i-STAT User Guide Rev Date 4 Feb 2016

System Components

Quality Check Messages and Codes i-STAT Cartridges

i-STAT 1 Analyzer

Electronic Simulator

i-STAT 1 Downloader

i-STAT 1 Downloader/Recharger

i-STAT Printer

Message

Cause

Action

Date Invalid, Check Clock

Date outside six month lifetime of software.

Select 5-Clock Set from Administration Menu. (Password protected.)

Dead Batteries, Replace Batteries

Insufficient power to complete a test cycle.

Replace disposable batteries or recharge the rechargeable battery.

Temperature Out of Range, Check Status page

Temperature outside operating range of 16 to 30 °C.

Check handheld temperature by pressing 1 for Analyzer Status under the Administration Menu. Move handheld to warmer area if below operating range or to cooler area if above the range.

Invalid or Expired CLEW

Software expired or corrupt.

Verify that the handheld’s date is correct. Change software if expired. Update again if not expired.

Analyzer Interrupted, Use Another Cartridge

Last cartridge run not completed.

Check the battery pack inserted properly. Check for Low Battery startup warning.

Cartridge Error

Usually problem with sample or cartridge filling.

Use another cartridge. If same code repeats more than twice, try another handheld.

Cartridge Preburst

Calibrant pack burst before cartridge inserted into handheld.

Use another cartridge - do not press on center of cartridge. Check that cartridges have not been frozen.

Unable to Position Sample

Cartridge not sealed. Clot in sample. Aberrant cartridge.

Use another cartridge.

Sample Positioned Short of Fill Mark

Cartridge underfilled.

Use another cartridge - fill to Fill Mark.

Sample Positioned Beyond Fill Mark

Cartridge overfilled.

Use another cartridge - do not fill beyond Fill Mark.

Test Cancelled by Operator

User did not respond to mandatory prompt before handheld time out.

No action required.

Cartridge Type Not Recognized

Software does not recognize cartridge.

Update software. Check to see if cartridges are expired.

For in vitro diagnostic use. See System Manual for instructions. Martel Printer

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. 2

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Replacing Paper in the i-STAT Printer 1.

Open the paper compartment lid by pulling up on the release lever and remove any remaining paper.

2.

Reel off a few centimeters of paper from the new paper roll, with the leading edge of the paper feeding forward from the bottom of the roll.

3.

Sit the new paper roll in the compartment such that the leading edge is resting outside the compartment on the printer casing.

4.

Close the lid until it snaps into place.

Blood Collection Acceptable Samples for Cartridges ■

Arterial: Plain syringe, heparinized syringe labeled for analytes to be tested and filled to capacity, or syringe with minimum volume of heparin to prevent clotting (10 U/mL of blood). For ionized calcium, use balanced heparin syringes. Mix heparinized syringes by rolling between palms for at least 5 seconds in 2 directions, then invert the syringe repeatedly for at least 5 seconds. Test for lactate immediately. Samples for pH, PCO2, PO2 , TCO2 and ionized calcium should be tested within 10 minutes. Test for other analytes within 30 minutes.

• Avoid drawing air into syringes for blood gas and ionized calcium tests. • If not tested immediately, remix and discard 2 drops of blood before filling cartridge.

• Do not use iced samples.

Troubleshooting ■

Unexpected Results When results do not reflect the patient’s condition, repeat the test using a fresh cartridge and sample. If results are still suspect, test the lot of cartridges in use with i-STAT control solutions. If the controls are in range, there may be an interfering substance in the sample. Check the Cartridge and Test Information sheets for the test in question. Test by another method to verify the result. If the controls are out of range there may be a problem with the cartridge lot number. Use another lot number or repeat the test using another method, and refer to Support Services Information in the Technical Bulletin section of the i-STAT 1 System Manual.

Venous: Collection tube with lithium or sodium heparin filled to capacity and mixed by gentle inversion at least 10 times. Test within 10 minutes.

• Do not leave tourniquet on for more than 2 minutes. • Do not draw above an I.V. ■

Skin puncture: Lithium heparin capillary tubes for testing all analytes but ionized calcium. For all analytes including ionized calcium, use plain or balanced heparin capillary tubes. Test immediately.

• Allow alcohol to dry over puncture site before collecting sample. • Do not “milk” finger or heel while collecting sample. ■

Coagulation Tests:

• The ACT test can be performed using venous or arterial samples, while the

Startup Messages

PT/INR test can be performed using capillary or venous samples.

