Arkray ASSURE PLATINUM User manual

Quality Assurance / Quality Control
(QA/QC) Reference Manual
ASSURE®PLATINUM
BLOOD GLUCOSE MONITORING SYSTEM

Table of Contents
Introduction
Section A System Components
Assure®Platinum Meter............................................................................... 1
Assure®Platinum Meter Display Screen...................................................... 2
Assure® Platinum Meter Specications ....................................................... 3
Assure®Platinum Test Strips ....................................................................... 4
Assure®Dose Control Solutions .................................................................. 7
Section B Meter Operation and Set-Up
Meter Set-Up............................................................................................... 9
Blood Glucose Testing................................................................................11
Obtaining a Drop of Blood....................................................................11
Performing a Blood Glucose Test .........................................................12
Performing a Control Solution Test ......................................................14
Meter Memory ...........................................................................................16
Inserting or Replacing the Battery .............................................................18
Cleaning and Disinfecting ..........................................................................19
Guidelines for Cleaning and Disinfecting the Assure Platinum ............19
Cleaning and Disinfecting Procedures................................................. 20
F-Tag 880 (Infection Control Requirements for Blood Glucose Monitoring) ...........21
Cleaning and Disinfecting FAQ.............................................................21
Troubleshooting......................................................................................... 22
Performance Characteristics for Consumers .............................................27
Performance Characteristics for Healthcare Professionals........................27
Section C In-Service Guide
In-Service Training..................................................................................... 29
Competency Checklist .............................................................................. 30
Instructor Training Record..........................................................................31
Nurse In-Service Training Record ............................................................. 32
Self-Test ..................................................................................................... 33
Meter Tracking Form................................................................................. 36
Field Inspection Report ............................................................................. 37
Quality Control Record.............................................................................. 38
QA/QC Protocols Competency Checklist.................................................. 39
Section D Addendums
Product Ordering........................................................................................41
Warranty.....................................................................................................41
Returns .......................................................................................................41
Sample Policy and Procedures.................................................................. 42
Policy: Infection Control....................................................................... 43
Policy: Performing a Blood Glucose Test
with the Assure Platinum Meter.......................................................... 46
Policy: Quality Control Testing on Assure Platinum Meter.................. 48
Policy: Maintaining the Assure Platinum Meter ...................................51

Introduction
The Assure® Platinum Blood Glucose Monitoring System is intended for the quantitative
measurement of glucose in fresh capillary whole blood from the ngertip. Testing is done
outside the body (in vitro Diagnostic Use). It is indicated for use by healthcare professionals
in a clinical setting, or at home (over the counter [OTC]) by persons with diabetes, as an aid
to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or
screening for diabetes mellitus, and is not intended for use on neonates.
We recommend that healthcare professionals wear gloves when handling a blood glucose
meter as contact with blood presents a potential infection risk. We also suggest cleaning
and disinfecting the meter between residents/patients. Please refer to the appropriate user
instruction manual or this QA/QC manual for additional information on testing and cleaning.
This comprehensive manual has been designed to provide you with a thorough reference
source for the Assure Platinum Blood Glucose Monitoring System including:
• Product operations
• Training and in-services
• Guidelines for policies and procedures
• Quality Assurance and 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
reviewing 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 Platinum
Blood Glucose Monitoring System, Assure Platinum Test Strips or Assure Dose Control
Solution. Please see the instructions included with each product for additional detail.

