Instruction Manual for ASSURE PRISM models including: 2761-53010 Blood Glucose Monitoring System, 2761-53010, Blood Glucose Monitoring System

Assure Prism multi Blood Glucose Meter | ARKRAY, Inc.

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

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

Table of Contents

Section A Section B
Section C Section D Section E Section F

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

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

SECTION

System Components

A

ASSURE® PRISM MULTI BLOOD GLUCOSE METER

Test Strip Port
Insert test strip here

Backlight Button
Turns the backlight on/off (15­second duration)
 Button
Selects or changes information, marks control solution test results and scrolls through memory results

Test Strip Ejector
Slide upward to release strip
Display
Shows results, messages
 Button
Selects or changes information

Data Transmission Port
Used to transfer data from the meter to a
computer with a cable

m Button
Turns the meter on/off and confirms menu selections

ORDERING DETAILS ARKRAY Product Code # 530001 NDC # 08317-5300-01

1

SECTION
A

METER DISPLAY SCREEN
Appears when test results stored in the memory are displayed
Appears when the time alarm has been set

Appears only when the sound is set to OFF
Appears when the test result is saved as a control solution test

Indicates a low battery
Appears when the temperature is displayed
Appears during post-meal testing and when post-meal test results are displayed

Date/

Time

Temperature

Indicates meter is ready for testing

Test result display panel

NOTE
· It is recommended to check if the display screen on the meter matches the illustration above every time the meter turns on. Do not use the meter if the display screen does not exactly match the illustration as the meter may show incorrect results.
· The unit of measurement for your Assure® Prism multi Blood Glucose meter is preset and fixed in mg/dL.

2

ASSURE® PRISM MULTI TEST STRIPS
The Assure Prism multi Blood Glucose Test Strips are for use with the Assure Prism multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites (forearm, palm, thigh and calf). Alternative site testing should be used only during steady-state blood glucose conditions. The Assure Prism multi Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single-use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

SECTION
A

Confirmation Window

Check here to see

whether sufficient blood

sample has been applied.

Insert

Contact Bars Gently push the test strip, with its contact bars facing up, into the test strip port of the meter.
Edge to Obtain Blood Sample

Obtain blood sample here for testing by touching the

Storage and Handling

application tip at the end of the test strip to the blood drop on finger.

· Store unused test strips only in their original bottle/box. · Store test strips in a cool and dry place between 34-86°F (1-30°C).

· Keep the test strips away from direct sunlight and heat.

· Do not freeze test strips.

· Close bottle cap tightly immediately after taking out a test strip.

· Use the test strip immediately after taking it out of the bottle/individual wrap.

· Handle test strips only with clean, dry hands.

· Do not bend, cut or alter the test strips in any way.

· Do not force a test strip into the meter. Gently push it into the meter's test strip port.

· Apply only fresh capillary whole blood to the test strip.

· Use all of the test strips within the expiration date printed on the test strip bottle/box label.

· Do not use the expired test strips and dispose the expired test strips immediately because using test strips past the expiration dates can produce incorrect test results.

· If the test strips are used and stored according to its storage and handling methods, test strips in new, unopened bottle/boxes, test strips in bottle/boxes that have been opened can be used until the expiration date printed on the test strip bottle/box label.

UNEXPECTED RESULTS
· Low or high blood glucose readings can indicate a potentially serious medical condition. If the blood glucose reading is unusually low or high, or symptoms do not match the test result, repeat the test using a new test strip.
· If the result is still not consistent with the symptoms observed or if blood glucose result is less than 60 mg/dL or higher than 240 mg/dL consult your patients healthcare provider.

3

SECTION
A

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

Ordering Details

Product Description

ARKRAY Product Code#

NDC#

Assure Prism multi Test Strips 50 count Assure Prism multi Test Strips 100 count

530050 530100

08317-5300-50 08317-5301-01

Assure Prism multi Test Strips ­ Foil-wrapped 50-count 532050

08317-5320-50

4

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

SECTION
A

Ordering Details

Product Description

ARKRAY Product Code#

NDC#

Assure Prism Control Solution ­ Level 1 and 2

530006

08317-5300-06

5

SECTION
A

METER SPECIFICATIONS
For additional information refer to the Assure® Prism multi Blood Glucose Monitoring System User Manual.

Product Specifications

Test strips Measurement range Sample size

Assure Prism multi Blood Glucose Test Strips 20­600 mg/dL Minimum 0.5 µL

Test time

5 seconds

Sample type

Fresh capillary whole blood

Calibration

Plasma-equivalent

Assay method

Electrochemical

Battery life

1,000 tests

Power

Two 3.0 lithium batteries (disposable, type CR2032)

Memory

500 test results

Size

3.66 x 2.20 x 0.83 inch (93 x 56 x 21 mm)

Weight

2.10 oz (59.6 g) with batteries

Operating Ranges Temperature Relative humidity Hematocrit Altitude Unit of measurement

50­104°F (10­40°C) 10­90% 20­60% 10,000 ft (3,048 meters) mg/dL

6

Meter Operation and Set-up

METER SET-UP
You should check and update the meter settings such as time and date before using your meter or after changing the meter batteries. Press and hold the button for 3 seconds to enter the SET mode. Whenever you want to complete the settings and exit from the SET mode, press and hold the button for 3 seconds again. Press or to reach the accurate value. Press and hold to scroll faster.
Adjusting the Date and Time
Step 1: Entering the SET Mode Press and hold the button for 3 seconds. After all the segments flash across the screen, SET will be displayed on the screen. Press the button again to progress to the next step.

Step 2: Setting the Year
Press or until the correct year appears. Press and hold button to scroll through the numbers quickly. After setting the year, press the button to confirm your selection and progress to the next step.

Step 3: Setting the Month
A number indicating the month will be blinking on the left corner of the screen. Press or until the correct month appears. Press the button to confirm your selection and progress to the next step.

Step 4: Setting the Date
Press or until the screen displays the correct date. Press the confirm the date and progress to the next step.

button to

Step 5: Setting the Time Format
The meter can be set in, 12-hour (AM/PM) or the 24-hour clock format. Press or to select a format. AM/PM is not displayed in the 24-hour format. After selecting the format, press the button to progress to the next step.

