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

Quality Assurance / Quality Control

(QA/QC) Reference Manual

Table of Contents

Introduction

Section A System Components

Assure

Platinum Meter

Assure

Platinum Meter Display Screen

Assure

Platinum Test Strips

Assure

Dose Control Solutions

Assure

Platinum Meter Specications

Section B Meter Operation and Set-Up

Meter Set-Up

Blood Glucose Testing

Obtaining a Drop of Blood

Performing a Blood Glucose Test

Performing a Control Solution Test

Meter Memory

Recalling Results

Inserting or Replacing the Battery

Cleaning and Disinfecting

Troubleshooting

Troubleshooting Control Procedure

Frequently Asked Questions

Assure

Platinum Test Strips

Assure

Dose Control Solution

Section C In-Service Training

In-Service Guide

Competency Checklist

Self-Test

Nurse In-Service Training Record

Section D Quality Assurance/Quality Control Recording Forms

Meter Tracking

Quality Control Record

Field Inspection Report

Section E Regulatory Review and Guidelines for QA/QC Protocols

Competency Checklist

Section E Addendums

Product Ordering

Warranty

Returns

Introduction

The Assure

Platinum Blood Glucose Monitoring System is intended for the quantitative

measurement of glucose in fresh capillary whole blood from the ngertip. 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. The

intended use of each meter can be found in: Intended Use, (Section B) of the Assure

Platinum Test Strips Insert and the Assure

Dose Control Solutions Insert.

The Assure

Platinum Blood Glucose Monitoring System is designed for institutional/clinical

and/or multi-patient settings. 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 QA/QC manual for additional information

on testing and cleaning.

ARKRAY recognizes the challenges in establishing quality control programs within healthcare

facilities. We understand our responsibility in assisting our customers in developing and

implementing a bedside blood glucose monitoring program.

This comprehensive manual has been designed to provide you with a thorough reference

source for the Assure

Platinum 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 Customer Service Department at

800.818.8877 (toll-free), option 5, 24 hours a day, 7 days a week, USA and Canada.

SECTION

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) Used to access memory.

Button:

Forward Button: Marks control solution test and used to scroll through

formats and memory.

Back Button: Marks control solution test and used to scroll through

formats and memory.

Battery Cover Latch: Located on the backside of the meter. Press latch to open

battery cover.

Meter Range: Located on the backside of the meter.

Battery Compartment: Located on the backside of the meter and holds two AAA

batteries. Powers the system.

Serial Number: Located on the backside 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

The Assure

Platinum Test Strips come in a moisture-proof, light-protected bottle, and are

designed to work with the Assure

Platinum 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.

ASSURE

PLATINUM METER DISPLAY SCREEN

ASSURE

PLATINUM TEST STRIPS

Full Display Screen Layout

mg/dL

MEM

AVG

DAY

DST

d-m-d

HYPO

Date Format

Hypo Warning

Remove Test Strip

Test Result Flag

Temperature Warning

Unit of Measurement

Audible Beep

Off

Alarm

Control Solution Test

Low Battery

Time

Daylight

Savings

Time

Memory Mode

Date

Average Test Reading

Test Strip

Contact Bars

Reaction Site

Sample Application Tip

(Apply blood to end of test

strip. Capillary draw will pull

blood to reaction site.)

Insert into

meter

this way

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

ASSURE

DOSE CONTROL SOLUTIONS

High (Level 2)

Control

Solution

Normal (Level 1)

Control

Solution

Assure

Dose

Control Solution

Normal

High (Level 2)

Control

Solution

Normal (Level 1)

Control

Solution

Assure

Dose

Control Solution

High

ORDERING DETAILS

ARKRAY Product Code# NDC#

Assure

Dose

Control Solution 500006 08317-5000-06

(Normal and High)

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

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 20–80 mg/dL.

Audible Beep ON

Audible Beep OFF

A. B.

mg/dL

HYPO

SECTION

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.

DST

A. B.

1A. 2A.

d-m-d

m-d

d-m-d

d-m

-d

A. B.

A. B. C.

SECTION

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

Lockout Safety Lancet. Call Customer Service at 800.818.8877 (toll-free), 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

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.

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

(Diagram B).

PCS will ash three times and then disappear. The

will stay on the

screen and also mark a result in the memory mode.

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.

360°

SECTION

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

appear on the screen,

perform a control solution test (see next page).

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.

Capillary action will pull the blood into the strip.

Note: 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.

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.

Enough

Blood

Not Enough

Blood

Too Much

Blood

Insert contact bars

into meter.

Sample Application Tip

Contact

Bars

SECTION

Step 3:

Meter will count down by showing “7”. The meter will show the result in

7 seconds.

Results will be shown in units of mg/dL. Results will not show a decimal point.

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.

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.

mg/dL

SECTION

mg/dL mmol/L

MEM

AVG

DAY

CODE

d-m-d

HYPO

Performing a Control Solution Test

Healthcare Professionals: Perform control solution tests in accordance with your state

regulatory guidelines.

Step 1

Insert test strip as shown. The meter will turn on automatically. The full

screen will come on for a moment. Make sure all symbols appear on

the screen. The strip symbol and ashing blood drop will automatically

be displayed.

Note: If both PCS and

appear on the screen, perform a control

solution test.

Step 2

Press the Back

Forward button one time to enter the control solution

mode. A control solution bottle “

mg/dL mmol/L

MEM

AVG

DAY

CODE

d-m-d

HYPO

” will appear at the top right of the screen.

If you do not enter 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.

will prompt you to

apply control solution.

Step 3

Mix solution by gently inverting control solution bottle several times (do not

shake). Remove the cap from the control solution bottle and place on at

surface. Squeeze the bottle and discard the rst drop. Apply the second

drop to the top of the clean cap.

