AVIVA ACCU-CHEK Owner'S Booklet Download Page 43 | Manualshive

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Chapter 3: Testing Your Blood Sugar

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Symptoms of High or Low Blood Sugar

Being aware of the symptoms of high or low blood sugar can help you understand your test results and decide
what to do if they seem unusual. Here are the most common symptoms:

High blood sugar (hyperglycemia): fatigue, increased appetite or thirst, frequent urination, blurred vision,
headache, general aching, or vomiting.

Low blood sugar (hypoglycemia): sweating, trembling, blurred vision, rapid heartbeat, tingling, or numbness
around mouth or fingertips.

If you are experiencing any of these symptoms, test your blood sugar. If your blood sugar result is
displayed as LO or HI and you have symptoms of low or high blood sugar, contact your doctor
immediately. If your blood sugar result does not match how you feel, follow the steps under “Unusual
Test Results.”

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Summary of Contents for ACCU-CHEK

Page 1: ...BLOOD GLUCOSE METER Owner s Booklet ACCU CU CHEK HEK Aviva ...

Page 2: ......

Page 3: ... booklet will help you get the most from your ACCU CHEK Aviva system To start testing quickly you can also refer to the First Time Guide If you have questions we re here to help Just call the ACCU CHEK Customer Care Service Center toll free at 1 800 858 8072 We offer assistance 24 hours a day 365 days a year in Spanish and many other languages You can also visit www accu chek com for diabetes mana...

Page 4: ...cet drum may be sold separately Why Regular Blood Sugar Testing Is Important Testing your blood sugar regularly can make a big difference in how you manage your diabetes every day We ve made it as simple as possible Your meter is easy to use plus you can adjust the lancet device for your comfort Need Help If you have questions we re here to help Just call the ACCU CHEK Customer Care Service Center...

Page 5: ...ps Other test strips will give inaccurate results Health Related Information If you are very dehydrated or urinating frequently you may get a test result that is lower than what your blood sugar really is If you think you are dehydrated call your doctor right away If you have followed the steps in the booklet but still have symptoms that don t seem to match your test results or if you have questio...

Page 6: ...ults 18 Chapter 3 Testing Your Blood Sugar 20 Using the ACCU CHEK Multiclix Lancet Device 20 Inserting a Lancet Drum 21 Preparing the Lancet Device for Fingertip Testing 23 Running a Blood Sugar Test with Blood from Your Fingertip 25 Changing the Lancet Drum 28 Running a Blood Sugar Test with Blood from Your Palm Forearm Upper Arm Thigh or Calf 30 Flagging Test Results 39 Understanding Your Test R...

Page 7: ...ubleshooting 59 Changing the Battery 59 Cleaning Your Meter 60 Maintenance and Testing 61 Cleaning Your Lancet Device 61 Screen Messages and Troubleshooting 62 Chapter 6 Technical Information 66 Product Limitations 66 Specifications 66 Product Safety Information 67 Warranty Money back Offer 68 Limited License 70 Additional Supplies 72 Information for Healthcare Professionals 73 References 74 Index...

Page 8: ...roll through results Test Strip Slot Insert test strip here Infrared IR Window Used to transfer data from the meter to a computer See Chapter 4 On Off Set Button Turns the meter on or off and sets options Battery Door Flip open the battery door by pushing the tab in the direction of the arrow Code Key Slot Insert code key into this opening 6 Code Key for example Battery Insert with symbol facing u...

Page 9: ...trol solution here Comfort Dial with Depth Selection Cap Lancet Device Release Button Plunger Lancet Drum Clear Cap for obtaining blood from places other than your fingertip Test Strip Golden End Insert this end of the test strip into the meter Control Solution Bottle some items may be sold separately Lancet Counter Depth Indicator ...

Page 10: ...Meter A new code key is inside each new box of test strips 1 Make sure your meter is turned off 2 Turn the meter over 3 Remove the old code key if there is one in the meter and throw it away Change the code key every time you open a new box of test strips ...

