Arkray Assure 530001 User manual

Quality Assurance/Quality Control
(QA/QC) Reference Manual

Quality Assurance/Quality Control
(QA/QC) Reference Manual

Table of Contents
Introduction ........................................................................................ i
Section A
System Components
Assure® Prism multi Blood Glucose Meter ................................................. 1
Meter Display Screen .............................................................................. 2
Assure Prism multi Test Strips .................................................................. 3
Assure Prism Control Solution .................................................................. 5
 MeterSpecications ............................................................................... 6
Section B Meter Operation and Set-up
Meter Set-up .......................................................................................... 7
Performing a Blood Glucose Test .............................................................. 9
Performing a Control Solution Test ..........................................................11
Meter Memory ......................................................................................13
Inserting or Replacing the Batteries .........................................................14
Cleaning and Disinfecting the Meter ........................................................15
Cleaning and Disinfecting FAQ.........................................................................17
F-Tag 880 (Infection Control Requirements for Blood Glucose Monitoring).....................17
Troubleshooting .....................................................................................18
Section C Regulatory Review and Guidelines for QA/QC Protocols
Regulatory Review and Guidelines for QA/QC Protocols ............................20
Accuracy and Precision Studies ...............................................................21
Alternative Site Testing Evaluation ...........................................................22
Section D Addendums
Product Ordering ............................................................................................ 23
Warranty
..............................................................................................23
Section E In-service Training
 In-serviceTrainingandCertication .........................................................24
Competency Checklist ............................................................................25
Instructor Training Record .......................................................................26
Healthcare Professional In-service Training Record ....................................27
Self-test ................................................................................................28
Section F Quality Assurance/Quality Control Recording Forms
Meter Tracking Record ...........................................................................31
Quality Control Record ...........................................................................32
Field Inspection Report ..........................................................................33
Sample Policy and Procedures........................................................................ 34
Policy: Infection Control: Cleaning and Disinfecting the
Assure Prism multi Meter........................................................................... 35
Cleaning and Disinfecting the Meter.......................................................... 36
Policy: Performing a Blood Glucose Test
with the Assure Prism multi Meter ............................................................ 38
Policy: Quality Control Testing on Assure Prism multi Meter .....................41
Policy: Maintaining the Assure Prism multi Meter..................................... 43

i
Introduction
The Assure® Prism multi Blood Glucose Monitoring System is intended for the quantitative
measurementofglucoseinfreshcapillarywholebloodsamplesdrawnfromthengertipsand
alternative sites such as the forearm, palm, thigh and calf.
Alternative site testing should be used only during steady-state blood glucose conditions. The
system is intended for use outside the body (in vitro) and is intended for multiple-patient use in
a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This
system is only to be used with an auto-disabling, single-use lancing device. It is not intended for
use on neonates and is not intended for the diagnosis or screening of diabetes.
This comprehensive manual has been designed to be a thorough reference source for the Assure
Prism multi Blood Glucose Monitoring System and includes:
• Product operations
• Training and in-services
• Guidelines for policies and procedures
• Quality Assurance/Quality Control (QA/QC) programs
• Reviews of regulatory materials
All of these materials have been designed to assist you in meeting the necessary requirements
forvariouscerticationprogramsandagencies.
We trust that this Quality Assurance/Quality Control manual will provide you with the needed
support tools for your blood glucose monitoring program. If you have any questions after
receiving the manual, please call ARKRAY’s Technical Customer Service Department at
800.818.8877, option 5, 24 hours a day, 7 days a week.
NOTE
• This Quality Assurance/Quality Control reference manual should be used as a reference only.
It does not replace the instructions supplied with the Assure Prism multi Blood Glucose
Monitoring System, Assure Prism multi Test Strips or Assure Prism Control Solution. Please
see the instructions included with each product for additional detail.

i 1
SECTION
A
System Components
ORDERING DETAILS
ARKRAY Product Code # 530001 NDC # 08317-5300-01
Display
Shows results, messages
Test Strip Ejector
Slide upward to release strip
Test Strip Port
Insert test strip here
mButton
Turns the meter on/off and
confirms menu selections
Backlight Button
Turns the backlight on/off
(15–second duration)
 Button
Selects or changes information
 Button
Selects or changes information,
marks control solution test
results and scrolls through
memory results
ASSURE® PRISM MULTI BLOOD GLUCOSE METER
Data Transmission Port
Used to transfer data
from the meter to a
computer with a cable

