Lifescan InDuo User Manual

Combined blood glucose monitoring and insulin dosing system

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User manual (96 pages)

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Manual (90 pages)

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Manufactured by:

Novo Nordisk A/S

2880 Bagsvaerd, Denmark

in cooperation with

LifeScan Inc.

Milpitas, California 95035, U.S.A.

Revision date: 01/2003

Combined blood glucose

monitoring and

insulin dosing system

User manual

Diagram of the InDuo™ system

Look at the diagram inside this cover for the names of the different parts of

the InDuo™ system. You can unfold the diagram to help you while you follow

the instructions.

The InDuo™ system should only be used in combination with products that are

compatible therewith and allow the InDuo™ system to function safely and effectively.

OneTouch

Ultra™ test strips are designed to be used with the InDuo™ blood

glucose meter.

Penfill

3ml cartridges and NovoFine

needles are designed to be used with the

InDuo™ insulin doser.

InDuo™, Penfill

and NovoFine

are trademarks owned by Novo Nordisk A/S.

The CE-mark on the InDuo™ doser indicates that the product conforms with the provisions in the

EC Directive for Medical Devices 93/42/EEC. The InDuo™ insulin doser fulfils the specification limits for dose

accuracy according to ISO 11608-1. Pen-Injectors for Medical use, Part 1: Requirements and test methods.

The CE-mark on the InDuo™ blood glucose meter, test strips and control solution indicates that the

products conform with the provisions in the EC Directive for In Vitro Diagnostic Medical Devices 98/79/EC.

