OneTouch VitA User Handbook Manual

Page 1
Blood Glucose Monitoring System
User’s Handbook
Page 2
Page 3
OneTouch® Vita™ System User’s
Handbook
Symbols
Manufacturer
Authorised Representative
Caution: See instructions for use
Serial number
Lot Number
In Vitro Diagnostic Medical Device
Expiry Date
Sterilised by irradiation
Low battery
Direct current
Storage temperature limits
Consult instructions for use
Contains sucient for <n> tests
Do not re-use
SN
LOT
IVD
STERILE R
EC REP
æ
2
i
n
Page 4
Thank you for choosing OneTouch®!
The OneTouch® Vita™ Blood Glucose Monitoring System is one of the latest product innovations from LifeScan. Every OneTouch® meter is designed to make it easy to test your blood glucose and help you manage your diabetes.
While the Starter Guide teaches the basics of testing, this User’s Handbook oers a more complete explanation of how to use your new meter and testing supplies, and reviews the do’s and don’ts of blood glucose testing. Clear instructions and visual aids will help you get comfortable using the OneTouch® Vita™ Meter, so you can expect to get reliable results every time you test. Please keep it handy.
Of course, you may still have questions. If you do, our Customer Care representatives would be happy to answer your call. You can reach them at 0800 121 200 (UK) or 1800 535 676 (Ireland). You can also obtain information at www.LifeScan.co.uk.
We hope OneTouch® products and services will continue to be a part of your life.
ii
Page 5
iii
Table of Contents
Setting up your system 2
Preparing for a test 7
Testing with a ngertip sample 8
Interpreting unexpected test results 17
Testing with a forearm or palm sample 19
Attaching after-meal ags to your test results 24
Reviewing past results and averages 26
Control solution testing 30
Care and maintenance 34
Battery 36
Troubleshooting 38
Detailed information about your system 46
Index 48
Page 6
iv
Before you begin
Before using this product to test your blood glucose, carefully read the Starter Guide, this User’s Handbook and the inserts that come with the OneTouch® Vita™ Test Strips and OneTouch® Vita™ Control Solution.
Intended use
The OneTouch® Vita™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The OneTouch® Vita™ System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the eectiveness of diabetes control. It should not be used for the diagnosis of diabetes or for testing newborns.
Test principle
Glucose in the blood sample mixes with special chemicals in the test strip and a small electric current is produced. The strength of this current changes with the amount of glucose in the blood sample. Your meter measures the current, calculates your blood glucose level, displays the result, and stores it in its memory.
Page 7
1
The OneTouch® Vita Blood Glucose
Monitoring System
Carrying Case
OneTouch® Vita™ Meter
(battery included)
Lancing Device
OneTouch®
Clear Cap
Sterile Lancets
m WARNING:
Keep the meter and testing supplies away from young children. Small items such as the battery door, battery, test strips, lancets, protective covers on the lancets, and control solution vial cap are choking hazards.
OneTouch® Vita™
Control Solution**
OneTouch® Vita™
Test Strips*
If the lancing device shown here is not included with your kit, see the user instructions for the lancing device included.
* Some kits do not include OneTouch® Vita™ Test Strips or OneTouch® Vita™ Control Solutions. Test strips and control solutions are available separately. ** For Control Solution, contact Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 8
27/FEB/08 14:07
mmol/L
5.5
▲▼
2
Setting up your system
Getting to know your OneTouch® VitaBlood Glucose Meter
Display
Data port
Up and down buttons
Select or change information
Insert test strip here to turn meter on
Connect to download
to computer
Test strip port
OK button
Turns the meter on/o
Conrms selections and settings
▲▼ Indicates
selection and settings available using up or down button
mmol/L is the pre-set unit of measurement
Meter
Test Strip
Edge to apply sample
Conrmation window
Contact bars
Insert into test strip port
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 9
MENU
SETTINGS
METER SETTINGS
MEAL FLAGS
3
Setting up your system
Turning your meter on
Press and hold
until the
meter turns on.
After the black start-up screen, the MAIN MENU appears.
OK
m CAUTION: Display check. If you see any light areas
within the black start-up screen, there may be a problem with the meter. Call Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
METER OFF
MAIN MENU
LAST RESULT
ALL RESULT S
AV ERAGES
SETTINGS
Setting the meter language, date and time
Before using your meter for the rst time, you should check these settings. When using the meter for the rst time, you will automatically start at the SETTINGS screen.
1. Go to the
SETTINGS screen
From the
MAIN MENU, press or
to highlight SETTINGS and press OK.
Then, press
or to select METER
SETTINGS
and press OK.
METER OFF
MAIN MENU
LAST RESULT ALL RESULTS
AV ERAGES
SETTINGS
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 10
4
Setting up your system
If the pre-set language, date and time are correct, press OK to return to the MAIN MENU.
If any setting is not correct, press or to select CHANGE and press OK (go to step 2).
