Patient Self-Learning ManualCoaguChek® XS

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS 1

Introduction

Welcome to the world of patient self-testing and thank you for choosing the CoaguChek® XS System for your coagulation monitoring. The CoaguChek XS System provides a fast and reliable INR result from a finger-prick drop of blood. It is easy-to-use and portable, so you can bring it with you when traveling. This Self-Learning Manual is a guide to help you use your CoaguChek XS System safely and correctly to do Prothrombin (INR) self-testing.

Life Matters 2Oral Anticoagulants 3About INR and TTR 3-4 Eating and Exercise 5Patient Self-Testing 6About CoaguChek® 7Getting Started 8Preparation 9 Performing a Test 10Error Messages 11Cleaning and Care 11Roche Quality 12Traveling 13Test your Knowledge 14-15Help and Support 16

IMPO

RTA

NT The CoaguChek XS System is a safe and reliable way to obtain

an INR result for most patients, but a physician’s prescription is required to ensure that it is appropriate for each individual patient’s use. The CoaguChek XS System may not be appropriate for patients with anti-phospholipid antibodies (Lupus antibodies) or Hirudin. Please refer to the CoaguChek XS PT Test package insert for a list of the known test limitations and interferences or call the Coagulation Info-Line at 1-877-426-2482.

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS2

Life Matters

If you are taking oral anticoagulant medication called warfarin, also known as Coumadin®, you know that regular monitoring of your blood coagulation is an important part of your care.

Time and again, clinical studies have shown that maintaining your blood anticoagulation level in the target therapeutic INR range set by your physician will optimise your treatment and reduce your risk of serious bleeding or clotting complications like pulmonary embolism or stroke.

In addition to knowing your INR value, taking an active interest in your condition will help you better understand the impact that diet, exercise and lifestyle can have on your blood coagulation level, allowing you to make the right choices for your health.

PHOTO À VENIR

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS 3

Oral Anticoagulants

There are over 6 million people worldwide on long-term oral anticoagulant therapy. Anticoagulant medication slows down blood coagulation. There are a variety of anticoagulants on the market, the best known is warfarin. In Canada, warfarin is sold under the brand name of Coumadin® and generic names Apo-Warfarin®, Taro-warfarin®, Mylan-warfarin®, and Novo-warfarin®.

Warfarin counteracts the activity of vitamin K which is essential for blood coagulation or clotting. Warfarin therapy is the most widely-used method of treatment for the prevention of strokes in people with conditions such as stroke, atrial fibrillation, mechanical heart valves, pulmonary embolism, venous or deep vein thrombosis (DVT) and coagulation diseases.

Warfarin has been an approved anticoagulant medication for over 60 years, so its actions on the human body are well understood and doctors are very familiar with its effects, antidote and safety profile.

Like any other medication, the efficacy of warfarin may be affected by other substances, so care must be taken to ensure that it is maintaining its desired level of anticoagulation. In order to ensure that your warfarin is working well, you should be careful with drug interactions, your diet, lifestyle and the amount of alcohol that you consume. Travel, stress, and health conditions such as fever, diarrhea, cancer and other diseases may also influence your anticoagulation.

About INR

The International Normalized Ratio (INR) was developed by the United Nations and is a measure of the time it takes for your blood to clot.

A person who does not take any oral anticoagulants (warfarin) has an INR value of 1.

• The lower your INR, the more quickly your blood will clot (“thick”)

• The higher your INR, the longer it takes for your blood to clot (“thin”)

You were given an INR therapeutic range or window by your doctor according to the condition for which you are taking anticoagulants. This therapeutic range is where you will be at the lowest risk for a complication. You should know your personal INR therapeutic range and your most recent INR test values.

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS4

About TTRYour overall TTR (Time in the Therapeutic Range) is the total percentage of time that your INR values are within the INR therapeutic range. The higher your TTR, the more time you spend in your therapeutic range. This is what your physician has prescribed for you.

There are two ways to calculate your TTR:

It is a good idea to keep track of your INR results in the CoaguChek Data Log booklet or in a software application so that you can monitor and improve your TTR. Keeping track of your INR values will help you better manage your blood coagulation levels, improving your safety and your quality of life.