SECTION
A
2
SECTION
AMETER DISPLAY SCREEN
NOTE
• It is recommended to check if the display screen on the meter
matches the illustration above every time the meter turns on.
Do not use the meter if the display screen does not exactly
match the illustration as the meter may show incorrect results.
• The unit of measurement for your Assure® Prism multi Blood
Glucosemeterispresetandxedinmg/dL.
Appears when test results stored in the
memory are displayed
Appears when the time alarm
has been set
Indicates a low battery
Appears when the temperature
is displayed
Appears during post-meal testing and
when post-meal test results are displayed
Appears only when the sound
is set to OFF
Appears when the test
result is saved as a control
solution test
Test result display panel
Indicates meter is ready for testing
Date/
Temperature
Time

3
SECTION
A
ASSURE® PRISM MULTI TEST STRIPS
The Assure Prism multi Blood Glucose Test Strips are for use with the Assure Prism multi Blood
Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn
fromthengertipsandalternativesites(forearm,palm,thighandcalf).Alternativesitetesting
should be used only during steady-state blood glucose conditions. The Assure Prism multi Blood
Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) and
is intended for multiple-patient use in professional healthcare settings as an aid to monitor the
effectiveness of diabetes control. The system is only used with auto-disabling, single-use lancing
device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
Storage and Handling
• Store unused test strips only in their original bottle/box.
•Storeteststripsinacoolanddryplacebetween34-86˚F(1-30˚C).
• Keep the test strips away from direct sunlight and heat.
• Do not freeze test strips.
• Close bottle cap tightly immediately after taking out a test strip.
• Use the test strip immediately after taking it out of the bottle/individual wrap.
• Handle test strips only with clean, dry hands.
• Do not bend, cut or alter the test strips in any way.
• Do not force a test strip into the meter. Gently push it into the meter’s test strip port.
• Apply only fresh capillary whole blood to the test strip.
• Use all of the test strips within the expiration date printed on the test strip bottle/box label.
• Do not use the expired test strips and dispose the expired test strips immediately because
using test strips past the expiration dates can produce incorrect test results.
• If the test strips are used and stored according to its storage and handling methods, test strips
in new, unopened bottle/boxes, test strips in bottle/boxes that have been opened can be used
until the expiration date printed on the test strip bottle/box label.
UNEXPECTED RESULTS
• Loworhighbloodglucosereadingscanindicateapotentiallyseriousmedicalcondition.Iftheblood
glucose reading is unusually low or high, or symptoms do not match the test result, repeat the test
using a new test strip.
• If the result is still not consistent with the symptoms observed or if blood glucose result is less
than60mg/dLorhigherthan240mg/dLconsultyourpatientshealthcareprovider.
Contact Bars
Gently push the test strip, with its contact bars
facing up, into the test strip port of the meter.
Confirmation Window
Check here to see
whether sufficient blood
sample has been applied. Edge to Obtain Blood Sample
Obtain blood sample here for testing by touching the
application tip at the end of the test strip to the blood
drop on finger.
Insert

