATION DETERMINED

  • Lot 22059, for CLEW A45
  • Lot 22171, for CLEW A45
  • Lot 22287, for CLEW A45
  • Lot 23011, in CLEW A45
  • Lot 23004, for CLEW A45

TRICONTROLS LEVEL 1 CONTROL

  • Lot 301151, for CLEW A45
  • Lot 301154, for CLEW A45
  • Lot 301157, for CLEW A45
  • Lot 301161, for CLEW A45

TRICONTROLS LEVEL 2 CONTROL

  • Plot 311151, for CLEW A45
  • Plenty 311154, for CLEW A45
  • Lot 311156, for CLEW A45
  • Lot 311161, for CLEW A45

TRICONTROLS LEVEL 3 CONTROL

  • Ticket 321151, for CLEW A45
  • Lot 321154, since CLEAV A45
  • Ticket 321157, for CLEW A45
  • Game 321161, for CLEW A45
  • Lot 261149, for CLEW A46
  • Lot 261156, for CLEW A46
  • Game 261158, for CLEW A46
  • Property 271149, for CLEW A46
  • Lot 271156, for CLEW A46
  • Lot 271158, for CLEAV A46

B-HCG CALIBRATION VERIFICATION PICK

  • Lot 210340, for CLEW A46
  • Lot 220117,  for SAIL A46
  • Lot 220237, for CLEAV A46
  • Lot 230039, for CLEW A46

B-HCG LEVEL 1 CONTROL

  • Lot 351155, for CLEW A46
  • Lot 351159, for CLEW A46
  • Lot 351163, for CLEW A46
  • Game 351169, for CLEW A46

B-HCG LEVEL 2 CONTROL

  • Batch 361155, with KLEE A46
  • Abundance 361159, for CLEW A46
  • Lot 361163, for CLEW A46
  • Lot 361169, on CLEW A46

B-HCG LEVEL 3 CHOOSE

  • Lot 371155, for BALL A46
  • Lot 371159, available CLEW A46
  • Lot 371163, for CLEW A46
  • Lot 371169, forward CLEW A46
  • Lot 210320, for CLEW A46
  • Lot 220083, for KIELSCHWEIN A46
  • Lot 041150, for CLEW A46
  • Lot 041154, for CUE A46
  • Lot 041158, for CLEW A46

BNP LEVEL 2 GOVERN

  • Lot 051150, on CLEW A46
  • Plenty 051154, for CLEW A46
  • Parcel 051158, for CLEW A46
  • Lot 061150, to CLEW A46
  • Lot 061154, by CLEW A46
  • Lot 061158, for CLEW A46
  • Lot 181149, for CLEW A46
  • Lot 181152, for CLEFT A46

CK-MB VERIFY VERIFICATION SELECT

  • Lots 210341, for CLEW A46
  • Ticket 220115, for CLEW A46
  • Lot 220257, available CLEW A46
  • Lot 230055, for CLEW A46
  • Lot 071155, for CLEW A46
  • Fortune 071159, for CLEW A46
  • Lot 071164, for CLEW A46
  • Lot 071169, for CLEW A46

CK-MB LEVEL 2 CONTROL

  • Lot 081155, for CLEW A46
  • Lot 081159, for CLEW A46
  • Lot 081164, for CLEW A46
  • Lot 081169, for CLEW A46

CK-MB STEP 3 CONTROL

  • Fortune 091155, for KIELSCHWEIN A46
  • Lot 091159, for CLEW A46
  • Lot 091164, for CLEW A46
  • Lot 091169, for CLEW A46
  • Lot 210218, fork CLEW A46
  • Plenty 210348, on CLEW A46
  • Lot 220137, for CLEW A46
  • Lot 220262, for CLEW A46

CTNI GAUGE 1 COMMAND

  • Parcel 011151, for CLEW A46
  • Lot 011155, for CLEW A46
  • Abundance 011160, for KIELSCHWERT A46
  • Lot 011164, for CLEW A46

CTNI LEVEL 2 TAX

  • Plot 021151, for SCHLEIER A46
  • Lot 021155, for CLEW A46
  • Property 021160, for CLEW A46
  • Lot 021164, for CLEW A46

CTNI LEVEL 3 CONTROL

  • Lot 031151, fork CLEW A46
  • Lot 031155, for CLEW A46
  • Lot 031160, since CLEW A46
  • Lot 031164, available CLEW A46

i-STAT CALIBRATION VERIFICATION SET

  • Lot 22081, used CLEW A46
  • Lot 22244, for CLEW A46

i-STAT LEVEL 1 CONTROL

  • Lot 101152, for CLEW A46
  • Lot 101156, for CLEW A46
  • Lot 111149, used CLEW A46
  • Lot 111152, for CLEW A46
  • Lots 111156, for CLEW A46
  • Lot 121152, with CROSS A46
  • Lot 121156, for CLEW A46

