Quality Check Messages and Codes (continued)

i-STAT

Message Cause Action

Analyzer Error, Use Handheld detects Insert the Electronic Simulator. If
Electronic problem from which it PASS, continue to use handheld.
Simulator is likely to recover.

Analyzer Error, Handheld detects Insert Electronic Simulator. If PASS,

See Manual problem from which it insert a cartridge with sample
may not recover. or control. If the code does not
reappear, continue to use handheld.

No display Disposable batteries Change disposable batteries or

dead or rechargeable recharge battery. If still no display,
battery fully call Support Services.
discharged. Keypad
not responding. Start
switch broken.

Cartridge Locked Dead battery(s). Wait until handheld turns off. Turn
does not disappear Mechanical handheld on. If resets, remove
after test cycle problem. cartridge. If not, change or recharge
completed battery(s) and turn handheld on.

Abbott Point of Care Inc.

100 and 200 Abbott Park Road
Abbott Park, IL 60064 USA
i-STAT 1
Emergo Europe
Molenstraat 15
2513 BH The Hague
For information related to Article 33
of the EU REACH regulation
(EC No. 1907/2006), please refer
to PMIS.abbott.com. If you have
User Guide
The Netherlands issues logging into the website,
contact Abbott at: .......................
[email protected].

2016 Abbott Point of Care Inc. All rights reserved.

Printed in USA. i-STAT is a registered trademark of the
Abbott Group of Companies in various jurisdictions.
Art: 714254-00V Rev. Date: 15-Aug-16
 System Components Quality Check Messages and Codes

i-STAT Cartridges
Message Cause Action
Date Invalid, Date outside six Select 5-Clock Set from
Check Clock month lifetime of Administration Menu. (Password
software. protected.)

Dead Batteries, Insufcient power to Replace disposable batteries or

Replace Batteries complete a test cycle. recharge the rechargeable battery.

Temperature Out of Temperature outside Check handheld temperature by

Range, Check operating range of 16 pressing 1 for Analyzer Status under
Status page to 30 C. the Administration Menu. Move
i-STAT 1 Analyzer handheld to warmer area if below
operating range or to cooler area if
above the range.

Invalid or Expired Software expired or Verify that the handhelds date is

CLEW corrupt. correct. Change software if expired.
Update again if not expired.
Electronic
Simulator Analyzer Interrupted, Last cartridge run not Check the battery pack inserted
Use Another completed. properly. Check for Low Battery
Cartridge startup warning.

Cartridge Error Usually problem with Use another cartridge. If same code
sample or cartridge repeats more than twice, try another
i-STAT 1 lling. handheld.
Downloader
Cartridge Preburst Calibrant pack burst Use another cartridge - do not press
before cartridge inserted on center of cartridge. Check that
into handheld. cartridges have not been frozen.

Unable to Position Cartridge not sealed. Use another cartridge.

Sample Clot in sample.
Aberrant cartridge.
i-STAT 1
Downloader/Recharger Sample Positioned Cartridge underlled. Use another cartridge - ll to Fill
i-STAT Printer Short of Fill Mark Mark.

Sample Positioned Cartridge overlled. Use another cartridge - do not ll

Beyond Fill Mark beyond Fill Mark.

Test Cancelled by User did not respond No action required.

Operator to mandatory prompt
before handheld time
For in vitro diagnostic use. out.

Cartridge Type Not Software does not Update software. Check to see if
See System Manual for instructions. Recognized recognize cartridge. cartridges are expired.

Martel Printer

Intended Use: The i-STAT 1 Analyzer is intended for use with i-STAT cartridges
for the in vitro quantication of various analytes in whole blood.