1
SECTION
A
System Components
ASSURE®PLATINUM METER
Test Strip Port: Insertion site for test strip. Located on the top of the meter.
Strip Release Button: When pushed forward, releases the test strip from the test
strip port.
Display Screen: Shows blood glucose result and symbols that guide you
through the test.
M (Main/Memory) Button: Used to access memory.
Forward Button: Used to scroll through formats and memory. Press to set
meter in control solution mode.
Back Button: Used to scroll through formats and memory. Press to set
meter in control solution mode.
Battery Cover Latch: Located on the back of the meter. Press latch to open
battery cover.
Meter Range: Results Range for the Assure Platinum Meter.
Located on the back of the meter.
Battery Compartment:Located on the back of the meter and holds two AAA
batteries. Powers the system.
Serial Number:Located on the back of the meter.
S/N : 1040-4000000
BLOOD GLUCOSE METER
Meter Range㸸
20-600 mg/dL
For assistance call
800.818.8877
Made in China
For In Vitro diagnostic use
P/N 1806-01
MANUFACTURED FOR
Assure®Platinum Meter Front Assure®Platinum Meter Back
Battery
Cover Latch
Meter Range
Battery
Compartment
Display
Screen
“M” (Main/
Memory)
Button
Test Strip Port
Forward Button
Serial
Number
Strip
Release
Button
Back Button
ORDERING DETAILS
ARKRAY Product Code# 500001 NDC# 08317-5000-01

SECTION
A
2
SECTION
AASSURE®PLATINUM METER DISPLAY SCREEN
Full Display Screen Layout
mg/dL
MEM
AVG
DAY
DST
d-m-d
HYPO
am
pm
Date Format
Hypo Warning
Remove Test Strip
Test Result Flag Temperature Warning
Unit of Measurement
Audible Beep Off
On
Alarm
Control Solution Test
Low Battery
Time
Daylight
Savings
Time
Memory Mode
Date
Average Test Reading
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 Platinum Blood Glucose Meter is preset and
xed in mg/dL.

3
SECTION
A
ASSURE®PLATINUM METER SPECIFICATIONS
For additional information refer to the Assure®Platinum User Manual.
Product Specications
Test strips Assure Platinum Test Strips
Result range 20–600 mg/dL
Calibration Plasma referenced
Sample size Minimum 0.5 µL
Blood source Capillary whole blood
Test time 7 seconds
Assay method Biosensor, Glucose oxidase (Aspergillus niger sourced)
and Hexaammineruthenium (III) chloride
Power source Two 1.5V alkaline AAA batteries
Battery life
More than 5,000 tests at 4 tests per day
Display type Liquid Crystal Display (LCD)
Memory 500 results with time and date stamp
Average 7-, 14-, 30-, and 90-day averaging
Automatic shut off 2 minutes after last user action
Size 4.5” x 2.5” x 1.2”
Weight 2.8 oz. (without batteries)
Operating Ranges
Temperature 50°F–104°F (10°C–40°C)
Relative humidity 20%–80%
Hematocrit 30%–55%
Altitude 10,000 ft. (3,048 meters)
Unit of measurement mg/dL

SECTION
A
4
ASSURE®PLATINUM TEST STRIPS
Intended Use
Assure Platinum Test Strips are intended for the quantitative measurement of glucose in fresh
capillary whole blood from the ngertip when used with the Assure Platinum Blood Glucose
Meter. Testing is done outside the body (in vitro Diagnostic Use). They are indicated for use at
home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare
professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for
the diagnosis of, or screening for, diabetes mellitus and is not intended for neonates.
The Assure Platinum Test Strips come in a moisture-proof, light-protected bottle, and are
designed to work with the Assure Platinum Blood Glucose Meter. The test strips are sensitive
to moisture and light, so it is important that you keep the bottle sealed until you are ready
to use the strips. Do not leave any test strips outside the test strip bottle while not in use.
Replace the cap tightly after a test strip is removed from the bottle.
These test strips require only 0.5 µL of blood. Apply the application tip to the blood sample.
The strip draws in the blood by capillary action. The blood glucose reacts with the enzyme
on the test strip. This produces a current proportional to the blood glucose level. The meter
detects the current and converts it into a blood glucose reading. Assure Platinum Test Strips
use glucose oxidase chemistry.
Contact Bars
NOTE: Insert
Contact Bars
into Meter
Sample
Application Tip