Step 4

Bring meter and strip to drop. Test strip will draw up the solution.

The meter will show result in 7 seconds.

Step 5

Compare the result to the range printed on the test strip bottle.

Make sure the result is within the acceptable range. If the result

falls within this range, the meter and test strip are working correctly.

Do not use system if control solution result is out of range.

Healthcare Professionals: Record result in quality logbook.

Step 6

Remove the test strip by holding the meter so that the test strip points down.

Push the strip release button forward. The test strip will fall out and meter

will shut off automatically. Dispose of the used test strip. Wipe excess control

solution from cap and replace cap on control solution bottle.

Professionals: Repeat Steps 1–6 with a second control solution.

Control Solution Range (mg/dL)

(Rango de la solución de control)

Normal:

High:

11182A

2004-01

80-120

200-300

Date Opened (Fecha de Apertura)

(Use within 90 days of first opening)

(Usar dentro de los 90 dias a partir de la

fecha en que fue abierto)

Insert

contact

bars

into

meter.

Sample

Application Tip

Contact Bars

mg/dL

SECTION

METER MEMORY

The Assure

Platinum stores up to 500 test results. When more than 500 test results have

been performed, the meter drops the oldest result each time you add a new result. When

you recall test results from Memory, the most recent test result is always shown rst.

Remove the test strip from meter before using Memory.

Note:

We do not recommend using the memory feature in a multi-patient

setting. Results stored in the memory are not related to a specic patient.

Recalling Results

Step 1: Press the “M” button. The last result in memory will be shown.

MEM will be shown in the upper left side of the screen. This screen is a

stored result.

The meter will show the date and result number position (for example 001

for last result (Diagram A), 002 for second to last result (Diagram B), etc.).

It will then show the date and time. These will alternate until you press

the Back or Forward button.

Step 2: Continue to press either the Forward or Backward

button to scroll through memory.

Step 3: Press the “M” button to exit memory mode and

turn meter off.

mg/dL

MEM

mg/dL

MEM

Inserting or Replacing the Battery

To replace batteries:

1. Turn meter off.*

2. Press battery cover latch. Pull the battery

cover up on the back of the meter.

3. Remove the two used batteries.

4. Insert two new AAA batteries.

5. Close battery cover.

6. E00 may be displayed.

Check time and date.

7. Dispose of batteries as per guidelines.

Note:

Failure to turn meter off during

battery replacement will result in lost time

Battery life will decrease with backlighting. A ashing battery symbol

means the battery is

low. Replace batteries as soon as possible. Do not use rechargeable batteries.

Replace batteries within one minute to avoid losing the time and date setting.

Note:

To save battery power, the meter turns itself off two minutes after last use.

SECTION

Go to http://www.assureusa.com/cleandisinfect for the most up-to-date information

on approved cleaning and disinfecting procedures and materials for ARKRAY blood

glucose meters.

For wipes not listed, we recommend you create supporting documentation to justify your

choice. Choosing a wipe not listed above could shorten use life or affect performance of

the Assure

Platinum meter. If you experience any of these issues, please contact ARKRAY

Technical Customer Service immediately to obtain a free replacement meter. ARKRAY

recommends testing meters with control solution anytime you suspect the system is not

functioning properly.

Please see the Assure

Platinum QA/QC Manual or User Instruction Manual for step-by-step

instructions on how to clean and disinfect the Assure

Platinum Blood Glucose Meter.

Go to http://www.assureusa.com/cleandisinfect for the most up-to-date information

on approved cleaning and disinfecting procedures and materials for ARKRAY blood glucose

meters. If you have any questions, please contact our Technical Customer Service department

at 800.818.8877, (toll-free) option 5, 24 hours a day, 7 days a week, USA and Canada.

CLEANING AND DISINFECTING

ARKRAY has made a good-faith effort to test the durability and functionality of the Assure

Platinum meter with the most commonly used wipes. EPA registered wipes were used in

the study. Our testing conrmed the following wipes will not damage the functionality or

performance of the meter through 3,650 cleaning and disinfecting cycles.

Choosing a wipe not listed below could shorten use life or affect performance of the Assure

Platinum meter.

Manufacturer Disinfectant Brand Name EPA#

Clorox

Dispatch

Hospital Cleaner Disinfectant with Bleach

Clorox Healthcare

™

Bleach Germicidal Wipes

Clorox Healthcare

™

Hydrogen Peroxide Cleaner

Clinical Surface Wipes

EZ-Kill

Disinfectant/ Deodorizing/Cleaning Wipes

56392-8

67619-12

67619-25

59894-10

Medline Micro-Kill Individual 3”x 3” Wipe 69687-1

Cambridge Sensors USA Microdot

Bleach Wipe 69687-1

Metrex CaviWipes

™

46781-8

Professional Disposables

International, Inc. (PDI)

Super Sani-Cloth

Germicidal Disposable Wipes

Sani-Cloth

Bleach Germicidal Disposable Wipe

Sani Cloth

AF Germicidal Disposable Wipes

9480-4

9480-8

9480-5

Virox Technologies Accel TB Hydrogen Peroxide Cleaner/Disinfectant 74559-3

CLEANING AND DISINFECTING

Cleaning and Disinfecting FAQ

If a blood glucose meter is assigned to an individual

resident and not shared, does it still need to be

cleaned and disinfected?

CMS guidelines read that blood glucose meters need to be

cleaned and disinfected after each use. It is our interpretation

that individually assigned meters need to be cleaned and

disinfected. Each meter in use is subject to QC testing per

the facility’s policy.

What can be used to clean a blood glucose meter?

Cleaning can be accomplished by wiping the meter down with

soap and water or isopropyl alcohol, but will not disinfect a meter.

What can be used to disinfect a blood glucose meter?

