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Calculated:

Reportable

Reference Range

Test

Units

Range

(arterial)

(venous)

Hemoglobin/Hb

g/dL

5.1 – 25.5

12 – 17

12 – 17

g/L

51 – 255

120 – 170

120 – 170

mmol/L

3.2 –15.8

7 – 11

7 – 11

TCO

2

mmol/L (mEq/L)

5-50

23 – 27

24 – 29

(for all cartridges but
the CHEM8+ only)

HCO

3

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

sO

2

%

N/A

95 – 98

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 Check

See System Manual for this quality assurance procedure that is performed every six
months.

Cartridge

n

  

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

n

  

Verify the integrity of cartridges included in every shipment, upon receipt, by
analyzing two 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.

      

This is not a manufacturer's system instruction. It is a suggestion to comply with
regulatory requirements that may pertain to your laboratory.

Test Flags and Operator Action

n

    

***:  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.

n

    

< , > 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.

n

    

and 

:  Results that are above or below the action range.  Follow facility procedure

for samples with critical values.

8

13

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         to access the Administration Menu.

3.    Press         for Quality Tests.

4.    Press         for Simulator.

5.    Scan or enter Operator ID.

6.    Enter the Simulator ID (serial number).

3

4

MENU

Summary of Contents for i-STAT

Page 1: ...AT User Guide Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Symbols Symbols can be useful in reducing the necessity for translating important information into multiple languages parti...

Page 2: ...X X where X is one digit Analyzers whose label contains two blue triangles one in each of the upper corners are referred to as having Wireless Module FCC ID YOPGS1500M without SHA 256 support Firmware...

Page 3: ...for pH PCO2 PO2 TCO2 and ionized calcium should be tested within 10 minutes Test other analytes within 30 minutes Avoid drawing air into syringes for blood gas and ionized calcium tests If not tested...

Page 4: ...lood or plasma samples collected in syringes or evacuated tubes containing lithium or sodium heparin and lled to capacity or b non heparinized whole blood or plasma samples tested within one minute of...

Page 5: ...efore scanning the barcode 1 Press to turn on handheld 2 Press i STAT Cartridge 3 Follow handheld prompts 4 Scan the lot number on the cartridge pouch Position barcode 3 9 inches from scanner window o...

Page 6: ...rge Compartment 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 r...

Page 7: ...s Represents the 0 to 99 range of results Creatinine Kinase MB ng mL g L 0 0 150 0 0 0 3 5 CK MB Represents the 0 to 95 range of results Type Natriuretic pg mL ng L 15 5000 15 50 Peptide BNP Represent...

Page 8: ...r test may be used in the veri cation This is not a manufacturer s system instruction It is a suggestion to comply with regulatory requirements that may pertain to your laboratory Test Flags and Opera...

Page 9: ...sunlight Storage Conditions and Preparation for Use Cartridges n Store at temperatures between 2 and 8 C 35 46 F Do not use after expiration date on cartridge pouch and box n Equilibrate a single cart...

Page 10: ...ote If there are unsent results remaining in the handheld at the completion of a transmission attempt a Communication Ended message will appear on the handheld indicating how many unsent results are l...

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