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Owners Manual

Prestige IQ™ Blood Glucose Monitoring System

Congratulations on the purchase of your Prestige Smart System™ Blood Glucose Test System. You now have a very simple and accurate way to test your blood glucose (sugar) levels, anytime, anywhere.

Glucose testing is an important part of controlling your diabetes. Studies show that keeping glucose levels in control may lower the chance of developing serious diabetes-related health problems such as kidney problems and blindness. Regular testing lets you know if your sugar is 'too high', 'too low', or 'just right', depending on what you and your Healthcare Professional decide is 'just right' for you.

Do not use the Prestige Smart System™ IQ Meter in any way not recommended in this Booklet.

Table of Contents

Section 1 The Prestige Smart System
                IQ Meter
                Test Strip Vial
                Test Strip
                Meter Options
Section 2 Code the Meter
Section 3 Check the System
                Standard Strip Test
                Glucose Control Test
Section 4 Test Whole Blood
Section 5 Importance of Testing
Section 6 Meter Memory
                Recalling Blood Test Results
                Recalling Morning Average Value
Section 7 Maintenance
Section 8 Change Meter Battery
Section 9 Display Messages
Section 10 Troubleshooting
Section 11 Meter Specifications
References
Warranty

IMPORTANT:

1. Read ALL instructions before use.
2. Use only Prestige Smart System™ Test Strips and Prestige Smart System™ Blue Glucose Control Solution when testing with Prestige Smart System™ IQ Meters.
3. Code your IQ Meter: Meter Code and Test Strip Calibration Code MUST match to get correct test results.
4. Check any results that "feel" wrong: Repeat the test if your results seem much higher or lower than you think they should be.
5. Work with your Doctor or Healthcare Professional: Discuss your results with your Doctor or Diabetes Healthcare Professional.
6. Use only Whole Blood when testing with the Prestige Smart System™: If you choose to display results as plasma, the Meter uses the whole blood value to calculate and then display the plasma value.

Section 1 The Prestige Smart System™
Prestige Smart System™ IQ Meter

Display Screen:   Shows numbers, words and symbols needed to operate the Meter. Power Button: Turns Meter on and off. Meter turns off after 3 minutes of non-use. Test Strip Platform: Holds Test Strip or Standard Strip in place during a test.  Test Window: Area under Test Strip Platform that contains Meter optics.  Battery Compartment: Holds one replaceable AAA (1.5 volt) alkaline battery.  Meter Label: Provides Meter name, serial number and toll-free number for assistance.

Up/Down Button: Used to view Meter options, change Code Number, view stored results or Morning Average. Select (S) Button: Use to select options, access Memory or Morning Average.  Standard Strip Holder: Stores Standard Strip.  Standard Strip: Use for Standard Strip test.  Communication Port: Use to attach Prestige Smart System™ serial cable to Meter. WARNING! Use only Prestige Smart System™ serial cable in port. Putting anything else into port may damage Meter. Please call for more information about use of the Communication Port.

Prestige Smart System™ Test Strip Vial Label

Calibration Code: Meter Code must be matched to this number for vial of Test Strips being used.  Expiration Date: Date after which Test Strips cannot be used.  Control Range: Range of numbers in which Glucose Control test results must fall to be sure that System is working correctly.

Prestige Smart System™ Test Strip

4.   Test Spot:  Apply blood or Glucose Control  solution here.  5.   Color Spot: Changes color after blood or Control solution is applied to the Test Spot.

Meter Options

The Meter has the following options that can be customized to your needs. Options are listed below in the order that they appear in the Display.

Results as Whole Blood (blood): Whole blood is blood that comes directly from finger. Use only whole blood when testing.

Results as Plasma (plasma): Most laboratories use plasma, a component of blood, for testing. Plasma results are about 12% higher than whole blood results.1 When selecting this option, Meter uses the whole blood value to calculate and display the plasma result. NEVER use plasma for testing with Prestige Smart System™.

mg/dL: Glucose unit of measure expressed as milligrams per deciliter, used in US.

mmol/L: Glucose unit of measure expressed as millimoles per liter, used in some countries outside U.S. When selecting this option, choose either Com (comma: 6,1 mmol/L) or Per (period: 6.1 mmol/L).