5
SECTION
A
Storage and Handling
• Store test strip container in a cool, dry place between 39–86°F (4–30°C).
• Keep away from direct sunlight and heat. Do not freeze or refrigerate.
• Do not store or transfer the Assure Platinum Test Strips outside of the original vial.
• Do not bend, cut or alter an Assure Platinum Test Strip.
• As soon as you have removed a test strip, replace the cap securely on the vial.
• When you rst open the vial, write the date on the vial label. Use the test strips within
3 months of rst opening the vial.
• Do not use test strips beyond the expiration date ( ) on the label.
• Always clean and dry hands before handling a test strip. Do not touch the sample
application tip of the test strip.
• Do not re-use an Assure Platinum Test Strip.
• Only use Assure Platinum Test Strips with an Assure Platinum Blood Glucose Meter.
NOTE: Healthcare Professionals should wear gloves when testing patient.
IMPORTANT: Low or high blood glucose readings can indicate a potentially serious
medical condition. If blood glucose reading is unusually low or high, or the patient/
resident does not feel the way readings indicate, repeat the test using a new test
strip. If result is still not consistent with symptoms, or if blood glucose result is
less than 60 mg/dL or higher than 240 mg/dL contact the diabetes healthcare
professional for advice.
For use with the
Assure®Platinum
Blood Glucose
Monitoring System
Blood
Glucose
Test
Strips
BLOOD GLUCOSE TEST STRIPS
ORDERING DETAILS
ARKRAY Product Code# NDC#
Assure Platinum Test Strips 50-count 500050 08317-5000-50
Assure Platinum Test Strips 100-count 500100 08317-5001-00

SECTION
A
6
WARNINGS AND PRECAUTIONS
• For in vitro Diagnostic Use.
• Never make signicant changes to your diabetes control program or ignore physical
symptoms without consulting with your healthcare professional.
• Severe dehydration (excessive water loss) may cause false low results. If you believe
you are suffering from dehydration, consult your healthcare professional immediately.
• Extremes in hematocrit may affect test results. Hematocrit levels less than 30%
may cause falsely high readings. Hematocrit levels greater than 55% may cause
falsely low readings.
• Inaccurate results may occur in severely hypotensive 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 blood glucose meters.
• Patients undergoing oxygen therapy may yield false results.
• High levels of ascorbic acid may yield inaccurate results.
• Externally taken drug ephedrine will not interfere with blood glucose results when
taken at therapeutic concentrations. However, abnormally high concentrations in blood
may cause inaccurate results.
Healthcare Professionals: Please note additional limitations of procedure:
• Triglycerides at 3,300 mg/dL may signicantly affect test results.
• Metabolites of icodextrin (maltose, maltotriose and maltotetraose) do not signicantly
affect test results.
Limitations of System
• The Assure Platinum Blood Glucose Monitoring System is not designed to substitute
pathology laboratory equipment and should not be used for the diagnosis of diabetes.
• Use only fresh capillary whole blood. Do not use serum or plasma or venous whole blood.
• Do not use the Assure Platinum Blood Glucose Monitoring System to test neonates.
It has not been validated for neonatal use.
• Assure Platinum Test Strips may be used at altitudes up to 10,000 ft (3,048 m) without
effect.