Disinfecting can be accomplished with an EPA registered

disinfectant detergent or germicide that is approved for

healthcare settings or a solution of 1:10 concentration of

sodium hypochlorite (bleach).

Go to www.assureusa.com/cleandisinfect for a list of wipes

that have been tested on ARKRAY blood glucose meters.

Can cleaning and disinfecting be accomplished with

one wipe?

Many wipes act as both a cleaner and disinfectant. If blood is

visibly present on the meter, two wipes must be used; one

wipe to clean and a second wipe to disinfect.

What will happen if a blood glucose meter is not

cleaned and disinfected after use?

Per the CMS F-Tag 441 guideline, surveyors may issue a citation

if they observe no cleaning and disinfecting of meters after a

blood glucose test as they would not be in compliance with

CMS F-Tag 441.

It is important that an LTC facility establish a program for

infection control and identify a key individual responsible for

the overall program oversight. The program should include

addressing the cleaning and disinfection of blood glucose

meters along with other equipment and environmental surfaces.

The program should involve establishing goals and priorities,

planning, strategy implementation, post-surveillance and more.

Additionally, staff roles and responsibilities should be identied

and training should be documented. It is also important to

provide education on infection control and the proper use of

products. More information on establishing a comprehensive

infection prevention and control program can be found in the

CMS Infection Control Guidance Document.

F-Tag 441

Infection Control Requirements for

Blood Glucose Monitoring

What is the Centers for Medicare and

Medicaid Services (CMS) F-Tag 441?

F-Tag 441 is an interpretive guideline for

infection control programs in Long Term

Care facilities. It is put in place to prevent,

recognize and control the onset and spread

of infection. F-Tag 441 is used for guidance

by CMS Regional Ofces and State Survey

Agencies for [re-]certication and complaint

investigations.

Does F-Tag 441 only apply to blood

glucose meters?

No, F-Tag 441 applies to all resident care

equipment and environmental surfaces,

including blood glucose meters.

Why is Cleaning and Disinfecting of blood

glucose meters such a high priority?

Blood glucose meters are at high risk of

becoming contaminated with bloodborne

pathogens such as Hepatitis B Virus

(HBV), Hepatitis C Virus (HCV) and

Human Immunodeciency Virus (HIV).

Transmission of these viruses from resident

to resident has been documented due

to contaminated blood glucose devices.

According to the Centers for Disease

Control and Prevention, cleaning and

disinfecting of meters between resident

use can prevent the transmission of these

viruses through indirect contact.

How often do blood glucose meters need

to be cleaned and disinfected?

Per CMS F-Tag 441 Transmittal 55 dated

December 2, 2009, blood glucose meters

need to be cleaned and disinfected after

each use for individual resident care.

Lancets for obtaining a blood sample need

to be properly disposed of after one use.

More information is available at:

http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/index.html

http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html or

www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm

SECTION

TROUBLESHOOTING

Display Screen

Please rst read this section. If you still have questions, call Customer Service

at 800.818.8877 (toll-free), option 5 (24 hours a day, 7 days a week, USA and Canada

only). If outside the USA and Canada, contact your local ARKRAY distributor. Contact your

healthcare professional if you cannot reach Customer Service. Do not send your meter to

ARKRAY or your local dealer without rst calling to get approval to do so.

HI and Lo Messages

HI Message Your blood glucose level is more than 600 mg/dL.

Repeat test with new test strip. If this message shows again,

contact your healthcare professional immediately!

Lo Message Your blood glucose level is less than 20 mg/dL.

Repeat test with new test strip. If this message shows again,

contact your healthcare professional immediately!

Error Messages

The battery has been replaced.

Check that the time and date are set correctly. (The time and date will

be ashing). With the meter turned off, press and hold “M” button for two

seconds to enter “check meter settings mode.” Then conrm that the time

and date are correct. If they are not correct, press and hold “M” button to

enter set-up mode.

A used strip has been inserted. Or the meter is having a problem

reading the strip.

Repeat test with new test strip.

Battery power is getting low.

There is enough power for about 100 tests. Replace batteries soon.

Battery power low.

There is enough power for about 20 tests. Replace batteries soon.

The battery power is too low for testing.

Replace batteries.

Thermometer symbol.

The meter temperature is outside acceptable range of 41ºF–113ºF

(5ºC–45ºC). Allow the meter and test strips to warm up or cool down

for at least 30 minutes to adjust to new temperature.

mg/dL

SECTION

Test Strip Calibration Reading Error.

Meter detected abnormal signal of blanking on Assure

Platinum test strip.

Remove the test strip and insert again.

Corrupted Memory.

Result cannot be obtained. Call Customer Service at 800.818.8877

(toll-free), option 5.

Not enough blood was added to test strip.

Retest with new test strip. Apply at least 0.5 µL of blood to sample

application tip.

QC Reminder.

If the QC reminder is set to “On” in set-up mode, both PCS and

will

appear on the screen. PCS and alarm symbol act as a reminder to perform

a control solution test every 24 hours.

Flashing Thermometer Symbol.

The room is outside the preferred temperature range of 50°F–104°F

(10°C–40°C). Treat results obtained with caution. Repeat test where the

temperature is within preferred range. Allow meter and strips at least 30

minutes to adjust to new temperature. The ashing thermometer will be

shown during testing until meter is within preferred temperature range.

These readings will show a thermometer when results are recalled from memory.

Apply Blood Sample.

The blood drop symbol ashes to show that the meter detects a test strip

and is ready for the blood sample.

Apply Control Solution.

The blood drop symbol ashes to show that the meter has detected

a test strip. If the control solution bottle

is also on the screen, it is

ready for you to apply control solution.