InDuo™ SYSTEM AND ACCESSORIES

OneTouch

UltraSoft™

UltraClear™ Cap

Sterile Lancet

for alternate puncture site

InDuo™

OneTouch

Ultra™

OneTouch

Ultra™

OneTouch

UltraSoft™

Blood Glucose Meter

Control Solution

Test Strips

Adjustable blood sampler

InDuo™

NovoFine

Penfill

3 ml

Insulin Doser

Needles 10-pack

Insulin Cartridge

Table of Contents

Summary of Contents for Lifescan InDuo

Page 1 ® are trademarks owned by Novo Nordisk A/S. The CE-mark on the InDuo™ doser indicates that the product conforms with the provisions in the EC Directive for Medical Devices 93/42/EEC. The InDuo™ insulin doser fulfils the specification limits for dose accuracy according to ISO 11608-1.
Page 2 InDuo™ BLOOD GLUCOSE METER AND INSULIN DOSER InDuo™ METER AND INSULIN DOSER DISPLAY SYMBOLS InDuo™ COMPONENTS SYMBOLS Ketones? OneTouch UltraSoft™ Adjustable blood sampler OneTouch Ultra™ Data port ® ® SYMBOLS Indicates a control solution Appears when a blood glucose test...
Page 3: Table Of Contents
CONTENTS Welcome Getting your InDuo™ system ready for use Preparing your InDuo™ meter Preparing your InDuo™ insulin doser Testing your blood glucose levels Injecting your insulin Using the InDuo™ memory functions How to check your previous test results How to check your previous injection Viewing blood glucose test results on a personal computer Comparing the InDuo™...
Page 4: Welcome
InDuo™ will enable you to A warranty registration card is included check your blood glucose levels and with your InDuo™ system. If you prefer you administer insulin using one compact may complete the warranty card online by system. This manual contains instructions visiting our website - “induo.com”.
Page 5: Getting Your Induo™ System Ready For Use
InDuo™ meter display. Enter the setting mode • Press and hold down ˛ for 3 seconds. • The InDuo™ meter is now in the setting mode and you are ready to change the time using the meter display.
Page 6 GETTING YOUR InDuo™ SYSTEM READY FOR USE Setting the hour • The time will appear first, with the hour digits flashing. • Press and release Ñ until the correct hour is displayed. • To scroll faster, hold Ñ down. • After setting the hour, press ˛ to set the minutes.
Page 7 GETTING YOUR InDuo™ SYSTEM READY FOR USE Setting the time format • Press ˛ and the 24-hour format will start flashing. • Your InDuo™ meter can display the time in either a 12-hour format ¸ or a 24-hour format | to ‹.
Page 8 GETTING YOUR InDuo™ SYSTEM READY FOR USE Setting the month • Press ˛ and the date will appear on the display with the month display flashing. • Press and release Ñ until the correct month is displayed. • To scroll faster, hold Ñ down.
Page 9 • With the correct day on the display, press ˛ and the current unit of measurement will start flashing. The InDuo™ meter can display test results in milligrams per deciliter (Á) or in millimoles per liter (ﬁ). The Á unit is standard in the United States.
Page 10 GETTING YOUR InDuo™ SYSTEM READY FOR USE æ OneTouch ® Ultra™ test strips Top edge Apply a sample here, Your InDuo™ meter is designed for use only with where the narrow channel meets the OneTouch ® Ultra™ test strips. top edge of OneTouch ®...
Page 11 GETTING YOUR InDuo™ SYSTEM READY FOR USE • Apply only control solution or a blood sample to the top edge of the OneTouch Ultra™ test strip. ® Applying other substances to the top edge may cause inaccurate results. • Do not use OneTouch Ultra™...
Page 12 Code numbers are used to calibrate the OneTouch Ultra™ test strips with the InDuo™ meter. ® You must code the InDuo™ meter before using it for the first time, and then every time you change to another vial of OneTouch Ultra™ test strips. Each ®...
Page 13 GETTING YOUR InDuo™ SYSTEM READY FOR USE Match the code numbers (Example) The calibration code is stored in the meter memory until it is changed by the user. The current code number will appear on the display for 3 seconds.
Page 14: The Control Solution Test
• at least once a week. • when you begin using a new vial of OneTouch ® Ultra™ test strips. • if you suspect that your InDuo™ meter or OneTouch ® Ultra™ test strips are not working properly. • when your blood glucose test results are not consistent with how you feel, or when you think your results are not accurate.
Page 15 Do not use if expired. • Store control solution tightly closed at temperatures below 30°C (86ºF). • Do not refrigerate control solution. • The control solution, the InDuo™ meter, and the OneTouch Ultra™ test strips should be at room ®...
Page 16 GETTING YOUR InDuo™ SYSTEM READY FOR USE Before you use your InDuo™ meter to test your blood for the first time, practise the procedure using the control solution test. When you can do 3 tests in a row that are within the range printed on the OneTouch Ultra™...
Page 17 GETTING YOUR InDuo™ SYSTEM READY FOR USE • After the apply symbol R appears on the display, press Ñ. • The Ë symbol will appear on the display. With the Ë symbol on the display, the meter will mark your next test in the memory as a control solution test.