What is a good TTR? You should aim to have a TTR of at least 65%, and the higher the better.

In the example below, the INR therapeutic window is between 2.0 to 3.0 and the TTR is calculated using the Traditional (fraction) method.

15 tests in therapeutic range22 tests in total

Number of tests in range Number of days in rangeX 100 = TTR % X 100 = TTR %Total number of tests Total number of days

X 100 = TTR of 68%

INR

valu

es

* Schmitt L, Speckman J, Ansell J. Quality Assessment of Anticoagulation Dose Management: Comparative Evaluation of Measures of Time-in-Therapeutic Range. J Thromb Thrombolysis. 2003 Jun;15(3):213-6.

Traditional (fraction) method* Rosendaal method*

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS 5

Eating and Exercise

Maintain a steady, healthy and balanced diet.

Remember that vegetables (all kinds) and fruit belong in a well-balanced diet. Fasting or dieting may increase the effects of anticoagulants and is therefore not advised.

Avoid sudden changes in your diet of green leafy vegetables high in Vitamin K.

As warfarin is a vitamin K antagonist, food high in vitamin K will affect your anticoagulation. The following foods are amongst those high in Vitamin K and should be eaten in regular amounts (avoid eating a lot one day and nothing the next):• Liver, pistachios, lentils, green tea, cabbage, green onions, broccoli, rapini, Brussels sprouts and green leafy vegetables such as spinach, parsley and lettuce.

Natural products and dietary supplements

Natural products and dietary supplements may also influence your anticoagulation and should be taken with care. Examples are herbal teas, vitamins, homeopathic/traditional medicines and nutritional supplements. We recommend that you always discuss changes with a doctor or other health care professional before starting or stopping these.

Alcohol

Excessive or chronic alcohol consumption will impact your anticoagulation. Patients undergoing warfarin therapy should avoid drinking alcohol on a daily basis. Limit yourself to no more than 1 to 2 servings of alcohol occasionally. One alcohol serving is equivalent to:

• 150 ml (5 ounces) of wine (alcohol content of 12%)*• 350 ml (12 ounces) of beer/cider (alcohol content of 5%)*• 50 ml (1.5 ounces) of spirits (alcohol content of 40%)*

Regular exercise has a positive effect on your heart, body and mind.

The general recommendation for exercise for the anticoagulated patient is to keep your activity levels consistent so that you can better maintain your therapeutic INR range. But before you start an exercise regime or activity you should ask your doctor for advice to determine how much exertion will be suitable for you.

* A standard drink. Heretohelp 2014. BC Partners for Mental Health and Addictions Information. www.heretohelp.bc.ca

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS6

Patient Self-TestingThousands of people around the world have been benefitting from self-testing with the CoaguChek System since 1993.

With the CoaguChek XS System, you can measure your INR coagulation time rapidly in the comfort of your home or elsewhere. You will no longer need to have regular venous blood draws nor suffer the long waiting times at an anticoagulation clinic.

Most importantly, INR self-testing allows you to respond right away to any changes so you can remain within your therapeutic window over longer periods of time, thereby reducing your risk for complications.

INR self-testing:

• Enables you to be more involved in your treatment, providing you with confidence and comfort in knowing that you are in control of your anticoagulation therapy.• Allows you to test more frequently, which can help you improve your time in the therapeutic range (TTR), and potentially reduce the risk of complications.• Makes it much easier to tailor your warfarin to your lifestyle.• Gives you the freedom to enjoy a more independent life – at home, at work, or when traveling – with the flexibility to test anytime and anywhere.

As a self-tester, you can contact your healthcare professional with the INR result for advice on the next dosage, or if your doctor has permitted you to do so, adjust the dosage yourself using the dosage instructions tailored to you (called Patient Self-Management).

IMPO

RTA

NT If you believe that you are a good candidate for INR self-testing,

you should discuss this option with your physician. Using the CoaguChek XS System requires a moderate to high level of comfort with computer technology as well as a prescription from your physician.