For errors not listed, do not attempt to use meter. Contact Customer Service at

800.818.8877, (toll-free) option 5, 24 hours a day, 7 days a week, USA and Canada

SECTION

TROUBLESHOOTING CONTROL PROCEDURE

If the control solution test result is out-of-range, check the following and repeat the test:

Check Action

Did you do the test in control solution mode? Do you see the

control solution bottle symbol on the screen with the result?

If not, do the test again. Insert a test strip, press the Back

or Forward button for control solution mode.

should appear on screen.

Have the test strips and/or control solution expired?

Make sure that test strips and control solutions are not past

expiration date. This date is shown on bottle. Discard control

solution 90 days after bottle is opened.

Were control solutions stored correctly (35–86°F) (2–30°C)? If not, retest with new bottle of control solution.

Did you insert test strip rmly into meter? Make sure test strip is inserted all the way into test strip port.

Were the test strips stored correctly (between 39°–86°F

(4–30°C))? Was the bottle cap replaced immediately

after taking out a test strip?

If not, retest with a new bottle of test strips.

Is the test strip inserted properly?

Make sure that the test strip is inserted into

the test strip port correctly.

Is the meter damaged? Does it show an error code?

If yes, contact Customer Service at

800.818.8877 (toll-free), option 5.

Did you discard the rst drop of control solution? If not, do test again. Discard rst drop of control solution.

Did you touch the tip of the control solution bottle

to the test strip during use?

If yes, replace control solution.

Does your Control Solution result still read outside the range printed on the test strip bottle?

If yes, the system may not be working correctly. DO NOT USE the system to test your blood

glucose until the control solution result is within range. If you need help, please call Customer

Service at 800.818.8877 (toll-free), option 5, (24 hours a day, 7 days a week, USA and

Canada). Contact your diabetes healthcare professional if you cannot reach Customer Service.

SECTION

FREQUENTLY ASKED QUESTIONS

1. Can results vary between meters in side-by-side tests?

Yes. One meter is not a valid reference method for another meter. Readings would likely vary

because of the many variables that can affect the reading including:

• The naturally uneven distribution of glucose in blood between sites

• The time that the blood drop is exposed to the environment

• Whether you had to apply extra pressure to obtain the blood sample

• Inherent 15 to 20% variability of BGMs from laboratory reference methods

• Size of sample

• User technique

Medical studies reveal that it is not uncommon to get differences between the same brand

of test strips or between meters. Small variances are thought by many health professionals to

be perfectly reasonable.¹

Solution: To conrm the accuracy of your meter, test results should be compared to those

obtained from a laboratory.

2. Can the Assure

Platinum Meter results vary from the laboratory test results?

Yes. The test result you get with your meter should fall within 15% of the laboratory result.¹

However, the difference might exceed 20% on rare occasions because of the following

important variables:

a. Plasma versus whole blood

While blood glucose meters test whole blood, laboratory blood glucose measurements

are made either from a whole blood sample or from a blood plasma sample (blood with

the red cells removed). Both methods are widely used, and neither is more “correct”

than the other. However, the very nature of these two sample types produces

slightly different glucose measurements from the sample blood specimen. Plasma

measurements are, on average, about 12% higher than their whole blood counterparts.²

Solution: The Assure

Platinum System is “plasma-referenced. ”Assure

Platinum results

should fall within 15% to 20% of a laboratory result, which is based on testing a plasma

sample. Although the Assure

Platinum uses a whole blood sample, we have adjusted

its internal calibration so that it converts results to match a plasma-referenced result.

Assure

Platinum results will be, on average, 12% higher than laboratory results based on

whole blood testing. To compare Assure

Platinum results with a whole blood referenced

laboratory result, rst multiply the laboratory result by 1.12. Then Assure

Platinum results

should fall within 15% to 20% of the adjusted laboratory result.

b. Capillary versus venous blood

The blood you use to test from the ngertip is capillary blood, while laboratories generally

use venous blood. Unless the patient is in a fasting state, the blood sugar level of the

capillary blood will be higher than that of the venous blood. Capillary blood glucose levels

may be 20 to 70 mg/dL higher than venous blood glucose after food intake.³

SECTION

c. Time test was performed

If the meter test is not done within 30 minutes of the laboratory test, it will result

in variations in the readings as blood glucose levels can change quickly.

For example: Glucose levels of whole blood can drop up to 7 mg/dL each hour because

of glycolysis if the samples are left at room temperature.

Solution: Assure that the lab test is performed within 30 minutes of the blood

being drawn.

3. If testing is performed in extreme temperatures will it affect the test results

obtained from the meter?

Yes. The meter is designed to be used within the following temperature range:

50°F–104°F (10°C–40°C). Tests will be accurate when performed within this range.

4. Can plasma or serum be used in the Assure

Platinum Meter?

No. The Assure

Platinum Meter is designed to work with whole blood samples and

Assure

Dose Control Solutions only.

References:

1. “Self Monitoring of Blood Glucose,” Diabetes Care, Volume 19, Supplement 1, Jan. 1996, pp. S562-S566.

2. Tietz NW. Fundamentals of Clinical Chemistry, 4th Edition; Burtisand Ashwood, 1996.

3. Caraway WT: Carbohydrates. In Teitz NW (ed.) Fundamentals of Clinical Chemistry. Philadelphia.

WB Saunders Company.

SECTION

Assure

Platinum Test Strips

IMPORTANT: Please read this insert and your Assure

Platinum User Instruction Manual before testing.

INTENDED USE:

Assure Platinum Test Strips are intended for the quantitative measurement

of glucose in fresh capillary whole blood 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.

TEST PRINCIPLE:

Glucose in the blood sample mixes with chemicals on the test strip. This yields

a small electrical current. The Assure Platinum Meter measures this current.

It then shows the blood glucose result proportional to the current. This

professional grade system measures blood glucose in capillary whole blood.

