5
Notification: “Use of Fingerstick Devices on More than One Person Poses Risk
for Transmitting Bloodborne Pathogens: Initial Communication” (2010) at
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
You may also refer to the CDC Clinical Reminder: “Use of Fingerstick Devices
on More than One Person Poses Risk for Transmitting Bloodborne Pathogens”
(2010) at http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.
Limitations
•
Very high (above 70%) and very low (below 20%) hematocrit levels can
cause false results. Talk to your health care professional to find out your
hematocrit level.
•
If you are taking vitamin C (ascorbic acid > 3 mg/dL) then your glucose
results using this meter may not be reliable.
•
The system is tested to accurately read the measurement of glucose in
whole blood within the range of 45 to 600 mg/dL.
•
The VivaChek™ Ino Plus Blood Glucose Monitoring System has been
tested and shown to work properly up to 13123ft.
•
Critically ill patients should not be tested with this system.
•
Patient who is taking oxygen therapy is not recommended for testing with
VivaChek™ Ino Plus Blood Glucose Monitoring System.
•
Blood samples from patients in shock, or with severe dehydration or from
patients in a hyperosmolar state (with or without ketosis) have not been
tested and are not recommended for testing with VivaChek™ Ino Plus Blood
Glucose Monitoring System.
•
The VivaChek™ Ino Plus Blood Glucose Monitoring System should not be
used following xylose absorption procedures.
•
Not for neonatal use.
•
Not for screening or diagnosis of diabetes mellitus.
Note: This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause
undesired operation.
Please note that changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
Note: This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of
the following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver
is connected.
Consult the dealer or an experienced radio/TV technician for help.
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