SECTION
A
4
Warnings and Precautions
• Alternative site and fingertip results may differ significantly due to rapid changes in the
glucose level after meals or exercise, hypoglycemic symptoms, or effects of drugs such as
insulin. AST testing should only be conducted under steady-state blood glucose conditions.
Use a fingertip sample if you suffer from hypoglycemia or have experienced hypoglycemic
shock or symptoms.
• Test strips are for single use only. Do not reuse.
• If the test strip does not absorb the blood sample properly, please contact Technical
Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week.
• For instructions on how to obtain samples from alternative sites, please refer to the AST
section of the User Manual for your meter.
Alternative Site Blood Sampling (forearm, palm, thigh, calf)
Select a clean, soft and fleshy sample site free of visible veins and hair and away from bones.
Gently massage the sample site to increase blood circulation to minimize differences between
fingertip and alternative site test results. Place auto-disabling, single-use lancing device against
the sample site. Press the release button. Massage the site to obtain a round drop (at least 0.5
μL)ofblood.Applyteststriptiptobloodsample.
Limitations
• An abnormally high or low red blood cell count (hematocrit level over 60% or below 20%) may
produce inaccurate results.
• Inaccurate results may occur in severely hypotensive (having low blood pressure) individuals
or patients in shock. Inaccurate low results may occur for individuals experiencing a
hyperglycemic hyperosmolar state, with or without ketosis. Critically ill patients should not be
tested with the Assure® Prism multi Blood Glucose Monitoring System.
• Severe dehydration (excessive water loss) may cause falsely low results. If you believe your
resident is suffering from severe dehydration, consult their physician immediately.
• There is no effect from altitudes of up to 10,000 ft (3,000 m) above sea level.
• Interferences: Acetaminophen, ascorbic acid (vitamin C), uric acid and other reducing
substances (when occurring in normal blood or normal therapeutic concentrations) do not
significantly affect results. However, abnormally high concentrations in blood may cause
inaccurate high results.
• Blood samples that contain a high concentration of dissolved oxygen may lower the test result.
• Dispose used test strips in a proper waste container, according to your local waste authority.
• Not for neonatal use and not for screening or diagnosis of diabetes.
Ordering Details
Product Description ARKRAY Product Code# NDC#
Assure Prism multi Test Strips 50 count 530050 08317-5300-50
Assure Prism multi Test Strips 100 count 530100 08317-5301-01
Assure Prism multi Test Strips – Foil-wrapped 50-count 532050 08317-5320-50

5
SECTION
A
ASSURE® PRISM CONTROL SOLUTION
The Assure Prism Control Solutions are red in color. The Assure Prism Control Solutions are
for use with the Assure Prism multi Meter and Assure Prism multi Test Strips to check that
the meter and test strips are working together properly and that you are performing the test
correctly.
Storage and Handling
StoretheAssurePrismControlSolutionsattemperaturesbetween46-86˚F/8-30˚C,tightly
cappedthebottle.Itmustbekeptatroomtemperature(68-77˚F/20-25˚C)atleast30minutes
before testing to obtain correct results. Do not refrigerate or freeze the control solution.
Warnings and Precautions
• Assure Prism Control Solutions are for in vitro diagnostic use only.
• Use Assure Prism Control Solutions only with the Assure Prism multi Meter and test strips.
• Do not swallow or inject the control solution.
• Check the expiration date shown on the bottle label. Do not use if expired.
• Do not use beyond 3 months (90 days) after opening the bottle. Record the discard date
(3 months from the day the bottle was opened) on the bottle label.
• If the control solution test results are outside the range printed on the test strip bottle/box, do
not use the system to test blood until you have resolved the problem.
• Controlsolution,meterandteststripsmustbestoredatroomtemperature(68-77˚F/20-25˚C)
at least 30 minutes before testing.
• The control solution contains a dye that may stain clothes.
CAUTION
• The control solution ranges printed on the test strip bottle/box are for the Assure
Prism Control Solutions only. These ranges are used to check the meter and test
strip performance.
• These are not recommended ranges for blood glucose level.
Recommended Control Solution Use
• You want to practice the test procedure, using the control solution instead of blood
• YouusetheAssurePrismmultiMeterforthersttime
• You begin using a new bottle or box of individually wrapped test strips
• You suspect that the meter or the test strips are not working properly
• Youthinkthetestresultsareinaccurateortheydonotreecthowthepatientfeels
• If the meter has been dropped or damaged
Ordering Details
Product Description ARKRAY Product Code# NDC#
AssurePrismControlSolution–Level1and2 530006 08317-5300-06

SECTION
A
6
METER SPECIFICATIONS
For additional information refer to the Assure® Prism multi
Blood Glucose Monitoring System User Manual.
Product Specications
Test strips Assure Prism multi Blood Glucose Test Strips
Measurement range 20–600mg/dL
Sample size Minimum0.5µL
Test time 5 seconds
Sample type Fresh capillary whole blood
Calibration Plasma-equivalent
Assay method Electrochemical
Battery life 1,000 tests
Power Two 3.0 lithium batteries (disposable, type CR2032)
Memory 500 test results
Size 3.66 x 2.20 x 0.83 inch (93 x 56 x 21 mm)
Weight 2.10 oz (59.6 g) with batteries
Operating Ranges
Temperature 50–104°F (10–40°C)
Relative humidity 10–90%
Hematocrit 20–60%
Altitude 10,000 ft (3,048 meters)
Unit of measurement mg/dL

