Lloydspharmacy LCM 1 User manual

Cholesterol
Monitor
User Manual
Model No. LCM 1

Do not re-use
Keep dry
Operation temperature
limitation
In-vitro diagnostic
medical device
Lot number
CE certification
Manufacturer
Read instructions
Caution consult
accompanying documents
Storage temperature
limitation
Use by
Authorised representative in the
European Community
Catalogue number
(Product number)
Serial number
10ºC
40ºC
10ºC
30ºC
Do not dispose in
Household waste
2
0537

3
Introduction P.4
Features P.5
Parts P.7
General warnings and safety P.8
Before you start P.9
Using your Cholesterol Monitor P.10
Reading your results P.13
Maintenance and cautions P.16
Test Strip information P.17
Specification P.18
Troubleshooting P.20
Questions and answers P.21
Further information P.24
Notes P.25
Lancet manufacturer contact information P.26
Warranty P.27
Content

4
Thank you for purchasing the Lloydspharmacy Digital Cholesterol Monitor (Model
LCM1).You have selected a reliable and medically approved monitor that is easy to
use. In just three simple steps the Lloydspharmacy Digital Cholesterol Monitor will
provide you with the test results you need.
Two thirds of people in the UK have high cholesterol. Cholesterol is a type of fat that
is found in the body and is vital to help keep us healthy. However elevated levels of
cholesterol are a major risk factor for Coronary Heart Disease (CHD), Cardiovascular
Disease and stroke. There are two main types of cholesterol: good (HDL) and bad
(LDL) cholesterol.
This test measures total cholesterol (both good and bad)
You will find everything you need to know about this product in this user manual.
Before using the Lloydspharmacy Digital Cholesterol Monitor, please read the
instructions included in this user manual carefully.
Lloydspharmacy Digital Cholesterol Monitor is an in vitro diagnostic device for self
testing. This means that the system should only be used for testing outside of the
human body. High total blood cholesterol has been established as one of the key
factors associated with the occurrence of CHD. Lower blood levels of cholesterol are
linked with a decreased incidence of CHD.
Introduction

5
Lloydspharmacy Digital Cholesterol Monitor is designed for home users to measure
the amount of cholesterol in whole blood.When blood is applied to the test strip, a
current is formed, and the magnitude of the current produced is proportional to the
concentration of cholesterol.
The Lloydspharmacy Digital Cholesterol Monitor is intended for use with fresh whole
blood samples. The Digital Cholesterol Monitor will not give accurate results for
plasma or serum samples.
Some people with very high haematocrit levels can obtain falsely decreased test
results. Haematocrit is the percentage of blood volume that is occupied by red blood
cells.
The pack contains:
Digital Cholesterol Monitor See the diagrams on page 7 showing all the parts
of the Digital Cholesterol Monitor.
User Manual An illustrated booklet describing the product and
its operations.
Quick Start Guide This lists the basic operation steps for easy
reference.
Features

6
Storage Case A handy case for storage of the Digital Cholesterol
Monitor, there is also a section for storing the test
strips and lancet devices (sold separately).
Parts description
Set Button This button is to switch the function from one
mode to another. For example:You can press this
button to recall past test results. See “Recalling
Test Results”, page 13.
Beeper The Monitor will “Beep” as an alert.
Battery Compartment This compartment holds 2 x AAA batteries (not
included). See page 9 on how to install them.
Test Strip Platform Insert the test strips here for blood testing. See
“Finger Blood Testing Procedure”, page 10
On|Off Button This button turns the Digital Cholesterol Monitor
on and off.
LCD Display This is where the messages and test results are
displayed.
Features

digital
CHOLESTEROL MONITOR
on|off set
mmo/L
0537
Model Number – LCM 1
Biomedix, Inc, 40471 Encyclopedia Circle,
Fremont, CA 94538.U.S.A
Made in U.S.A.
E. C. REP Ltd., Marlborough,
Riding Street, Southport, PR8 1EW, England
C
7
Set Button
On/Off
Button
Test Strip
Platform
Front
LCD display Battery
Compartment
Back
Beeper
Contact
Bars
Reaction
Area
Cholesterol
Test Strip
Parts

8
Please carefully read and understand the following warnings and cautions to ensure
the safe and correct use of this device and to prevent injury.
Should not be used by anybody under 18 years of age, unless directed by your doctor.
DO NOT make any significant changes to your medication program without
consulting your doctor or Lloydspharmacist.
Cleaning the Digital Cholesterol Monitor is essential for reliable results (see page 16).
PLEASE NOTE: TEST STRIPS AND LANCETS ARE SOLD SEPARATELY. (Free with first
purchase)
DO NOT use the test strips beyond the expiry date.
DO NOT use test strips that have been damaged in any way (e.g. bent or creased).
Ensure that the silver contact bars are intact.
The test strips are individually foil wrapped and must be kept in the vial with the cap
in place. Keep them in a cool, dry place between 10ºC to 30ºC (50ºF to 86ºF) and
discard any unused strips 10 months after first opening the vial.
DO NOT freeze or expose the test strips to direct sunlight or heat.
Only use the Lloydspharmacy test strips with the Lloydspharmacy Digital
Cholesterol Monitor to obtain reliable results.
General warnings and safety