2 15
Replacing Paper in the i-STAT Printer Blood Collection
1. Open the paper compartment lid by pulling up on the release lever and remove
Acceptable Samples for Cartridges
any remaining paper.
n Arterial: Plain syringe, heparinized syringe labeled for analytes to be tested and lled to
2. Reel off a few centimeters of paper from the new paper roll, with the leading capacity, or syringe with minimum volume of heparin to prevent clotting (10 U/mL of
edge of the paper feeding forward from the bottom of the roll. 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
3. Sit the new paper roll in the compartment such that the leading edge is resting
repeatedly for at least 5 seconds. Test for lactate immediately. Samples for pH, PCO2,
outside the compartment on the printer casing.
PO2 , TCO2 and ionized calcium should be tested within 10 minutes. Test for other analytes
4. Close the lid until it snaps into place. 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 lling
cartridge.
Do not use iced samples.
Troubleshooting
n Venous: Collection tube with lithium or sodium heparin lled to capacity and mixed
Unexpected Results by gentle inversion at least 10 times. Test within 10 minutes.
Do not leave tourniquet on for more than 2 minutes.
When results do not reect the patients condition, repeat the test using a fresh cartridge
Do not draw above an I.V.
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 n Skin puncture: Lithium heparin capillary tubes for testing all analytes but ionized
sample. Check the Cartridge and Test Information sheets for the test in question. Test calcium. For all analytes including ionized calcium, use plain or balanced heparin
by another method to verify the result. If the controls are out of range there may be a capillary tubes. Test immediately.
problem with the cartridge lot number. Use another lot number or repeat the test using Allow alcohol to dry over puncture site before collecting sample.
another method, and refer to Support Services Information in the Technical Bulletin
Do not milk nger or heel while collecting sample.
section of the i-STAT 1 System Manual.
n 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 Use plain plastic syringes or plastic evacuated tubes with no anticoagulant,
corrected in the near future, but that will not affect results, is detected, a warning is activators, or serum separators.
displayed. The operator presses the 1 key to access the Test Menu. The handheld can Test sample immediately upon draw.
be customized to lock out the operator until the corrective action is taken.
For venipuncture, some experts recommend drawing and discarding a sample of
at least 1 mL prior to drawing samples for coagulation testing.
Message Action
If a second measurement is needed, draw a fresh sample.
Electronic Simulator Test Required Insert Electronic Simulator.
For Indwelling line testing for ACT:
Stored Memory Low Place handheld in Downloader. a. Fluid drip through the line must be discontinued.
Stored Memory Full Place handheld in Downloader. b. If blood must be drawn from an indwelling line, possible heparin contamination
and specimen dilution should be considered. The line should be ushed
Upload Required Place handheld in Downloader. with 5 mL of saline and the rst 5 mL of blood or six dead space volumes
should be discarded.
Battery Low Replace batteries or recharge battery.
c. Withdraw the sample into a fresh plastic syringe with no anticoagulant, and
CLEW Expiring, Update Required Update software. test immediately.
For extracorporeal line testing for ACT:
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.
14 3
n CHEM8+ Cartridges Charging Rechargeable Battery in External Recharge Compartment
a. CHEM 8+ cartridges require the use of whole blood collected in non- Placing a rechargeable battery into the recharging compartment will automatically initiate
heparinized evacuated tubes or syringes, as long as sample is tested trickle recharging. The indicator light near the recharging compartment will be green when a
immediately upon draw, or; rechargeable battery is placed in the compartment.
b. Heparinized whole blood collected in balanced heparin syringes or capillary
tubes, or; STEP / ACTION
c. Heparinized whole blood collected in evacuated tubes containing lithium
heparin, as long as the tubes are lled 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
n
up and the electrical contact end of the pack facing the contacts in the battery
Troponin I/cTnI and CK-MB Tests
compartment, insert the pack into the compartment as shown on the label.
a. cTnI and CKMB cartridges require the use of heparinized whole blood or 2 To remove the battery after it is charged, back the pack out of the compartment.
plasma samples collected in syringes or evacuated tubes containing lithium
or sodium heparin and lled to capacity, or; Full recharge from a discharged state takes approximately 40 hours.
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 Caution
containing no additives.
If you are using rechargeable batteries, use only rechargeable batteries and recharging
The use of whole blood or plasma samples containing other anticoagulants such as equipment supplied by your i-STAT distributor. Other batteries and rechargers may affect test
EDTA, oxalate, and citrate will cause deactivation of the alkaline phosphatase, results and pose other hazards to operators and patients.
resulting in decreased cTnI or CK-MB readings.
Capillary tubes and direct skin punctures (e.g., ngersticks) should not be used
with the cTnI or CK-MB cartridge. Cleaning the Handheld and Downloader

