ITC VerifyNow System Platelet Reactivity Test - Manual (Page 17)

Page 13 14439.C 03/2013
Precautions - 3
VerifyNow System User Manual | USA
3 Precautions
This section provides an overview of safe operating procedures and identifies potential hazards when
operating the VerifyNow instrument.
3.1 Safe Operating Procedures
The VerifyNow System is for in vitro diagnostic use only. Read the contents of this user manual
completely. The VerifyNow instrument and its components should only be used as directed in this
user manual. In particular, observe the following guidelines when collecting and handling samples and
operating the instrument:
3.1.1 Sample Collection and Handling
All patient samples should be handled as if capable of transmitting disease. Always follow Universal
Precautions 1 to minimize the risk of exposure to biohazardous blood products.
WARNING: Samples should be treated as biohazardous material
and handled according to your institution’s policies.
3.1.2 Instrument Operation
Operating the instrument involves the use of reagents and blood samples. The test device reagents are
manufactured with a material purified from human plasma that was found negative for all communicable
diseases tested, including HIV-1, HIV-2, Hepatitis B surface antigen (Hb
s
Ag) and HCV.
WARNING: Handle test devices and sample tubes as
biohazardous material and dispose of in an appropriate manner.
Observe the following guidelines to ensure the safe operation of the VerifyNow instrument, and to limit
operator exposure:
• Always follow Universal Precautions and your organization’s safety protocols when working around
the VerifyNow instrument to minimize the risk of exposure to biohazardous blood products.
• Do not insert fingers or anything other than a test device, cleaning device or EQC device into the
test device port of the VerifyNow instrument.
• The test device sample well contains a sharp needle. Do not insert fingers or anything other than a
sample tube into the sample well.
• The VerifyNow instrument operates with the test device under pressure once a test has begun. Do
not remove the test device or tube from the instrument until the test has completed.
• Do not remove sample tubes from used test devices. Discard used test devices and attached
sample tubes as a single unit.