The handheld performs self-checks when it is turned on. 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 access the Test Menu. The handheld can be customized to lock out the operator until the corrective action is taken. Message

Action

Electronic Simulator Test Required

Insert Electronic Simulator.

Stored Memory Low

Place handheld in Downloader.

Stored Memory Full

Place handheld in Downloader.

Upload Required

Place handheld in Downloader.

Battery Low

Replace batteries or recharge battery.

CLEW Expiring, Update Required

Update software.

• Use plain plastic syringes or plastic evacuated tubes with no anticoagulant, activators, or serum separators.

• Test sample immediately upon draw. • For venipuncture, some experts recommend drawing and discarding a sample of at least 1 mL prior to drawing samples for coagulation testing.

• If a second measurement is needed, draw a fresh sample. • For Indwelling line testing for ACT: a.

Fluid drip through the line must be discontinued.

b.

If blood must be drawn from an indwelling line, possible heparin contamination and specimen dilution should be considered. The line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded.

c.

Withdraw the sample into a fresh plastic syringe with no anticoagulant, and test immediately.

• For extracorporeal line testing for ACT:

14

a.

Flush the extracorporeal blood access line by withdrawing 5 mL of blood into a syringe and discard the syringe.

b.

Withdraw the sample into a fresh plastic syringe with no anticoagulant, and test immediately. 3

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a.

CHEM 8+ cartridges require the use of whole blood collected in nonheparinized capillary tubes, evacuated tubes, or syringes, as long as sample is tested immediately upon draw, or;

Placing a rechargeable battery into the recharging compartment will automatically initiate trickle recharging. The indicator light near the recharging compartment will be green when a rechargeable battery is placed in the compartment.

b.

Heparinized whole blood collected in balanced heparin syringes or capillary tubes, or;

STEP / ACTION

Heparinized whole blood collected in evacuated tubes containing lithium or sodium heparin, as long as the tubes are filled to capacity.

1

The battery pack has two labels: one for orientation in the handheld and one for orientation in the Downloader/Recharger. With the label with the Downloader facing up and the electrical contact end of the pack facing the contacts in the battery compartment, insert the pack into the compartment as shown on the label.

2

To remove the battery after it is charged, back the pack out of the compartment.

c.

■

Charging Rechargeable Battery in External Recharge Compartment

CHEM8+ Cartridges

Troponin I/cTnI, ß-hCG and CK-MB Tests a.

cTnI and CKMB cartridges require the use of heparinized whole blood or plasma samples collected in syringes or evacuated tubes containing lithium or sodium heparin and filled to capacity, or;

b.

Non-heparinized whole blood or plasma samples tested within one minute of drawing from a patient into a plastic syringe or plastic evacuated tube containing no additives.

• The use of whole blood or plasma samples containing other anticoagulants such as EDTA, oxalate, and citrate will cause deactivation of the alkaline phosphatase, resulting in decreased cTnI, ß-hCG or CK-MB readings.

Full recharge from a discharged state takes approximately 40 hours.

Caution If you are using rechargeable batteries, use only rechargeable batteries and recharging equipment supplied by your i-STAT distributor. Other batteries and rechargers may affect test results and pose other hazards to operators and patients.

• Capillary tubes and direct skin punctures (e.g., fingersticks) should not be used with the cTnI, ß-hCG or CK-MB cartridge. ■

BNP Tests

• BNP catridges require the use of EDTA whole blood or plasma samples collected

Cleaning the Handheld and Downloader Please see Section 17 of the i-STAT 1 System Manual (Routine Care of the Analyzer & Downloader) for instructions on cleaning and decontaminating the handheld and downloader.

in plastic syringes or evacuated tubes containing EDTA and filled to capacity.

• The use of whole blood or plasma samples containing other anticoagulants such as oxalate and citrate is not recommended.

Replacing Paper in the Martel Printer 1.

Squeeze the front and back of the paper cup to open.

2.

Remove remaining paper by pressing the Paper feed button. Do not pull paper through printer mechanism.

Limitations

3.

Reel off a few centimeters of paper from the new paper roll and check that the end has a clean straight edge.

Interfering substances in the patient’s sample may cause an increase or decrease in a result. Refer to the Cartridge and Test Information Sheets and Technical Bulletins for substances and/or conditions that may interfere with cartridge tests.

4.

Slide the leading edge of the paper through the paper entry slot until you feel resistance. Paper feeds from underneath the roll.