ENGLISH
27/FEB/08
14:07
mmol/L
OK
CHANGE
SETTINGS
3. Set the date
The date and time formats have been pre-set. You cannot change these settings.
In the DATE AND TIME screen, press or to change the year and press OK.
Repeat these steps to set the month and day.
DATE AND TIME
TIME:
14 : 07
DATE:
27 / FEB / 2008
2. Choose a language
Now press or to highlight the language you want and press OK.
Pressing OK after making your selection conrms each setting and takes you to the next screen.
If at any point you make the wrong selection, simply press and hold OK until the meter turns o. Then, turn the meter back on and re-start from step 1.
ENGLISH
ESPAÑOL
LANGUAGE
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 11
5
Setting up your system
DATE AND TIME
DATE:
27 / FEB / 2008
TIME:
14 : 07
4. Set the time of day
Press or to set the hour and press OK.
Repeat this step to set the minutes.
5. Conrm your settings
If your settings are correct, press OK to save them and return to the MAIN MENU.
If not, press or to highlight
CHANGE and press
OK
. You will
return to the LANGUAGE screen.
ENGLISH
27/FEB/08
14:07
mmol/L
OK
CHANGE
SETTINGS
m WARNING: The unit of measurement mmol/L should
be displayed here. If your display shows mg/dL rather than mmol/L, contact Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). You cannot change the unit of measure. Use of the wrong unit of measure may cause you to misinterpret your blood glucose level and may lead to incorrect treatment.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 12
6
Setting up your system
Turning your meter o after setup
There are three ways to turn your meter o:
Press and hold
OK
for three seconds,
or,
Your meter will turn o by itself if left alone for about
two minutes,
or,
From the MAIN MENU, press or to highlight METER
OFF
, then press OK.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 13
7
Preparing for a test
Have these things ready when you test: OneTouch® Vita Meter
OneTouch® Vita Test Strips
Use OneTouch® Vita™ Test Strips only.
Unlike some blood glucose meters, it does not require
a separate step to code your OneTouch® Vita™ system.
Make sure your meter and test strips are about the same
temperature before you test.
For the most accurate results, test as close to room temperature
(20–25°C) as you can (see page 46).
Tightly close the cap on the vial immediately after use to avoid
contamination and damage.
Store unused test strips only in their original vial.
Do not open the test strip vial until you are ready to remove a test
strip and perform a test.
Do not return the used test strip to the vial after performing a test.
Do not re-use a test strip that has had blood or control solution
applied to it. Test strips are for single use only.
m CAUTION:
Do not use your test strips if your vial is damaged or has been left open to air. This could lead to error messages or inaccurate results. Call Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland) immediately if the test strip vial is damaged.
• If you cannot test because of a problem with your testing supplies,
contact your health care professional. Failure to test could delay treatment decisions and lead to a serious medical condition.
• The test strip vial contains drying agents that are harmful if inhaled
or swallowed and may cause skin or eye irritation.
Lancing device Sterile lancets
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 14
8
Testing with a ngertip sample
Lancing Device
Blue (or black) cap (for ngertip sampling)
Depth indicator
Cocking control
Release button
OneTouch® Clear Cap
(for forearm and palm testing) See pages 19–23.
Sterile lancet
Lancet point
Protective cover
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 15
9
Testing (ngertip)
m CAUTION: To reduce the chance of infection:
• Never share a lancet or a lancing device with anyone.
• Always use a new, sterile lancet each time you test.
Obtaining a blood sample from the ngertip
Before testing, wash your
hands thoroughly with warm, soapy water. Rinse and dry.
1. Snap o the blue/black cap
2. Insert a sterile lancet
Firmly push the lancet into the holder.
Twist o the protective cover and save it for later use.
Replace the blue/black cap.
Always keep your meter and lancing device clean (see page 35).
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 16
10
Testing (ngertip)
3. Adjust the depth setting
Twist the blue/black cap until the desired setting appears. Smaller numbers are for shallower punctures, which may be less painful.
Shallower punctures work for children and most adults. Deeper punctures work well for people with thick or callused skin.
4. Cock the lancing device
Slide the cocking control back until it clicks.
If it does not click, that’s okay. It may have been cocked when you inserted the lancet.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 17
11
Testing (ngertip)
6. Lance your nger
Hold the lancing device rmly against the side of your nger.
Press the release button.
5. Insert a test strip to turn the meter on
Insert a test strip into the test strip port as shown, with the contact bars facing you.
Contact bars
Test strip port
When the APPLY SAMPLE screen appears on the display, you can apply your blood sample.
APPLY SAMPLE
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 18
12
Testing (ngertip)
1. Prepare to apply the sample
Keeping your nger extended and steady, move the meter and test strip toward the blood drop.
Fingertip
Applying blood and reading results
7. Get a round drop of blood
Gently squeeze your nger until you get a round drop of blood.