Page 11: ...way If you see a code turn the meter off and reinsert a code key in the meter 4 Turn the code key over so the code number faces away from you Push it into the meter until it stops 5 Leave the code key in the meter until you open a new box of test strips Remember to change the code key each time you open a new box of test strips ...

Page 12: ... and release or to decrease or increase the hour Press and hold or to scroll faster 3 Press and release to set the hour The minutes flash Adjusting the Time and Date First Time Use Your new meter comes with a preset time and date You may need to change the time to your time zone Having the right time and date in your meter is important if you use the meter memory or if you want to download your re...

Page 13: ... one you are changing 5 Once you set the year press and hold until the flashing test strip appears 6 See Chapter 4 Meter Setup to set other options Note When you install a new battery the meter automatically prompts you to check the time and date when you turn it on If it is correct press and hold to exit the set mode decrease increase ...

Page 14: ...p the test strips dry Use the test strip within three minutes after you take it out of the container Be sure to check the Use by date on the test strip container Do not use the test strips after that date Store the test strip container and your meter in a cool dry place such as a bedroom Store the test strips at 36 to 90ºF Do not freeze Do not apply blood or control solution to the test strip befo...

Page 15: ...esn t agree with how you feel You want to check if you are testing correctly About the Control Solutions Only use ACCU CHEK Aviva control solutions Your meter automatically recognizes the difference between a control solution and blood Write the date you opened the bottle on the bottle label The control solution is good for three months from that date or until the Use by date on the bottle label w...

Page 16: ...st strip into the meter in the direction of the arrow The meter turns on Note Most people just test the Level 1 control If you wish you can also test a Level 2 control A set of Level 1 and Level 2 control solutions is available for purchase Your meter automatically recognizes the difference between a control solution and blood The control solution results are not displayed in memory ...

Page 17: ...ontainer If you miss seeing the code number take the test strip out and reinsert it into the meter 3 Select the control solution you want to test You will enter the level later in the test 4 Place the meter on a flat surface like a table 5 Remove the control bottle cap and wipe the tip of the bottle with a tissue OR ...

Page 18: ...o not put control solution on top of the test strip When you see flash you have enough control solution in the test strip Wipe the tip of the bottle with a tissue then cap the bottle tightly 7 A result appears on the display along with a control bottle symbol and a flashing L Don t remove the test strip yet Press once to mark it as a Level 1 If you tested the Level 2 control press a second time ...

Page 19: ...l result and OK alternate on the display if the result is in range The range is printed on the test strip container label The control result and Err alternate on the display if the result is out of range Remove the test strip and throw it away in range example out of range example ...

Page 20: ...evel 2 control solutions The result you get should be inside this range Make sure you compare the result to the correct level of control When the control result is inside the range on the test strip container your test strips and your meter are working properly Range mg dL Level 1 25 55 Level 2 255 345 This is an example Refer to the ranges on your test strip container ...

Page 21: ...e still unsure of the problem Action If either is past the Use by date throw it away If the control solution was opened more than three months ago throw it away Wipe the tip of the bottle with a tissue Repeat the control test with a new test strip and a fresh drop of control solution If you think either may have been uncapped for some time replace the test strips or control solution Repeat the con...

Page 22: ...the one that s right for you For virtually pain free testing always use a new lancet for every test With the ACCU CHEK Multiclix lancet device you simply change the lancet with a twist To reduce the risk of infection never share your lancet device with anyone The clear cap is for testing other sites on the body not the fingertip The blue cap is for fingerstick testing only A new drum has a blue ri...

Page 23: ...ready for use 1 Remove the cap by pulling it straight off It is not a twist cap The easiest way to do this is to place your thumb to the side of the notch as seen in the illustration 2 Before you insert a drum be sure that the release button is not yellow Insert a new drum blue ring first until it stops It clicks into place ...

