SD Biosensor SD Gluco Navii Guía de referencia
Thank you for purchasing the SD Gluco Navii™ Blood Glucose Monitoring System.
This manual provides important information to help you to use the system properly.
Before using this product, please read the following contents thoroughly and carefully.
Please note that the following procedures are provided only as an example to help your
facility establish its own policy and procedures. Your own policy may differ. Please
consult with your director of nursing or administrator for further guidance.
For Questions Regarding Gluco Navii™
CALL (949) 753 - 0001
or
(888) 425 - 1149
CAUTION: Please carefully read the User’s Manual and all product instructions
before using the Gluco Navii™ Blood Glucose Meter.
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TABLE OF CONTENTS
Important Safety Precautions
Precautions & Limitations Interfering Substances
Before you begin
Intended Use
Test Principle
Alternative Site Testing
Meter Setup / Programming
Performing a Blood Glucose Test
Test Results
Using the Meter Memory to Review Results
Maintenance
Screen Messages and Troubleshooting
Warnings, Precautions and Limitations
System Specications
Electromagnetic Compatibility
Performance Characteristics
Training Tools
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4
5
5
6
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8
15
17
18
20
26
28
29
29
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32
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IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
Users need to adhere to Standard Precautions when handling or using this device. All
parts of the glucose monitoring system should be considered potentially infectious and
are capable of transmitting blood-borne pathogens between patients and healthcare
professionals. For more information, refer to “Guideline for Isolation Precautions:
Preventing Transmission of Infectious Agents in Healthcare Settings 2007”,
http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html.
WARNING
The GlucoNavii™ meter should be disinfected after use on each patient. The
Gluco Navii™ Blood Glucose Monitoring System may only be used for testing multiple
patients when Standard Precautions and the Manufacturer’s Disinfection Procedures
are followed. WHEN USED FOR TESTING MULTIPLE PATIENTS THE METER MUST
BE CLEANED/DISINFECTED AFTER USE ON EACH PATIENT.
WARNING
Only auto-disabling, single use lancing devices should be used with this device.
DO NOT USE REUSABLE LANCING DEVICES WITH THE Gluco Navii™
PRODUCT.
1. Use this device ONLY for the intended use, described in this manual.
2. DO NOT use accessories which are not specied by the manufacturer.
3. DO NOT use the device if it is not working properly or if it is damaged.
4. DO NOT under any circumstances use the device on neonates or infants.
5. This device does NOT serve as a treatment or a cure for any symptom or disease.
The data measured is for reference only.
6. Before using this device to test blood glucose, read all instructions thoroughly and
practice performing a test. Carry out all the quality control checks as directed.
7. Keep the device and testing equipment away from young children. Small items such
as the battery cover, batteries, test strips, lancets, vials and vial caps are choking
hazards.
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PRECAUTIONS & LIMITATIONS
INTERFERING SUBSTANCES
Interfering substances depend on the concentration. The interfering substances listed
below may produce elevated glucose test results (at or above the concentration levels
noted).
Regulatory Requirements
The Clinical Laboratory Improvement Amendments (CLIA) has classied tests of blood
glucose as tests that are waived. For all entities that conduct one or more tests,
including waived tests on materials derived from the human body for the purpose of
providing information for the diagnosis, prevention or treatment of any disease or
impairment of, or the assessment of the health of human beings, CLIA has stated that
the entity conducting the tests shall meet certain Federal requirements. If any entity
conducts tests for the aforementioned purposes, then the entity, under CLIA, is
considered to be a laboratory and thus must register with the CLIA Program.
KEEP THESE INSTRUCTIONS
IN A SAFE PLACE
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BEFORE YOU BEGIN
Severe dehydration and excessive water loss may cause readings which are lower
than actual values. If the patient is suffering from severe dehydration, consult a
healthcare professional immediately.
If the patient’s blood glucose results are lower or higher than usual, and they do not
have any symptoms of illness, repeat the test. If the patient has symptoms or
continues to get results which are higher or lower than usual, follow the treatment
advice of the healthcare professional.