If the blood smears or runs,
do not use that sample. Wipe
the area and gently squeeze another drop of blood or puncture a new site.
Approximate size
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 19
13
Do not apply blood to the top of the
test strip.
Do not hold the meter and test strip
underneath the blood drop. This may cause blood to run into the test strip port and damage the meter.
Testing (ngertip)
2. Applying the sample
Line up the test strip with the blood drop so that the narrow channel on the edge of the test strip is almost touching the edge of the blood drop.
Narrow channel
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 20
14
Do not smear or scrape the drop of blood with the
test strip.
Do not apply more blood to the test strip after you have
moved the drop of blood away.
Do not move the test strip in the meter during a test.
Gently touch the channel to the edge of the blood drop.
Be careful not to push the test strip against your ngertip or the test strip may not ll completely.
m CAUTION: You may get an ERROR 5 message or
an inaccurate result if the blood sample does not completely ll the conrmation window. See page 43. Discard the test strip and start the test process again.
Testing (ngertip)
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 21
15
3. Wait for the conrmation window to ll completely
The blood drop will be drawn into the narrow channel and the conrmation window should ll completely.
Conrmation
window full
Testing (ngertip)
When the conrmation window is full, this means you have applied enough blood. Now you can move the test strip away from the blood drop and wait for the meter to count down from 5 to 1.
Not fullFull
4. Read your result on the meter
Your blood glucose level appears on the display, along with the unit of measurement and the date and time of the test.
If mmol/L does not appear with the test result, call Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
(Example)
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 22
16
After getting a result
Once you have your result, you may:
Attach an after-meal ag to this result; see page 24,
or,
Review your meter memory by pressing OK; see page 26,
or,
Turn the meter o by removing the test strip.
Removing the used lancet
Remove the lancing device cap.
Place the lancet protective cover on a hard surface and push the lancet tip into the cover.
Remove the lancet and place it in a container for sharp objects.
Replace the blue/black cap.
Disposing of the used lancet and test strip
Used test strips and lancets may be considered biohazardous waste in your area. Make sure you follow your local regulations for proper disposal.
Testing (ngertip)
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 23
17
Interpreting unexpected test results
Low glucose results
• If your test result is lower than 3.9 mmol/L or is shown
as LOW GLUCOSE, it may mean hypoglycaemia (low blood glucose). Treat this condition immediately, according to your health care professional’s recommendations. Although this result could be due to a test error, it is safer to treat rst, then do another test.
• If you test at the low end of the operating temperature
range (10°C) and your blood glucose is high, you may get an inaccurate low result. Re-test in a warmer environment with a new test strip.
Refer to the following cautions whenever your test results are lower or higher than you expect.
High glucose results
• If your test result is higher than 10.0 mmol/L, it may mean
hyperglycaemia (high blood glucose) and you should consider re-testing. Talk to your health care professional if you are concerned about hyperglycaemia.
m CAUTION:
Dehydration and low glucose results
• You may get false low glucose results if you are
severely dehydrated. If you think you may be severely dehydrated, contact your health care professional immediately.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 24
18
Interpreting unexpected test results
Unusual red blood cell count
• A haematocrit (percentage of your blood that is red
blood cells) that is either very high (above 55%) or very low (below 30%) can cause false results.
Repeated unexpected glucose results
• If you continue to get unexpected results, check your
system with control solution. See Control solution testing, pages 30–33.
• If you are experiencing symptoms that are not
consistent with your blood glucose results and you have followed all the instructions in this User’s Handbook, call your health care professional. Never ignore symptoms or make signicant changes to your diabetes control regime without consulting your health care professional.
m CAUTION:
High glucose results (continued)
HIGH GLUCOSE is displayed when your blood glucose
level is higher than 33.3 mmol/L. You may have severe hyperglycae mia (very high blood glucose). Re-test your blood glucose. If the result is HIGH GLUCOSE again, this indicates a serious problem with your blood glucose control. Consult your health care professional immediately and follow his/her instructions.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 25
19
Testing with a forearm or palm sample
When your blood glucose is changing rapidly, such as:
within two hours after a meal
within two hours after a rapid-acting
insulin injection or insulin pump bolus
during or within two hours after exercise
Whenever you are concerned about the possibility of hypoglycaemia (low blood sugar)
If you have hypoglycaemia unawareness
If you are ill
During times of stress
Before or more than two hours after:
a meal
a rapid-acting insulin injection
or insulin pump bolus
exercise
The OneTouch® Vita™ Meter allows you to obtain a blood sample from your forearm or palm. Collecting a drop of blood from these “alternative sites” may be less painful than a ngertip sample.
If you are testing:
Fingertip, forearm, or palm
Fingertip only
Use a blood sample from your:
m CAUTION: Consult your health care professional
before using your forearm or palm for testing.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 26
20
Testing (forearm or palm)
Getting a blood sample
Getting a blood sample from your forearm or palm is dierent from obtaining a sample from your ngertip. Follow these instructions to get a sucient blood drop for testing.