7
SECTION
A
ASSURE®DOSE CONTROL SOLUTIONS
Intended Use
For use with Assure Platinum, GLUCOCARD Vital or ReliOn® Prime Blood Glucose Meter
and test strips as a quality control check to verify the accuracy of blood glucose test results.
Control solutions are available in two levels – Normal (Level 1) and High (Level 2).
Summary
Assure Dose Control Solution contains a known amount of glucose that reacts with the
test strips. Compare the control solution test result with the range printed on the test strip
bottle label.
Storage and Handling
• Store the Assure Dose Control Solution between 35–86°F (2–30°C).
• Keep away from direct sunlight and heat. Do not freeze.
• Use before the expiration date printed on the bottle.
• Use the Assure Dose Control Solution within 90 days (3 months) of rst opening. It is
recommended that you write the date of opening on the control solution bottle label
(“Date Opened”) as a reminder to dispose of the opened solution after 90 days.
• Always replace the cap immediately after use.
• Assure Dose Control Solution is not a cleaning solution. Do not clean your meter with
Assure Dose Control Solution.
WARNINGS AND PRECAUTIONS
For In Vitro Diagnostic Use.
• Assure Dose Control Solution is not intended for human consumption. Do not drink.
• Only use with Assure Platinum, GLUCOCARD Vital or ReliOn® Prime Blood Glucose
Meter and Test Strips.
• To avoid contamination, NEVER touch tip of control solution bottle to test strip.
• Dye in control solution may stain clothing or surfaces.
IMPORTANT: If you do not set the meter in the control solution mode, the control
solution result will NOT be valid. Using the control solution mode will also ag the
result in memory. This prevents the result from being part of the averages.

SECTION
A
8
Troubleshooting
If the result is outside the range printed on the test strip bottle, repeat the test. One or more of
the following may cause an out-of-range result:
• The meter was not placed in control solution mode before adding solution. Refer to
manual or test strip insert for more information.
• The control solution is expired or contaminated.
• The control solution was stored below 35°F (2°C) or above 86°F (30°C).
• The test strip was not stored correctly.
• The test strip was used after the expiration date on the bottle.
• The test strip bottle was open for more than 90 days (3 months).
• The test strip is inserted incorrectly.
• The meter has been damaged or has malfunctioned.
• The rst drop of control solution was not discarded.
• The control solution is contaminated as the tip of the control solution bottle touched the
test strip.
PLEASE NOTE: If your Assure® Dose Control Solution result continues to read outside the
required range printed on the test strip label, the system may not be working correctly.
DO NOT USE the system to test your blood glucose until the control solution result is within
the acceptable range. If you are unable to resolve the problem or need assistance, please
call Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week.
Contact your diabetes healthcare professional if you are unable to reach Technical
Customer Service.
ORDERING DETAILS
ARKRAY Product Code# NDC#
Assure Dose Control Solution 500006 08317-5000-06
(Normal and High)
High (Level 2)
Control
Solution
Normal (Level 1)
Control
Solution
Assure®Dose Control
Solution - Normal
(Level 1)
High (Level 2)
Control
Solution
Normal (Level 1)
Control
Solution
Assure® Dose Control
Solution - High
(Level 2)

9
SECTION
B
Meter Operation and Set-Up
METER SET-UP
Before using the Assure® Platinum Meter for the rst time, set the time and date. Do not
perform a blood glucose test until you have performed meter set-up. In the set-up mode,
there are menu options for audible beep, hypo warning, daylight savings time, time, date,
backlight, and QC reminder.
Basic rules for meter set-up
Step 1: Press “M” button to turn meter on. The full screen layout will be briey displayed
followed by the memory.
Step 2: Press and hold the “M” button for two seconds. You have now entered set-up mode.
The audible beep symbol appears at the bottom of the display screen.
Step 3: The current setting will be displayed for each menu option as you scroll through the
menu. Use the Back and Forward buttons to change setting.
Step 4: Press “M” button briey to accept the setting and move to the next option.
Step 5: To exit set-up mode at any time and save all settings, press and hold the “M” button
for more than two seconds. This will return you to the memory screen.
Step 6: Press the “M” button to turn meter off.
Setting the Audible Beep
The beep may be turned “On” (Diagram A) or “Off” (Diagram B).
If turned “On”, the beep will sound when:
• Meter is turned on.
• Test has ended and the result is displayed.
• HYPO warning is turned on and blood glucose
result is below HYPO setting.
• Meter starts to count down.
Setting the Hypoglycemic (HYPO) Warning
Set the HYPO Warning to remind someone to take action due to a low blood glucose result.
You must take caution if the HYPO Warning is used in a multi-patient setting as each resident
may have a different HYPO threshold.
If the HYPO Warning is set to “On” (Diagram A), you will be prompted
to select the value at which you wish the warning to sound. The value
will ash to show that it can be changed. You may pick a value between
20–80 mg/dL.
Audible Beep ON Audible Beep OFF
A. B.
mg/dL
HYPO
A.