Use only fresh whole blood samples to test patient’s blood glucose. Using other
substances will lead to incorrect results.DO NOT use Gluco Navii™ to test
serum, plasma or stored whole blood.
If the patient has symptoms that are inconsistent with the blood glucose test results
and you have followed all the instructions given in this owner’s manual, contact a
healthcare professional.
We do not recommend using this product on severely hypotensive individuals or
patients in shock. Readings which are lower than actual values may occur for
individuals experiencing a hyperglycaemic-hyperosmolar state, with or without ketosis.
Please consult the healthcare professional before use.
INTENDED USE
SD GlucoNavii™ blood glucose monitoring system is indicated for monitoring glucose
in fresh capillary whole blood samples drawn from the ngertip, palm, forearm or upper
arm. SD GlucoNavii™ meter must be used with SD GlucoNavii™ blood glucose test
strips and SD Control solutions. The SD control solutions Level M and Level H are
for use with SD GlucoNavii™ test system as quality controls to verify the accuracy of
blood glucose test results.
Testing with Gluco Navii™ is done outside the body (in vitro diagnostic use). This
system is indicated for home (over-the-counter, OTC) by persons with diabetes, or in
clinical settings by healthcare professionals, as an aid to monitor the effectiveness of
diabetes control. This system should not be used for the screening or diagnosis of
diabetes or for testing newborns or infants.
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ALTERNATIVE SITE TESTING
IMPORTANT:
There are limitations with AST (Alternative Site Testing).
The AST of the system can be used only during steady-state blood glucose conditions.
Please consult the doctor before you perform AST on the patient.
Measurements from AST should never be used to calibrate a continuous glucose
monitoring systems (CGMs) or entered into insulin dose calculators for insulin dosing
recommendations.
THE PRINCIPAL
SD GlucoNavii™ test strip is designed with an electrode that measures glucose levels.
Glucose in the blood sample mixes with reagent on the test strip which causes a small
electric current. The amount of current that is created depends on how much glucose is
in the blood.
SD GlucoNavii™ meter measures the current that is created and converts the mea-
surement to the amount of glucose that is in the blood. The blood glucose result is
displayed on the meter’s screen. By touching a drop of blood to the tip of the SD
GlucoNavii™ test strip, the strip’s reaction chamber automatically draws the blood into
the strip through capillary action. When the chamber is full, SD GlucoNavii™ meter
starts to measure the blood glucose level. It is a simple and practical system for the
daily monitoring of your blood glucose level.
7
What is AST?
Alternative site testing (AST) means that people use parts of the body other than
ngertips to check their blood glucose levels. The GlucoNavii™ system allows you to
test on the nger, palm and forearm.
What’s the advantage of AST?
Fingertips feel pain more readily because they are full of nerve endings (receptors).
Other body sites, since nerve endings are less concentrated, patients generally will not
feel as much pain compared to the ngertip.
When to use AST?
Food, medication, illness, stress and exercise can affect blood glucose levels. Capil-
lary blood at ngertip reects these changes faster than capillary blood at other sites.
Therefore when testing blood glucose during or immediately after meal, physical
exercise, or any other event, take blood sample from nger only. We strongly
recommend that you perform AST ONLY at the following times:
• With you healthcare providers permission.
• In a pre-meal or fasting state (more than 2 hours since the last meal).
• Two hours or more after taking insulin.
• Two hours or more after exercise.
Do NOT use AST if:
• The healthcare provider has not approved this type of testing.
• Your patient has frequent low blood glucose.
• The AST results do not match the way the patient feels.
• You are testing for hyperglycemia.
• You are testing for hypoglycemia.
• The patient’s routine glucose results are often uctuating.
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METER SET UP / PROGRAMMING
STEP-1 : Setting the Audible Beep
1. With the meter turned on, press the ON/OFF button for 3 seconds, the display
for setting the audible beep will appear (Note the small on the lower right area of
screen).
2. Set the beep mode on or off by pressing the left arrow button to select either ON or
OFF. If you select the ON feature, a ‘beep’ sound will be heard. If you select the OFF
feature, no sound will be heard.
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