2. Adjust the depth setting
You may need a deeper setting to get a sucient sample for testing.
Twist the cap to increase the depth
.
Be sure to cock the lancing device.
1. Insert a lancet and snap on the clear cap
Carefully insert a new, sterile lancet (see page 9).
Snap on the OneTouch® Clear Cap.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 27
21
Testing (forearm or palm)
3. Choose a sample site
Before testing, make sure you
wash the puncture site with soap and water. Rinse and dry thoroughly.
Choose a spot that is not close
to bone, veins or hair. Massage the site to increase blood ow.
Choose a spot with no visible
veins and avoid deep lines, which may cause your blood sample to smear.
Forearm
Palm
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 28
22
Testing (forearm or palm)
5. Remove the lancing device
Carefully lift the lancing device away from your skin. Do not smear the blood sample.
If the drop of blood runs or spreads due to contact with hair or a line in your palm, Do not use the sample. Try lancing again in a smoother area.
Forearm or Palm
Forearm or Palm
4. Lance your forearm or palm
Firmly press and hold the lancing
device against the sample site.
Looking through the clear cap,
you should see the sample site change colour as blood collects under the skin. This lets you know that there is adequate blood to obtain a sucient sample for testing.
Press the release button while
continuing to apply pressure.
Keep holding the lancing device
against your skin until a round drop of blood forms under the cap. Do not squeeze the site excessively.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 29
23
See pages 12–15 for more information on applying the
blood sample to the test strip.
See pages 17–18 for more information on interpreting
unexpected test results.
6. Apply the sample to the test strip
Forearm
Palm
Testing (forearm or palm)
Keep your forearm or palm steady and use your other hand to bring the top edge of the test strip to the drop of blood.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 30
24
MENU
SETTINGS
METER SETTINGS
MEAL FLAGS
MEAL FLAGS
NO
YES
NOW SET TO:ON
CHANGE TO OFF?
Attaching after-meal ags to your test results
Your meter allows you to attach an after-meal ag to your blood glucose results.
You can attach an after-meal ag straight after a blood glucose test. You can also add or remove a meal ag when reviewing a past result.
3. Press
to highlight YES, then
press
OK
to conrm the setting
and return to the MAIN MENU
1. From MAIN MENU, press or to select SETTINGS and press
OK
2. From the SETTINGS screen, select MEAL FLAGS and press
OK
We suggest you talk to your health care professional to see how after-meal ags may help you manage your diabetes.
Your meter comes pre-set with the meal ags feature turned on. If you do not want to use this feature, you can turn it o.
Turning the meal ags feature o
Ç
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 31
25
Attaching after-meal ags
Using the after-meal ag feature
1. Adding an after-meal ag
To add an after-meal ag, the meal ag feature must be turned on.
When a glucose test result is displayed, the up arrow
at the bottom right corner of the screen will blink next to the words AFTER MEAL?. Press
to add an after-meal ag to
this result.
2. Choosing not to add an after-meal ag
If you do not want to add an after­meal ag, press
OK
instead of
.
You will go to the MAIN MENU.
If you choose not to add an after-meal ag when the meal ag feature is on, AFTER MEAL? and a blinking up arrow
will appear at the bottom of
the screen.
3. Removing an after-meal ag
You can remove an after-meal ag from any test result. Press
while
your after-meal ag is displayed, then press
OK.
Your ag will be removed
and you will go to the MAIN MENU.
27/FEB/08 14:07
AFTER MEAL?
mmol/L
6.8
27/FEB/08 14:07
AFTER MEAL
mmol/L
6.8
27/FEB/08 14:07
AFTER MEAL?
mmol/L
6.8
Indicates an after-meal
ag has been added
Indicates no ag added
or ag removed
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 32
27/FEB/08 14:07
mmol/L
6.8
AFTER MEAL
METER OFF
MAIN MENU
LAST RESULT
ALL RESULT S
AV ERAGES
SETTINGS
26
Reviewing past results and averages
If your meter is o, press and hold OK until the meter turns on. If you have just completed a test, press
OK
to get to the
MAIN MENU.
From the MAIN MENU, choose:
LAST RESULT to view your most
recent result,
ALL RESULTS to review up
to 350 of your most recent results, or
AVERAGES to select result averages.
Press or to highlight your selection and press OK.
Last result
The meter will display your most recent result.
Press
OK
to return to the
MAIN MENU.
Unit of
measurement
After-meal
ag
Time
Date
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 33
27
Reviewing past results
All results
The meter will display four results at a time, starting with the most recent. The following symbols may also appear:
HI if the result was above
33.3 mmol/L
LO if the result was below
1.1 mmol/L
C if the result is from a control
solution test
3 if the result is agged AFTER MEAL
When the meter memory is full, the oldest result is dropped as the newest is added.
Press to move backward and to move forward through your results. Pressing and holding or allows you to move more quickly.