7
SECTION
B
Meter Operation and Set-up
METER SET-UP
You should check and update the meter settings such as time and date before using your meter
or after changing the meter batteries. Press and hold the button for 3 seconds to enter the SET
mode. Whenever you want to complete the settings and exit from the SET mode, press and hold
the button for 3 seconds again. Press or to reach the accurate value. Press and hold to
scroll faster.
Adjusting the Date and Time
Step 1: Entering the SET Mode
Press and hold the buttonfor3seconds.Afterallthesegmentsashacrossthe
screen, SET will be displayed on the screen. Press the button again to progress
to the next step.
Step 2: Setting the Year
Press or until the correct year appears. Press and hold button to scroll
through the numbers quickly. After setting the year, press the buttontoconrm
your selection and progress to the next step.
Step 3: Setting the Month
A number indicating the month will be blinking on the left corner of the screen.
Press or until the correct month appears. Press the buttontoconrmyour
selection and progress to the next step.
Step 4: Setting the Date
Press or until the screen displays the correct date. Press the button to
conrmthedateandprogresstothenextstep.
Step 5: Setting the Time Format
The meter can be set in, 12-hour (AM/PM) or the 24-hour clock format.
Press or to select a format. AM/PM is not displayed in the 24-hour format.
After selecting the format, press the button to progress to the next step.
Step 6: Setting the Hour
Press or until the correct hour appears. After the hour is set, press
the button to progress to the next step.
Step 7: Setting the Minute
Press or until the correct minute appears. After setting the minute,
press the button to progress to the next step.

8
SECTION
B
Step 8: Setting the Sound On/OFF
On pressing or , the screen will display On or OFF. Press the
buttontoconrmtheselection.
The meter will beep in the following instances if set to On:
• When you press the button and/or button to turn on the meter or to
set the alarm.
• When the test strip is inserted in the meter.
• When the blood or control solution sample is absorbed into the test strip
and the test starts.
• When the test result is displayed.
If the sound is set to OFF, none of the sound functions will work.
NOTE
•
In a multi-patient setting, we do not recommend using the memory feature including
post-meal alarms, pre-set blood glucose or averaging. Results stored in the memory are
notrelatedtoaspecicpatient.
NOTE
•symbol is displayed only when the sound is set to OFF.
• At any stage, press the button for 3 seconds to exit SET mode and turn off the meter.
• Press and hold button to quickly scroll through the numbers.

9
SECTION
B
PERFORMING A BLOOD GLUCOSE TEST
CAUTION
Before performing a blood glucose test, observe the following safety
precautions:
• All components that come into contact with blood samples should be considered to be
biohazardous and capable of transmitting viral diseases between patients and healthcare
professionals.
• Before testing each patient, a new pair of clean gloves should be worn by the user.
• Wash hands thoroughly with soap and water before putting on a new pair of gloves and
performing the next patient test.
• Use only an auto-disabling, single-use lancing device for each patient.
• After use on each patient, the meter should be cleaned and disinfected. Refer to the
Cleaning and Disinfection section in this manual.
For more information, please refer to the following guidelines:
1.“BiosafetyinMicrobiologicalandBiomedicalLaboratories(BMBL)”,
www.cdc.gov/biosafety/publications/bmbl5/
2.“ProtectionofLaboratoryWorkersFromOccupationallyAcquiredInfections;Approved
Guideline-ThirdEdition”ClinicalandLaboratoryStandardsInstitute(CLSI)M29-A3.
Preparing the Lancing Device
A lancing device is needed in order to collect a blood sample. Only an auto-disabling, single-use
lancing device should be used. The auto-disabling, single-use lancing device can be purchased
from your medical distributor or by telephone from the manufacturer.
Please read the instructions provided by the lancing device
manufacturer before using the device.
Step 1
Wash hands and the sample site with soap and warm water. Rinse and
dry thoroughly.
Wear appropriate protective gear such as disposable gloves.
Preparing the Meter and Test Strip
Step 2
With the contact bars facing up, insert a test
strip into the meter’s test strip port.
Push the test strip gently into the test strip port until the meter automatically
turns on and the symbol appears.