Avg=14d: The average of all morning blood glucose results for the last 14 days.

Avg=30d: The average of all morning blood glucose results for the last 30 days.

12 hr: Time based on 12 hour clock (am/pm).

24 hr: Time based on 24 hour clock.

m-d-y: Date displayed as month-day-year (12-25-2004

d.m.y: Date displayed as day.month.year (25.12.2004).

If you have any questions regarding these Options, please call for assistance.

Set Meter Options

	Press and hold Power Button until Display flashes, then release Power Button. Meter beeps and displays "Set-up" and then "Type".
	Press top or bottom of the Up/Down Button to switch between the selections available. Press Select (S) Button to set the option.

Meter Options

	Press UplDown Button to change the flashing number. Press Select (S) to set.
	Press Up/Down Button to switch between m-d-y and d.m.y. Press Select (S) to set.
	Press Up/Down Button to change the flashing number.  Press Select (S) to set.  Turn meter off.  Meter is now ready to use for testing.

Section 2 Code The Meter

1.Gather supplies needed.
	Meter  Test Strip Vial
2. Turn Meter on.	Press and release Power Button.
3. Match Codes.	Compare Code shown in Display to Code printed on Strip vial being used. Codes must match. If Codes DO NOT match, go to Step 4. (Calibration Code Numbers range from 0 - 23)
	Press top of Up/Down Button to increase number; press bottom of Button to decrease number. Meter stores Code automatically.

Section 3 Check The System

There are two types of Quality Control tests to assure that the System is working properly and testing technique is good.

• Standard Strip test uses a hard gray plastic strip (Standard Strip). The Standard Strip does not have a lot number or an expiration date, and can be used with any Meter Code.
• Glucose Control test uses a dark blue liquid (Glucose Control) that contains a known amount of glucose. Glucose Control is available in both high and low levels.

These tests should be performed:

• When using the Meter for the first time
• When using a new vial of Test Strips
• When results do not 'agree' with how you feel
• When you suspect that results are incorrect
• To practice using the System
• After cleaning the Meter or replacing the Test Strip Platform (ALWAYS perform the Standard Strip test).

The Standard Strip Test

1. Gather supplies.
	Meter Standard Strip
2. Remove Standard Strip from Meter.
	Clean Strip with water only and dry thoroughly before use. Do not bend Standard Strip.
3. Turn Meter on.	Press and release Power Button.
4. Perform test.
	Slide Standard Strip all the way into Test Strip Platform with Range Label facing up. NOTE: Do not move Standard Strip or Meter during testing or an error message may appear Meter detects Strip and begins test.  When test is complete, the result is displayed.
5. Check result.
	Compare Meter result to range of numbers printed on Range Label. If test result is within range, Meter is working properly.
NOTE: If result is NOT within range, clean Test Window and Standard Strip (see Sec. 7, Maintenance), dry thoroughly and repeat test. If result is still outside of range, call for assistance.
6. Replace Standard Strip.
	Remove Strip from Test Platform and place it back into the Holder with Range Label facing down.

The Glucose Control Test

The Control test is performed exactly like a blood test. Control is used instead of blood. Be sure to read Glucose Control Instructions for Use before using for the first time. Control results are not stored in Memory.