Results shown as plasma values.

STORAGE AND HANDLING:

• Store test strip container in a cool, dry place between 39°F-86°F (4°C-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

bottle.

• 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

bottle.

• When you rst open the bottle, write the date on the bottle label. Use the

test strips within 3 months of rst opening the bottle.

• 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.

TEST PROCEDURE:

Materials provided: Assure Platinum Test Strips.

Materials required but not provided: Assure Platinum Meter.

User Instruction Manual. Lancing Device. Sterile lancet.

Step 1 – Wash hands in warm, soapy water. Rinse and dry thoroughly.

Step 2 – Insert test strip to turn on meter.

Insert test strip contact bars rst, facing up.

Step 3 – Obtain blood sample. Touch the sample

application tip at the end of the strip to the blood

drop on your finger.

Capillary action will pull the blood to the reaction site.

Add enough blood to the end of the test strip. The

meter will begin to count down. Discard strip if meter

does not start to count down.

Correct

Incorrect, Re-test

Step 4 – The meter will show a result in 7 seconds.

The result will be automatically stored in memory.

The meter will shut off by itself when you remove

the test strip.

IMPORTANT: The minimum sample volume is 0.5 µL.

Smaller samples may not start the meter or can start the meter

countdown and provide an E13 error message. Ensure blood

completely fills the reaction site.

IMPORTANT: Read the User Instruction Manual for more

information on test strips, coding the meter and how to test.

TEST RESULTS:

If your test result is lower than 20 mg/dL, the meter will show ‘LO’. If your

test result is greater than 600 mg/dL the meter will show ‘HI’. Seek medical

assistance immediately if you obtain high or low results.

IMPORTANT: Follow all instructions fully. If you have symptoms that are not

consistent with your test result, call your healthcare professional.

RANGE OF EXPECTED VALUES:

Expected blood glucose levels for people without diabetes

1,2

Fasting 70-110 mg/dL

2 hours after meals 70-140 mg/dL

IMPORTANT: Low or high blood glucose readings can indicate a potentially

serious medical condition. If your blood glucose reading is unusually low or high,

or you do not feel the way your readings indicate, repeat the test using a new

strip. If your result is still not consistent with your symptoms or if your blood

glucose result is less than 60 mg/dL or higher than 240 mg/dL contact your

diabetes healthcare professional for advice.

WARNINGS AND PRECAUTIONS:

For In Vitro Diagnostic Use.

Never make significant 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.

REAGENT COMPOSITION:

Each Assure Platinum Test Strip contains approximately:

Glucose Oxidase (Aspergillus niger sourced) 1.5-1.9 U

Hexaamminerutherium (III) Chloride 30-35 µg

Non-reactive ingredients 6-8 µg

LIMITATIONS OF SYSTEM:

The Assure Platinum System is not designed to substitute pathology laboratory

equipment and should not be used for the diagnosis of diabetes.

Use only fresh capillary 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.

WHEN TO CHECK YOUR SYSTEM USING ASSURE DOSE CONTROL

SOLUTION:

• Before testing with the Assure Platinum System for the rst time.

• When you open a new bottle of test strips.

• Whenever you suspect the meter or test strips may not be functioning

properly.

• If test results appear to be abnormally high or low or are not consistent with

clinical symptoms.

Contact Bars

Insert

contact bars

into meter.

Sample

Application Tip

SECTION

• 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%.

• To check your technique.

• When the Assure Platinum Meter has been dropped or stored below 32°F (0°C)

or above 122°F (50°C).

• Each time the batteries are changed.

HOW TO CHECK YOUR SYSTEM WITH ASSURE DOSE CONTROL SOLUTION:

See Control Solution insert for more information.

Step 1 – Insert a test strip into the meter. Be sure the contact bars go in rst

and face up.

Step 2 – Press the Back or Forward button one time to enter control solution

mode.

Step 3 – Remove the cap from the control solution bottle. Place cap on a at

surface. Squeeze the bottle and discard the rst drop.

Step 4 – Apply the second drop to the top the clean cap.

Step 5 – Bring the meter and strip to drop.

Step 6 – Compare the result to the range printed on the test strip bottle.

Healthcare Professionals: Repeat Steps 1-6 with a second control solution.

If the control solution results are out-of-range, repeat test. Results that fall

outside the range may be caused by:

• 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 3 months.

• The test strip is inserted incorrectly.

• The Assure Platinum 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

acceptable range, the system may not be working correctly. DO NOT USE the

system until the control solution result is within the acceptable range. If you

are unable to solve the problem or need help, please call Customer Service at

800.818.8877 (24 hours a day, 7 days a week, USA and Canada). Contact your

diabetes healthcare professional if you cannot reach Customer Service.

PERFORMANCE CHARACTERISTICS FOR CONSUMERS:

Assure Platinum performance has been evaluated both in laboratory and

clinical tests.

Diabetes experts have suggested that glucose meters should agree within 15

mg/dL of a laboratory method and within 20% of a laboratory method when

the glucose concentration is 75 mg/dL or higher. The chart below displays how

often the Assure Platinum meter achieves this goal. The chart is based on a

study done to see how well the Assure Platinum blood glucose meter compared

to laboratory results.

FINGERTIP RESULTS -

Participant

For glucose results lower than 75 mg/dL, the percent

(and number) of meter results that match the laboratory

method within 15 mg/dL:

100%

6/6

For glucose results at 75 mg/dL or higher, the percent

(and number) of meter results that match the laboratory

method within 20%:

97%

92/95

Total number of patients in the study: 101

PERFORMANCE CHARACTERISTICS FOR HEALTH CARE PROFESSIONALS:

Precision:

Precision results indicate that on average you can expect a 2.2% variation from

back-to-back testing across a 39 - 585 mg/dL glucose range. The table shows

Coefcient of Variation (CV%s) values for ve glucose levels that cover the

glucose range typical of persons with diabetes. Values are averages for three

separate lots of test strips.