Step 6: Setting the Hour
Press or until the correct hour appears. After the hour is set, press the button to progress to the next step.

Step 7: Setting the Minute
Press or until the correct minute appears. After setting the minute, press the button to progress to the next step.

SECTION
B

7

SECTION
B

Step 8: Setting the Sound On/OFF
On pressing or , the screen will display On or OFF. Press the button to confirm the selection.
The meter will beep in the following instances if set to On:
· When you press the button and/or button to turn on the meter or to set the alarm.
· When the test strip is inserted in the meter.
· When the blood or control solution sample is absorbed into the test strip and the test starts.
· When the test result is displayed.
If the sound is set to OFF, none of the sound functions will work.

NOTE · symbol is displayed only when the sound is set to OFF. · At any stage, press the button for 3 seconds to exit SET mode and turn off the meter. · Press and hold button to quickly scroll through the numbers.
NOTE · In a multi-patient setting, we do not recommend using the memory feature including
post-meal alarms, pre-set blood glucose or averaging. Results stored in the memory are not related to a specific patient.

8

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

SECTION
B

Push the test strip gently into the test strip port until the meter automatically turns on and the symbol appears.

9

SECTION
B

Applying the Blood Sample Step 3 Obtain a blood sample using a lancing device. Place the lancing device against the sampling site in the direction of the arrow. The best puncture sites are areas on the middle or ring fingers. Remove the device from the finger.
Wait a few seconds for a blood drop to form. A minimum volume of 0.5 microliter is needed to fill the confirmation window.

Step 4
After the symbol appears on the screen, apply the blood sample to the narrow end of the test strip until the meter beeps. If the confirmation window is not filled in time because of abnormal viscosity or insufficient volume, an Er4 message may appear.
It is recommended that the application of the blood sample to the test strip be performed virtually vertical to the sample site as shown in the diagram.

Approximate Size

Good Insufficient Sample Sample
NOTE · The meter will switch off if the blood sample is not applied within 2 minutes of the symbol
appearing on the screen. If the meter turns off, remove the test strip, reinsert it, and start from Step 2.
Step 5 The test result will appear after the meter counts down from 5 to 1. The result will be automatically stored in the meter's memory.

Step 6
Slide the ejector button on the right side of the meter to safely discard used test strips in a disposable container.
If the test strip is removed, the meter will automatically turn off after 3 seconds.

Turning On the Backlight When the meter is on, pressing the backlight button powers on the display backlight.
The backlight will turn off after 15 seconds or when you press the backlight button again.
10

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

SECTION
B
11

SECTION
B

Step 4 After the symbol appears on the display, apply the solution to the narrow edge of the test strip until the meter beeps. Make sure the confirmation window fills completely.
NOTE · The meter will switch off if the control solution sample is not applied within 2 minutes of the
symbol appearing on the screen. If the meter turns off, remove the test strip, reinsert, and start from step 2.

Step 5
A test result will appear after the meter counts down from 5 to 1.
After your control solution result appears on the display, press for 3 seconds until "check" appears on the display. When "check" is displayed, the result is stored in the meter's memory but it is not included in the averages.

Compare the result displayed on the meter to the range printed on the test strip bottle or box of individually wrapped test strips. If the result falls within the specified range, you are ready to use the meter and test strips to test with blood.
Step 6 Remove the used test strip from the meter's test strip port. The meter will turn off automatically. Used test strips should be safely discarded in disposable containers.

Control Solution Range Control 1: Control 2:

CAUTION · The ranges printed on the test strip bottle or box of individually wrapped test strips are for the
Assure® Prism Control Solutions only. They do not have any connection to blood glucose level.
NOTE · Assure Prism Control Solution can be purchased from your local supplier or pharmacy. If they do
not stock it, contact ARKRAY Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week.

12

Comparing the Control Solution Test Results
The test result of each control solution test should be within the range printed on the label of the test strip bottle or box of individually wrapped test strips. Repeat the control solution test if the test result falls outside of this range. Out-of-range results may occur due to the following factors:

Situations

Actions

· When the control solution bottle was not shaken well. · When the meter, test strip or the control solution were exposed to high or low temperatures. · When the first drop of the control solution was not discarded or the top of the cap was not wiped clean. · When the meter is not functioning properly.

Repeat the control solution test.

· When the control solution is past the expiration date printed on the bottle.

Discard the used control solution

· When the control solution is past its discard date (the date the bottle was opened plus three [3] months). and repeat the test using a new

· When the control solution is contaminated.

bottle of control solution.

If results continue to fall outside the range printed on the test strip bottle or box of individually wrapped test strips, the test strip and meter may not be working properly. Do not use your system and contact Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week.
METER MEMORY
The Assure® Prism multi Blood Glucose Meter can save up to 500 test results with time, date and temperature. If the memory is full, the oldest test result will be deleted and the latest test result will be stored.

NOTE
· In a multi-patient setting, we do not recommend using the memory feature including post-meal alarms, pre-set blood glucose or averaging. Results stored in the memory are not related to a specific patient.

Viewing Test Results
Step 1
Press the or button to turn the meter on. The current date and time will be displayed on the bottom of the screen followed by the 1-day average value and the number of the test results saved within the current day.
Step 2
Use the button to scroll through the test results, starting from the most recent and ending with the oldest. The test date and the recorded temperature will display alternately.
Press the to return to the results seen previously.
After checking the stored test result, press the button to turn off the meter.

The number of tests within the current day
button button

NOTE
· The control solution test results saved with the "check" symbol will be displayed with the "check" symbol when you review the stored test results.

SECTION
B

13

SECTION
B

INSERTING OR REPLACING THE BATTERIES

The Assure® Prism multi Blood Glucose Meter uses two 3.0 V lithium batteries. Before using the

meter, check the battery compartment and insert batteries if empty. When the

symbol

appears on the display while the meter is in use, the batteries should be replaced as soon as

possible. The test results may not be saved if the batteries run out.

Step 1

Make sure the meter is turned off. Push the cover in the direction of the arrow to open the battery compartment.

Step 2
To remove the used batteries, place your finger under each battery and pull upward. Insert two new batteries with the + side facing up and make sure the batteries are inserted firmly.

Step 3

Slide the cover back on the battery compartment. Push down until you hear the tab click into place.

