Abbott i-STAT 1 User guide

i-STAT
Important!
i-STAT®1 System Manual for Waived Tests Update
Art: 732080-00F Page 1 of 1 Rev. Date: 19-Oct-17
As of November 2017, the current i-STAT®1 System Manual for Waived Tests has been updated. Please ADD and DELETE the
sheets as listed below. Once the updates have been completed these instructions may be discarded. If you have any questions
about these instructions, please contact your i-STAT support services provider.
A ADD SHEET D DESTROY SHEET
Item Art#
AQuick Reference Guide 716942-00L
D Quick Reference Guide 716942-00K (or lower)
ASection 1 – Start-up Guide 720672-00J
D Section 1 – Start-up Guide 720672-00I (or lower)
ASection 2 – Testing Procedures for i-STAT Chemistry Cartridges 725592-00K
D Section 2 – Testing Procedures for i-STAT Chemistry Cartridges 725592-00J (or lower)
ASection 3 – System Resources 720660-00K
D Section 3 – System Resources 720660-00J (or lower)
END
© 2017
A
bbott Point of Care Inc., 100 and 200 Abbott Park Road,
A
bbott Park, Il 60064 • USA
i-STAT is a trademark of the Abbott Group of Companies in various jurisdictions.

Quick Reference Guide
for the i-STAT®1 Handheld and
i-STAT Chemistry Cartridges
For use with a CLIA Certificate of Waiver
CHEM8+
Crea
G
E3+
EC4+
6+

2
Quick Reference Guide for the i-STAT®1
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.
CLIA-waived status applies to testing performed on venous whole blood collected in
tubes with lithium heparin anticoagulant only.
Your facility must have a CLIA Certificate of Waiver in order to perform waived tests,
must meet all applicable state and local laboratory testing laws, and must follow the
manufacturer’s instructions.
You should read the complete test procedure before performing the test. See the
i-STAT System Manual for Waived Tests for complete information.
• Individual Cartridge: Must be at room temperature for at least 5 minutes before using it.
• Box of Cartridges: Must be at room temperature for at least 1 hour before using the cartridges.
• Do not remove the cartridge from the pouch until instructed to in the procedures.
Prepare the Cartridge
To scan the barcoded cartridge lot number, position the barcode 3-9 inches from laser barcode scanne r
window on the handheld. Press and hold to activate the scanner. Align the red laser light so it covers
the entire barcode. The handheld will beep when it reads the barcode successfully.
SCAN
Tear open pouch at notch.
Remove cartridge.
Always hold by sides.Place on level surface.
Scan the barcode.
Fill Mark
Tab for Snap Closure
Sample Well
(Blood or control fluid
goes here)
Cartridge Features

3
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
• Control Ampule: Must be at room temperature for at least
30 minutes before using it.
• CHEM8+ Cartridges: use the TriControl Level 1 control.
• 6+ & Crea Cartridges: use the i-STAT or TriControl Level 1
control.
• EC4+, E3+, Glucose Cartridges: use the i-STAT or TriControl
Level 3 control.
Test Control
Control Testing Procedure
Shake ampule Break ampule
MENU
1
3
1. Press to turn on handheld.
2. Press to change screen to Administration Menu.
3. Press for the Quality Tests menu.
4. Press for Control.
5. As prompted by the handheld, scan or manually enter the
Operator ID and Control Lot number.
6. Scan the barcoded cartridge lot number.
7. Remove cartridge from pouch.
8. Shake the ampule hard for 10 seconds.
9. Break the ampule open. Use an ampule breaker or
protect fingers by covering the ampule with gauze.
Continued

4
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
Fill cartridge
Fold closure
Control Testing Procedure - continued
Review Results
• Compare results on handheld to the Value Assignment
Sheet.
• If any result is out of range, repeat the control testing with
a fresh ampule and syringe.
• If any result is still out of range, do not use the cartridge
lot, and call Technical Support at 800-284-0702,
Option 1.
11. Fill the cartridge with the control fluid. Fold the
closure over the sample well until it snaps into place.
12. Push cartridge into the handheld port until it clicks into place, and do not remove until the “DO
NOT REMOVE CARTRIDGE – CARTRIDGE LOCKED” message is gone .

5
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.
• 6+, EC4+, E3+, Crea, and G: Test the sample within 30 minutes
after collecting it.
Patient Testing Procedure
1. Press to turn on handheld.
2. Press (i-STAT Cartridge).
3. As prompted by the handheld, use number
keys to enter the Operator ID and Patient ID.
4. Scan the barcoded cartridge lot number.
5. Remove cartridge from pouch.
6. Use a sample transfer device to remove some
sample from the tube. Dispense 3 drops of
sample onto a gauze pad.
7. Hold the sample transfer device over the
cartridge sample well.
Test Sample
Get sample
Fill cartridge
2
8. Dispense sample until blood reaches the
cartridge fill mark. Some blood must be left in
the cartridge well.
Continued

6
9. Fold the snap closure over the sample well until it clicks into place.
Press on the tab. Do not press directly over the sample well.
Pt: 12345
16:10 25JanYY
i-STAT CHEM8+
Na mmol/L 141
K mmol/L 4.2
Cl mmol/L 104
iCa mmol/L 1.22
TCO2mmol/L 26
Page
Pt: 12345
16:10 25JanYY
i-STAT CHEM8+
Glu mg/dL 90
BUN mg/dL 17
Crea mg/dL 1.0
Hct %PCV 42
H b g/dL 14.3
AnGap mmol/L 16
Page
If all results are not displayed on the first
screen, press to page through all
screens.
Fold closure
Insert cartridge
Review Results
• View results on the handheld.
Report results as per your
facility policy.
Patient Testing Procedure - continued
10. Push the cartridge into the handheld port until it clicks into place.
Do not remove the cartridge from the handheld until the
“DO NOT REMOVE CARTRIDGE - CARTRIDGE LOCKED” message
is gone. For Hct testing, the handheld should remain level until a
result is obtained. A level surface includes running the handheld in the
downloader/recharger.
• See i-STAT 1 System
Manual for Waived Tests
if the results are not
displayed or if results are
questioned.
11. After reviewing results, discard gloves, tube, transfer device and cartridge in
biohazard waste container.

7
Abbott Point of Care Inc.
400 College Road East
Princeton, NJ 08540
www.pointofcare.abbott
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
Cartridge Receipt
• Check the temperature strip included with each shipment.
Do not use the cartridges if the 3rd or 4th windows on the strip are colored.
Contact Technical Support at 800.284.0702, option 1.
Cartridge Storage
• Do not use the cartridges after the expiration date on the cartridge pouch and
box.
• Refrigerated Storage: 2-8 ˚C (35 to 46 ˚F)
• Room Temperature Storage: Follow instructions on the cartridge pouch
and box.
Control Storage
• Do not use controls after the expiration date on the labeling.
• Refrigerated Storage: 2-8 ˚C (35 to 46 ˚F)
• Room Temperature Storage: 18-30 ˚C (64 to 86 ˚F) for up to 5 days.
Cartridge and Control Storage
Precautions
To protect yourself and others from infection, use standard precautions
as defined by your organization or by the Occupational Safety and
Health Administration (OSHA).
A falling or dropped handheld: place handheld and peripherals on a stable
surface.
Barcode scanner: do not look into laser beam coming from scanner, or
point into eyes of someone else .
Potential Sources of
Harm to the Operator