n
Please see Section 17 of the i-STAT 1 System Manual (Routine Care of the Analyzer &
BNP Tests
Downloader) for instructions on cleaning and decontaminating the handheld and
BNP catridges require the use of EDTA whole blood or plasma samples collected downloader.
in plastic syringes or evacuated tubes containing EDTA and lled to capacity.
The use of whole blood or plasma samples containing other anticoagulants such Replacing Paper in the Martel Printer
as oxalate and citrate is not recommended.
1. Squeeze the front and back of the paper cup to open.
Capillary tubes and direct skin punctures (e.g., ngersticks) should not be used
with the BNP cartridge. 2. Remove remaining paper by pressing the Paper feed button. Do not pull paper
through printer mechanism.
n Total -hCG Tests 3. Reel off a few centimeters of paper from the new paper roll and check that the
Total -hCG cartridges require the use of heparinized whole blood or plasma end has a clean straight edge.
samples collected in plastic syringes or evacuated tubes containing lithium or 4. Slide the leading edge of the paper through the paper entry slot until you feel
sodium heparin and lled to capacity. resistance. Paper feeds from underneath the roll.
The use of whole blood or plasma samples containing other anticoagulants such
5. Press the Paper Feed button and feed the paper through the printer mechanism.
as EDTA, oxalate and citrate will cause deactivation of the alkaline phosphatase,
resulting in decreased Total -hCG readings. 6. Keep the Paper Feed button depressed until the paper passes through the
paper exit slot.

Limitations 7. Sit the new paper roll in the paper cup and close the lid.

Interfering substances in the patients 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 13
Procedure Patient Test Procedures
1. Turn the handheld on and press MENU to access the Administration Menu.
Cartridge Test Procedure
2. Press 3 for Quality Tests.
DO NOT open cartridge pouch before scanning the barcode.
3. Press 1 for Control.
1. Press to turn on handheld.

4. Press 1 for i-STAT Cartridge (if prompted). 2. Press 2 i-STAT Cartridge.

5. Scan or enter Operator ID. 3. Follow handheld prompts.

6. Enter the control lot number.
4. Scan the lot number on the cartridge pouch.
7. Scan the lot number on the cartridge pouch.
Position barcode 3 - 9 inches from scanner
8. Fill a cartridge with the control and close the cover. window on the handheld.

9. Insert the cartridge into the cartridge port. Press and hold 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 handhelds display. The handheld will beep when it reads the
barcode successfully.
12. Remove and discard cartridge when Cartridge Locked message disappears.
Laser Radiation Do not stare into beam. Class 2 laser product.
Laser Diode 650 nm Maximum Output 1.0 mW.
13. Press 1 for Test Options on the results page and press 1 for Next Level if
testing another level of control.

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 rst.

5. Slide the battery compartment door into place.

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

No damage will be caused if a handheld with disposable batteries installed is placed in 7. Review results.
the Downloader/Recharger.

12 5
Reviewing Test Results 4. Press 4 for Simulator.
n The 0 key can be used to backlight the display to view
5. Scan or enter Operator ID.
results in dim lighting. (The backlight turns off after 90
seconds or when the 0 key is pressed again.) 6. Enter the Simulator ID (serial number).
n Test results are displayed numerically and with bar graphs. 7. Insert the simulator into the cartridge port.
Tick marks indicate the reference ranges on the bar 8. View results on handhelds screen.
graphs. (Blood gases and their associated calculated
values are not displayed with bar graphs and reference 9. If PASS is displayed, continue to use the handheld.
ranges.) 10. If FAIL is displayed for the external simulator, reinsert the simulator.
n Test results are displayed for 2 minutes or a customized If FAIL is displayed a second time, do not use the handheld and contact your
time. To recall the last set of results to the screen, turn the Support Services representative.
handheld on and press 1 for Last Result.
Thermal Probes and Room Temperature Checks
n To review results from the same patient, when results are
displayed, press 1 for Test Options and then 3 for History. See System Manual for these quality assurance procedures that are performed once or
Scroll through test records using the 1 and 2 keys. twice per year.

