Dialab GmbH
Operator's Manual DIAcheck series Rev-4 Page 16
1.5.3 SAFETY INFORMATION REGARDING RISK OF HEALTH
Bleeding or Thrombosis
Diagnosis and medication of human coagulation system based on false
results may lead to critical bleeding or thrombosis. For risk reduction it is
essential to follow the hints below.
Regarding risks:
Caused by faulty condition of the instrument, reagent or calibration data:
Perform a quality control before running a series of patient samples or after
reconstitution of a vial or after test calibration to eliminate failure of
theinstrument, reagent or calibration data.
Caused by imprecise pipet:
Validate your pipette every year and label it with the last date of validation.
Caused by false assignment of target values:
Run interlaboratory quality control standards.
Caused by purified water:
Use only high purified water to reconstitute controls or reagents. Check
visualy that the water is free of any particles.
Caused by expired reagent:
Do not use IVD reagents or other materials after their expiry date.
Consider all
surfaces and materials which might be in contact with plasma or
other biological liquid as potentially contaminated with infectious material.
Avoid contact:
Wear medical infection grade protective gloves for all works involving
potential contact with infe
ctious material and use each pair of gloves only.
Use a hand disinfectant product, e.g. Sterillium
®
, to disinfect your hands after
completion of the work.
Dispose:
Dispose i
nfectious materials, such as cuvette waste and liquid waste, in
compliance with your local regulations governing for infectious materials.
Hygienic conditions:
Validate your hygienic management system according to German GLP federal
bureau for good laboratory practice or similar quality standard. Any waste
material must be
considered as potentially infectious. Direct contact must be
avoided. Protective gloves during operation, service or cleaning are required.
Avoid direct eye exposure.
The internal CCD barcode scanner is assigned to
EN 55022:2010 class B, EN 62471:2008.
To Next Page
Loading...
