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Analyzer

System Components

2

19

Intended Use: The i-STAT 1 Wireless Analyzer is
intended for use, together with i-STAT Cartridges, 
by trained medical professionals. 

Note: UL Certification UL File Number E470709 covers
the i-STAT 1 Wireless Analyzer and the Electronic
Simulator only. 

Appendix 1:  i-STAT 1 Wireless Analyzer Labels

Note:

Pictured below are the three different labels that the i-STAT 1 Wireless

Analyzer may have.  This label can be found on the back of the analyzer.
Analyzers whose label contains a triangle in the upper right corner are referred
to as having 

Wireless Module FCC ID: PI405W (Firmware: 6.5.X.X/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:
GEXPSX.X.X/MCUX.X)

.  Analyzers whose label contains two orange

triangles, one in each of the upper corners, are referred to as having

Wireless Module FCC ID: YOPGS1500M with SHA-256 support
(Firmware: GEXPSX.X.X/MCUX.X)

.

Wireless Module FCC ID: PI405W 

(Firmware: 6.5.X.X/X.X)

Wireless Module FCC ID: YOPGS1500M without SHA-256 support

(Firmware: GEXPSX.X.X/MCUX.X)

Wireless Module FCC ID: YOPGS1500M with SHA-256 support

(Firmware: GEXPSX.X.X/MCUX.X)

i-STAT 1

Downloader

Electronic

Simulator

i-STAT Printer

Martel Printer

See System Manual for instructions.

For

in vitro

diagnostic use.

i-STAT 1

Downloader/Recharger

i-STAT Cartridges

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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