Prima PL311 User manual

®
USER MANUAL
IN / IN
MULTIPARAMETER
DIAGNOSTIC DEVICE
PRIMA® SELF-TESTING KIT
TRIGLYCERIDES
CHOLESTEROL
GLUCOSE *
ENGLISH
PL300 / PL311 Made in Italy.
PRIMA Lab SA
Via Antonio Monti 7
6828 Balerna
Switzerland
 ()   
[e-mail]
primahometest.com
* ONLY FOR THE PRIMA® IN.
0344

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Thank you for choosing the system PRIMA®2in1/3in1 test for cholesterol, triglyc-
erides, and glucose* directly to your home. This manual contains instructions
on how to use step by step the instrument and its maintenance. Please read the
manual carefully before performing the test.
Before carrying out the measurement we recommend that you become familiar
with the instrument and procedures.
Please also read the instructions inside the boxes of dierent types of stripes. In
case of any questions please call customer service.
INDEX
What’s the Prima® 2in1/3in1 system for? 3
Contents of the packaging 4
The digital meter 5
Display and symbols 6
Setting up the meter for the rst time 7
Inserting the batteries 8
Meter settings (SET) 9
Requirements to perform a measurement 11
Introduction to test strips and data-chips 11
Programming the device 12
How to obtain a blood sample 13
Performing a measurement 16
Quality control recommendations 18
Memory 18
Care and maintenance 19
Error messages 19
Performance specications 21
Warranty 22
Important Notes 22
Ordering informations 23
Product limitations 24

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CONTENTS OF THE PACKAGING
• One digital meter,
• 5 cholesterol strips (a box of 25 strips is available to purchase separately),
• 5 triglycerides strips (a box of 25 strips is available to purchase separately),
• 10 glucose strips* (a box 50 strips* is available to purchase separately),
• Three Data-chips: one for the cholesterol, one for triglyceride and one
for glucose* testing. The chip contains lot-specic information of the
calibration curve for either cholesterol, triglycerides or glucose* test,
• One lancing device,
• 25 sterile lancets,
• One user manual,
• One carrying case.
Articles non included within the packaging:
• Control solutions (available separately),
• Logbook,
• PC cable (available separately) and software.
WHAT’S THE PRIMA®2IN1/3IN1 SYSTEM FOR?
The PRIMA®2in1/3in1 kit is a new system designed for the self-monitoring in vitro
(therefore outside of the body), through the blood obtained from a nger prick, of
the quantitative determination of the levels of cholesterol, triglycerides and glu-
cose*. These parameters are often measured together as they are the key factors
for the estimation of the risk of cardiovascular disease. It is designed for home
use by people who want to monitor these parameters and on the basis of their
levels to understand whether it is necessary to consult a doctor; and / or control
the same parameters if they are too high.
Cholesterol is a waxy substance that acts as a precursor of bile acids, steroids
and vitamin D. It is synthesized primarily in the liver and in the intestinal wall. In
normal conditions, the liver maintains the balance between the amount of cho-
lesterol and draw to that excreted. This balance, however, can be altered by cer-
tain diseases such as diabetes, hypertension, hypercholesterolemia and family
factors also linked to an unhealthy lifestyle such as smoking, alcohol abuse and
a diet rich in saturated fats in combination with a lack of physical activity . In ad-
dition, stress, oral contraceptives and pregnancy can cause elevated cholesterol
levels. A high concentration of cholesterol is a major risk factor for cardiovascular
events.
The Canadian Cardiovascular Society recommends the frequent measurement
of blood cholesterol for men above the age of 40 and women over the age of 45,
unless there are other risk factors. If, on the contrary, there are other factors, it is
recommended to perform the test above 25 years of age.
The triglycerides (consisting of three molecules of fatty acids and a glycerol) are
the most common form of fat that our body digests. To be absorbed these mol-
ecules are broken down in the small intestine, and then reassembled with cho-
lesterol to form chylomicrons. Therefore in blood triglycerides are present in the
form of plasma lipids related to cholesterol. While cholesterol is used to build cell
membranes and some hormones, the main function of triglycerides is to store
energy. All the extra calories that come from carbohydrates are converted into
triglycerides and stored as fat to be burned later as a source of energy. Although
it is not yet clear how, high levels of triglycerides are placed in relation to the
thickening and hardening of the artery walls - atherosclerosis - which increases
the risk of heart attack and heart disease. The disease is known as hypertriglyc-
eridemia, and ignoring the high-calorie foods, can be caused by diabetes, kidney
failure or genetic derivation.
The test cannot be used on infants since it has not been validated for this pur-
pose. It does not diagnose any disease, and like any other test, the compliance
with instructions is critical to obtain accurate results.

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DISPLAY AND SYMBOLS
The display should be checked every time you turn on the instrument. The meter
momentarily shows all the symbols that may appear in the display. Regular mo-
nitoring of all the display symbols prevents a misinterpretation of the instrument
due to defects in the display.
The symbols on the display have the following meanings:
1. Data-chip inserted
2. Meter mode in use
3. Battery level indicator
4. Test results and other messages
5. Units of measure
6. Parameter being tested
7. Temperature indicator
8. Time
9. Day, Month, Year
10. Beeper
Meter’s modalities
The meter has three modalities:
STANDBY
It’s the default mode that appears every time you turn
on the instrument by pressing the ON switch. The strip
symbol will ash and the display will show the number of
the data chip, the date and time.
RearFront
THE DIGITAL METER
General overview of the meter
1. Display
2. Switch on button
3. ‘+’ button
4. ‘-’ button
5. Test strip slot
6. PC cable port
7. Cover
8. Battery space
9. Data-chip slot
10. Strip ejection button

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MEMORY
When in Standby mode by pressing the ‘+’ or ‘-’ is entered
in memory mode. The instrument will show the MEM sym-
bol in the upper part of the display.
SETTINGS
Press and hold for 3 seconds the power button when the instrument is turned
on. The instrument will display the SET symbol in the upper part of the display.
SETTING UP THE METER FOR THE FIRST TIME
When you use the tool for the rst time before turning to perform the following
steps:
1. Insert the batteries.
2. Setting the time, date, and unit.
3. Insert the data-chip (it can also be done just before the measurement).
INSERTING THE BATTERIES
1. Ensure that the instrument is turned o. Open the battery cover by sliding
the cover.
2. Insert two 3V lithium batteries (CR 2032) in the slot as shown, paying at-
tention to the symbols “+” and “-” ends of the batteries. Use only 3V lithium
batteries (CR 2032). Remember to always change both batteries at the same
time as batteries with dierent capacity may interfere with the functionality
of the instrument.
3. Close the battery compartment by sliding the cover until you hear a “click”.
4. Turn the instrument to test the operation of the new batteries.
5. When you change the batteries, you have to insert the new ones within 1
minute to keep the same settings for date and time. If you exceed the minute
you have to set new date and time. The results of the various measurements,
including date and time, as well as the other settings are retained even if the
batteries are not included.
To respect the environment dispose of used batteries in accordance with the
requirements of local laws of your own country. Do not throw batteries on ames
as they may explode.