Mean Glucose Level (mg/dL) n SD (mg/dL) CV%

39 100 1.12 2.90

102 100 2.31 2.28

142 100 3.24 2.28

219 100 6.10 2.78

289 100 6.34 1.63

585 100 9.20 1.57

Accuracy:

Assure Platinum was assessed against the YSI Model 2300. Studies were

conducted by Healthcare Professionals. The results below were obtained from

subjects with Type 1 or Type 2 diabetes.

Assure Platinum Professional

Slope 1.00

Y-Intercept -2.33

Correlation coefcient (r) 0.99

Number of subjects 288

Range tested (mg/dL) 26-480 mg/dL

The tables below show how well the Assure Platinum Blood Glucose

Monitoring System compared to the laboratory results.

Professional Fingerstick Accuracy:

* Acceptance criteria in ISO15197 are that 95% of all differences in glucose

values should be within 15 mg/dL for glucose values less than 75 mg/dL

(top table) and within 20% for glucose values greater than 75 mg/dL

(bottom table).

Note: When glucose meter results are compared to the laboratory results,

difference values below 75 mg/dL are expressed in mg/dL, while those above

75 mg/dL are compared in percent.

U.S. Patent No. 6,916,410 B2

Denition and Diagnosis of Diabetes Mellitus and Intermediate Hyperglycaemia.

World Health Organization, 2006.

Diabetes Care, Vol. 33 Jan; 1 S82-86, 2010.

P/N 1793-02

Rev 6/12

Made in Taiwan.

Manufactured for

ARKRAY USA, Inc.

Minneapolis, MN 55439 USA

TEL 800.818.8877

FAX 952.646.3110

www.arkrayusa.com

Glucose results lower than 75 mg/dL (< 75 mg/dL)

Range differences in values

between the laboratory results

and the Assure Platinum Blood

Glucose Monitoring System

Within

± 5 mg/

Within ±

10 mg/dL

Within

± 15 mg/

The number and percent of

how many times the results fell

within the ranges listed above

42/48

88%

48/48

100%

48/48

100%

Glucose results greater than or equal to 75 mg/dL ( ≥ 75 mg/dL)

Range differences in values

between the laboratory results

and the Assure Platinum Blood

Glucose Monitoring System

Within

± 5 %

Within

± 10 %

Within

± 15 %

Within

± 20%

The number and percent of

how many times the results fell

within the ranges listed above

127/240

53%

189/240

79%

231/240

96%

240/240

100%

SECTION

Assure

Dose Control Solution

IMPORTANT INFORMATION:

Please read this information and your Assure

Pro, PocketChem™ EZ,

Assure

Platinum, GLUCOCARD

Vital™ or ReliOn

Prime Blood

Glucose System User Instruction Manual before testing.

INTENDED USE:

For use with Assure Pro, 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.

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.

Materials required: Meter, Test Strips, Control Solution(s), and User

Instruction Manual for reference.

USE CONTROL SOLUTION:

• Before testing with the system for the first time.

• When you open a new bottle of test strips.

• Whenever you suspect the meter or test strips may not be functioning

properly.

• If test results appear to be abnormally high or low or are not

consistent with clinical symptoms.

• 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%.

• To check your technique.

• When the meter has been dropped or stored below 32°F (0°C) or

above 122°F (50°C).

• Each time the batteries are changed.

REAGENT COMPOSITION:

Normal (Level 1): ≈80 mg/dL glucose High (Level 2): ≈250 mg/dL glucose

99% non-reactive ingredients 99% non-reactive ingredients

LIMITATIONS:

Use only with Assure Pro, Assure Platinum, GLUCOCARD Vital or ReliOn

Prime Blood Glucose Meter and Test Strips.

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 Pro, 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.

STORAGE AND HANDLING:

• Store the 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 control solution within 90 days (3 months) of first 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.

TEST PROCEDURE:

Allow control solution to reach room temperature prior to use.

Follow these instructions and refer to the appropriate Blood Glucose

System User Instruction Manual for additional information.

Step 1 – Insert a test strip. The meter will turn on automatically. The full

screen will appear briefly. Make sure that all symbols appear on the screen.

Step 2 – Press the Back or Forward button one time to enter the control

solution mode. A control solution bottle

will appear at the top right

of the screen.

Important: If you do not enter the control solution mode, the control

solution result will NOT be valid. Using the control solution mode will

also flag the result in memory. This prevents the result from being part

of the averages.

will prompt you to apply the control solution.

Step 3 – Mix solution by gently inverting control solution bottle several

times. Remove the cap from the control solution bottle. Place cap on flat

surface. Squeeze the bottle and discard the first drop. Apply the second

drop to the top of the clean cap.

Step 4 – Bring meter and strip to drop. Test strip will draw up the

solution. The meter will show result.

Step 5 – Compare the result to the range printed on the test strip bottle.

Make sure the result is within acceptable range. If the result falls within

this range, the meter and test strip are working correctly.

Healthcare Professionals: Record result in the quality logbook.

Step 6 – Remove the test strip and dispose.

Healthcare Professionals: Repeat steps 1-6 with a second control solution.

EXPECTED VALUES:

Refer to the test strip bottle for the acceptable range.

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 first drop of control solution was not discarded.

• The control solution is contamination as the tip of the control solution

bottle touched the test strip.

Repeat the test, using new control solution or a new test strip, as

appropriate. Compare the result with the range printed on the test strip

bottle you are using.