9
Remove the cover sited on the back of the Monitor. Insert 2 x AAA batteries (not
included). Replace the cover.
• Non-rechargeable batteries are not to be recharged.
• Always remove exhausted batteries from the monitor.
• The supply terminals are not to be short circuited.
• Do not mix old and new batteries or different types of batteries. Do not use
rechargeable batteries. Only batteries of the same or equivalent type as
recommended are to be used. Batteries must be handled with care under adult
supervision. If batteries leak and come into contact with skin or eyes, wash
immediately with copious amounts of water.
1 Press and hold the on|off button for approx 15 seconds until you see the “y09”
(year) sign flash on the display. Release the on|off button.
2 Press the set button to select the desired year. Ex. “y10” means 2010.
Before you start
Setting the date and time

digital
CHOLESTEROL MONITOR
mmol/L
digital
CHOLESTEROL MONITOR
digital
CHOLESTEROL MONITOR
digital
CHOLESTEROL MONITOR
1234
10
3 Press the on|off button to confirm the year; then the month. The month will
flash on the display. Repeat the procedure - pressing the set button to change
and the on|off button to confirm at each stage, setting the month, day,
hour, minutes in sequence.
4 There is one Beep after the minutes are confirmed.The Monitor will automatically
return to the “InS” display (InS = Insert Strip).
Finger blood testing procedure
This method of home testing requires you to follow the instructions below in detail.
If you have difficulty obtaining a reading in the first instance, do not worry, the more
Using your Cholesterol Monitor
Before you start

11
you familiarise yourself with this method of testing the more confident you will be.
Select a clean, dry work surface. Press the on|off button to turn the Digital
Cholesterol Monitor on.The display will show”InS” and flash an image of a strip. If
you insert a cholesterol strip whilst the monitor is turned off it will automatically
turn the machine on.
Insert the test strip.The strip must be flat against the test strip platform with the
letter “C” facing up and the two green stripes visible. Carefully but firmly insert the
test strip. The display will show “CHO” and an image of one blood drop.
Using the Lancets and getting a finger blood sample
Wash your hands using warm and soapy water then rinse thoroughly.Warm water
is preferable because it will stimulate blood flow to your fingers. It may also help
to hang your arm down by your side for 10-15 seconds prior to testing. Dry hands
thoroughly.
Remove the protective cap from the safety lancet. Place the raised white area of
the lancet device against the side of the finger to be used (we recommend that you
use the side of your finger - see fig 1 on page 13). Push the top of the safety lancet
Using your Cholesterol Monitor

12
whilst it is firmly placed against the finger to activate the device (see fig 2 on page
13). The needle will then retract for safety (single use only). Please dispose of safely.
Allow a large drop of blood to hang from your finger by gently squeezing it.Wipe the
first drop of blood away using a clean, dry tissue and squeeze a second large drop
(around the size of a peppercorn - see fig 3 on page 13).
Place the large hanging drop of blood on the semi circular well on the left hand side
of the strip (see fig 4 on page 13). Do not remove the test strip from the monitor to
apply the blood.
You must ensure that you hold the large drop of blood to the strip for at least 3-5
seconds on the reaction area. Do not smear the blood on the test strip or touch
the reaction area with your finger. If the amount of blood is sufficient, the unit will
beep and the count down will begin. Do not apply a second drop of blood after the
monitor starts to count down as this may alter your result.
The cholesterol result will be shown in 30 seconds (see page 14 for how to read your
results). If not enough blood has been applied the count down won’t begin and you
will have to start the testing procedure again using a new test strip.
Once you remove the test strip the unit will automatically turn off.
Using your Cholesterol Monitor

1234
13
N.B.We recommend that you test using the side of your finger.
Recalling the test results
1 With the Digital Cholesterol Monitor off, press and hold the on|off button for
approx 5 seconds to enter the memory mode. You will see “M” flash on the upper
left hand side of the display, release the button – “CHO” will appear on the screen.
2 After a few seconds, the display will show the last test result reading including the
date and time of the test.
3 Press the set button once to read the second last test result. Up to 99 readings can
be stored in the memory.
4 Press on|off button to return back to “Ins” display.
Reading your results
Using your Cholesterol Monitor

digital
CHOLESTEROL MONITOR
mmol/L
digital
CHOLESTEROL MONITOR
mmol/L
M
digital
CHOLESTEROL MONITOR
mmol/L
M
digital
CHOLESTEROL MONITOR
M
1234
14
Total Cholesterol Classification Advice/Action
Less than 5 mmol/L Desirable Re-test in 3 months.
5 to 8 mmol/L Slightly raised Contact your local Lloydspharmacist
who will be able to advise if you would
benefit from a cholesterol and heart check.
More than 8 mmol/L High You should contact your doctor or
healthcare professional.
Reading your results