1. Gather supplies needed:
	Meter Test Strips Glucose Control Solution (dark blue)
2. Check expiration dates.
	Check expiration date on Strip vial and Control bottle. If your bottle of Control is being used for first time, write date opened on bottle.
3. Turn Meter on.	Press and release Power Button.
NOTE: Use expiration date printed on unopened Control bottle label. Once Control bottle is opened, Control solution expires 2 months from the date opened.
4. Match Codes.
	Meter Code must match to Code printed on Strip vial being used. If Codes do not match, see Sec. 2, Code the Meter.
5. Per fo r m tes t.
	Remove one Strip from vial, hold Strip at end away from Test Spot. Immediately close vial tightly.
NOTE: Do not put Strip down on a damp or dirty surface. Do not cut or alter Strips in any way.
	Gently swirl bottle several times. DO NOT SHAKE.
	Remove cap from bottle. Hold bottle upside down and squeeze one full drop onto a tissue.
	While holding Control bottle upside down, place bottle over Test Spot of Test Strip. Squeeze one drop onto Test Spot.
NOTE: Do not apply more than one drop of Control to Test Spot Do not allow Control to be drawn back into bottle. Do not use if Control drop contains air bubbles.
	Turn Strip over. Check Color Spot for full color development.
NOTE: If Color Spot looks like this... (large white spots/white areas) there is not enough Control on the Test Strip. DO NOT add more Control to Test Spot! Discard Strip and repeat test using new Strip. If Color Spot appears "wet" there is too much Control on the Test Strip. Discard Strip and repeat test using new Strip.
	Turn Strip over so Test Spot faces up. Point arrow printed on Strip towards Meter and slide Strip into Test Strip Platform within 60 seconds.
WARNING! Slide Strip all the way into Test Strip Platform to avoid error message or a false result.
	Meter is counting seconds.
	Test is complete. Result is displayed.
6.  Check Control results.
	Compare result to Control Range printed on vial of Strips being used. Compare to Low Range for Low Control, or High Range for High Control.
7. Discard Strip.	Slide Strip out of Meter.
8. Wipe tip of Bottle with tissue.
	Recap bottle. Store bottle in a cool, dry place at 59°-86°F or 15°-30°C

Section 4  Test Whole Blood

1. Gather supplies.
	Clean, dry work surface not under very bright light or direct sunlight. Meter Test Strips Lancing Device Sterile, disposable lancet Tissue
2. Check expiration date
	Check expiration date on Strip vial. Do not use if expiration date has passed.
3. Turn Meter on.	Press and release Power Button.
4. Match Code.
	Meter Code must match to Code number on Strip vial being used. If Codes do not match, see Sec. 2, Code the Meter.
5. Perform test.
	Remove one Strip from vial, holding Strip at end away from Test Spot. Immediately close vial tightly.
NOTE: Do not put Strip down on a damp or dirty surface. Do not cut or alter Strips in any way.
	Clean finger and dry thoroughly. Lance finger.   Gently massage finger to form a drop of blood. Allow Test Spot to absorb blood. The blood drop should completely cover Test Spot.
	Turn Strip over. Check Color Spot. Check for full color development.
NOTE: If Color Spot looks like this...   (large white spots/white areas) there is not enough blood on the Test Strip. DO NOT add more blood to Strip! Discard Strip and repeat test using new Strip. If Color Spot appears "wet" there is too much blood on the Test Strip. Discard Strip and repeat test using new Strip.
	Turn Strip over so Test Spot faces up. Point arrow printed on Strip towards Meter and slide Strip into Test Strip Platform within 60 seconds.
WARNING! Slide Strip all the way into Test Strip Platform to avoid error message or a false result.
	Meter is counting seconds. Test normally takes 10 to 50 seconds.
	Test is complete. Result is displayed. If result is higher or lower than you expected, see Sec. 10, Troubleshooting Guide.
6. Record result in Daily Log Book.
7. Discard Strip.	Slide Strip out of Meter.

Section 5 Importance of Testing

Clinical studies demonstrate the importance of controlling diabetes and reducing its complications by frequent self-testing of blood glucose. It is very important to record every result in your log book to:

• Help you manage your diabetes.
• Provide your Diabetes Healthcare Professional with a record of your results. Bring your logbook with you when visiting your Doctor or Diabetes Healthcare Professional.
• Receive payment from Medicaid and Medicare. Your supplier may need a copy of your logbook.

If your results are outside your personal target glucose range as determined by your Doctor or Diabetes Healthcare professional, and you are sure that the System is working properly, consult with your Doctor or Diabetes Healthcare professional.