NOTE
· Removing the meter batteries will not affect your stored results. You may, however, need to reset your meter settings.

14

CLEANING AND DISINFECTING THE METER
To minimize the risk of transmitting blood borne pathogens, the cleaning and disinfection procedure should be performed as recommended in the instructions below.
The meter should be cleaned and disinfected after use on each patient. The Assure Prism multi Blood Glucose Monitoring System may only be used for testing multiple patients when standard precautions and the manufacturer's disinfection procedures are followed. The cleaning procedure is needed to clean dirt, blood and other bodily fluids off the exterior of the meter before performing the disinfection procedure.
The disinfecting procedure is needed to prevent the transmission of blood borne pathogens.
Only wipes with EPA registration numbers listed below have been validated for use in cleaning and disinfecting the meter. Any disinfectant product containing these EPA registration numbers may be used on this device. These EPA registration numbers can be found on the EPA website. Wipes with EPA registration numbers not listed below should not be used to clean and disinfect the Assure Prism multi Meter. Please read the manufacturer's instructions carefully before using their wipes on the meter.

Manufacturer Clorox® Professional Products Company
Professional Disposables International, Inc. (PDI) Metrex® Research

Disinfectant Brand Name Clorox Healthcare Bleach Germicidal Wipes Dispatch® Hospital Cleaner Disinfectant Towels with Bleach Super Sani-Cloth® Germicidal Disposable Wipe

EPA # 67619-12 56392-8
9480-4

CaviWipes1TM

46781-13

Clorox and Dispatch are trademarks or registered trademarks of Clorox. Sani-cloth is a trademark or registered trademark of PDI. Metrex and CaviWipes1 are trademarks or registered trademarks of Metrex.

Guidelines for Cleaning and Disinfecting the Assure® Prism multi Blood Glucose Monitoring System (BGMS)

NOTE · Do not get fluids inside the meter through the test strip port, data port or battery
compartment.
· Never immerse the meter or hold it under running water because it will damage the meter. · Two disposable wipes will be needed for each cleaning and disinfecting procedure; one wipe
for cleaning and a second wipe for disinfecting.

Cleaning
Step 1: Wear appropriate protective gear such as disposable gloves.
Step 2: Open the cap of the disinfectant container and pull out 1 towelette and close the cap.
Step 3: Wipe the entire surface of the meter 3 times horizontally and 3 times vertically using 1 towelette to clean blood and other body fluids. Carefully wipe around the test strip port by inverting the meter so that the test strip port is facing down. This prevents disinfectant liquid from entering the meter.
Step 4: Properly dispose of the used towelette.





Assure® Prism Multi Blood Glucose Meter

· For multiple patients / professional use.

· Use with Assure Prism Multi Blood Glucose Test Strip.

· For testing outside of the body (in vitro diagnostic use only).

· Model: GM505RA

3V, 11 mA (CR2032 X 2)

Manufactured for
Minneapolis, MN 55439 USA 800.566.8558 www.arkrayusa.com

Contact Customer Service at 800.566.8558, 24 hours a day, 7 days a week, USA and Canada.

Made in Korea

P/N 5117-00 REV 07/14

Front


Back Both sides

SECTION
B
15

NOTE · No actual drying of the meter is necessary before starting the disinfecting procedure.

SECTION
B

Disinfecting (The meter should be cleaned prior to disinfection.)
Step 5: Open the towelette container and pull out 1 towelette and close the lid.
Step 6: Wipe the entire surface of the meter 3 times horizontally and 3 times vertically to remove blood-borne pathogens. Carefully wipe around the test strip port by inverting the meter so that the test strip port is facing down. This prevents disinfectant liquid from entering the meter.
Step 7: Properly dispose of the used towelette.
Step 8: Treated surface must remain wet for recommended contact time. Please refer to the Assure Prism multi BGMS User Manual for hepatitis B contact times. For all other contact times, refer to wipe manufacturers' instructions. DO NOT WRAP THE METER IN A WIPE. Once contact time is complete, wipe meter dry.
Step 9: After disinfection, the user's gloves should be removed and thrown away. Wash hands before proceeding to the next patient.

 
Front
 


Assure® Prism Multi Blood Glucose Meter

· For multiple patients / professional use.

· Use with Assure Prism Multi Blood Glucose Test Strip.

· For testing outside of the body (in vitro diagnostic use only).

· Model: GM505RA

3V, 11 mA (CR2032 X 2)

Manufactured for
Minneapolis, MN 55439 USA 800.566.8558 www.arkrayusa.com Made in Korea

Contact Customer Service at 800.566.8558, 24 hours a day, 7 days a week, USA and Canada.
P/N 5117-00 REV 07/14

Back Both sides

If any of the following deterioration signs appear after cleaning or disinfecting, please stop using the system and contact Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week.
· When the inscriptions on the exterior of the meter have been removed. · When the color of the meter has changed or faded. · When cracks or roughness develop on the meter. · When a part of the segment on the meter display does not flash.

More information is available at: · www.cdc.gov/injectionsafety/blood-glucose-monitoring.html
16

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?
To ensure compliance ARKRAY recommends that blood glucose meters be cleaned and disinfected after each use. Each meter in use is subject to QC testing per the facility's policy.
Can cleaning and disinfecting be accomplished with one wipe?
No, each time the cleaning and disinfecting procedure is performed two wipes are needed. One wipe to clean the meter and a second wipe to disinfect the meter.
What will happen if a blood glucose meter is not cleaned and disinfected after use?
Per the CMS F-Tag 880 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 880.
LTC facilities are required to 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 disinfecting 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 identified 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 880
The CMS has implemented phase 2 of cleaning and disinfecting standards in the facility assessment code 483.70 ..........................................................................
INFECTION CONTROL REQUIREMENTS FOR BLOOD GLUCOSE MONITORING
What is the Centers for Medicare and Medicaid Services (CMS) F-Tag 880?
F-Tag 880 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 880 is used for guidance by CMS Regional Offices and State Survey Agencies for [re-]certification and complaint investigations.
Does F-Tag 880 only apply to blood glucose meters?
No, F-Tag 880 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 Immunodeficiency 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.