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 accepta ble range. If

you are unable to resolve the problem or need assistance, please call

Customer Service at 800.818.8877 (24 hours a day, 7 days a week, USA

and Canada). Contact your diabetes healthcare professional if you are

unable to reach Customer Service.

P/N 1803-04

Rev 03/14

SECTION

Name of facility:

IN-SERVICE TRAINING

IN-SERVICE GUIDE

ASSURE

PLATINUM BLOOD GLUCOSE MONITORING SYSTEM:

IN-SERVICE TRAINING AND CERTIFICATION

Certied Instructor: Before signing checklist, the trainee must meet objectives listed below.

1. Familiarization with components of the Assure® Platinum

Blood Glucose Monitoring System:

Meter:

Features (strip release

button, test strip port, etc.)

Serial Number

Storage

Cleaning and Disinfecting

Toll-free Customer

Service Number

Test Strips:

Lot Number

Expiration Date

Storage

Control Solution Range

Proper Strip Insertion

Handling

Control Solutions:

Expiration Date

Acceptable Range

Test Procedure

Safety Lancets:

Usage / Activation

Disposal

2. Describe/Demonstrate:

Initial Meter Set-Up

Options: Default: Option:

Audible Beep

On Off

Hypo Warning

Off On

Daylight Savings Time

Off On

Time Format

12H 24H

Date Format

m-d d-m

Backlight Setting

Off (0) On

qcProGuard®/QC Reminder

Off (0) On

Instructor Name (Print) Operator-Trainee Name (Print) Date

Instructor Name (Signature) Operator-Trainee Name (Signature)

Operator Certied Yes No Next In-Service (Month/Year) Date Due:

SECTION

Name of facility:

COMPETENCY CHECKLIST

ASSURE

PLATINUM BLOOD GLUCOSE MONITORING SYSTEM:

Certied Operator

Date

Certied Trainer

The Certied Trainer should observe the Operator performing the following tasks:

1. Select and prepare the ngerstick site correctly.

YES NO

2. Use lancet/lancing device correctly.

YES NO

3. Insert test strip into meter correctly.

YES NO

4. Apply blood to sample application tip correctly.

YES NO

5. Dispose of lancet correctly.

YES NO

6. Identify when to repeat test or check result with a laboratory test.

YES NO

7. Record result correctly.

YES NO

8. Follow facility protocol for quality control testing.

YES NO

9. Clean/disinfect meter correctly.

YES NO

10. Change battery.

YES NO

Did the Operator perform each task correctly?

YES NO

If yes, the Operator is now certied to use the Assure

Platinum Blood Glucose

Monitoring System. If no, retrain and perform tasks again.

SECTION

Name of facility:

SELF-TEST

ASSURE

PLATINUM BLOOD GLUCOSE MONITORING SYSTEM:

The following is a multiple choice self-test that is designed to test your prociency in using

the Assure

Platinum Meter. Answer the questions by circling the letter of the statement that

is CORRECT. Check your answers against the correct answers, which are located at the end

of the test. More than one answer may be acceptable on some questions.

If you respond incorrectly to any of the questions, make sure you study the section or talk to

your certied instructor.

1. The Assure Platinum Meter

a. Uses reectance technology

b. Uses biosensor technology

c. Stores up to 500 tests in memory

d. Can be used with any brand of test strips

2. The Assure Platinum Test Strips

a. Have a CODE chip that is packaged with every box of test strips

b. Can be used with other meters besides the Assure Platinum

c. Are not sensitive to light, moisture, and humidity

d. Do not require you to code the meter; they are auto-coding

3. When obtaining a blood sample

a. You should not wash the patient’s hand

b. Hang the patient’s arm down below their heart for 10 to 15 seconds

to increase blood ow

c. You should lance the side of ngertip

d. You should use the same site selection of the ngertip each time

4. When performing a test with control solutions

a. Solutions should be applied to test strip before it is inserted into the meter

b. The test strip must be in the meter before solutions are applied

c. Use any brand of control solutions

d. Press the “M” Button to enter control solution mode prior to applying

solution to the test strip

SECTION

5. Assure Dose Control Solutions

a. Are for cleaning the meter

b. Are used to verify that the test strips are reacting properly

c. Are good for 90 days after opening

d. Should be used if strips have been exposed to extremes in temperature,

light, or humidity

6. When applying blood to the Assure Platinum Test Strips

a. Smear the blood sample

b. Apply it to the reaction site of the test strip

c. Apply it to the sample application tip

d. If meter does not start after adding the rst blood drop, you may apply a second drop.

7. The Assure Platinum can be used with

a. Whole blood

b. Serum or plasma

c. Neonatal blood samples

d. Venous blood

8. The Assure Platinum should be cleaned and disinfected between patient tests to

avoid cross-contamination? ❏ True ❏ False

9. Nurses who use the Assure Platinum meter to test patients should

a. Wear gloves when cleaning the meter

b. Test the meter with two control solutions

c. Not rely on the memory or average features as they are not related to a specic patient

d. Use a safety lancet, such as the Assure

Lance, to obtain a patient’s blood sample

Name:

Date:

Score:

SECTION

1. b, c

2. d

3. b, c

4. b

5. b, c, d

6. c

7. a

8. True

9. a, b, c, d

Answer Key:

SELF-TEST

ASSURE

PLATINUM BLOOD GLUCOSE MONITORING SYSTEM

SECTION

NURSE IN-SERVICE TRAINING RECORD

ASSURE

PLATINUM BLOOD GLUCOSE MONITORING SYSTEM

The healthcare professionals listed below have been trained to use the

Assure

Platinum Blood Glucose Monitoring System.

Certied Trainer Name

To be used during the initial training on theAssure

Platinum Blood Glucose Monitoring System

by an ARKRAY Representative or Certied Trainer within the facility.

To be kept on le in the Nursing Unit and updated by Certied Trainer.

