i
Introduction
The Assure
®
Prism multi Blood Glucose Monitoring System is intended for the quantitative
measurementofglucoseinfreshcapillarywholebloodsamplesdrawnfromthengertips
and alternative sites such as the forearm, palm, thigh and calf.
Alternative site testing should be used only during steady-state blood glucose conditions.
The system is intended for use outside the body (in vitro) and is intended for multiple-patient
use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes
control. This system is only to be used with an auto-disabling, single-use lancing device. It is
not intended for use on neonates and is not intended for the diagnosis or screening of diabetes.
This comprehensive manual has been designed to be a thorough reference source for the
Assure
Prism multi Blood Glucose Monitoring System and includes:
• Product operations
• Training and in-services
• Guidelines for policies and procedures
• Quality Assurance/Quality Control (QA/QC) programs
• Reviews of regulatory materials
All of these materials have been designed to assist you in meeting the necessary
requirementsforvariouscerticationprogramsandagencies.
We trust that this Quality Assurance/Quality Control manual will provide you with the needed
support tools for your blood glucose monitoring program. If you have any questions after
receiving the manual, please call ARKRAY’s Customer Service Department at 800.818.8877,
24 hours a day, 7 days a week, USA and Canada.