Once you have a prescription from your physician, we highly recommend that you consult a CoaguChek Expert healthcare professional who can provide you with personalised services related to INR testing and the use and care of your CoaguChek XS System. See www.coaguchek.ca for a list of CoaguChek Experts.

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS 7

About CoaguChek®

The CoaguChek System is the leading point-of-care INR testing meter, also known as a coagulometer. It is trusted by hospitals, medical clinics and patients the world over.

The CoaguChek XS kitThe CoaguChek XS kit is designed for patient self-testing and contains the CoaguChek® XS monitor along with accessories to help you get started.

The CoaguChek XS kit contains• 1 CoaguChek XS monitor• 1 carry case (black)• 4 (AAA) batteries (1.5v)• 1 CoaguChek Softclix lancing device• 20 CoaguChek Softclix lancets• 1 Warranty card• 1 Data Log booklet• 1 User’s Manual

CoaguChek Products Roche Product for self-testing Number UPC

CoaguChek XS kit 04870026001 0 64562 21237 0CoaguChek XS PT Test strips (6) 04625374190 0 64562 31257 5CoaguChek XS PT Test strips (24) 04625358019 0 64562 31258 2CoaguChek XS PT Test strips (2x24) 04625315019 0 64562 31259 9CoaguChek Softclix lancets (50) 03506509001 0 64562 21323 0

CoaguChek reimbursement

Except for Quebec, there is limited provincial healthcare coverage for PT/INR Patient Self-Testing; however this may change in the near future. Please refer to www.coaguchek.ca for timely updates on CoaguChek reimbursement and coverage.

Some private medical insurance plans may offer coverage for PT/INR testing meters and test strips, depending on the plan. Please consult with your insurance carrier for further details.

There is no provincial, federal or harmonized sales tax on the purchase of the CoaguChek XS kit or test strips.

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS8

Getting Started Please read the entire User’s Manual and set-up the monitor as per the sections Starting Up, Code Chip and Monitor Setup.

1. Insert the batteries.2. Insert the calibration code chip found inside the test strip box.3. Configure the date, time and unit of measure (INR).4. Enter your own INR therapeutic window into the monitor.

IMPORTANT• Keep your test strips in its original closed container. Close the container immediately after removing a test strip from the container.

• Always leave the calibration code chip inserted in the monitor. There is only one calibration code chip in each box of test strips and it cannot be replaced. Change the calibration code chip only when you open a new box of strips. Do not use the code chip from a different package.

Relax...With practice, you will have plenty of time to run a test so there is no need to feel rushed.

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS 9

PreparationSet-up• Have your material ready: CoaguChek monitor, test strips, Softclix pen and log book.

Clean and warm hands• Wash your hands with warm water and soap. Avoid using antiseptic alcohol as it may interfere with the test result.• The puncture site should be warm. If necessary, use a source of dry heat to warm the site (do not soak your hands in hot water).• Massage your arm and fingers starting from the upper arm to the fingertip.• Let your hand hang down so that blood pools towards your fingers due to gravity.

How to prick your finger• Prick the side angle (corner) of the fingertip to obtain a drop of blood with the CoaguChek Softclix pen.• Wait 1-2 seconds for a drop of blood to form. • Suspend the drop from your finger and apply to the transparent area of test strip within 15 seconds of making the puncture. It can be applied to the top or sides of the transparent area.

Practice makes perfectYou can practice applying blood to a test strip by dipping your finger into a glass of lukewarm water, suspending it on your finger for a moment, and then applying the drop to a strip of paper within 15 seconds.

TIPSThe CoaguChek System only requires one nice drop of blood to runan INR test. • Use the first drop of blood.• After you apply a drop of blood to the test strip, do not try to add more blood.• If you need to repeat the test, use a new finger. For best results, avoid using the little finger, the thumb and remove finger rings.

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS10

Performing a Test1. Wash your hands with soap and water.

2. Put a CoaguChek XS test strip in the monitor and close the vial. The code number of the code chip inserted in the monitor flashes in the display. Check that this number is identical with the code number printed on the label of the test strip vial, and confirm by pressing the M button.