SECTION
B

More information is available at: · www.cdc.gov/injectionsafety/blood-glucose-monitoring.html
17

SECTION
B

TROUBLESHOOTING
Display Screen Messages Please read this section first. If you still have questions, call Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week. Contact your healthcare professional if you cannot reach Technical Customer Service. Do not send your meter to ARKRAY or your local dealer without first calling to get approval to do so.
HI and Lo Messages The meter displays results between 20­600 mg/dL.
HI Message "HI" appears when the blood glucose level is greater than 600 mg/dL and indicates severe hyperglycemia (much higher than normal glucose levels). If "HI" is displayed again upon retesting, please contact the patient's healthcare provider immediately.
Lo Message "Lo" appears when a test result is less than 20 mg/dL and indicates severe hypoglycemia (very low glucose levels). If "Lo" is displayed again upon retesting, please contact the patient's healthcare provider immediately.

NOTE · If messages for hyperglycemia or hypoglycemia are displayed, even if the patient does not
have those conditions, please contact Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week.

Error Messages Er1: A used test strip was inserted. Repeat the test with a new test strip.
Er2: The blood or control solution sample was applied before the symbol appeared.
Repeat the test with a new test strip and wait until the symbol appears before applying the blood or control solution sample.
Er4: The blood sample has abnormally high viscosity or insufficient volume. Repeat the test with a new test strip.
Er5: This error message may appear when the wrong blood glucose test strip is used instead of an Assure® Prism multi Blood Glucose Test Strip. Repeat the test with an Assure Prism multi Blood Glucose Test Strip.
Er6: There is a problem with the meter. Do not use the meter. Contact Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week.

18

HIF: The temperature during the test was above the operating range.
Move to an area where the temperature is within the operating range (50­104°F/10­40°C) and repeat the test after the meter and test strips have reached a temperature within the operating range.

LoF: The temperature during the test was below the operating range.
Move to an area where the temperature is within the operating range (50­104°F/10­40°C) and repeat the test after the meter and test strips have reached a temperature within the operating range.

Low batteries.

If the

symbol appears on the display while the meter is in use, the batteries

should be replaced as soon as possible. The test results may not be saved if the

batteries run out.

NOTE
· If the error messages persist, please contact Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week.

General Troubleshooting

Problem
The display is blank even after inserting a test strip.

Troubleshooting · Check whether the test strip is inserted with the contact
bars facing up.
· Check if the test strip has been inserted completely into the test strip port.

· Check if the appropriate test strip was used. · Check if the batteries are inserted with the "+" side facing up.

· Replace the batteries.

The test does not start · Check if the confirmation window is filled completely. even after applying the · Repeat the test after inserting a new test strip. blood sample to the test strip tip.

The patient's test result does not match their symptoms.

· Repeat the test after inserting a new test strip. · Check the expiration date of the test strip. · Perform control solution test.

NOTE
· If the problem is not resolved, please contact Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week.

SECTION
B

19

SECTION
C

Regulatory Review and Guidelines for QA/QC Protocols

COMPETENCY CHECKLIST

Personnel/Training

Joint Commission on

Clinical and Laboratory

Accreditation of Healthcare Standards Institute (CLSI)

Organizations (JCAHO)

(Formerly NCCLS)

· 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 and written examination.

Clinical Laboratory Improvement Amendments (CLIA)
· 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, identification, 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 Linearity/Calibration

· Written quality control plan that specifies how procedures will be controlled.
· At the least, perform as frequently as recommended by manufacturer.
· Should include two levels of control solution.
· At the least, quality control procedures are performed once each day on each instrument used for resident testing (PC.16.50).
· Linearity not covered in the standards.

· On each day of use, two control solutions (Level 1 and 2) should be performed per instrument.
· Prior to the first test of the day, each operator is to perform a quality control test.
· Additional checks should be performed when: · A new bottle/box of test strips is opened. · Each time a reagent lot is changed. · To ensure the test strips and meter are functioning properly.
· Initially and as specified by manufacturer or as required by government or accrediting bodies.

· Follow manufacturer's instructions.
· Follow manufacturer's instructions.

Proficiency Training · Not specified.

· Participate in program that meets accreditation, federal and state regulations.

· Not specified.

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.

20

ACCURACY AND PRECISION STUDIES
Performance Characteristics
The performance of the Assure® Prism multi Blood Glucose Monitoring System has been evaluated in laboratory and clinical tests.
ACCURACY: The Assure Prism multi Blood Glucose Monitoring System is calibrated to yield results equivalent to plasma glucose concentrations. The accuracy of the Assure Prism multi Blood Glucose Monitoring System was tested by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer, a lab instrument.
The results below were obtained by diabetic patients at clinic centers.

Slope
Y-intercept Correlation coefficient(r) Number of samples
Range tested

Obtained by Healthcare Professionals

Obtained by Lay Users

1.017 -7.39 mg/dL

1.022 -8.31 mg/dL

0.992

0.992

122 40-577 mg/dL

118 58-577 mg/dL

Accuracy

Results for glucose concentration < 75 mg/dL

Within ± 5 mg/dL

Within ± 10 mg/dL Within ± 15 mg/dL

11/11 (100%)

11/11 (100%)

11/11 (100%)

Results for glucose concentration  75 mg/dL

Within ± 5%

Within ± 10%

Within ± 15%

47/111 (42%)

89/111 (80%)

109/111 (98%)

Within ± 20% 111/111 (100%)

Precision
Studies were performed in a laboratory using the Assure Prism multi Blood Glucose Monitoring System.

Within Run Precision

Blood avg.* Blood avg.* Blood avg.* Blood avg.* Blood avg.*

41.4 mg/dL 79.6 mg/dL 129.8 mg/dL 201.9 mg/dL 349.6 mg/dL

SD = 1.8 mg/dL SD = 2.8 mg/dL CV = 2.6% CV = 3.1% CV = 2.7%

Total Precision Control avg.* Control avg.* Control avg.*

36.2 mg/dL 117.0 mg/dL 321.8 mg/dL

SD = 1.3 mg/dL CV = 2.3% CV = 2.4%

* This study shows that there could be variation of up to 3.1%.

SECTION
C

21

ALTERNATIVE SITE TESTING EVALUATION
Comparison of results using various alternative site testing with the results of YSI measurements.