Date Healthcare Professional’s Name Unit/Station Certified Trainer Initials

Name of facility:

SECTION

Quality Assurance/Quality Control

Recording Forms

METER TRACKING

Active Meters

Per Unit

Meter Serial Number

New Replacement

Name of facility:

SECTION

Name of facility:

Quality Control Record Assure

Platinum Blood Glucose Monitoring System:

Assure Platinum Meter Serial # _________________________ Unit _______________________ Month/Year

Operator Meter Cleaned Meter Test Test Strip Normal Normal Normal High High High

Station/ Initials/ and Disinfected Strip Exp. Normal Expiration Control Control High Exp. Control Control Corrective

Date Shift Shift (Y / N) Lot # Date Lot # Date Range Result Lot # Date Range Result Action

ARKRAY USA, Inc.

Minneapolis, MN 55439 USA

TEL 800.818.8877

FAX 952.646.3110

www.arkrayusa.com

SECTION

Field Inspection Report Assure

Platinum Blood Glucose Monitoring System:

Facility: _________________________________ Date: ___________________________ Contact: ___________________________

Address: ________________________________ Time: ___________________________ Phone: _____________________________

_________________________________ ARKRAY Representative Signature: _______________________________________

Meter Set to

Normal Control Solution High Control Solution Cleaned and Disinfected Batteries

Correct

Station Meter Serial # Range Result Range Result (Y/N) OK Changed Settings Comments

Comments: _______________________________________________________________________________________________________

__________________________________________________________________________________________________________________

ARKRAY USA, Inc.

Minneapolis, MN 55439 USA

TEL 800.818.8877

FAX 952.646.3110

www.arkrayusa.com

Name of facility:

SECTION

Regulatory Review and Guidelines

for QA/QC Protocols

COMPETENCY CHECKLIST

Joint Commission on

Accreditation of Healthcare

Clinical and Laboratory

Standards Institute (CLSI)

(Formerly NCCLS)

Clinical Laboratory

Improvement

Amendments (CLIA)

Personnel/Training • Staff members can describe

or demonstrate their roles and

responsibilities (HR.2.20)

• Participate in ongoing in-

services

• Education is documented

(HR.2.30)

• Competence to perform job

responsibilities is assessed,

demonstrated, and maintained

(HR.3.10)

• Formal training & written

examination

• Follow manufacturer’s

instructions

Quality Assurance • Current and complete policies

are available to the person

performing the test

• Written policies and

procedures for: specimen

collection, identication, and

required labeling; specimen

preservation; instrument

calibration; quality control and

remedial action; equipment

performance evaluation; test

performance

• Follow manufacturer’s instructions

for calibration

• Written procedure manual

• Manual contains principles of

operation, reagents/equipment,

calibration, quality control, stepwise

procedure, reporting results,

procedure limitations, references,

supplemental material, review and

updates

• Follow manufacturer’s

instructions

Quality Control • Written quality control plan

that species how procedures

will be controlled

• Performed at least as

frequently as recommended

by manufacturer

• Should include two levels of

control

• Quality control procedures are

performed at least once each

day on each instrument used

for resident testing (PC.16.50)

• On each day of use, two controls

(high & normal) should be

performed per instrument

• Each operator to perform a quality

control prior to the rst patient test

of the day

• Additional checks should be

performed when a new bottle of

strips is opened, each time a reagent

lot is changed and to ensure the

strips and meter are functioning

properly

• Follow manufacturer’s

instructions

Linearity/Calibration • Linearity not covered in

the standards

• Initially and as specied by

manufacturer or as required by

government or accrediting bodies

• Follow manufacturer’s

instructions

Prociency Training • Not specied • Participate in program that meets

accreditation, federal and state

regulations

• Not specied

Inspections • Currently triennial (APP-5) • Not a certifying agency • Not subject to routine

survey

• Conducted only when

authorized by the RO

ARKRAY provides this checklist as a guideline only. These guidelines are subject to change by the

regulating body at any time. Utilize this checklist in accordance with your facility’s policy.

SECTION

Addendums

PRODUCT ORDERING

ORDERING DETAILS ARKRAY Product Code # NDC#

Assure

Platinum Meter 500001 08317-5000-01

Assure

Platinum Test Strips 50-count 500050 08317-5000-50

Assure

Platinum Test Strips 100-count 500100 08317-5001-00

Assure

Dose Control Solution (Normal & High) 500006 08317-5000-06

WARRANTY

You are a valued customer of ARKRAY. It is important to us that you are satised with your

Assure

Platinum Meter.

ARKRAY warrants that your Assure

Platinum Meter will be free from defects in materials

and workmanship for a period of ve years from the date of the original purchase. If during

this time the meter does not work properly because of a defect in materials or workmanship,

ARKRAY agrees to replace or repair, free of charge any and all parts proven to be defective

and subject to warranty.

This warranty is in lieu of all other warranties, expressed or implied, including any implied

warranty of merchantability or tness for any purpose, other than stated herein.

This warranty does not apply to the performance of the Assure

Platinum Meter that has

been damaged by accident or has been altered, misused, tampered with, or abused in any

way. This warranty only applies to the original purchaser of the meter and/or its agents.

RETURNS

You must contact ARKRAY Customer Service at 800.818.8877 (toll-free), option 5,

24 hours a day, 7 days a week, USA and Canada, before returning your meter. If you are

located outside of the USA and/or Canada, please contact your local ARKRAY distributor.

You will be instructed how to return the meter to ARKRAY. Returned meters without this

authorization will not be accepted.

P/N 6368-04 REV 12/14

Customer Service, 800.818.8877

24 hours a day, 7 days a week, USA and Canada.

Manufactured for

Minneapolis, MN 55439 USA

TEL 800.818.8877