Page 18 GETTING YOUR InDuo™ SYSTEM READY FOR USE Apply control solution • Shake the control solution vial well. • Remove the cap. • Squeeze the vial and discard the first drop and wipe off the dispenser tip to obtain an accurate result.
Page 19 InDuo™ system may not be working properly. • Do not use the InDuo™ system to continue testing your blood if the control solution test results continue to fall outside the expected range.
Page 20 GETTING YOUR InDuo™ SYSTEM READY FOR USE The control solution test troubleshooting There are several reasons why the results of a control solution test may fall outside the expected range (as printed on the OneTouch Ultra™ test strip vial label).
Page 21: Preparing Your Induo™ Insulin Doser
GETTING YOUR InDuo™ SYSTEM READY FOR USE PREPARING YOUR InDuo™ INSULIN DOSER Before you are ready to inject your insulin, the InDuo™ insulin doser must be loaded with a prefilled insulin cartridge, Penfill . Also a needle must be ®...
Page 22 GETTING YOUR InDuo™ SYSTEM READY FOR USE To load Penfill ® • Pull out the InDuo™ insulin doser a. • The very first time the insulin doser is pulled out, the insulin doser display stays blank until the slide is opened.
Page 23 GETTING YOUR InDuo™ SYSTEM READY FOR USE • Insert Penfill ® into the InDuo™ insulin doser by pushing it slightly backwards as shown d. The end with the rubber stopper goes in first. Make sure that the colour-coded cap fits firmly into place e.
Page 24 Do not bend or damage the needle before use. How to prime the InDuo™ insulin doser Priming the InDuo™ insulin doser is a method of making sure that the insulin is ready to flow when you make your injection. Otherwise, you will not receive the full insulin dose.
Page 25 GETTING YOUR InDuo™ SYSTEM READY FOR USE Priming your InDuo™ insulin doser ® for the first time and after changing Penfill æMake sure that a NovoFine ® needle is attached, the push button is pressed completely in, and the slide is closed. If the slide is not closed, the release button will be locked.
Page 26 GETTING YOUR InDuo™ SYSTEM READY FOR USE • Dial 8 units b. • Hold the InDuo™ insulin doser with the NovoFine ® needle upwards and tap the slide gently with your finger a few times c, to ensure that any air in Penfill rises to the top.
Page 27: Testing Your Blood Glucose Levels
® Ultra™ test strip package insert found in this system kit box carefully before testing. Before using your InDuo™ meter to test your blood glucose level, check that you have all the items needed to complete the procedure. These are: •...
Page 28 TESTING YOUR BLOOD GLUCOSE LEVELS Check that the InDuo™ meter display is working properly. You will know the meter display is working properly because each time the InDuo™ meter is turned on, all the segments of the meter display appear briefly (see “InDuo™ meter and insulin doser display symbols”...
Page 29 TESTING YOUR BLOOD GLUCOSE LEVELS Obtaining a drop of blood Insert a lancet in the blood sampler • Twist the cap of the blood sampler counter- clockwise to remove it. • Insert a new lancet into the lancet holder, and push down firmly until it is fully seated a.
Page 30 TESTING YOUR BLOOD GLUCOSE LEVELS • Replace the cap c. • Turn the cap clockwise until it fits snugly but not too tight. • Adjust puncture depth setting if necessary. Twist the knob toward the smaller bumps for a shallower ®...
Page 31 TESTING YOUR BLOOD GLUCOSE LEVELS Cock the blood sampler • Slide the ejection/cocking control back until it clicks e. • If it does not click, the blood sampler may have been cocked when the lancet was inserted. Wash your hands and the puncture site •...
Page 32 TESTING YOUR BLOOD GLUCOSE LEVELS Getting a fingertip blood sample The InDuo™ system requires a very small blood drop to perform a test. You may obtain it from a fingertip or arm. (See page 33 for information on obtaining a blood sample from the arm).
Page 33 TESTING YOUR BLOOD GLUCOSE LEVELS Important information about arm testing • Under certain conditions, blood • Testing performed within two hours glucose test results obtained using after meals, an insulin dose or physical samples taken from your arm may exercise, or whenever you feel that your differ significantly from fingertip glucose levels may be changing rapidly, samples.
Page 34 TESTING YOUR BLOOD GLUCOSE LEVELS Getting a blood sample from the arm The arm has fewer nerve endings than the fingertip so you may find that obtaining a blood sample from the arm may be much less painful than using the fingertip. The Actual size of technique for obtaining a blood drop from the arm is required blood...
Page 35 If you are having difficulty obtaining blood from the arm, call Customer Service at your local Novo Nordisk or LifeScan office for assistance. The blood sample must be at least 1 microliter in volume or you may get an Æ or possible inaccurate test result.
