Data Management; Interfacing; Note Regarding System Reliability; Symbols - Abbott i-STAT 1 System Manual

Data Management

Test records can be transmitted to the Data Manager where they can be printed
and/or transmitted to the Laboratory Information System or Hospital Information
System. An optional portable printer enables the operator to print results at the
point of care.

Interfacing

The Data Manager can be interfaced to a Laboratory Information System (LIS) or
Hospital Information System (HIS) to automate billing and patient record keeping.
The i-STAT System automatically runs a comprehensive set of quality checks of
Note Regarding
analyzer and cartridge performance each time a sample is tested. This internal quality
System Reliability
system will suppress results if the analyzer or cartridge does not meet certain internal
specifications (see Quality Control section in System Manual for detailed information).
To minimize the probability of delivering a result with medically significant error the
internal specifications are very stringent. It is typical for the system to suppress a
very small percentage of results in normal operation given the stringency of these
specifications. If however the analyzer or cartridges have been compromised,
results may be persistently suppressed, and one or the other must be replaced to
restore normal operating conditions. Where unavailability of results while awaiting
replacement of analyzers or cartridges is unacceptable, Abbott Point of Care Inc.
recommends maintaining both a backup i-STAT System analyzer and cartridges
from an alternate lot number.

Symbols

Symbols can be helpful in reducing the necessity for translating important information
into multiple languages, particularly where space is limited. The following symbols
may be found on components of the i-STAT System.
Symbol
Attention: See instructions for use.
Caution: Risk of electrical shock.
Laser radiation hazard symbol.
Biological Risks.
Temperature limitations. The upper and lower limits for storage are adjacent to upper
and lower arms.
Upper limit of temperature.
The upper limit for storage is adjacent to the upper arm
Use by or expiration date.
An expiration date expressed as YYYY-MM-DD means the last day the product can be
used.
An expiration date expressed as YYYY-MM means the product cannot be used past the
last day of the month specified.
Art: 714363-00U
Definition
Rev. Date: 02-Aug-12
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