10
SECTION
B
Setting the Daylight Savings Time
This meter has the function of switching from
standard time to daylight saving time (DST).
“ON” (Diagram A) or “OFF” (Diagram B) will blink.
Setting the Time Format
The time can be displayed in either a 12-hour format
(Diagram A) or a 24 hour format (military time) (Diagram B).
Setting the Time
The hour (Diagram 1A) and minute setting
(Diagram 2A) will ash to indicate that it may
be changed.
Setting the Date Format
The date can either be displayed in the month/day format
(m-d) (Diagram A) or the international day/month format
(d-m) (Diagram B).
Setting the Date
Set the month (Diagram A), day (Diagram B)
and year (Diagram C).
Setting the Backlight Setting
To save the battery life, the backlight level is pre-set not to come on.
Select settings of “0,” “5,” “10,” “15,” and “100.”
0..................Backlight off.
5, 10, 15 .......Backlight will stay on for 5, 10 or 15 seconds.
100 ..............Backlight will always stay on.
Setting the qcProGuard®/QC Reminder
This can be set to remind someone to perform a control solution test.
When set to “On” (Diagram A), the reminder will prompt you to do a
control solution test every 24 hours. If a control test has not been
performed within 24 hours of the previous test, PCS (Perform Control
Solution test) will ash on the screen along with
am
(Diagram B).
PCS will ash three times and then disappear. The
am
will stay on the
screen and also mark a result in the memory mode.
DST
am
DST
am
A. B.
A. B.
am
1A. 2A.
am
d-m-d
d-
m-d
d-m-d
d-m
-d
A. B.
A. B. C.
B.
A.
NOTE: If PCS ashes when inserting strip, then enter control solution mode by pressing
either the Back or Forward button when the apply blood symbol appears on the screen. PCS
will not be on the screen. You will see a control solution bottle at the top right of your
screen.

11
SECTION
B
BLOOD GLUCOSE TESTING
OBTAINING A DROP OF BLOOD
NOTE:
• We recommend that healthcare professionals use any auto-disabling, single-use safety
lancet to obtain patient blood samples. These instructions are for the Assure®Lance
Safety Lancet. Call Technical Customer Service at 800.818.8877, option 5 to nd a
distributor.
• We advise healthcare professionals to wear gloves during blood testing.
• Meter system must be at room temperature for testing.
Step 1
Wash patient’s hands with soap and warm water.
Dry hands thoroughly. If alcohol wipes are used, make sure the area
is dry before taking blood sample. Residual alcohol may lead to
inaccurate readings.
Step 2
Let the arm hang down for 10 to 15 seconds. (Holding the arm below
the heart and massaging the wrist, palm and nger makes it easier
to obtain a blood drop).
Step 3
Choose a site on the side of a ngertip to minimize pain.
Step 4
Grasp the outer white edge of the Assure Lance Safety Lancet.
Twist the protective cap 360° to remove.
Do not put your thumb on the top button while removing the
cap; this prevents a misre.
Step 5
Place lancet against side of ngertip. Press button rmly.
After use, discard in sharps container.
360°