SECTION
C

Alternative site test results for glucose concentration < 75 mg/dL

Within ± 5 mg/dL

Within ± 10 mg/dL

Within ± 15 mg/dL

Fingertip

2/2 (100%)

2/2 (100%)

2/2 (100%)

Forearm

2/2 (100%)

2/2 (100%)

2/2 (100%)

Palm

1/2 (50.0%)

2/2 (100%)

2/2 (100%)

Thigh

1/2 (50.0%)

2/2 (100%)

2/2 (100%)

Calf

1/2 (50.0%)

2/2 (100%)

2/2 (100%)

Alternative site test results for glucose concentration  75 mg/dL

Within ± 5%

Within ± 10%

Within ± 15%

Within ± 20%

Fingertip 34/56 (60.7%)

51/56 (91.1%)

55/56 (98.2%)

56/56 (100%)

Forearm 32/56 (57.1%)

52/56 (92.9%)

56/56 (100%)

56/56 (100%)

Palm

31/56 (55.4%)

52/56 (92.9%)

54/56 (96.4%)

56/56 (100%)

Thigh

27/56 (48.2%)

44/56 (78.6%)

54/56 (96.4%)

56/56 (100%)

Calf

24/56 (42.9%)

43/56 (76.8%)

53/56 (94.6%)

56/56 (100%)

22

Addendums

PRODUCT ORDERING
Product Description Assure® Prism multi Meter Blood Glucose Meter Assure Prism multi Test Strips 50 count Assure Prism multi Test Strips 100 count Assure Prism multi Test Strips - Foil wrapped 50 count Assure Prism Control Solution ­ Level 1 and 2

ARKRAY Product Code #

NDC #

530001

08317-5300-01

530050

08317-5300-50

530100

08317-5301-01

532050

08317-5320-50

530006

08317-5300-06

WARRANTY
Manufacturer's Warranty
ARKRAY USA, Inc. warrants that the Assure Prism multi Blood Glucose Monitoring System shall be free of defects in material and workmanship in normal use for a period of three (3) years. The meter must have been subjected to normal use. The warranty does not cover improper handling, tampering, use, or service of the meter. Any claim must be made within the warranty period.
The ARKRAY USA, Inc. company will, at its discretion, repair or replace a defective meter or meter part that is covered by this warranty. As a matter of warranty policy, ARKRAY USA, Inc. will not reimburse the consumer's purchase price.
Obtaining Warranty Service
To obtain warranty service, you must return the defective meter or meter part along with proof of purchase to ARKRAY USA, Inc. Do not send your meter or meter parts to ARKRAY without first calling to get approval to do so. Technical Customer Service may be reached at 800.818.8877, option 5, 24 hours a day, 7 days a week.

SECTION
D

23

SECTION
E

Name of facility:

IN-SERVICE TRAINING AND CERTIFICATION Assure® Prism multi Blood Glucose Monitoring System
Instructor: Before signing checklist, the trainee must meet objectives listed below.

1. Familiarization with components of the Assure Prism multi Blood Glucose Monitoring System:

Meter
n Features (test strip release button, test strip port, etc.)
n Serial Number n Storage n Cleaning and Disinfecting n Technical Customer
Service Number

Test Strips n Lot Number n Expiration Date n Storage n Control Solution Range n Proper Test Strip Insertion n Handling

Control Solutions n Expiration Date n Acceptable Range n Test Procedure
Safety Lancets n Usage / Activation* n Disposal

*Actual blood sampling is not required.
2. Describe/Demonstrate:
Initial Meter Set-Up Options n Audible Beep n Time Format n Date Format

Instructor Name (Print) Instructor Name (Signature)

Operator/Trainee Name (Print)

Date

Operator/Trainee Name (Signature) Date

3. Additional Training In-service Completion:
 Assure ID Safety Pen Needle Training  Discharge Program Training  Phaxix® Pill Swallowing Gel

24

Name of facility:
COMPETENCY CHECKLIST Assure® Prism multi Blood Glucose Monitoring System
Operator
Date
Trainer
The Trainer should observe the Operator performing the following tasks: 1. Follow facility protocol for quality control testing. 2.Change battery. 3.Select and prepare the fingerstick site correctly. 4.Use lancet/lancing device correctly.* 5.Dispose of lancet correctly. 6.Insert test strip into meter correctly. 7.Apply blood to sample-application tip correctly. 8.Record result correctly. 9.Identify when to repeat test or check result with a laboratory test. 10. Perform control solution test correctly. 11. Save control solution test correctly. 12. Clean/disinfect meter correctly.
* Actual blood sampling is not required.

n YES n NO n YES n NO n YES n NO n YES n NO n YES n NO n YES n NO n YES n NO n YES n NO n YES n NO n YES n NO n YES n NO n YES n NO

SECTION
E

Did the Operator perform each task correctly?

n YES

If yes, the Operator is now certified to use the Assure Prism multi Blood Glucose

Monitoring System. If no, perform tasks on list and document performance on

competency checklist again.

n NO

25

Name of facility:

INSTRUCTOR TRAINING RECORD
Assure® Prism multi Blood Glucose Monitoring System
The healthcare professionals listed below have been trained to serve as Trainers for the Assure Prism multi Blood Glucose Monitoring System. They are qualified to perform initial training of operations, conduct performance reviews, and maintain records concerning Operators.

ARKRAY Representative Name _________________________________________________

Healthcare Professional's Name

Title

Training Date

SECTION
E

To be used during the initial training on the Assure Prism multi Blood Glucose Monitoring System by an ARKRAY Representative within the facility. To be kept on file in the Nursing Unit and updated by Trainer.
26

Name of facility:

HEALTHCARE PROFESSIONAL IN-SERVICE TRAINING RECORD Assure® Prism multi Blood Glucose Monitoring System
The healthcare professionals listed below have been trained to use the Assure Prism multi Blood Glucose Monitoring System.
Trainer Name

Healthcare Professional's Name

Unit/Station

Trainer Initials

SECTION
E

To be used during the initial training on the Assure Prism multi Blood Glucose Monitoring System by an ARKRAY Representative or Trainer within the facility. To be kept on file in the Nursing Unit and updated by Trainer.
27

SECTION
E
28

Name of facility:

SELF-TEST Assure® Prism multi Blood Glucose Monitoring System
The following is a multiple choice self-test that is designed to test your proficiency in using the Assure Prism multi Blood Glucose Monitoring System. 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 instructor.