To view details of an individual result, press or to highlight the result, then press OK. If you wish to add or remove a meal ag for this result, see page 25.
To return to the previous screen, press OK.
To return to the MAIN MENU, highlight MENU, then press OK.
MENU
ALL RESULTS
08/FEB
07/FEB 06/FEB 05/FEB
mmol/L
10:01
17:21 14:08 08:33
6.8
HI
6.6
6.9
C

Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 34
28
Reviewing past results
Averages
The meter will display two types of averages:
all test results
after-meal results
All results average
If the meal ags feature is o, selecting AVERAGES from the
MAIN MENU will lead directly to
the ALL RESULTS AVG screen.
Press
OK
to go back to the AVERAGES screen.
To return to the MAIN MENU, highlight MENU, then press OK.
The meter will display your averages for all results for the past 7 days, 14 days and 30 days
MENU
AV ERAGES
ALL RESULTS AV G
MEAL AVERAGES
MENU
AV ERAGES
ALL RESULTS AV G
MEAL AVERAGES
MENU
ALL RESULTS AVG
LAST 7 DAYS 14 DAYS 30 DAYS
mmol/L
6.5
6.7
7.0
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 35
MENU
MEAL AV ERAGES
LAST 7 DAYS 14 DAYS 30 DAYS
mmol/L
6.7
7.0
7.1
6.7
7.2
7.1
29
Reviewing past results
In result averages, a HI result is always counted as
33.3 mmol/L, and a LO result is always counted as 1.1 mmol/L. (See pages 17–18 for more information on high and low glucose results.)
The meter calculates averages based on the 7-, 14- and 30-day periods ending on the current date setting. If you change your date setting, your averages may change, too.
Result averages provide information from past results.
Do not use result averages to make immediate treatment decisions.
Downloading results to a computer
You can download data from the meter to a computer to store and analyse your test results.
Visit www.LifeScan.co.uk for more information or call Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
Average of all unagged results
Average of after-meal
agged results
Meal averages
The meter will display the averages of all AFTER MEAL results for the past 7 days, 14 days and 30 days. This screen is not available when the meal ags feature is o.
m WARNING: To avoid a possible shock, Do Not insert a test strip while the meter is connected to a computer.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 36
30
Control solution testing
OneTouch® Vita™ Control Solution is used to practice the test and to check that the meter and test strips are working properly. Control solution is available separately from Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
m CAUTION:
• Donot swallow control solution; it is not for human consumption.
• Do not apply control solution to the skin or eyes as it may cause irritation.
• Use only OneTouch® Vita™ Control Solution with your OneTouch® Vita™ Meter.
• Control solution tests must be done at room temperature (20–25°C). Make sure your meter, test strips and control solution are at the same temperature before testing.
• 
Tightly close the cap on the control solution vial immediately after use to avoid contamination or damage.
Performing a control solution test
1. Insert a test strip to turn
the meter on
Wait for the
APPLY SAMPLE screen
to appear on the display.
Contact bars
Test strip port
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 37
31
Control solution testing
2. Press to display the APPLY CONTROL screen
3. Prepare and apply control solution
Shake the control solution vial and remove the cap.
Squeeze the vial to discard the rst drop, then wipe the tip with a clean tissue or cloth.
Touch and hold a hanging drop of control solution to the narrow channel in the top edge of the test strip.
Control solution should not be applied on top of the test strip.
Apply drop here
NARROW CHANNEL
TOP EDGE
APPLY CONTROL
When the APPLY CONTROL screen is displayed, you can be sure that the test result will be correctly recorded in the meter memory as a control solution test.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 38
27/FEB/08 14:07
mmol/L
6.8
CONTROL TEST
32
Control solution testing
5. Check if the result is in range
Compare the result displayed on the meter to the OneTouch® Vita™ Control Solution range printed
on the
test strip vial
. If your control solution result falls outside the expected range, repeat the test with a new test strip.
(Example range)
4. Read your result
When the conrmation window is full, the meter will count down from 5 to 1.
Your control solution result will then appear on the display, along with the date, time, unit of measurement, and the words CONTROL TEST.
Control solution results can be seen when reviewing past results, but are not included in result averages.
(Example)
m CAUTION: If the words CONTROL TEST do not
appear on the screen, repeat the test with a new test strip. If the problem persists, contact Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
Conrmation window full
OneTouch®
Vita™
4.7–8.3 mmol/L
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 39
33
Control solution testing
Out-of-range
results m
ay be due to:
not following the instructions given on pages 30–32,
use of control solution that is contaminated, expired
or past its discard/use-by date,
use of a test strip that is contaminated, expired or past
its discard/use-by date,
a problem with the meter, or
control solution test was performed outside the correct
temperature range (20–25°C).
m CAUTION:
If you continue to get control solution test results
that fall outside the range printed on the test strip vial, do not use the meter, the test strips or the control solution. Call Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
The control solution range(s) printed on the test strip
vial are for OneTouch® Vita™ Control Solution only. They are not recommended ranges for your blood glucose level.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 40
34
Care and maintenance
Storing your system
Store your meter, test strips, control solution and other items in your carrying case. Keep in a cool, dry place below 30°C, but do not refrigerate. Keep all items away from direct sunlight and heat.