5.

Press the Paper Feed button and feed the paper through the printer mechanism.

6.

Keep the Paper Feed button depressed until the paper passes through the paper exit slot.

7.

Sit the new paper roll in the paper cup and close the lid.

• Capillary tubes and direct skin punctures (e.g., fingersticks) should not be used with the BNP cartridge.

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Procedure

Patient Test Procedures

1.

Turn the handheld on and press MENU to access the Administration Menu.

2.

Press

Cartridge Test Procedure 3 for Quality Tests. • DO NOT open cartridge pouch before scanning the barcode. 3.

Press

1

for Control.

4.

Press

1

for i-STAT Cartridge (if prompted).

5.

Scan or enter Operator ID.

6.

Enter the control lot number.

7.

Scan the lot number on the cartridge pouch.

8.

Fill a cartridge with the control and close the cover.

• Position barcode 3 - 9 inches from scanner window on the handheld.

9.

Insert the cartridge into the cartridge port.

• Press and hold

1. Press 2. Press

to turn on handheld. 2

i-STAT Cartridge.

3. Follow handheld prompts. 4. Scan the lot number on the cartridge pouch.

SCAN

to activate the scanner.

10. Enter chart page information if applicable.

• Align the red laser light so it covers entire barcode.

11. View results on handheld’s display.

• The handheld will beep when it reads the barcode successfully.

12. Remove and discard cartridge when Cartridge Locked message disappears. 13. Press 1 for Test Options on the results page and press testing another level of control.

1 for Next Level if

Laser Radiation – Do not stare into beam. Class 2 laser product. Laser Diode 650 nm Maximum Output 1.0 mW.

5. Continue normal procedures for preparing the sample, filling and sealing cartridge.

Hardware Procedures Replacing Batteries 1.

Slide the battery compartment door off.

2.

Tilt the handheld slightly to slide out the battery carrier.

3.

Remove the old batteries from the carrier and replace with 2 new 9V lithium batteries.

4.

Insert the carrier back into the compartment – label facing up and electrical contacts first.

5.

Slide the battery compartment door into place.

Charging the Rechargeable Battery Placing a handheld in a Downloader/Recharger will automatically initiate recharging of the rechargeable battery. The indicator light on top of the Downloader/Recharger will be green (trickle charge), red (fast charge), or blinking red (fast charge pending) when a handheld with a rechargeable battery is placed in the Downloader/Recharger. No damage will be caused if a handheld with disposable batteries installed is placed in the Downloader/Recharger.

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REDESIGNED CARTRIDGE

ORIGINAL CARTRIDGE

6. Push the sealed cartridge into the handheld port until it clicks into place. Wait for the test to complete. Note: For ACT, PT/INR, Hct and immunoassay testing, the handheld must remain on a level surface with the display facing up during testing. A level surface includes running the handheld in the Downloader/Recharger. 7. Review results.

5

Reviewing Test Results ■

■

4. Press 4

The 0 key can be used to backlight the display to view results in dim lighting. (The backlight turns off after 90 seconds or when the 0 key is pressed again.) Test results are displayed numerically and with bar graphs. Tick marks indicate the reference ranges on the bar graphs. (Blood gases and their associated calculated values are not displayed with bar graphs and reference ranges.)

■

Test results are displayed for 2 minutes or a customized time. To recall the last set of results to the screen, turn the handheld on and press 1 for Last Result.

■

To review results from the same patient, when results are displayed, press 1 for Test Options and then 3 for History. Scroll through test records using the 1 and 2 keys.

■

for Simulator.

5.

Scan or enter Operator ID.

6.

Enter the Simulator ID (serial number).

7.

Insert the simulator into the cartridge port.

8.

View results on handheld’s screen.

9.

If PASS is displayed, continue to use the handheld.

10. If FAIL is displayed for the external simulator, reinsert the simulator. If FAIL is displayed a second time, do not use the handheld and contact your Support Services representative.

Thermal Probes and Room Temperature Checks See System Manual for these quality assurance procedures that are performed once or twice per year.

To review another patient’s results, turn the handheld on and press the Menu key followed by the 2 key for Data Review and the 1 key for patient. Scan or enter the Patient’s ID number. Use the 1 and 2 keys to scroll through the test records. Or, press the Menu key followed by the 7 key for List. Select the test record(s) to be reviewed and press the Enter key.