1. The Assure Prism multi Blood Glucose Meter stores up to the memory. a. 200 b. 50 c. 500 d. 10

tests in

2. The Assure Prism multi Blood Glucose Test Strips
a. May be reused.
b. Can be used with other meters besides the Assure Prism multi Blood Glucose Monitoring System.
c Are sensitive to light, moisture and humidity. d. Has a confirmation window used to determine if a sufficient amount of blood sample has
been applied.

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 flow.
c. You should lance the side of fingertip. d. You should use the same site selection of the fingertip each time.

4. When performing a test with control solutions
a. Any brand of control solutions may be used.
b. The test strip must be in the meter before solutions are applied. c. A clean tissue or cloth may be used to wipe the first 1 or 2 drops of control solution from
the tip of the cap.
d. Compare the result displayed on the meter to the range printed on the test strip bottle or box of individually wrapped test strips.

5. Assure Prism Control Solutions a. Are used 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 test strips have been exposed to extremes in temperature, light or humidity.

6. When applying blood to the Assure® Prism multi Blood Glucose Test Strips a. Smear the blood sample. b. Apply it to the narrow end of the test strip until the meter beeps. c. The test result will appear after the meter counts down from 5 to 1. d. You may apply a second blood drop if meter does not start after adding the first drop.
7. The Assure Prism multi Blood Glucose Meter can be used with a. Whole blood. b. Serum or plasma. c. Neonatal blood samples. d. Venous blood.
8. The Assure Prism multi Blood Glucose Monitoring System should be cleaned and disinfected between patient tests to avoid cross-contamination? n True n False
9. Nurses who use the Assure Prism multi Blood Glucose Monitoring System 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 specific patient. d. Use a safety lancet, such as the Assure Lance, to obtain a patient's blood sample.
10. The Assure Prism multi Blood Glucose Meter uses four 3.0V lithium batteries n True n False

SECTION
E

Name: Date: Score:

29

SELF-TEST Assure® Prism multi Blood Glucose Monitoring System

Answer Key

1. c 2. c, d 3. b, c 4. b, c, d 5. b, c, d

6. b, c 7. a 8. True 9. a, b, c, d 10. False

SECTION
E

30

Name of facility:
METER TRACKING FORM
Active Meters Per Unit
1
2
3
4
5
6
7

Meter Serial Number

New

Replacement

SECTION
F

31

Corrective Action (Y/N)

Control Result

Control Range

High (Level 2) Control Range

Exp. Date

Lot #

Control Result

Control Range

Normal (Level 1) Control Range

Name of facility:
QUALITY CONTROL RECORD
Assure® Prism multi Blood Glucose Monitoring System: Assure Prism multi Meter Serial # _____________________________ Unit ___________________________ Month/Year _________________
SECTION
F
32

Exp. Lot # Date

Test Strip Exp.
Lot # Date

Operator Initials

Station/ Shift

Date

Name of facility:
FIELD INSPECTION REPORT Assure® Prism multi Blood Glucose Monitoring System:

Facility: _________________________________ Date: ___________________________ Contact: _________________________________________ Address: ________________________________ Time: __________________________ Phone: __________________________________________
_________________________________ ARKRAY Representative Signature: ____________________________________________________

Station

Meter Serial #

Normal (Level 1) Control Solution

Range

Result

High (Level 2) Control Solution

Range

Result

Batteries OK Changed

Set to Correct Settings

Meter Replaced
(Y/N)

Comments

SECTION
F
33

SAMPLE POLICY AND PROCEDURES
NOTE: The following Sample Policies and Procedures are provided only as an example to help your facility establish your own policies and procedures. Your own policy may vary depending upon your facility's existing procedures. Please consult with your Director of Nursing for further direction.
SECTION
F
34

POLICY: INFECTION CONTROL
Purpose
The purpose of this guide is to ensure that correct cleaning and disinfecting of the Assure® Prism multi Blood Glucose Monitoring System is followed to prevent the potential transmission of infectious organisms through the Assure Prism multi Blood Glucose Monitoring System. A strong, consistent facility policy will provide lasting benefits to healthcare professionals and patients. Please consult with your nursing or infection control managers to determine your own stated policy. Both the Centers for Disease Control (CDC) and Joint Commission (JCAHO) recommend that precautions be taken during all procedures and in all circumstances where there is a possibility of exposure to blood or any body fluid. To assist you with the infection control process we suggest you use the following ideas to assist you in developing an Infection Control Policy and Procedure Guide for your Assure Prism multi Blood Glucose Monitoring System. Remember, this is not designed to replace your policy, but to provide a guideline for blood glucose infection control procedures. Protocol Notes
Personnel should review and follow their organization's principles of aseptic and infection control. Personnel should prevent contamination of themselves and cross-contamination to patients and other staff by adhering to their organization's facility-wide infection control policy. Level of Responsibility: RN/LPN Equipment Needed:
· Assure Prism multi Meter
· Assure Prism multi Test Strips
· Lancet or lancing device (we recommend the Assure Lance Safety Lancet)
· Gloves
· Prepared disinfectant
· Appropriate containers for contaminated disposable equipment/gowns
Procedure
1. Prepare for Testing
Wash hands thoroughly. Gather all of the supplies needed to perform a blood glucose test. Wear gloves and a gown according to organization's policy. 2. Perform the Test
Follow the instructions on how to perform a test with an Assure Prism multi Meter (detailed in Section B of the QA/QC Manual). 3. Dispose of used test strip and lancet
Dispose of the used Assure Prism multi test strip and lancet after the test is performed in the appropriately marked containers or follow your facility's printed policy of disposal for this type of matter. 4. Clean and Disinfect
5. Dispose of used gloves or garments in appropriate containers.