Page 36 ® Ultra™ test strip in firmly until it will go no further. • The InDuo™ meter will turn on automatically. All segments on the meter display will appear briefly. Then the code number is displayed, followed by the apply symbol R with the units of measurement (Á...
Page 37 • Hold the blood drop to the top edge of the test strip until blood has completely filled the confirmation window before the meter begins to count down. The InDuo™ meter display will begin to count down from N to A.
Page 38 You must remove the test strip and insert it back into the InDuo™ meter to restart the test. The InDuo™ meter measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
Page 39 TESTING YOUR BLOOD GLUCOSE LEVELS Read the results • Your blood glucose test result will appear after the InDuo™ meter counts down from N to A. • Turn off the InDuo™ meter by removing the OneTouch Ultra™ test strip. ®...
Page 40 TESTING YOUR BLOOD GLUCOSE LEVELS Special messages HI: If your blood glucose test result is above 600 mg/dL (33.3 mmol/L), S will appear on the meter display. This indicates severe hyperglycemia (high blood glucose). You should re-check your glucose level, and if S call your healthcare professional immediately.
Page 41: Injecting Your Insulin
æ Before beginning, read Important Information on page 65. To begin preparation for injecting your insulin, pull out the InDuo™ insulin doser. Do not press any buttons on the meter cap while you remove the insulin doser. Attach a NovoFine needle.
Page 42 • Dial 1 unit d (When inserting a new Penfill start ® with 8 units) • Hold the InDuo™ insulin doser with the needle upwards and tap the slide gently with your finger a few times e. • Press the push button completely in until it locks f.
Page 43 INJECTING YOUR INSULIN How to dial your dose • Make sure that a NovoFine needle is attached and ® that the push button is pressed completely in. • Press the release button a and the push button will jump out. The display will show 0. •...
Page 44 INJECTING YOUR INSULIN How to change a dose dialled • If you accidentally dial a larger dose than you need, dial back to the correct number of units a. • You can continue changing the dose that has been dialled until you press the push button. How to cancel a dose dialled •...
Page 45 6 seconds to ensure that the full insulin dose has been delivered. The InDuo™ insulin doser helps you to do this by providing a built-in timer. • When the push button is pressed in completely, the segments turn on two by two “...
Page 46 INJECTING YOUR INSULIN • When the circle symbol § appears b, the full insulin dose has been delivered and you can withdraw the needle. After you have withdrawn the needle, a few drops of insulin may appear at the needle tip. This is normal and has no effect on the dose delivered.
Page 47 In this situation, you must change Penfill ® • The InDuo™ insulin doser will not let you dial a larger dose than that remaining in Penfill ® æDo not force the dose selector to turn, instead change Penfill ®...
Page 48 • Change Penfill (see page 49). ® • Prime the InDuo™ insulin doser (see page 24). • Inject the whole dose at once. • Inject the remaining insulin, making a note of the amount of insulin you have injected.
Page 49 INJECTING YOUR INSULIN How to change Penfill ® • Make sure that the push button is pressed in completely a. • Make sure there is no needle on the insulin doser. • Open the slide. • Take out the used Penfill ®...
Page 50 INJECTING YOUR INSULIN InDuo™ insulin doser function check If you think that the InDuo™ insulin doser is not working properly, follow the procedure: • Screw on a new NovoFine needle, as described on ® page 41. • Prime the insulin doser as described on page 42.
Page 51: Using The Induo™ Memory Functions
Both the InDuo™ meter and the InDuo™ insulin doser have memory functions. How to check your previous test results Your InDuo™ meter has a memory that can store the 150 most recent blood glucose and control solution test results, together with the date and time at which they were carried out.
Page 52 USING THE InDuo™ MEMORY FUNCTIONS How to recall test results • After 3 seconds, the 30-day average will be replaced by the most recent test result with date and time. • Press Ñ once and the next most recent test result will appear.
Page 53 USING THE InDuo™ MEMORY FUNCTIONS Other memory functions of the InDuo™ meter The InDuo™ meter can provide valuable information on variations in your blood glucose levels. Average blood glucose test results over 14 days and 30 days • The meter provides 2 averages of your blood glucose tests.
Page 54: How To Check Your Previous Injection
USING THE InDuo™ MEMORY FUNCTIONS How to check your previous injection • Pull out the InDuo™ insulin doser. • After the display test (see page 82), your previous dose (or priming) and the time passed since delivery can be seen on the insulin doser display.
Page 55: Viewing Blood Glucose Test Results On A Personal Computer
You can transfer blood glucose test results to your PC for home viewing. This requires a LifeScan Interface Cable and OneTouch Diabetes Management ® Software which is available from LifeScan. OneTouch Software and the LifeScan Interface Cable ® are not included with your InDuo™ and must be obtained separately.