Severe dehydration can cause false low blood glucose results on virtually all blood glucose monitoring products.2

If you suspect that you are suffering from severe dehydration, call your Doctor immediately!

Section 6 Meter Memory

The Meter automatically stores each blood glucose result in Memory, up to 365 results (Control and Standard Strip results are not stored in Memory). When the Memory is full, the oldest result is discarded and the newest result is added. When you recall results from Memory, the results are displayed in order, beginning with the most recent result.

To recall results:
1. Turn Meter on.	Press and release Power Button.
2. Display Memory.
	Press and release Select (S) Button twice.
3. View results in Memory.
	Press Up/Down Button. Meter beeps twice and displays most recent result in Memory. Press top of Up/Down Button to view oldest to most recent results. Press bottom of Up/Down Button to view most recent to oldest results.
NOTE. Blood glucose results stored in Memory are displayed according to the options set in the Meter at that time. For example, if a glucose test is performed when the 'plasma' option is set but the result is accessed from Memory when the 'blood' is set, that test result will reflect a whole blood value, not a plasma value.

Morning Average

Test results recorded in Log Book, along with Morning Average value provide a Doctor or Diabetes Healthcare Professional with an overall picture of diabetes control. They may use all of this information to determine the right treatment plan for you. Morning Average value is calculated using time period (days) chosen when setting this Option (See Sec. 1, Set Meter Options).

NOTE: Memory must contain at least one result stored from 4:00-9:59 AM to display a Morning Average value. If there is no Morning Average value, Meter displays three dashes.

To display Morning Average:
1. Turn Meter on.
	Press and hold the center of Up/Down Button with one hand. Press and release Power Button with other hand. Continue to hold Up/Down Button until Code number displays, then press and release Select (S) Button twice with other hand.
2. Display Morning Average.
	After five seconds, release Up/Down Button. Morning Average value is displayed. (See Sec. 1, Set Meter Options).

Section 7 Maintenance

• To assure that you continue to got accurate results:
• Clean Meter at least once each week. If blood or Control gets onto Meter, clean right away.
• Handle with care. Dropping Meter may damage it.
• NEVER
  ... immerse Meter in water.
  ... leave Meter, Strips, or Controls in very hot or cold places, or in high humidity. Store Meter, Test Strips and Control as directed.
  ... take Meter apart.
  ... CLEAN METER WITH ALCOHOL!

Clean the Meter.
1. Gather supplies.	Clean, dry work surface Meter Dry cotton swab or tissue Water
2. Remove Test Strip Platform.
	Lift up bottom end of Platform and gently pull up.
3. Clean Test Strip Platform.
	Rinse Platform with water. Lift up top piece of Platform for more thorough cleaning (do not detach from bottom piece). Dry thoroughly. Close gently.
4. Clean Test Window.
	Use dry cotton swab or swab moistened with WATER ONLY to remove stubborn spots. Dry the Window thoroughly with clean cotton swab.
5. Replace Test Strip Platform.
	Angle and slide narrow end of Platform down into Meter. Gently press wide end of Platform down.
6. Wipe outside of Meter with clean, dry cloth.
7. ALWAYS run Standard Strip test after cleaning the Meter. (See Sec. 3, Standard Strip Test).
8. Turn Meter off.
NOTE: Do not perform Control or blood tests until Standard Strip test has given good results

Section 8 Change Meter Battery

If Meter does not turn on, Display is blank or shows the following, the battery must be changed:

Change Battery.
1. Gather supplies.
	Meter 1 new AAA (1.5 volt) alkaline battery
2. Rem ove Battery Door.
	Turn Meter over, slide Battery Compartment Door up with thumb, and lift Door up to remove.
3. Remove Old Battery.
	Gently pull up ribbon that is placed under battery or hold Meter with one hand and gently tap Meter with other hand to loosen battery.
4. Replace Battery.
	Place ribbon at bottom of Battery Compartment. Insert new battery over ribbon, with positive (+) end facing left.
5. A Battery Door.
	Slide Door back until locked into position.
6. Verify Date and Time settings.
	Press and release Power Button. If date and time are not correct, reset (see Sec. 1, Set Meter Options).