n To review another patients results, turn the handheld on

and press the Menu key followed by the 2 key for Data Cartridge
Review and the 1 key for patient. Scan or enter the n Immediately check temperature strip enclosed with each shipment of cartridges.
Patients ID number. Use the 1 and 2 keys to scroll Follow the instructions on the card.
through the test records. Or, press the Menu key followed
by the 7 key for List. Select the test record(s) to be n Verify the integrity of cartridges included in every shipment, upon receipt, by
reviewed and press the Enter key. 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 verication.
* This information is not a manufacturers system instruction. It is a suggestion to
Reportable and Reference Range comply with regulatory requirements that may pertain to your laboratory.

Measured:
Reportable Reference Range Verification of Cartridges Using 2 Levels of Specified Controls
Test Units Range (arterial) (venous) Cartridge Type Control Type

Sodium/Na mmol/L (mEq/L) 100 180 138 146 138 146 G, Crea, E3+, EC4+, TriControls
6+, EC8+, G3+, CG4+, or

Potassium/K mmol/L (mEq/L) 2.0 9.0 3.5 4.9 3.5 4.9 EG6+, EG7+, CG8+ i-STAT controls (and RNA Medical controls if testing hematocrit)
CHEM8+ TriControls
Chloride/Cl mmol/L (mEq/L) 65 140 98 109 98 109 or
CHEM8+ and RNA Medical hematocrit controls
Glucose/Glu mmol/L 1.1 38.9 3.9 5.8 3.9 5.8
mg/dL 20 700 70 105 70 105 ACTk, ACTc i-STAT ACT controls
g/L 0.20 7.00 0.70 1.05 0.70 1.05 PT/INR i-STAT PT/INR controls
Lactate/Lac mmol/L 0.30 20.00 0.36 1.25 0.90 1.70 cTnI i-STAT cTnI controls
mg/dL 2.7 180.2 3.2 11.3 8.1 15.3
CK-MB i-STAT CK-MB controls
Creatinine/Crea mg/dL 0.2 20.0 0.6 1.3 0.6 1.3 BNP i-STAT BNP controls
mol/L 18 1768 53 115 53 115
-hCG i-STAT -hCG controls

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

6 11
 Transmitting Results Reportable and Reference Range (continued)

1. Place handheld in Downloader or Downloader/Recharger. Measured (continued): Reportable Reference Range

2. Do not move handheld until Communication in Progress message Test Units Range (arterial) (venous)
disappears.
pH 6.50 8.20 7.35 7.45 7.31 7.41
PCO2 mmHg 5 130 35 45 41 51
kPa 0.67 17.33 4.67 6.00 5.47 6.80
TCO2 mmol/L (mEq/L) 5-50 23 27 24 29
(on CHEM8+ cartridge only)
Storage Conditions and Preparation for Use
PO2 mmHg 5 800 80 105
Cartridges kPa 0.7 106.6 10.7 14.0
n Store at temperatures between 2 and 8 C (35-46 F). Do not use after expiration Ionized Calcium/iCa mmol/L 0.25 2.50 1.12 1.32 1.12 1.32
date on cartridge pouch and box. mg/dL 1.0 10.0 4.5 5.3 4.5 5.3

n
Urea Nitrogen/BUN mg/dL 3 140 8 26 8 26
Equilibrate a single cartridge for 5 minutes or a box of cartridges for 1 hour at room Urea mmol/L 1 50 2.9 9.4 2.9 9.4
temperature before opening pouches. mg/dL 6 300 17 56 17 56

