Arkray Assure 530001, Справочное руководство

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Introduction
The Assure® Prism multi Blood Glucose Monitoring System is intended for the quantitative
measurement of glucose in fresh capillary whole blood samples drawn from the fingertips 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 requirements
for various certification programs and agencies.
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 Technical Customer Service Department at
800.818.8877, option 5, 24 hours a day, 7 days a week.
NOTE
• This Quality Assurance/Quality Control reference manual should be used as a reference only.
It does not replace the instructions supplied with the Assure Prism multi Blood Glucose
Monitoring System, Assure Prism multi Test Strips or Assure Prism Control Solution. Please
see the instructions included with each product for additional detail.