Section 9 Display Messages

Display:	What It Means:	What to Do:
	Self Check Display, Meter is doing an internal function check.	If any part of number or symbols in Display are missing, call Technical Services.
	"Insert Strip" symbol flashes when it is ready for Test Strip.	If symbol remains in Display after Strip is inserted, turn Meter off, discard Strip, and clean Meter (see Sec. 7). Repeat test.
	When testing has begun, Meter counts seconds. Test normally takes up to 50 seconds.	If numbers do not count up after Strip is inserted, turn Meter off, discard Strip, and clean Meter (see Sec. 7). Repeat test.
	Dashes flash across Display during a Standard Strip test.	If result does not appear in Display after 10 seconds, call Technical Services.
	Standard Strip not inserted fully into Test Strip Platform or Meter was moved during test.	Turn Meter off. Repeat test (see Sec. 3) without moving Strip or Meter.
	Meter is cold. May not give correct result.	Move Meter and Strips to warmer place (59°-98°F or 15°-37°C). Allow Meter and Strips to adjust to temperature. Run Standard Strip test before using Meter (see Sec. 3).
	Meter is hot. May not give correct result.	Move Meter and Strips to cooler place (59°-98°F or 15°-37°C).). Allow Meter and Strips to adjust to temperature. Run Standard Strip test before using Meter (see Sec. 3).
	Results are 600 mg/dL (33.3 mmol/L) or higher.	Repeat test immediately. If result is still high, review Section 10 to troubleshoot. If no error is found, call your Doctor or Diabetes Healthcare Professional immediately!
	Battery must be replaced.	Remove old battery and install new one (see Sec. 8).
Blank or No Display	Battery must be replaced.	Remove old battery and install new one (see Sec. 8). If there still is no Display, call Technical Services.
	Meter does not detect blood or Control on Test Strip.	Discard Strip. Repeat test with new Strip. Check Color Spot. If error message persists, call Technical Services.
	Meter will not operate.	Call Technical Services. Meter must be replaced.
	Not enough blood or Control on Test Strip. Strip may be defective. Strip was not inserted properly. Result is 25 mg/dL (1.4 mmol/L) or lower.	Remove Strip and check Color Spot. Turn Meter off. Discard Strip. Clean Meter (see Sec. 7). Repeat test with new Strip. If error message persists, call your Doctor or Diabetes Professional immediately!
	Test Strip was removed from Meter during test.	Turn Meter off. Discard Strip. Repeat test with new Strip.
	Standard Strip or Meter was moved during test.	Turn Meter off. Place Meter on flat surface and repeat test. Do not move Standard Strip or Meter during test.
	Sun error; too much light for Meter to perform properly.	Take Meter to area where light is less bright.
Any Other Error Message or Warnings		Call Technical Services.

Section 10 Troubleshooting Guide

If result is higher or lower than expected, or does not agree with how you feel, follow these steps:

1. Turn Test Strip over and check the Color Spot to see if enough blood was applied (see Sec. 1).
   -  If entire area of Color Spot is fully developed, go to Step 2.
   -  If entire area of Color Spot is not fully developed (not enough blood), or if Color Spot appears "wet" (too much blood), go to Step 5.
2. Check to see that vial of Strips or Control has NOT expired.
3. Check to see that the Meter Code matches Code printed on vial of Test Strips being used. Change Meter Code if needed.
4. Clean Meter Test Window (see Sec. 7). After cleaning, carefully replace Test Strip Platform and perform Standard Strip test.
5. Repeat blood test with new Strip. Follow all instructions exactly (see Sec. 4). After applying blood to Test Spot, turn Strip over and check Color Spot before inserting Strip into Meter (see Step 1). If second test result is higher or lower than expected, go to Step 6.
6. Perform Standard Strip test to assure that Meter is working correctly (see Sec. 3). If result is within range of numbers printed on Standard Strip label, go to Step 7. If result is NOT within range printed on label, clean Test Window (see Sec. 7). After replacing Test Strip Platform, perform another Standard Strip test. If second test result is within range printed on label, go to Step 7. If second test result is not within range, call Technical Service.
7. Perform Control test to assure that System (Meter, Test Strips, and testing technique) is working properly (see Sec. 3).
8. If both Steps 6 and 7 give acceptable results, then blood glucose results are correct.
9. If you still feel that your results are not correct, contact your Doctor or Healthcare Professional, or call Technical Service for assistance.
10. If Meter displays error message, please refer to Section 9 DISPLAY MESSAGES, for further instructions.
11. If Meter beeps and flashes "Low Battery" symbol, and then shuts off, battery is too low to test. Replace battery (see Sec. 8).