n Store cartridges at room temperature for the timeframe indicated on the cartridge box. Hematocrit/Hct %PCV 15 75 38 51 38 51
Mark the cartridge box or cartridge pouches with the room temperature expiration date. Fraction 0.15 0.75 0.38 0.51 0.38 0.51
Do not expose to temperatures above 30 C (86 F). Do not return cartridges to the
refrigerator after room temperature equilibration. Celite Activated seconds 50 1000 74 125 (Prewarm) 74 125 (Prewarm)
Clotting Time/ 84 139 (Nonwarm) 84 139 (Nonwarm)
n
Celite
Use cartridge immediately after opening pouch. If the pouch has been punctured, ACT
the cartridge should not be used. The range from 80 - 1000 seconds has been veried through method comparison studies.

Kaolin Activated seconds 50 1000 74 137 (Prewarm) 74 137 (Prewarm)

Analyzer Clotting Time/ 82 152 (Nonwarm) 82 152 (Nonwarm)
n
Kaolin
Storage/Transport temperature: -10 to 46 C (14-115 F). ACT
The range from 77 - 1000 seconds has been veried through method comparison studies
n The handhelds operating temperature range is 16 to 30 C (61-86 F).
Prothrombin Time / PT INR 0.9 8.0
n Store handhelds near the testing location or in an area close to the temperature of Performance characteristics have not been established for INRs above 6.0
the testing area. Do not store handhelds near equipment that gives off heat or in Troponin I / cTnI ng/mL (g/L) 0.00 50.0 0.00 0.03*
direct sunlight. 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.
Quality Assurance ** Represents the 0 to 99% range of results.
Handheld
Creatinine Kinase MB ng/mL (g/L) 0.0 150.0 0.0 3.5***
Electronic Simulator / CK-MB
Perform an electronic check on each handheld in use once a day with either the internal or
***Represents the 0 to 95% range of results.
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 -Type Natriuretic pg/mL (ng/L) 15 5000 <15 50#
inserted into the cartridge port. If the internal simulator result is PASS, the cartridge test Peptide / BNP
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 # Represents the 0 to 95% range of results
as follows:
Total Beta-Human IU/L 5.0 2000.0 <5.0
1. Turn the handheld on. Chorionic Gonadotropin
2. Press MENU to access the Administration Menu. /-hCG

3. Press 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:
Reportable Reference Range Without Downloader or Downloader/Recharger
Test Units Range (arterial) (venous)
1. Turn printer on if green power light is not on.
Hemoglobin/Hb g/dL 5.1 25.5 12 17 12 17
2. Align IR windows of handheld and printer.
g/L 51 255 120 170 120 170
mmol/L 3.2 15.8 7 11 7 11
3. Display results.
TCO2 mmol/L (mEq/L) 5-50 23 27 24 29
(for all cartridges but 4. Press .
the CHEM8+ only)
5. Do not move handheld or printer until printing is complete.
HCO3 mmol/L (mEq/L) 1.0 85.0 22 26 23 28 6. If printer is not powered from a wall outlet, turn printer off.
BE mmol/L (mEq/L) (-30) (+30) (-2) (+3) (-2) (+3)

Anion Gap/AnGap mmol/L (mEq/L) (-10) (+99) 10 20 10 20 With Downloader or Downloader/Recharger

sO2 % N/A 95 98
1. Place handheld in Downloader or Downloader/Recharger that is wired to printer.

2. Display results.

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

Test Flags and Operator Action 4. If printer is not powered from a wall unit using the AC adapter, turn printer off.
n ***: Results that are not reportable due to sensor errors or interfering substances.
Draw a fresh sample and repeat test. If results are agged again, send sample to
the lab. Printing more than one result
n < , > and < >: Results that are below or above the reportable range or dependant on 1. Turn the handheld on.
results that are outside the reportable range. Send sample to the lab if necessary.
n and : Results that are above or below the action range. Follow facility procedure 2. Press MENU .
for samples with critical values.
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. 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.

8 9