OneTouch® Vita™ Test Strips
With clean, dry hands, you may touch the test strip anywhere on its surface. Do not bend, cut or modify the test strips in any way.
Checking for expiry or damage to test strips and control solution
Expiration dates for test strips and control solutions are printed on their vial labels. When you rst open a new vial of test strips or control solution, record the discard/use-by date on the label. Refer to the test strip or control solution vial for instructions on determining the discard/use-by date.
m CAUTION: DO NOT use the test strips or control
solution after the expiry date or the discard/use-by date, whichever comes rst, or your results may be inaccurate.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 41
35
Care and maintenance
Cleaning and caring for your meter
Wipe the outside with a soft cloth dampened with water and mild detergent to remove dirt or other contaminants.
Do not use alcohol or any other solvent.
Do not allow liquids, dirt, dust, blood or control solution
to enter the test strip port or the data port. (See meter illustration on page 2.)
Do not spray cleaning solution on the meter or immerse
it in any liquid.
Cleaning your lancing device and OneTouch® Clear Cap
To clean these items, wipe them with a soft cloth dampened with water and mild detergent. Do not immerse the lancing device in any liquid.
To disinfect these items, prepare a solution of one part household bleach to ten parts water. Wipe the lancing device with a soft cloth dampened with this solution. Immerse the caps only in this solution for 30 minutes. Rinse briey with water and let both items dry in the air.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 42
36
Battery
Your OneTouch® Vita™ Meter uses one 3.0 Volt CR 2032 lithium battery (or equivalent).
See pages 43–44 for information on when to change the meter battery.
Meter battery
m WARNING: To avoid a possible shock, Do not
change the battery while the meter is connected to a computer.
Replacing the battery
1. Removing the old battery
Make sure the meter is turned o. Open the battery door and pull up on the battery ribbon.
Meter battery
Battery
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 43
37
Battery
2. Insert the new battery
With the “+” side facing up towards you, place the battery in the compartment within the fold of the ribbon.
Push the battery until it snaps into the battery clasp.
Replace the battery door.
If the meter does not power on after you have replaced the battery, check that the battery is correctly installed with the “+” side up. If the meter still does not power on, call Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
3. Check your meter settings
Removing the meter battery will not aect your stored results. However, you may need to re-set your meter settings. (See pages 3
to
6.)
4. Dispose of battery
This product contains a lithium ion battery, which contains perchlorate materials – special handling may be required. Dispose of batteries according to your local environmental regulations.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 44
38
Troubleshooting
The OneTouch® Vita™ Meter displays messages when there are problems with the test strip, with the meter, or when your blood glucose levels are higher than 33.3 mmol/L or lower than 1.1 mmol/L. Improper use may cause an inaccurate result without producing an error message.
You may have a very low blood glucose level (severe hypoglycaemia), lower than
1.1 mmol/L.
This may require immediate treatment according to your health care professional’s recommendations.
Although this message could be due to a test error, it is safer to treat rst and then do another test.
Message What it means What to do
WARNING
AFTER MEAL?
LOW GLUCOSE
BELOW 1.1 mmol/L
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 45
39
Troubleshooting
Your control solution test result is below
1.1 mmol/L.
Test again with control solution and a new test strip. If the result is LOW
GLUCOSE
again, do not use the meter. Contact Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
Message What it means What to do
You may have a very high blood glucose level (severe hyperglycaemia), above
33.3 mmol/L.
Re-test your blood glucose. If
the result is HIGH
GLUCOSE
again, consult your health care professional and follow his/her instructions without delay.
Your control solution test result is above
33.3 mmol/L.
Test again with control
solution and a new test strip. If the result is HIGH
GLUCOSE
again, do not use the meter. Contact Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
WARNING
AFTER MEAL?
HIGH GLUCOSE
ABOVE 33.3 mmol/L
WARNING
CONTROL TEST
LOW GLUCOSE
BELOW 1.1 mmol/L
WARNING
CONTROL TEST
HIGH GLUCOSE
ABOVE 33.3 mmol/L
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 46
40
Troubleshooting
Message What it means What to do
Meter is too cold (below 10°C) to work correctly.
WARNING
SEE USER’S HANDBOOK
TEMPERAT URE
ERROR
TEMPERATURE
TOO LOW
Meter is too hot (above 44°C) to work correctly.
WARNING
SEE USER’S HANDBOOK
TEMPERAT URE
ERROR
TEMPERATURE
TOO HIGH
Move the meter and test strips to a cooler area. Insert a new test strip when the meter and test strips are within the operating temperature range (10–44°C). If you do not get another
TEMPERATURE ERROR
message, you can proceed with testing.
