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