Page 56 Software User’s Guide. ® Connect the LifeScan Interface Cable • Connect the LifeScan Interface Cable to a serial port on the back of your computer. • With the InDuo™ meter turned off, connect the LifeScan Interface Cable to the data port located on the top of the InDuo™...
Page 57 • If no command is received within 2 minutes, the InDuo™ meter will turn itself off. • Pressing ˛ will also turn off the InDuo™ meter. • Follow the instructions in your OneTouch Software ®...
Page 58: Comparing The Induo™ Meter And Laboratory Results
InDuo™ test results can be affected before doing comparison tests. by factors and conditions that do not • Take your InDuo™ meter with you to affect laboratory results in the same way. the laboratory. Your InDuo™ meter glucose value should...
Page 59 COMPARING THE InDuo™ METER AND LABORATORY RESULTS • Never use your InDuo™ meter with test. It is therefore best to fast for 8 blood that has been collected in a test- hours before doing a comparison test tube with a grey-coloured top.
Page 60: Caring For Your Induo
• Please read the package insert in the down the outside of the meter. Penfill pack. This will tell you how to • Do not soak InDuo™, wash it or ® store Penfill cartridges and how long lubricate it. This will damage the ®...
Page 61 CARING FOR YOUR InDuo™ SYSTEM Power supply The InDuo™ system is powered by batteries so that it is portable and self-contained with regard to its power supply. The InDuo™ system comes with 2 battery systems already installed: • The meter battery provides you with enough power to perform approximately 1000 blood glucose or control solution tests.
Page 62 CARING FOR YOUR InDuo™ SYSTEM When to change your InDuo™ meter battery Your InDuo™ meter will alert you when the power is getting low by displaying the following messages. a This message appears when the meter display is turned on and all the other display messages are functional.
Page 63 How to replace the InDuo™ meter battery • To replace the meter battery, make sure that the InDuo™ meter is turned off. • Turn your InDuo™ meter over and locate the battery compartment. • Open the battery door on the back of the meter a.
Page 64 When to replace your InDuo™ insulin doser A flashing display indicates that the insulin doser battery power is low. • Be sure to replace your InDuo™ insulin doser within 30 days. The battery cannot be changed. Call Customer Service at your local Novo Nordisk or LifeScan office to obtain a new InDuo™...
Page 65: Æ Important Information
• As a precautionary measure, always carry a spare insulin delivery system in • Do not change the dose after you case your InDuo™ doser is lost or have pressed the push button. damaged. • Always make sure that the insulin •...
Page 66 3 ml ® solution test (see page 14). cartridges, you should use an InDuo™ insulin doser for one insulin, • Your InDuo™ system is for use by e.g. a rapid acting analogue, and an one person only. Innovo ® insulin doser for the other,...
Page 67 Testing before the injected. meter, strips, and control solution reach the same relative temperature • Do not try to repair a faulty InDuo™ may result in an inaccurate glucose component. reading.
Page 68: Display Messages And Problem-Solving Guide
There are a number of messages and symbols that appear on the insulin doser and meter displays during use of the InDuo™ system. The following is a summary of all display messages. The meter gives an error message when it detects a problem which could cause an inaccurate result.
Page 69: The Induo™ Meter
DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE The InDuo™ meter Here is a summary of the different messages given on the InDuo™ meter display. Meter display What it means Action This indicates that the meter is If segments are missing, running a system check. It appears...
Page 70 DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE Meter display What it means Action This is the code number stored in Make sure that this code the InDuo™ meter number matches the code number on the vial of the OneTouch Ultra™ test strips ®...
Page 71 DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE Meter display What it means Action Five-second countdown. The meter No action required is calculating the result. At the end of the countdown, the meter will display the test result A blood glucose test result No action required if this is in mg/dL the unit your healthcare...
Page 72 DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE Meter display What it means Action A blood glucose test result with a You may want to check your suggestion to check your ketone ketone levels. Act according levels to the instructions of your healthcare professional (Example) Indicates that you may have a very You should recheck your...