Move the meter and test strips to a warmer area. Insert a new test strip when the meter and test strips are within the operating temperature range (10–44°C). If you do not get another
TEMPERATURE ERROR
message, you can proceed with testing.
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 47
The sample was applied before the meter was ready.
Troubleshooting
Error message could be caused either by a used test strip or a problem with the meter.
WARNING
RETEST WITH A
NEW STRIP
ERROR 2
METER OR STRIP
PROBLEM
There is a problem with the meter.
Do not use the meter.
Contact Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
WARNING
CALL CUSTOMER
SERVICE
ERROR 1
METER PROBLEM
Message What it means What to do
WARNING
RETEST WITH A
NEW STRIP
ERROR 3
METER WAS NOT
READY
Repeat the test with a new test strip. Apply a blood or control solution sample only after APPLY
SAMPLE
or APPLY CONTROL appears on the display. If this message continues to appear,
contact Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
Repeat the test with a new test strip; see blood application (pages 12–15) or control solution testing (pages 30–32). If this message continues to appear, contact Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
41
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 48
42
Troubleshooting
Message What it means What to do
You may have tested in an environment near the low end of the system’s operating temperature range.
or,
The test strip may have been damaged or moved during testing.
or,
The sample was improperly applied.
or,
There may be a problem with the meter.
Make sure you are testing within the operating temperature range (10–44°C) and repeat the test with a new test strip; see blood application (pages 12–15) or control solution testing (pages 30-32). If the error message appears again,
contact Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland).
WARNING
SEE USER’S HANDBOOK
ERROR 4
STRIP PROBLEM
Oneofthefollowingmayapply:
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 49
43
Troubleshooting
Message What it means What to do
Meter battery is low but still has enough power to perform a test.
This message will appear when you turn the meter on and there is enough power for a minimum of 100 more tests. Press OK to continue, but replace the battery as soon as possible; see pages 36–37.
The meter has detected a problem with the test strip. Possible causes are test strip damage or an incompletely lled conrmation window.
Repeat the test with a new test strip. See blood application (pages 12–15) or control solution testing (pages 30–32) for instructions on properly lling the conrmation window. If this message continues to appear
, contact Customer Service on 0800 121 200 (UK) or 1800 535 676 (Ireland).
WARNING
RETEST WITH A
NEW STRIP
ERROR 5
STRIP PROBLEM OR
SAMPLE TOO SMALL
WARNING
SEE USER’S HANDBOOK
LOW BATTERY
REPLACE BATTERY
SOON
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 50
44
Troubleshooting
Message What it means What to do
Meter battery does not have enough power to perform a test.
Replace meter battery; see pages
36–37
.
Meter battery is low but still has enough power to perform a test.
Once the LOW
BATTERY/REPLACE BATTERY SOON
message is displayed, this symbol will continue to appear until you replace the battery. Test results will still be accurate, but replace the battery as soon as possible; see pages 36–37.
27/FEB/08 14:07
AFTER MEAL
mmol/L
6.8
WARNING
SEE USER’S HANDBOOK
LOW BATTERY
REPLACE BATTERY
NOW!
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 51
45
Troubleshooting
No result in memory, such as the rst time use of the meter, or your meter was unable to recall this result. This result will not be included in result averages.
You can still perform a blood glucose test and get an accurate result.
Contact Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland)
to report
this occurrence,
unless this is your
rst use of the meter.
Message What it means What to do
Your meter was unable to recall this result. This result will not be included in result averages since there are no results in memory to display.
You can still perform a blood glucose test and get an accurate result, but
contact Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland)
to report this
occurrence.
MENU
ALL RESULTS
04/FEB 03/FEB
01/FEB
mmol/L
09:44 13:23
10:12
LO
5.0
---
HI
MENU
MEAL AVERAGES
LAST 7 DAYS 14 DAYS 30 DAYS
mmol/L
6.7
7.0
---
6.7
7.2
---
–––
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 52
46
Detailed information about your system
Technical specications
Reported result range 1.1–33.3 mmol/L
Calibration Plasma-equivalent
Sample Fresh capillary whole blood
Testing time 5 seconds
Assay method Glucose oxidase biosensor
Meter power source One 3.0 Volt CR 2032 lithium battery or
equivalent
Unit of measurement mmol/L
Memory 350 test results
Automatic shuto About two minutes after last action
Size 95 x 65 x 22.5 mm
Weight Approximately 60 g, with battery
Operating ranges Temperature: 10–44°C
Relative humidity: 10–90%
Altitude: up to 3048 meters (10,000 feet)
Haematocrit: 30–55%
Battery ratings 1 x 3.0 V d.c., 60 mA
(1 x CR 2032 battery or equivalent) direct current
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 53
47
Details about your system
Guarantee
LifeScan guarantees that the OneTouch® Vita™ Meter will be free of defects in material and workmanship for three years, valid from the date of purchase. The guarantee extends only to the original purchaser and is not transferable.