3. Prepare your finger and lancing device. Wait for the blood drop symbol to flash on the monitor, indicating that the monitor is ready to test. You have a 180-second countdown to place a drop of blood on the strip.

First, prepare your finger and lancing device. Gently massage your arm and hand to bring more blood to your finger tip so that it turns slightly red.

4. Prick the side angle of your finger tip.Let a drop of blood form, and place the blood on the strip area within 15 seconds of pricking your finger, apply the blood directly from the finger to the center (or side) of the transparent sample application area of the test strip.

The monitor will display a QC icon with a tick indicating that the monitor and test strip have passed the quality control step.

5. Read the result on the CoaguChek display.After 1 minute, results will be displayed in the unit selected: INR, Seconds, or % Quick Value.

Your CoaguChek XS monitor can retain up to 100 results. It is also recommended that you record your results in a log book or software application for tracking your overall time in the therapeutic range (TTR).

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS 11

Error messages

Depending on the circumstances an error message may appear on the display of your meter. Your first step on receiving an error message should be to try the solution suggested for that error. If the problem persists, please contact the Coagulation Info-Line at 1-877-426-2482.

A complete list of display messages and symbols is provided in your CoaguChek User’s Manual.

Cleaning and CarePlease follow the procedures in the User’s Manual to clean and disinfect your CoaguChek monitor.

• Make sure the monitor is turned off.• Clean the monitor only when contaminated with blood.• Do not use sprays of any sort.• Ensure that the cloth or cotton swab is only damp, not wet, to protect against moisture entering the meter.• Never immerse your CoaguChek meter in water or liquid.• Store your monitor and strips in a secure, dry place between 2-30˚C (36-86˚F).• Change the calibration code chip and the batteries only when the monitor is turned OFF.• You have one (1) minute to change the batteries without losing the configuration parameters.

IMPORTANTConsult your healthcare professional if your results are outside your target INR range or the dosing instructions given to you.

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS12

Roche QualityThe CoaguChek XS System is Health Canada approved and its quality and precision of the CoaguChek monitors has been confirmed in multiple peer-reviewed clinical studies. You will take comfort in knowing that CoaguChek XS System comes complete with On-Board-Integrated- System Controls (OBIS), and multiple built-in safety features to ensure accurate INR readings.

The CoaguChek XS monitor is guaranteed for 2 years against manufacturing defects. Please complete your Warranty Card online at www.coaguchek.ca or send the warranty card in the envelope that is included with your CoaguChek monitor to Roche Diagnostics Canada within 30 days of purchase to validate the guarantee.

Quality AssuredThe CoaguChek XS System has a number of inbuilt quality-control functions that check the test strip, electronic and system controls with every use.

Your healthcare professional may also ask that you follow a quality assurance program to ensure the proper use and safety of your CoaguChek meter.

If you are not participating in a quality assurance program, we recommend that you run a correlation test for your CoaguChek meter against a laboratory INR test when you first obtain your CoaguChek meter and every year afterwards. It is important that the two tests be done within a few minutes of one another and the results should be close within 0.5-1.0 INR units (if your CoaguChek INR value is between 2.5-4.5). It is best to consistently use your CoaguChek INR results so long as your CoaguChek meter is in good operating condition and checked annually.

If you have any doubts or concerns about the CoaguChek System or how to run a correlation test, please contact the Coagulation Info-Line at 1-877-426-2482.

IMPORTANT

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS 13

Traveling

It is important to maintain your INR level within your therapeutic range at all times, including while traveling or on vacation.

Keeping your diet and lifestyle consistent while traveling can be quite challenging. People on oral anticoagulants need to take care to keep their consumption of foods with vitamin K as close to what they are used to as possible; the same goes for alcohol. A change in climate and temperature can also be a strain on your blood circulation, and may impact your coagulation.

INR self-monitoring allows you to respond right away to any changes. You can then either contact your doctor with the result for advice on the correct dosage, or if your doctor has trained you to do so, change the dosage yourself if appropriate.

For international travel, we recommend that you prepare for customs by having your CoaguChek receipt on hand, as some customs officials may ask to see it. If you no longer have your receipt, contact the Coagulation Info-Line to request a letter confirming the purchase of your CoaguChek monitor in Canada.