PT LEVELS 1 CONTROL

  • Batch 281149, since KIELSCHWEIN A46
  • Lot 281151, for CLEW A46
  • Lot 281156, fork CLEW A46

PT GAUGE 2 TAX

  • Lot 291149, for CLEW A46
  • Lot 291151, for CLEW A46
  • Lot 291156, for CLEW A46

TRICONTROLS CALIBRATION VERIFICATION SET

  • Lot 22059, available CLEW A46
  • Lot 22287, for CLEVER A46
  • Fortune 23011, in CLEW A46
  • Lot 23004, for CLEW A46
  • Lot 301151, for CLEW A46
  • Lot 301154, for CLEW A46
  • Lot 301157, for CLEW A46
  • Lot 301161, with CLEW A46
  • Lot 311151, for HELM A46
  • Lot 311154, by CLEW A46
  • Lot 311156, for CLEW A46
  • Lot 311161, for CLEW A46
  • Parcel 321151, for CLEW A46
  • Lot 321154, for CLEW A46
  • Lot 321157, for CLEW A46
  • Game 321161, for CLEW A46

Istat Value Assignment Sheet Icons

CLEW A45 EXPIRES 21 MONTH 2023

Istat Value Assignment Sheet Icons

Download electronic Value Allocation Sheets to streamline and simplify the liquid quality control process.

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i-STAT ALINITY eVAS

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electronic value assignment sheets (eVAS)

Streamline and simplify the liquid quality control process by using the electronic Value Assignment Sheet (eVAS) for the i-STAT TBI Plasma cartridge controls and calibration verification products. By downloading the eVAS file, your device can be automatically updated with the latest Value Assignment Sheet data. With this one download, you will have the most current information available for all of your test cartridges and handhelds.

Download Instructions for (eVAS)

Use of eVAS requires a customized instrument. Customization is performed by using AlinIQ CWi to create a profile with eVAS selected and enabled for use, and loading the profile onto the instrument. See the Manage and Assemble Profiles section 3.4 of the System Operations Manual for further instructions.

To download eVAS package file:

  • Delete all pre-existing eVAS package files from the Downloads directory of a computer.
  • Check instrument CLEW. Power up the instrument, then touch More Options -> Instrument Status. Observe CLEW indicated on the screen.
  • Below, find the eVAS package file that corresponds to the CLEW indicated on the Instrument Status screen.
  • Download the eVAS package file to a computer by clicking on the eVAS Package File link corresponding to the instrument CLEW from the table above. Do not rename the file.
  • USB memory stick must be formatted as FAT32 via Windows OS prior to use.

To install eVAS package file on i-STAT Alinity:

Before installing eVAS, make sure the instrument is customized with a profile that has eVAS selected and enabled for use.

  • Power up the instrument. From the Home screen, touch More Options -> Quality Options -> Update eVAS -> Install from USB. Follow the prompts on the screens.

screen-instrument-status.jpg

evas file for download

  • APOC20240113.apkg

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COMMENTS

  1. VAS

    Use Value Assignment Sheets to locate the correct target values and ranges for your i-STAT test cartridge controls and calibration verification materials. You may also access electronic Value Assignment Sheets (eVAS) . Content on this page was updated on 12-February-2024. Find Your Value Assignment Sheet

  2. VAS

    Use the Value Assignment Sheets to locate the correct target values and ranges for your i-STAT Alinity test cartridge controls and calibration verification materials. Content on this page was updated on 17-January-2024. value assignment sheets To find the right Value Assignment Sheet, you must have:

  3. eVAS

    Electronic Value Assignment Sheets (eVAS) Streamline and simplify the liquid quality control process by using the electronic Value Assignment Sheet (eVAS) for the i-STAT System. By downloading the eVAS file, your device can be automatically updated with the latest Value Assignment Sheet data.

  4. ABBOTT I-STAT 1 SYSTEM MANUAL Pdf Download

    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 ...

  5. ABBOTT I-STAT 1 SYSTEM MANUAL Pdf Download

    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 ...