SECTION
F

35

SECTION
F

CLEANING AND DISINFECTING THE METER
To minimize the risk of transmitting blood borne pathogens, the cleaning and disinfection procedure should be performed as recommended in the instructions below.
The meter should be cleaned and disinfected after use on each patient. The Assure® Prism multi Blood Glucose Monitoring System may only be used for testing multiple patients when standard precautions and the manufacturer's disinfection procedures are followed.
Cleaning and Disinfection The cleaning procedure is needed to clean dirt, blood and other bodily fluids off the exterior of the meter before performing the disinfection procedure.
The disinfecting procedure is needed to prevent the transmission of blood borne pathogens.
Only wipes with EPA registration numbers listed below have been validated for use in cleaning and disinfecting the meter. Any disinfectant product containing these EPA registration numbers may be used on this device. These EPA registration numbers can be found on the EPA website. Wipes with EPA registration numbers not listed below should not be used to clean and disinfect the Assure Prism multi Meter. Please read the manufacturer's instructions carefully before using their wipes on the meter.

Manufacturer
Clorox® Professional Products Company
Professional Disposables International, Inc. (PDI) Metrex® Research

Disinfectant Brand Name Clorox Healthcare Bleach Germicidal Wipes Dispatch® Hospital Cleaner Disinfectant Towels and Bleach Super Sani-Cloth® Germicidal Disposable Wipe
CaviWipes1TM

EPA # 67619-12 56392-8
9480-4
46781-13

· A list of Environmental Protection Agency (EPA) registered disinfectants effective against HIV, hepatitis B and hepatitis C viruses can be found at the following website: www.epa.gov/pesticide-registration/selected-epa-registered-disinfectants
Go to www.arkrayusa.com/diabetes-management/disinfect for the most up-to-date information on approved cleaning and disinfecting procedures and materials for ARKRAY meters. If you have any questions, please contact our Technical Customer Service department at 800.818.8877, option 5, 24 hours a day, 7 days a week.
Cleaning and Disinfecting Procedures

NOTE · Do not get fluids inside the meter through the test strip port, data port or battery
compartment.
· Never immerse the meter or hold it under running water because it will damage the meter. · Two disposable wipes will be needed for each cleaning and disinfecting procedure; one wipe
for cleaning and a second wipe for disinfecting.

More information is available at: · www.cdc.gov/injectionsafety/blood-glucose-monitoring.html
36

Cleaning
Step 1: Wear appropriate protective gear such as disposable gloves.
Step 2: Open the towelette container and pull out 1 towelette and close the lid.
Step 3: Wipe the entire surface of the meter 3 times horizontally and 3 times vertically using 1 towelette to clean blood and other body fluids. Carefully wipe around the test strip port by inverting the meter so that the test strip port is facing down. This prevents disinfectant liquid from entering the meter.
Step 4: Properly dispose of the used towelette.





Assure® Prism Multi Blood Glucose Meter

· For multiple patients / professional use.

· Use with Assure Prism Multi Blood Glucose Test Strip.

· For testing outside of the body (in vitro diagnostic use only).

· Model: GM505RA

3V, 11 mA (CR2032 X 2)

Manufactured for
Minneapolis, MN 55439 USA 800.566.8558 www.arkrayusa.com

Contact Customer Service at 800.566.8558, 24 hours a day, 7 days a week, USA and Canada.

Made in Korea

P/N 5117-00 REV 07/14

Front


Back Both sides

NOTE · No actual drying of the meter is necessary before starting the disinfecting procedure.

Disinfecting (The meter should be cleaned prior to disinfection.)
Step 5: Open the towelette container and pull out 1 towelette and close the lid.
Step 6: Wipe the entire surface of the meter 3 times horizontally and 3 times vertically to remove blood-borne pathogens. Carefully wipe around the test strip port by inverting the meter so that the test strip port is facing down. This prevents disinfectant liquid from entering the meter.
Step 7: Properly dispose of the used towelette.
Step 8: Treated surface must remain wet for recommended contact time. Please refer to the Assure Prism multi BGMS User Manual for hepatitis B contact times. For all other contact times, refer to wipe manufacturers' instructions. DO NOT WRAP THE METER IN A WIPE. Once contact time is complete, wipe meter dry.
Step 9: After disinfection, the user's gloves should be removed and thrown away. Wash hands before proceeding to the next patient.

 
Front
 


Assure® Prism Multi Blood Glucose Meter

· For multiple patients / professional use.

· Use with Assure Prism Multi Blood Glucose Test Strip.

· For testing outside of the body (in vitro diagnostic use only).

· Model: GM505RA

3V, 11 mA (CR2032 X 2)

Manufactured for
Minneapolis, MN 55439 USA 800.566.8558 www.arkrayusa.com Made in Korea

Contact Customer Service at 800.566.8558, 24 hours a day, 7 days a week, USA and Canada.
P/N 5117-00 REV 07/14

Back Both sides

If any of the following deterioration signs appear after cleaning or disinfecting, please stop using the system and contact Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week.
· When the inscriptions on the exterior of the meter have been removed. · When the color of the meter has changed or faded. · When cracks or roughness develop on the meter. · When a part of the segment on the meter display does not flash.

SECTION
F

37

SECTION
F

POLICY: PERFORMING A BLOOD GLUCOSE TEST WITH THE ASSURE® PRISM MULTI METER
Patients who require daily administration of insulin or oral hypoglycemic agents will have: · Glucose levels monitored using the Assure Prism multi Blood Glucose Meter in
accordance with a physician's order. When no physician's order is present, registered nurse should monitor at least daily. · Fasting serum blood glucose test performed as ordered by the physician. Patients with diet-controlled diabetes mellitus will have: · Glucose levels monitored using the Assure Prism multi Blood Glucose Meter in accordance with a physician's order. When no physician's order is present, registered nurse should monitor at least weekly. · Fasting serum blood glucose test performed as ordered by the physician. Level of Responsibility: RN/LPN Equipment Needed: · Assure Prism multi Blood Glucose Meter · Assure Prism multi Test Strips · Safety Lancet · Gloves · Alcohol Wipe
Procedure: Consult manufacturer's direction for additional information regarding the use of the Assure Prism multi Blood Glucose Meter. 1. Verify physician's order 2. Assemble equipment 3. Identify the resident 4. Explain procedure 5. Provide privacy
Preparing the Lancing Device A lancing device is needed in order to collect a blood sample. Only an auto-disabling, single-use lancing device should be used. The auto-disabling, single-use lancing device can be purchased from your medical distributor or by telephone from the manufacturer.
Please read the instructions provided by the lancing device manufacturer before using the device.
Step 1
Wash hands and the sample site with soap and warm water. Rinse and dry thoroughly. If alcohol wipes are used, make sure the area is dry before taking blood sample. Residual alcohol may lead to inaccurate readings. Wear appropriate protective gear such as disposable gloves.