Be sure to take your CoaguChek monitor on board with you on the plane. The CoaguChek monitor can be x-rayed at the airport: this won’t damage it in any way. In addition, taking your medication and CoaguChek XS System in your carry-on luggage on board the aircraft would reduce your stress should your checked baggage be lost.

Once you arrive at your destination, you can store your CoaguChek monitor and strips in their vial at room temperature (between 2-30˚C or 36-86˚F). Avoid placing the items in direct sunlight next to a window or exposing them to humidity greater than 85%.

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS14

Test your Knowledge

1. What are anticoagulants used for? [1 point]

a. To increase heart rate. c. To open blocked arteries. b. To slow coagulation of the blood. d. To thicken the blood.

2. Which oral anticoagulation medication that you are taking? [1 point]

a. Aspirin c. Warfarin (Coumadin) b. Nicoumalone (Sintrom) d. None of these

3. What blood test do you need to take in order to know whether your warfarin (vitamin K antagonist) anticoagulant is working appropriately? [1 point]

a. BLT c. INC b. PHD d. INR

4. How often should you be testing with your CoaguChek monitor? [1 point]

a. Once a week c. Twice a month b. Once a month d. Once every 6 weeks

5. What is your therapeutic range? [1 point]

a. 1.0 – 2.0 c. 2.5 – 3.5 b. 2.0 – 3.0 d. 3.0 – 4.0

6. What is the risk when your result is below your therapeutic range? [1 point] a. Risk of bleeding b. Risk of clotting

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS 15

TIPSTotal Score = /12 points. Answers are located on the Help and Support page.

7. True or false, your test strips may be stored at room temperature 2-30˚C or 36-86˚F. [1 point] a. True b. False

8. True or false, you may use your test strips after its expiry date. [1 point] a. True b. False

9. Once you prick your finger, how much time do you have to place the drop of blood on the test strip? [1 point]

a. 180 seconds (3 minutes) c. 15 seconds b. 1 minute d. No time limit

10. What is the risk when your result is above your therapeutic range? [1 point]

a. Risk of bleeding b. Risk of clotting

11. How often should you run a quality control (correlation) test for your CoaguChek monitor against a laboratory test? [1 point]

a. As per the protocol of your physician or anticoagulation clinic. b. At the time of your CoaguChek purchase and every year afterwards. c. If you are concerned or in-doubt about your CoaguChek results. d. Upon request by a healthcare professional or a Coagulation Info-Line agent. e. All of the above.

12. What resources are available to you if you need help with your CoaguChek monitor? [1 point]

a. A CoaguChek Expert Healthcare Professional b. Telephone hotline: Coagulation Info-Line c. CoaguChek Canada website and online tools: www.coaguchek.ca d. All of the above

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS16

Help and Support

Some CoaguChek help and resources available to you:

• CoaguChek Canada Website: www.coaguchek.ca User training: CoaguChek Handling Video and Quick Start Guide. Patient education on anticoagulation. Frequently Asked Questions and answers. Find a CoaguChek Expert: Google map and search by postal code. CoaguChek Product Information Warranty Card The latest information and tools for CoaguChek users

• CoaguChek Handling Video on DVD

• CoaguChek Data Log booklet

• CoaguChek User’s Manual

• CoaguChek XS PT Test package insert

• Network of CoaguChek Expert Healthcare Professionals In-person training and consultation for patients at pharmacies and clinics across Canada.

• The Coagulation Info-Line (8am-5pm, Monday to Friday) Telephone support agents with anticoagulation training and in-depth knowledge of the CoaguChek XS system.

Test Your Knowledge Answers: 1=b, 2=Ask your physician, 3=d, 4=Ask your physician, 5=Ask your physician. 6=b, 7=a, 8=b, 9=c, 10=a, 11=e, 12=d.

CoaguChek Info-Line

1-877-426-2482

PATIENT SELF-LEARNING MANUAL - COAGUCHEK XS18

COAGUCHEK, SOFTCLIXand BECAUSE IT’S MY LIFEare trademarks of Roche.

©2014 Roche Diagnostics

0487

5974

001