Abbott I-STAT 1 Guida utente

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

bbott Point of Care Inc., 100 and 200 Abbott Park Road,

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

E3+

EC4+

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

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

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

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.

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

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

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.

Hold the sample transfer device over the

cartridge sample well.

Test Sample

Get sample

Fill cartridge

8. Dispense sample until blood reaches the

cartridge fill mark. Some blood must be left in

the cartridge well.

Continued

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.

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

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