12
SECTION
B
PERFORMING A BLOOD GLUCOSE TEST
CAUTION: To reduce the chance of infection
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 biohazards capable of transmitting viral diseases between patients and
healthcare professionals.
• A new pair of clean gloves should be worn by the user before testing each patient.
• 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.
• The meter should be cleaned and disinfected after use on each patient.
CAUTION: Failure to follow instructions may cause inaccurate results.
Step 1
Remove Assure® Platinum Test Strip from the bottle.
Immediately replace the bottle cap tightly.
Insert test strip as shown in the diagram.
Meter will turn on automatically.
Verify that all symbols appear on the screen.
NOTE: If both PCS and
am
appear on the screen,
perform a control solution test.
The strip and ashing blood drop indicate the meter is ready for use.
Step 2
Obtain a blood sample. Touch the sample application tip
at the end of the strip to the blood drop on your nger,
using a 90º angle. Capillary action will pull the blood
into the strip.
Insert contact bars
into meter.
Sample Application Tip
Contact
Bars
NOTE: Apply blood to test strip within 20
seconds of obtaining a blood sample. The meter
will start to count down when it detects that
blood has been applied. If meter does not start
after adding the rst blood drop, remove the test
strip and test with a new test strip. Discard strip if
meter does not start to count down.
Enough
Blood
Not Enough
Blood
Too Much
Blood
IMPORTANT: The minimum sample volume is
0.5 µL. Smaller samples may not start the meter
or can start the meter count down and provide an
E13 error message. Ensure blood completely lls
the reaction site.

13
SECTION
B
Step 3:
Meter will count down by showing “7”. The meter will show the result in
7 seconds.
Option: Flagging Test Result in Memory
• Results may be marked with an “!” if you feel the result
is incorrect or the test procedure was not followed correctly.
• Mark the test result with an “!” by pressing either the
Forward or Back button after result is on screen.
Marked results will not be included in the 7-, 14-, 30-,
or 90–day averages.
NOTE: Healthcare Professionals: Record test result in patient’s chart.
Step 4:
The ashing arrow reminds you to remove the test strip.
Remove the test strip by holding the meter so that the
test strip points down. Push the test strip release button forward.
Dispose of test strip. The meter shuts off automatically when you
remove the test strip.
NOTE: Results will be shown in units of mg/dL. Results will not show a decimal point.
mg/dL
am
mg/dL
am
mg/dL

14
SECTION
B
mg/dLmmol/L
MEM
AVG
DAY
CODE
d-m-d
HYPO
am
pm
PERFORMING A CONTROL SOLUTION TEST
You should check your meter and test strips using Assure® Dose Control Solutions
(Normal-Level 1 and High-Level 2) to conrm the meter and test strips are working properly,
or to check if you are testing correctly. Assure Dose 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 vials have Assure Dose Control Solution ranges printed on the labels.
Compare the result displayed on the meter to the Assure Dose Control Solution range
printed on the test strip vial. Before using a new meter or a new vial of test strips, you should
conduct a control solution test following the procedure with two different levels of control
solutions (Normal-Level 1 and High-Level 2).
USE CONTROL SOLUTION
• To test your technique.
• Before testing with the meter for the rst time.
• When you open a new bottle of test strips.
• When you suspect the meter or test strips may not be functioning properly.
• If the test results appear to be abnormally high or low or are not consistent with clinical
symptoms.
• When the meter has been dropped or stored below 32ºF (0ºC) or above 122ºF (50ºC).
• The test strip bottle has been left open or has been exposed to light, temperatures below
39°F (4°C) or above 86°F (30°C), or humidity levels above 80%.
• Each time the batteries are changed.
SETTING THE QUALITY CHECK REMINDER
The qcProGuard quality check reminder can be set to remind someone to perform a control
solution test.
When set to “On”, the reminder will prompt you to do a control solution
test every 24 hours. If a control test has not been performed within 24 hours
of the previous test, PCS (Perform Control Solution test) will ash on the
screen along with
am
. PCS will ash three times and then disappear.
The
am
will stay on the screen and also mark a result in the memory mode.
WARNINGS AND PRECAUTIONS:
For in vitro Diagnostic Use.
• Assure Dose Control Solution is not intended for human consumption.
• Do not drink.
• Only use with Assure Platinum, GLUCOCARD Vital or ReliOn® Prime Blood Glucose
Meter and Test Strips.
• To avoid contamination, NEVER touch tip of control solution bottle to test strip!
• Dye in control solution may stain clothing or surfaces.
NOTE: Healthcare Professionals: Perform control solution tests in accordance with your
state regulatory guidelines.