10
SECTION
B
Applying the Blood Sample
Step 3
Obtain a blood sample using a lancing device. Place the lancing device
against the sampling site in the direction of the arrow. The best puncture
sitesareareasonthemiddleorringngers.Removethedevicefrom
thenger.
Wait a few seconds for a blood drop to form. A minimum volume
of0.5microliterisneededtolltheconrmationwindow.
Step 4
After the symbol appears on the screen, apply the blood sample to the
narrow end of the test strip until the meter beeps.
Iftheconrmationwindowisnotlledintimebecauseofabnormal
viscosityorinsufcientvolume,anEr4messagemayappear.
It is recommended that the application of the blood sample to the test strip
be performed virtually vertical to the sample site as shown in the diagram.
NOTE
• The meter will switch off if the blood sample is not applied within 2 minutes of the symbol
appearing on the screen. If the meter turns off, remove the test strip, reinsert it, and start
from Step 2.
Step 5
The test result will appear after the meter counts down from 5 to 1. The result will be
automatically stored in the meter’s memory.
Step 6
Slide the ejector button on the right side of the meter to safely discard used
test strips in a disposable container.
If the test strip is removed, the meter will automatically turn off after
3 seconds.
Good
Sample
Insufcient
Sample
Approximate
Size
Turning On the Backlight
When the meter is on, pressing the backlight button powers on the
display backlight.
The backlight will turn off after 15 seconds or when you press the
backlight button again.

11
SECTION
B
PERFORMING A CONTROL SOLUTION TEST
You should check your meter and test strips using Assure® Prism Control
Solutions(Level1and2).AssurePrismControlSolutionscontainknown
amounts of glucose and are used to check that the meter and the test strips
are working properly. The test strip bottles or individually wrapped test strip
box have Assure Prism Control Solution ranges printed on the labels*. Compare
the result displayed on the meter to the Assure Prism Control Solution range
printed on the test strip bottle or individually wrapped test strip box. Before
using a new meter or a new bottle or box of test strips, you should conduct a
control solution test following the procedure with two different levels of control
solutions(Level1and2).
* For the individually wrapped test strips, Assure Prism Control Solution ranges are printed on the boxes.
NOTE
• Use Assure Prism Control Solutions only.
•Checktheexpirationdatesprintedonthebottle.Whenyourstopenacontrolsolution
bottle, record the discard date (date opened plus three [3] months) in the space provided
on the label.
• Make sure your meter, test strips and control solutions are at room temperature before
testing.Controlsolutiontestsmustbedoneatroomtemperature68–77˚F(20–25˚C).
•Beforeusingthecontrolsolution,shakethebottle,discardtherst1or2dropsandwipethe
top of the control solution cap clean.
•Closethecontrolsolutionbottletightlyandstoreatatemperatureof46–86˚F(8–30˚C).
You should do a control solution test:
• To practice the test procedure using the control solution instead of blood.
•Whenusingthemeterforthersttime.
• Whenever a new bottle or box of individually wrapped test strips is opened.
• If the meter or test strips do not function properly.
• If the patient’s symptoms are inconsistent with the blood glucose test result and you feel
that the meter or test strips are not working properly.
• If the meter is dropped or damaged.
Assure Prism Control Solution Testing
Step 1
Insert a test strip into the meter’s test strip port, with the contact bars
facing upwards.
Gently push the test strip into the test strip port until the meter beeps.
Be careful not to bend the strip while pushing it in. The symbol will be
displayed on the screen.
Step 2
Shake the Assure Prism Control Solution bottle well before each test.
Step 3
Removethecapandsqueezethebottletodiscardtherst1or2drops.
Apply one drop of control solution to the top of the control solution cap.