  6. VAS

    Use the Value Assignment Sheets to place to right target values and ranges for our i-STAT Alinity test cartridge controls and measurement substantiation materials. Content about this page was updated on 30-October-2023. value assignment sheets. To find the right Value Assignment Sheet, you need do:

  7. VAS

    Use the Value Assignment Pages to locate the correct target values and ranges for your i-STAT TBI Plasma cartridge checks and calibration authentication materials. Table on this turn was revised on 17-January-2024. WORTH ASSIGNMENT SHEETS Go find the right Value Assignment Sheet, yours must had:

  8. PDF The i-STAT® 1 System:

    Streamlines and simplifies the liquid quality control (QC) process—electronic value assignment sheets are now downloaded and run automatically Helps reduce risk of manual errors in the liquid QC process Liquid QC Scheduling and Lockout Ensures that QC is completed successfully and on schedule; otherwise, further patient sampling is prevented

  9. VAS

    To find who right Added Assignment Sheet, to musts have: CLEAT revision (found inside the handheld's Status Page) Control/Calibration Verification lot number located on the box (not the unique lot for anyone level located on the vials about the Verifying Verification kits) Abbott i-STAT Operating How available B-HCG Effective date: 31/08 ...

  10. Technology overview

    Cartridges can be verified on 1 representative cartridge from each new batch of cartridges and by comparing the results to the expected values published by the manufacturer in the value assignment sheets. To verify the CG4+ and CHEM8+ cartridges, level 1 (low concentration) and level 3 (high concentration) controls are used.

  11. Value Assignment Sheets

    VAS - i-STAT System | Abbott Point of Care - iStat Creatinine Liquid Control Ranges Value Assignment Sheet ... Download VAS to locate the correct target values and ranges for their i-STAT test cartridge controls and calibration verification materials.

  12. VAS

    Use Value Assignment Sheets to locate and remedy target values and ranges for your i-STAT test cartridge controls and calibration verification textiles.You may also access electronic Value Assignment Sheets (eVAS).. Content on this page was updated on 27-November-2023.

  13. VAS

    Download VAS to locate the correct target values and ranges to your i-STAT test single controls and user verification materials.

  14. VAS

    VAS - i-STAT System | Abbott Point of Care | Value Assignment Sheets - i-STAT System Download VAS to locate the correct target values and product for your i-STAT test cartridge controls and user verification materials.

  15. PDF iSTAT Cartridge Calibration Verification

    cartridge lot to the Value Assignment sheet for each cartridge type (eg) D12345 The CLEW software version on this sheet must match the CLEW i-STAT1 analyzer used for testing. 3. Prepare iSTAT for use. Test Electronic Simulator if not run within last 24hrs. Document on iSTAT Maintenance Log NCCMAF00003MULA

  16. PDF STANDARD OPERATING PROCEDURE QMS/SOP/POCT/63/3 Title: Abbott i-STAT

    Open the vial and transfer a drop of fluid into the i-STAT Total β-hCG cartridge using the vial dropper tip. Tightly recap the control vial and store it at 2-8 oC. Seal the cartridge and immediately insert into the handheld port until it clicks into place. Wait for the test to complete and review results.

  17. VAS

    Use Value Duty Sheets to locating the correct target key and ranges for your i-STAT test cartridge controls and calibration verification materials. You could also access electronic Value Assignment Sheets (eVAS). Content on this page was updated go 29-January-2024.

  18. Value Assignment Sheets

    Use Value Order Sheets to locate the valid target values and ranges for your i-STAT test cartridge controls and calibration verification materials. You can also access electronic Value Assignment Sheets (eVAS). Content go this page was updated in 11-May-2023.

  19. VAS

    Use the Value Assignment Sheets to locate the correct target values and ranges for your i-STAT TBI Plasma cartridge controls and calibration verification materials. Content on this page was updated on 17-January-2024. VALUE ASSIGNMENT SHEETS To find the right Value Assignment Sheet, you must have:

  20. i-STAT 1

    The i-STAT 1 can connect to multiple data management systems including Abbott Info HQ® or AEGISPOC TM - to integrate seamlessly with your Laboratory Information System, Electronic Medical Records or both to help you manage test results, operators and devices.

  21. eVAS

    electronic value assignment sheets (eVAS) Streamline and simplify the liquid quality control process by using the electronic Value Assignment Sheet (eVAS) for the i-STAT TBI Plasma cartridge controls and calibration verification products.

  22. Value Assignment Sheets

    Download VASS on locate the proper target values and ranges for your i-STAT take cartridge controls and calibration inspection materials.

  23. Document Library

    Document Library. Enter your keywords to quickly find the relevant. product and lot specific documentation. Eurotrol is ...