OKRA 06, Руководство пользователя

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OKRA OKRA
6 7
Important Safety Instructions
The Centers for Disease Control and Prevention (CDC) and the US Food and Drug
Administration (FDA) have become increasingly concerned about the risks for
transmitting hepatitis B virus (HBV) and other bloodborne pathogens to people
undergoing finger stick procedures for blood sampling. For instance, people with
diabetes who require assistance monitoring their blood glucose levels.
Reports of HBV infection outbreaks linked to diabetes care have been increasing.
This notice serves as a reminder that finger stick devices should never be used for
more than one person.
WARNING:
1. The OKRA Pro meter and the reusable lancing device are for single patient use only. Do not share
them with anyone including other family members. Do not use on multiple patients.
2. All parts of the kit are considered bio-hazardous and can potentially transmit infectious diseas-
es, even after you have performed cleaning and disinfection.
3. Always use a new, sterile lancet. Lancets are for single use only.
4. Please refer to page 46 and 51 for cleaning and disinfecting the OKRA Pro Blood Glucose
Monitoring System.
“FDA Public Health Notification: Use of Fingerstick Devices on More than One Person
Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication Update
11/29/2010”
http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm 224025.htm
“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