12
SECTION
B
Step 4
After the symbol appears on the display, apply the solution to the narrow
edgeoftheteststripuntilthemeterbeeps.Makesuretheconrmation
windowllscompletely.
NOTE
• The meter will switch off if the control solution sample is not applied within 2 minutes of the
symbol appearing on the screen. If the meter turns off, remove the test strip, reinsert, and
start from step 2.
Step 5
A test result will appear after the meter counts down from 5 to 1.
After your control solution result appears on the display, press
for3secondsuntil“check”appearsonthedisplay.
When“check”isdisplayed,theresultisstoredinthemeter’smemory
but it is not included in the averages.
Compare the result displayed on the meter to the range printed
on the test strip bottle or box of individually wrapped test strips.
If the result falls within the specied range, you are ready to use
the meter and test strips to test with blood.
Step 6
Remove the used test strip from the meter’s test strip port. The meter
will turn off automatically. Used test strips should be safely discarded in
disposable containers.
CAUTION
• The ranges printed on the test strip bottle or box of individually wrapped test strips are for the
Assure® Prism Control Solutions only. They do not have any connection to blood glucose level.
NOTE
• Assure Prism Control Solution can be purchased from your local supplier or pharmacy. If they do
not stock it, contact ARKRAY Technical Customer Service at 800.818.8877, option 5, 24 hours a
day, 7 days a week.
Control Solution Range
Control 1:
Control 2:

13
SECTION
B
If results continue to fall outside the range printed on the test strip bottle or box of individually
wrapped test strips, the test strip and meter may not be working properly. Do not use your
system and contact Technical Customer Service at 800.818.8877,option 5, 24 hours a day,
7 days a week.
Comparing the Control Solution Test Results
The test result of each control solution test should be within the range printed on the label of the
test strip bottle or box of individually wrapped test strips. Repeat the control solution test if the
test result falls outside of this range. Out-of-range results may occur due to the following factors:
Situations Actions
• When the control solution bottle was not shaken well.
• When the meter, test strip or the control solution were exposed to high or low temperatures.
• When the rst drop of the control solution was not discarded or the top of the cap was not wiped clean.
• When the meter is not functioning properly.
Repeat the control solution test.
• When the control solution is past the expiration date printed on the bottle.
• When the control solution is past its discard date (the date the bottle was opened plus three [3] months).
• When the control solution is contaminated.
Discard the used control solution
and repeat the test using a new
bottle of control solution.
METER MEMORY
The Assure® Prism multi Blood Glucose Meter can save up to 500 test results with time, date
and temperature. If the memory is full, the oldest test result will be deleted and the latest test result
will be stored.
NOTE
•
In a multi-patient setting, we do not recommend using the memory feature including post-meal
alarms, pre-set blood glucose or averaging. Results stored in the memory are not related to a
specicpatient.
Viewing Test Results
Step 1
Press the or button to turn the meter on. The current
date and time will be displayed on the bottom of the screen
followed by the 1-day average value and the number of the
test results saved within the current day.
Step 2
Use the button to scroll through the test results, starting
from the most recent and ending with the oldest. The test
date and the recorded temperature will display alternately.
Press the to return to the results seen previously.
After checking the stored test result, press the button to
turn off the meter.
NOTE
• Thecontrolsolutiontestresultssavedwiththe“check”symbolwillbedisplayedwith
the“check”symbolwhenyoureviewthestoredtestresults.
The number of
tests within
the current day
button
button

14
SECTION
B
INSERTING OR REPLACING THE BATTERIES
The Assure® Prism multi Blood Glucose Meter uses two 3.0 V lithium batteries. Before using the
meter, check the battery compartment and insert batteries if empty. When the symbol
appears on the display while the meter is in use, the batteries should be replaced as soon as
possible. The test results may not be saved if the batteries run out.
Step 1
Make sure the meter is turned off. Push the cover in the direction of the arrow
to open the battery compartment.
Step 2
Toremovetheusedbatteries,placeyourngerundereachbatteryandpull
upward. Insert two new batteries with the + side facing up and make sure the
batteriesareinsertedrmly.
Step 3
Slide the cover back on the battery compartment. Push down until
you hear the tab click into place.
NOTE
• Removing the meter batteries will not affect your stored results. You may, however, need to
reset your meter settings.