Cartridge ■

Immediately check temperature strip enclosed with each shipment of cartridges. Follow the instructions on the card.

■

Verify the integrity of cartridges included in every shipment, upon receipt, by analyzing 2 levels of appropriate controls (see table below) along with a representative sample of each new lot and by comparing the results to the expected values published in the Value Assignment Sheets. Any analyzer that has passed the Electronic Simulator test may be used in the verification. Note: this information is not a manufacturer’s system instruction; it is a suggestion to comply with regulatory requirements.

Reportable and Reference Range Measured: Test

Units

Reportable Range

Reference 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 – 109

98 – 109

Glucose/Glu

mmol/L mg/dL g/L

1.1 – 38.9 20 – 700 0.20 – 7.00

3.9 – 5.8 70 – 105 0.70 – 1.05

3.9 – 5.8 70 – 105 0.70 – 1.05

Lactate/Lac

mmol/L mg/dL

0.30 – 20.00 2.7 – 180.2

0.36 – 1.25 3.2 – 11.3

Creatinine/Crea

mg/dL µmol/L

0.2 – 20.0 18 – 1768

Urea Nitrogen/BUN Urea

mg/dL mmol/L mg/dL

3 – 140 1 – 50 6 – 300

6

Verification of Cartridges Using 2 Levels of Specified Controls Cartridge Type G, Crea, E3+, EC4+, 6+, EC8+, G3+, CG4+, EG6+, EG7+, CG8+ CHEM8+

Control Type TriControls or i-STAT controls (and RNA Medical controls if testing hematocrit) ®

TriControls or CHEM8+ and RNA® Medical hematocrit controls

ACTk, ACTc

i-STAT ACT controls

PT/INR

i-STAT PT/INR controls

0.90 – 1.70 8.1 – 15.3

cTnI

i-STAT cTnI controls

CK-MB

i-STAT CK-MB controls

0.6 – 1.3 53 – 115

0.6 – 1.3 53 – 115

BNP

i-STAT BNP controls

ß-hCG

i-STAT ß-hCG controls

8 – 26 2.9 – 9.4 17 – 56

8 – 26 2.9 – 9.4 17 – 56

■

Verify that the storage conditions listed above have been maintained. 11

Transmitting Results 1.

Place handheld in Downloader or Downloader/Recharger.

2.

Do not move handheld until Communication in Progress message disappears.

Reportable and Reference Range (continued) Measured (continued): Test

Units

pH

Storage Conditions and Preparation for Use ■

Store at temperatures between 2 and 8 °C (35-46 °F). Do not use after expiration date on cartridge pouch and box.

■

Equilibrate a single cartridge for 5 minutes or a box of cartridges for 1 hour at room temperature before opening pouches.

■

Store cartridges at room temperature for the timeframe indicated on the cartridge box. Mark the cartridge box or cartridge pouches with the room temperature expiration date. Do not expose to temperatures above 30 °C (86 °F). Do not return cartridges to the refrigerator after room temperature equilibration. Use cartridge immediately after opening pouch. If the pouch has been punctured, the cartridge should not be used.

Analyzer ■

Storage/Transport temperature: -10 to 46 °C (14-115 °F).

■

The handheld’s operating temperature range is 16 to 30 °C (61-86 °F).

■

Store handhelds near the testing location or in an area close to the temperature of the testing area. Do not store handhelds near equipment that gives off heat or in direct sunlight.

Quality Assurance Handheld Electronic Simulator Perform an electronic check on each handheld in use once a day with either the internal or external Electronic Simulator or as needed for regulatory compliance. The internal simulator check is initiated, every 24 hours or according to a customized schedule, when a cartridge is inserted into the cartridge port. If the internal simulator result is PASS, the cartridge test proceeds and the simulator results are stored. If FAIL is displayed for the internal simulator, reinsert the cartridge or use an external simulator. The external simulator check is performed as follows: 1.

Turn the handheld on.

2.

Press

3.

Press

mmHg kPa

TCO2

mmol/L (mEq/L)

Reference Range (arterial) (venous)

6.50 – 8.20

7.35 – 7.45

7.31 – 7.41

5 – 130 0.67 – 17.33

35 – 45 4.67 – 6.00

41 – 51 5.47 – 6.80

5-50

23 – 27

24 – 29

(on CHEM8+ cartridge only)

Cartridges

■

PCO2

Reportable Range

MENU to access the Administration Menu.