Section 11 Meter Specifications

Power Supply: One replaceable AAA size alkaline battery. 

Measurement Range: 25 to 600 mg/dL (1.4 to 33.3 mmol/L). Lower results are displayed as "E05". Higher results are displayed as "Hi". 

System Operating Range: Temperature 59°-98°F (15°-37° C).

Humidity: Any non-condensing atmosphere. 

Size: 2.75" x 4.0" x 0.8" (7.0 x 10.2 x 2.0 cm) 

Weight: Approximately 3.6 oz or 102 gms with battery. 

Blood Source: Fresh Whole Blood. 

Test Time: Typically 10 to 50 seconds. 

Memory: 365 most recent results (Glucose Control and Standard Strip results are not stored in Memory).

Code Numbers: 24 total (Code 0 through Code 23). 

Accuracy & Precision: See Prestige Smart System™ Blood Glucose Test Strips Instructions for Use.

Storage Conditions: Temperature -4°-140°F (-20°-60°C).

References

1. American Diabetes Association Clinical Practice Recommendations. Diabetes Care 23 (Suppl. 1): S32- S60, 2000
2. Raskin P, Rifkin H., Diabetes Mellitus, Vo1.5, 1981, Chap. 12 "Diagnosis", p. 105.
3. Beaser, R.S., with Hill, J.V.C.: The Joslin Guide to Diabetes. New York, NY: FIRESIDE (1995), 151.
4. Caraway R.I.; Fundamentals of Clinical Chemistry: "Carbohydrates", Tietz N.W Editor, Philadelphia PA, Saunders, pp. 242-243 (1976).
5. Hackett, J., Aziz, K., Review Criteria Assessment of Portable Blood Glucose Monitoring in Vitro Diagnostic Devices using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology; FDA Draft Document, p. 6 (1997).

Limited Warranty

Home Diagnostics, Inc. provides the following Warranty to the original retail purchaser of the Meter:

1. Home Diagnostics, Inc. warrants this Meter to be free of defects in materials and workmanship at the time of purchase. If the Meter becomes inoperative prior to five (5) years from the date of the original retail purchase, Home Diagnostics, Inc. will replace the Meter with an equivalent Meter, at its option, at no cost to the purchaser. Failure of the Meter due to abuse or use not in accordance with the instructions for use is not covered by this Warranty.
2. This Warranty does not include the battery supplied with the Meter.
3. Do not take the Meter apart. This action will void the Warranty and cause the Meter to display false results.
4. The duration of any implied Warranty, including any implied Warranty of merchantability or fitness for a particular purpose shall be limited to five (5) years from the date of original retail purchase. Some states do not allow limitations on how long an implied Warranty lasts, so the above limitation may not apply.
5. Home Diagnostics, Inc. disclaims liability for incidental or consequential damages for breach of any expressed or implied Warranty, including any implied Warranty of merchantability or fitness for a particular use with respect to the Meter. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitations or exclusion may not apply.
6. This Warranty gives the user specific legal rights, and the user may also have other rights, which vary from state to state.

Your Prestige Smart System™ Technical Service Representative will be able to provide detailed information regarding procedures for returning your Meter, if necessary.

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