Page 73 A blood glucose test result stored No action required in the memory (Example) A control solution test result stored No action required in the memory (Example) There is no test result stored in this No action required place in the InDuo™ memory...
Page 74 Average of the last 30 days. No action required (∑ means that 138 tests were performed during this period) (Example) Error message that indicates that Do not use the InDuo™ there is a problem with the meter. Call Customer at your local InDuo™ meter Service...
Page 75 If the error message appears again call Customer Service at your local Novo Nordisk or LifeScan office Error message that indicates that Repeat the test with a new the blood sample or control OneTouch ®...
Page 76 DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE Meter display What it means Action Error message that If you tested in a cool environment, indicates one of the repeat the test in a warmer following conditions may environment with a new test strip. be present: If the error message appears again, contact Customer Service...
Page 77 DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE Meter display What it means Action Error message that indicates that Repeat the test with a new the InDuo™ meter has detected a OneTouch ® Ultra™ test problem with the test strip. strip. Refer to pages 34...
Page 78 Replace the battery at once. The battery symbol É appears The InDuo™ meter will not on the display by itself. The power operate of the battery is too low to run a test...
Page 79 InDuo™ meter and operating range. You cannot OneTouch ® Ultra™ test strips perform a test until the InDuo™ have reached a temperature meter and the OneTouch ® Ultra™ within the operating range test strips reach a temperature within the operating range of 6–44ºC (43–111ºF)
Page 80 DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE Here are the answers to some questions you might ask when using your InDuo™ meter: What should I do if the InDuo™ meter does not display a message after a OneTouch Ultra™ test strip has been inserted? ®...
Page 81 DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE What should I do if the InDuo™ meter does not start running the blood glucose test after the OneTouch Ultra™ test strip has been inserted? ® Probable reasons Action Insufficient blood sample Repeat the test with a new OneTouch ®...
Page 82: The Induo™ Insulin Doser
DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE The InDuo™ insulin doser As with the meter display, a number of messages and symbols appear on the InDuo™ insulin doser display during use of the insulin doser. Message What it means Action The very first time the insulin doser is...
Page 83 DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE Message What it means Action The display shows the number of No action required insulin units dialled The segments turning on two by two No action required tell you how long to leave the needle under the skin during injection The display shows the number of No action required...
Page 84 The battery in the insulin doser cannot be changed. Call Customer Service at your local Novo Nordisk or LifeScan office to get a new insulin doser A minus symbol on the display tells Dial forward until the you that the dose selector has been...
Page 85 Here are answers to some Why is the display showing a minus questions you might ask about symbol? your InDuo™ insulin doser display: The dose selector has been dialled below zero 0. Dial forward until the Why has the display turned off?
Page 86 DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE Why does no insulin appear when I try button completely in until it locks. to prime the InDuo™ insulin doser? Then change Penfill as described on ® The needle may be blocked. Change page 49.
Page 87 The needle may be blocked. button completely in until it locks. Change the needle and prime the Remove the needle and open the InDuo™ doser as described on page slide. If the slide still cannot be 42. Check to see if Penfill ®...
Page 88: Specifications
SPECIFICATIONS InDuo™ system Size: 123 mm x 54 mm x 35 mm (4.84 in x 2.13 in x 1.38 in) Weight: 125 g with battery (4.40 ounces) Operating ranges: Temperature: 6-40°C (43-104ºF)* Relative humidity: 10-90% Haematocrit: 30-55% InDuo™ meter Result range: 20-600 mg/dL (1.1–33.3 mmol/L)
Page 89: Guarantee
5 years from manufacturing date GUARANTEE The makers guarantee that the InDuo™ system shall be free of defects in material and workmanship for a period of 3 years. This guarantee is valid from the date of purchase. The guarantee extends only to the original purchaser and is not...
Page 90: Blood Glucose Value Targets
BLOOD GLUCOSE VALUE TARGETS Times of day Glucose ranges for people Your target ranges (mg/dL) without diabetes (mg/dL) Before breakfast 70-105 Before lunch or dinner 70-110 1 hour after meals Less than 160 2 hours after meals Less than 120 Between 2 and 4 am Greater than 70 Source: Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual, Philadelphia:...

Lifescan InDuo User Manual

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