ITC ProTime Microcoagulation System - Manual (Page 6)

6
Operating Precautions
• For in vitro Diagnostic Use.
• The ProTime instrument is designed for use only with ProTime cuvettes.
• The ProTime instrument will not perform a test if the cuvette is past its expiration date or has been
improperly stored.
• The ProTime instrument is designed to be used for testing in a stationary position. DO NOT perform
testing while carrying or holding the instrument.
• In order to charge the ProTime instrument, the AC power cord should be plugged into an electrical
service outlet and the AC/DC power module while the DC power cord from the AC/DC power module is
plugged into the DC port in the back of the ProTime instrument.
• DO NOT expose the ProTime instrument to extreme temperature (above 35°C, 95°F). Such exposure
could affect the performance of any type of electronic instrumentation.
• DO NOT drop the ProTime instrument, and do not use the results if the instrument is dropped during
a test.
• DO NOT attempt to open the ProTime instrument other than for battery replacement, as there are no
user-serviceable parts.
• DO NOT remove the AC/DC power module from the ProTime instrument by pulling on the cord.
Patient specimens and used cuvettes are potentially infectious. The cuvettes include materials that have
been prepared from human plasma or serum that has been tested using US FDA recognized methods and
found to be non-reactive for HIV antibody and for hepatitis B surface antigen. Handle with appropriate care and
dispose of cuvettes and blood collection materials in accordance with standard methods of biohazard control.
The use of accessory equipment (e.g., printers, etc.) not identified in this manual either in the patient
vicinity, or that does not comply with either the equivalent safety requirements of this equipment or
UL/IEC 60601-1 or IEC 60601-1-2, may lead to a reduced level of safety with the resulting system.
Limitations
• The ProTime instrument uses only fresh capillary or venous whole blood. Plasma or serum cannot be
used. Glass tubes or syringes must not be used to collect venous samples. Use only plastic syringes
without anticoagulants to collect venous samples. Poor fingerstick blood collection technique may
affect results.
• In clinical trials, no significant difference was observed between fingerstick and venous specimens run
on ProTime. During those trials, ProTime measured patients with an INR range of 0.8 to 7.0.
ProTime is programmed to calculate and report INR results as follows:
If the calculated INR is: Then ProTime displays:
< 0.6 INR LOW
0.6 - 0.79 INR < 0.8
0.8 - 7.0 Result
7.1 - 9.9 Result - followed by "*"
10.0 - 12.0 INR > 9.9
> 12.0 INR HIGH
• Results may be affected in patients receiving heparin or who have an abnormal response to heparin.
• Correlation of results reported by the ProTime instrument to laboratory results depends on the precision
of the laboratory method and on the ISI value of the laboratory reagent and instrument system.
• Do not disturb instrument while test is in progress.
As with all diagnostic tests, ProTime Microcoagulation System test results should be scrutinized in light of a
specific patient’s condition and anticoagulant therapy. Any results exhibiting inconsistency with the
patient’s clinical status should be repeated or supplemented with additional test data.
Follow doctor’s instructions if you have difficulty performing the test or receive a result outside of the
prescribed therapeutic range.