User's Guide

Biological safety:

• Always follow the safety procedures and precautions listed here and

throughout this user guide, plus those adopted by your healthcare

facility.

• Xprecia Prime™ should only be used by operators trained in handling

biohazardous materials. Parts of the Xprecia Prime™ meter could

become contaminated during testing and thus capable of transmitting

blood-borne pathogens between patients and healthcare professionals.

For more information, consult:

o “FDA Public Health Notification: Use of Fingerstick Devices on More

than One Person Poses Risk for Transmitting Bloodborne Pathogens:

Initial Communication” (2010),

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm2

24025.htm

o “Protection of Laboratory Workers From Occupationally Acquired

Infections; Approved Guideline-Fourth Edition”, Clinical and

Laboratory Standards Institute (CLSI) M29-A4.

o “Guideline for Isolation Precautions: Preventing Transmission of

Infectious Agents in Healthcare Settings 2007”,

http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html

o “CDC Clinical Reminder: Use of Fingerstick Devices on More than One

Person Poses Risk for Transmitting Bloodborne Pathogens”, (2010),

http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

o Biosafety in Microbiological and Biomedical Laboratories (BMBL)

found at http://www.cdc.gov/biosafety/publications/bmbl5/

• Each LQC kit makes use of human source material. Each donor or donor

unit was tested and found to be negative for human immunodeficiency

virus (HIV) 1 and 2, hepatitis B virus (HBV), and hepatitis C virus (HCV)

using tests that conform with the In Vitro Diagnostic Directive of the EU

or are approved by the FDA. Because no known test can offer complete

assurance of the absence of infectious agents, all human-derived

products—such as the lyophilized plasma in this kit—should be handled

with appropriate caution.