38

Preparing the Meter and Test Strip
Step 2 With the contact bars facing up, insert a test strip into the meter's test strip port.

Push the test strip gently into the test strip port until the meter automatically turns on and the symbol appears.
Applying the Blood Sample Step 3 Obtain a blood sample using a lancing device. Place the lancing device against the sampling site in the direction of the arrow. The best puncture sites are areas on the middle or ring fingers. Remove the device from the finger.
Wait a few seconds for a blood drop to form. A minimum volume of 0.5 microliter is needed to fill the confirmation window.
Step 4 After the symbol appears on the screen, apply the blood sample to the narrow end of the test strip until the meter beeps. If the confirmation window is not filled in time because of abnormal viscosity or insufficient volume, an Er4 message may appear. It is recommended that the application of the blood sample to the test strip be performed virtually vertical to the sample site as shown in the diagram.

Approximate Size

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Good Insufficient Sample Sample
NOTE · The meter will switch off if the blood sample is not applied within 2 minutes of the symbol
appearing on the screen. If the meter turns off, remove the test strip, reinsert it, and start from Step 2.
Step 5 The test result will appear after the meter counts down from 5 to 1. The result will be automatically stored in the meter's memory.
Step 6 Slide the ejector button on the right side of the meter to safely discard used test strips in a disposable container. If the test strip is removed, the meter will automatically turn off after 3 seconds.
39

Turning On the Backlight When the meter is on, pressing the backlight button powers on the display backlight. The backlight will turn off after 15 seconds or when you press the backlight button again.
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POLICY: QUALITY CONTROL TESTING ON ASSURE® PRISM MULTI METER
Quality control testing using the Assure Prism Control Solution will be performed to examine the performance of the Assure Prism multi Blood Glucose Monitoring System. The Assure Prism Control Solution checks if the meter and test strips are working correctly as a system and if you are testing correctly. Perform a Control Solution Test: · Before testing with the Assure Prism multi Blood Glucose Monitoring 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 Assure Prism multi Meter has been dropped or stored below 32°F (0°C) or
above 122°F (50°C). · Each time the batteries are changed.
IMPORTANT: Depending on state regulations, control solution testing may be required on a daily basis. Please check with your local inspector's regulations or facility procedures.
IMPORTANT: · Assure Prism Control Solution is not intended for human consumption. Do not drink. · Only use with Assure Prism multi Blood Glucose Meter and Assure Prism multi Test
Strips. · To avoid contamination NEVER touch the tip of the bottle to the test strip! · Dye in control solution may stain clothing or surfaces. · Store the control solution between 35­86°F (2­30°C). · Keep away from direct sunlight and heat. Do not freeze. · Use before the expiration date printed on 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 Prism Control Solution is not a cleaning solution. Do not clean your meter with control solution. Level of Responsibility: RN/LPN Equipment Needed: · Assure Prism Control Solution (Normal and High) · Assure Prism multi Test Strips · Assure Prism multi Meter · Record Sheet

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41

Assure® Prism Control Solution Testing
Step 1
Insert a test strip into the meter's test strip port, with the contact bars facing upwards.
Gently push the test strip into the test strip port until the meter beeps. Be careful not to bend the strip while pushing it in. The symbol will be displayed on the screen.
Step 2
Shake the Assure Prism Control Solution bottle well before each test.
Step 3 Remove the cap and squeeze the bottle to discard the first 1 or 2 drops. Apply one drop of control solution to the top of the control solution cap.
Step 4 After the symbol appears on the display, apply the solution to the narrow edge of the test strip until the meter beeps. Make sure the confirmation window fills completely.

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NOTE
· The meter will switch off if the control solution sample is not applied within 2 minutes of the symbol appearing on the screen. If the meter turns off, remove the test strip, reinsert, and
start from step 2.

Step 5 A test result will appear after the meter counts down from 5 to 1.
After your control solution result appears on the display, press for 3 seconds until "check" appears on the display. When "check" is displayed, the result is stored in the meter's memory but it is not included in the averages.
Compare the result displayed on the meter to the range printed on the test strip bottle or box of individually wrapped test strips. If the result falls within the specified range, you are ready to use the meter and test strips to test with blood.
Step 6
Remove the used test strip from the meter's test strip port. The meter will turn off automatically. Used test strips should be safely discarded in disposable containers.

Control Solution Range Control 1: Control 2:

CAUTION · The ranges printed on the test strip bottle or box of individually wrapped test strips are for the
Assure® Prism Control Solutions only. They do not have any connection to blood glucose level.
NOTE · Assure Prism Control Solution can be purchased from your local supplier or pharmacy. If they do
not stock it, contact ARKRAY Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week. 42

POLICY: MAINTAINING THE ASSURE PRISM MULTI METER
Level of Responsibility: RN/LPN

INSERTING OR REPLACING THE BATTERIES

The Assure Prism multi Blood Glucose Meter uses two 3.0 V lithium batteries. Before using the

meter, check the battery compartment and insert batteries if empty. When the

symbol

appears on the display while the meter is in use, the batteries should be replaced

as soon as possible. The test results may not be saved if the batteries run out.

Step 1

Make sure the meter is turned off. Push the cover in the direction of the arrow to open the battery compartment.

Step 2
To remove the used batteries, place your finger under each battery and pull upward. Insert two new batteries with the + side facing up and make sure the batteries are inserted firmly.

Step 3

Slide the cover back on the battery compartment. Push down until you hear the tab click into place.

NOTE
· Removing the meter batteries will not affect your stored results. You may, however, need to reset your meter settings.

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DISTRIBUTED BY:
ARKRAY USA
5182 West 76th Street Minneapolis, MN 55439 U.S.A 800.818.8877 www.arkrayusa.com
Customer Service, 800.818.8877, option 5 24 hours a day, 7 days a week.

Assure is a trademark of ARKRAY, Inc. Clorox is a trademark of The Clorox Company.
PDI and Sani-Cloth are trademarks of Professional Disposables International, Inc.
CaliWipe1 is a trademark of Metrex.
© ARKRAY USA, Inc. All Rights Reserved.
AS-1481-v1 Rev. 03/21



References

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