15
This test measures total cholesterol only. The test is designed to give you a
guide to your cholesterol level only, results should not be interpreted as exact
cholesterol levels. Total cholesterol is only one element of determining your risk
of developing heart disease and stroke.A full risk assessment (available at selected
Lloydspharmacies) is recommended to assess multiple risk factors.
The Lloydspharmacy Digital Cholesterol Monitor requires at least 12 μl (microlitres)
of whole blood for cholesterol testing. If not enough blood is used the unit will not
start the count down so it is important to visually check that there is enough blood
on the test area of the test strip. If the amount of blood is sufficient, the unit will
beep and the count down will begin.
• The Digital Cholesterol Monitor displays results between 2.6 - 10.3 mmol/L.
• Results above 10.3 mmol/L are displayed as “Hi”.
• Results below 2.6 mmol/L are displayed as “Lo”.
Reading your results

16
Clean the Digital Cholesterol Monitor test strip platform with alcohol swabs
(not included) to prevent contamination.
Do not drop or throw the Digital Cholesterol Monitor.
Do not expose the Digital Cholesterol Monitor to extreme temperatures or
humid conditions for long periods of time.
Do not tamper or attempt to fix the Digital Cholesterol Monitor.
Do not immerse the Digital Cholesterol Monitor in water.
Store the Digital Cholesterol Monitor in the storage case whenever possible.
Maintenance and cautions

17
Test Strips and Lancets sold separately
Write the date on the vial of strips when opening for the first time. Discard any
unused strips 10 months after first opening the vial.
Use the test strip immediately after removing it from the foil. Always keep the
test strips stored inside the original vial ensuring that the foil is not broken. Always
ensure the cap is firmly secured back on the vial after removing your test strip.
Store the test strips at a temperature between 10ºC and 30ºC (50ºF and 86ºF).
Avoid direct exposure to sunlight.
Test strips are usable up to the expiry date if they have not been opened.
Do not use test strips beyond their expiry date.
Do not use test strips that have been altered or damaged in any way.
Do not use test strips more than once.
Do not touch the reaction area when handling the test strips.
Caution: Keep all components of the Lloydspharmacy Digital Cholesterol
Monitor out of the reach of children.They may be potentially hazardous if
mishandled, inhaled, or swallowed.
Test Strip information

18
Specification
Digital Cholesterol Monitor Performance Characteristics
Operating Temperature 18ºC to 30ºC (64ºF to 80ºF)
Operating Humidity 20%-80% relative humidity (non-condensing).
Power Supply 2 x AAA alkaline batteries (not included).
Automatic Shut-Off After two minutes.
Dimensions 107mm (length) x 64mm (width) x 28mm (height) approx.
Weight Approximately 57g.
Measurement Range 2.6 - 10.3 mmol/L.
Measurement Time 30 seconds.
Memory Capacity Total 99 readings.

19
Cholesterol Strip Performance Characteristics
The Lloydspharmacy Digital Cholesterol Monitor has been calibrated during
production. If you need to check it, please use Q.STEPS™ Control Solution, which
is used to check Lloydspharmacy Digital Cholesterol Monitor. You can buy this at
Biomedix Service Centre. Go to www.biomedixusa.com or call 888-246-6318 (USA)
Following the same procedure as the Finger Blood Testing Procedure (page 10). This
time, drop the Control Solution on the test strip instead of a blood sample.
Storage Conditions 10ºC to 30ºC (50ºF to 86ºF). Store in capped test strip vial.
Operating Temperature 18ºC to 30ºC (64ºF to 86ºF).
Operating Humidity 20%-80% relative humidity (non-condensing).
Dimensions 49mm (length) x 10mm (width) approx.
Blood Source 12 μl – 15μl whole blood.
Blood Application On the left hand side of the sensor strip.
Specification
Calibration for Lloydspharmacy Digital Cholesterol Monitor

20
Lo Below 2.6 mmol/L Test again and consult your
Lloydspharmacist or doctor.
Hi Above10.3 mmol/L Test again and consult your
Lloydspharmacist or doctor.
Err + strip symbol Used strip Use new strip.
Battery is low Battery is low Insert new batteries.
symbol
Displayed Message Description of Error Troubleshooting
Troubleshooting
Blank screen - the
count down does
not begin
Not enough blood used Remove the strip and re-test using a new
strip and a larger blood sample.
If the Cholesterol Monitor is still reporting an error after checking all of the above
please contact Lloydspharmacy Customer Services on 0845 600 3565 (option 2).