Operating precautions, Limitations – ITC Hemochron Signature+ Whole Blood Microcoagulation System User Manual

Page 22

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OPERATING PRECAUTIONS
The AC/DC Power Module should be plugged into a standard AC outlet to charge the instrument when it is
not in use.
DO NOT remove the AC/DC Power Module from the instrument by pulling on the cord. Although the AC/DC
Power Module can be left plugged into an AC outlet when the instrument is unplugged, it is recommended
that the AC/DC Power Module be unplugged from the AC outlet when it is not being used to charge the
instrument.
DO NOT use cuvettes that are past their marked expiration date or which have been improperly stored.
DO NOT force a cuvette into the instrument. If resistance to insertion is encountered, gently remove the
cuvette and examine the cuvette slot. Remove any obstruction before attempting further use of the
instrument (see Service and Maintenance on page 48).
DO NOT use excessive force in pressing the instrument keys.
DO NOT expose the instrument to extreme temperatures (above 37 °C).
DO NOT drop the instrument.
The HEMOCHRON Jr. Signature+ instrument should only be used by healthcare professionals trained and
certified in the use of the system and operated in accordance with facility policies and procedures.
All biohazard safety guidelines pertaining to the handling and disposal of human blood should be strictly
adhered to when collecting and handing blood specimens and when operating the HEMOCHRON Jr.
Signature+ Microcoagulation instrument.
Used HEMOCHRON Jr. test cuvettes should be considered as potentially infectious. They should be handled
according to individual institutional policies concerning the disposal of potentially infectious materials.
HEMOCHRON Jr. Signature+ test results should always be scrutinized in light of a specific patient’s
condition or anticoagulant therapy. Any test results exhibiting inconsistency with the patient’s clinical status
should be repeated or supplemented with additional diagnostic tests. Samples with a hematocrit less than
20% or greater than 55% are not recommended, due to an optical density outside the detection level of the
HEMOCHRON Jr. Signature+ Microcoagulation instrument.

CAUTION: Verify that any third-party connectivity software to be used is compatible with the
software version of the HEMOCHRON Signature+ instrument in use. Transferred data will be
lost if third-party connectivity software is used with non-compatible versions of HEMOCHRON
Signature+ software.

LIMITATIONS
Test results of the HEMOCHRON Jr. Signature+ Microcoagulation instrument are affected by poor
technique during blood collection and delivery to the sample well. The accuracy of the test is largely
dependent upon the quality of the blood specimen, including the blood sample collection and the transfer
of blood to the test cuvette. Refer to the individual assay package insert for specific limitations.

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