PO2

mmHg kPa

5 – 800 0.7 – 106.6

80 – 105 10.7 – 14.0

Ionized Calcium/iCa

mmol/L mg/dL

0.25 – 2.50 1.0 – 10.0

1.12 – 1.32 4.5 – 5.3

1.12 – 1.32 4.5 – 5.3

Hematocrit/Hct

%PCV Fraction

10 – 75 0.10 – 0.75

38 – 51 0.38 – 0.51

38 – 51 0.38 – 0.51

Celite Activated Clotting Time/ Celite ACT

seconds

50 – 1000

74 – 125 (Prewarm) 74– 125 (Prewarm) 84 – 139 (Nonwarm) 84 – 139 (Nonwarm)

The range from 80 - 1000 seconds has been verified through method comparison studies. Kaolin Activated Clotting Time/ Kaolin ACT

seconds

50 – 1000

74 – 137 (Prewarm) 74 – 137 (Prewarm) 82 – 152 (Nonwarm) 82 – 152 (Nonwarm)

The range from 77 - 1000 seconds has been verified through method comparison studies Prothrombin Time / PT

INR

0.9 – 8.0

Performance characteristics have not been established for INRs above 6.0 Troponin I / cTnI

ng/mL (µg/L)

0.00 – 50.0

0.00 – 0.03* 0.00 – 0.08** Performance characteristics have not been established for cTnI values above 35.00 ng/mL. * Represents the 0 to 97.5% range of results. ** Represents the 0 to 99% range of results. Creatinine Kinase MB / CK-MB

ng/mL (µg/L)

0.0 – 150.0

0.0 – 3.5***

15 – 5000

<15 – 50#

***Represents the 0 to 95% range of results. ß-Type Natriuretic Peptide / BNP

pg/mL (ng/L)

# Represents the 0 to 95% range of results Total Beta-Human IU/L Chorionic Gonadotropin /ß-hCG

5.0 – 2000.0

<5.0

3 for Quality Tests. Celite is a registered trademark of Celite Corporation, Santa Barbara, CA. for its diatomaceous earth products.

10

7

Reportable and Reference Range (continued)

Printing Test Results from a i-STAT Printer or Martel Printer

Calculated: Test

Units

Reportable Range

Reference Range (arterial) (venous)

Hemoglobin/Hb

g/dL g/L mmol/L

3.4 – 25.5 34 – 255 2.1 –15.8

12 – 17 120 – 170 7 – 11

12 – 17 120 – 170 7 – 11

TCO2 (for all cartridges but the CHEM8+ only)

mmol/L (mEq/L)

5-50

23 – 27

24 – 29

HCO3

mmol/L (mEq/L)

1.0 – 85.0

22 – 26

23 – 28

BE

mmol/L (mEq/L)

(-30) – (+30)

(-2) – (+3)

(-2) – (+3)

Anion Gap/AnGap

mmol/L (mEq/L)

(-10) – (+99)

10 – 20

10 – 20

sO2

%

N/A

95 – 98

Test Flags and Operator Action ■

***: Results that are not reportable due to sensor errors or interfering substances. Draw a fresh sample and repeat test. If results are flagged again, send sample to the lab.

■

< , > and < >: Results that are below or above the reportable range or dependant on results that are outside the reportable range. Send sample to the lab if necessary.

■

↑ and ↓: Results that are above or below the action range. Follow facility procedure for samples with critical values.

Without Downloader or Downloader/Recharger 1.

Turn printer on if green power light is not on.

2.

Align IR windows of handheld and printer.

3.

Display results.

4.

Press

5.

Do not move handheld or printer until printing is complete.

6.

If printer is not powered from a wall outlet, turn printer off.

.

With Downloader or Downloader/Recharger 1.

Place handheld in Downloader or Downloader/Recharger that is wired to printer.

2.

Display results.

3.

Press

4.

If printer is not powered from a wall unit using the AC adapter, turn printer off.

. Do not move handheld or printer until printing is complete.

Printing more than one result 1.

Turn the handheld on.

2.

Press MENU .

3.

Press

2 for Data Review.

4.

Press

7 for List.

5.

Scroll through the test records using the ← and → keys.

6.

Press the numbered key for the test record(s). (Press the numbered key again to deselect a record.)

7.

Align handheld and printer IR window or place in Downloader or Downloader/Recharger attached to printer. Press

8

.

8.

Do not move handheld or printer until printing is complete.

9.

If printer is not powered from a wall unit using the AC adapter, turn printer off.

9