Electrical and safety standards
This meter complies with CISPR 11: 2003, Class B (Radiated Only). Emissions of the energy used are low and not likely to cause interference in nearby electronic equipment. The meter has been tested for immunity to Level 3 electrostatic discharge as specied in IEC 61000-4-2. This meter has been tested for immunity to radio frequency interference over the frequency range 80 MHz to 2.5 GHz at 3 V/m as specied in IEC 61000-4-3.
Degree of protection rating: IP32
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 54
48
Index
Alternative site testing procedure........................................................ 19
Averages ........................................................................................................28
Battery ............................................................................................................ 36
Buttons on meter ..........................................................................................2
Cleaning your meter and lancing device ............................................ 35
Control solution testing ............................................................................30
Data port ..........................................................................................................2
Date setting .....................................................................................................4
Dehydration ................................................................................................. 17
Discard/use-by date, control solution and test strips ................... 34
Display check ..................................................................................................3
Disposal, lancets and test strips ............................................................ 16
Downloading results to a computer ....................................................29
Error messages ..................................................................................... 14, 38
Expiry date, control solution and test strips .....................................34
Fingertip testing procedure ......................................................................8
Guarantee .....................................................................................................47
HIGH GLUCOSE Control Test message ................................................ 39
HIGH GLUCOSE message ............................................. 17, 18, 27, 29, 39
Hyperglycaemia ...................................................................................17, 39
Hypoglycaemia ............................................................................. 17, 19, 38
Infection, reduce the risk ....................................................................9, 35
Intended use ..................................................................................................iv
Kit components ..............................................................................................1
Lancing device ........................................................................................8, 20
Language, setting .........................................................................................4
LOW BATTERY messages ................................................................... 43, 44
LOW GLUCOSE Control Test message ................................................. 39
LOW GLUCOSE message ..................................................... 17, 27, 29, 38
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 55
49
Index
MAIN MENU screen ................................................................................3, 26
Meal ags feature ....................................................................................... 24
mmol/L ........................................................................................... 2, 5, 15, 46
OneTouch® Clear Cap ....................................................................... 1, 8, 20
Plasma calibration ...................................................................................... 46
Results, reviewing past ............................................................................. 26
Settings .............................................................................................................3
Start-up screen ...............................................................................................3
Storing your system ................................................................................... 34
Symbols .............................................................................................................i
Technical specications ........................................................................... 46
Temperature ...............................................................................7, 30, 34, 46
TEMPERATURE ERROR messages ......................................................... 40
Test strip, applying drop of blood ........................................................ 12
Test strip, conrmation window ................................................2, 15, 32
Test strip, contact bars ...................................................................2, 11, 30
Time setting .....................................................................................................5
Turning meter o ...................................................................................6, 16
Turning meter on......................................................................3, 11, 26, 30
Unexpected test results .................................................................... 17, 18
Unit of measurement ......................................................... 2, 5, 15, 26, 46
Unusual red blood cell count (haematocrit).....................................18
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 56
50
Reminders
Time of day
Before breakfast
Before lunch or dinner
1 hour after meals
2 hours after meals
Between 02:00 and 04:00
Your target ranges
from your health care
professional
Expected blood glucose levels for people without diabetes are:
1
Before breakfast 3.9–5.8 mmol/L
Before lunch or dinner 3.9–6.1 mmol/L
1 hour after meals < 8.9 mmol/L
2 hours after meals < 6.7 mmol/L
Between 02:00 and 04:00 >3.9 mmol/L
You should consult your health care professional to set the range of expected blood glucose values and testing times that are appropriate for you, and discuss the meaning of your test results.
1. Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual. Philadelphia: Lea and Febiger (1989), p. 138.
Patented
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 57
51
NOTES:
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 58
NOTES:
52
Customer Care Freephone 0800 121 200 (UK) or 1800 535 676 (Ireland)
Page 59
LifeScan self-test blood glucose monitoring devices conform to the following EU Directives:
IVDD (98/79/EC):
Blood Glucose Meter, Test Strips, and
Control Solution.
MDD (93/42/EEC):
Lancets
Blood Sampler
LifeScan, Inc. Milpitas, CA 95035 U.S.A.
LifeScan Regulatory Aairs Europe Division of Ortho-Clinical Diagnostics France 1, rue Camille Desmoulins 92787 Issy-les-Moulineaux Cedex 09 France
0344
0120
Page 60
Call Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland) Or visit us at www.LifeScan.co.uk
© 2008 LifeScan, Inc. Rev. Date: 03/2008
Distributed by: LifeScan UK/Ireland, A div. of Ortho-Clinical Diagnostics, Johnson & Johnson, 50 - 100 Holmers Farm Way, High Wycombe, Bucks HP12 4DP United Kingdom www.LifeScan.co.uk
AW 06528302A
Loading...