Page 24: ...n until it stops by aligning the notch on the cap with the notch on the device 4 You are now ready to use the first lancet The lancet counter on the plunger shows five white bars meaning you have five new lancets remaining Inserting a Lancet Drum continued ...

Page 25: ...y pain free test 1 Make sure the blue cap is on the lancet device Do not use the clear cap to do a fingerstick test 2 Adjust the depth by turning the Comfort Dial The depth indicator shows the current depth selection The higher the number the deeper the penetration If you have soft skin start at a depth of 2 If your skin is calloused or thick try a higher setting ...

Page 26: ...e plunger in as far as it will go like a pen 4 The release button turns yellow Do not press the release button while pressing the plunger Set the lancet device aside until later in the test Preparing the Lancet Device for Fingertip Testing continued ...

Page 27: ...d test 1 Wash your hands with warm soapy water and dry 2 Put a test strip into the meter in the direction of the arrow The meter turns on 3 Make sure the code number on the display matches the code on the test strip container If you miss seeing the code number remove the test strip and reinsert it into the meter 4 When the blood drop flashes obtain a drop of blood from your fingertip To test from ...

Page 28: ...ze your finger to assist the flow of blood This helps you get a blood drop Touch the drop to the tip of the yellow window of the test strip Do not put blood on top of the test strip 7 When you see flash you have enough blood in the test strip If you applied blood but do not see the flashing you may reapply more blood within five seconds Running a Blood Sugar Test with Blood from Your Fingertip con...

Page 29: ...sting we recommend that you advance to a new sterile lancet after each test To load the next lancet twist the plunger one quarter turn forward until it stops then twist it back all the way 10 The lancet counter decreases by one white bar For safety reasons once you advance to a new lancet you cannot go back to a used lancet Note Do not twist the plunger when the release button is yellow or when th...

Page 30: ...off the lancet device by pulling it straight off It is not a twist cap The easiest way to do this is to place your thumb to the side of the notch as seen in the illustration 2 Hold the drum between your thumb and index finger and pull it straight out of the lancet device Two red stripes are visible on the white part indicating that the drum has been used ...

Page 31: ... a used drum is dropped on a hard surface the lancets may protrude slightly from the drum If you drop a drum always pick it up at the red striped end 3 Throw the old drum away 4 Before you insert a drum be sure that the release button is not yellow Insert a new drum blue ring first until it stops It clicks into place OR ...

Page 32: ...fingertip testing You have the option of testing other places on your body besides the fingertip You can test the palm forearm upper arm thigh or calf While fingertip blood can be tested at any time during the day there are times when testing from another site is not ideal usually when your blood sugar is rapidly changing Please read the following section before you try testing from other places ...

Page 33: ... is low If you often don t notice when your blood sugar is low When basal insulin is most active After injecting rapid acting insulin two hours or less Do not change your treatment because of just one result NEVER ignore symptoms of high or low blood sugar If your blood sugar doesn t match how you feel do a fingertip test to confirm your result If the fingertip result still doesn t match how you f...

Page 34: ... in your kit 1 Remove the blue cap from the lancet device by pulling it straight off It is not a twist cap The easiest way to do this is to place your thumb to the side of the notch as seen in the illustration 2 Put the clear cap on by lining up the notched sections on the cap and the lancet device Chapter 3 Testing Your Blood Sugar 32 ...

Page 35: ... 4 Press the plunger in as far as it will go like a pen The release button turns yellow Set the lancet device aside until later in the test 5 Put a test strip into the meter in the direction of the arrow The meter turns on Note Once you run a successful test you may want to find the lowest depth setting that provides enough blood with the least amount of pain ...

Page 36: ...ting Your Blood Sugar 34 6 Make sure the code number on the display matches the code number on the test strip container If you miss seeing the code number remove the test strip and reinsert it into the meter 7 When the blood drop flashes obtain a drop from the site ...

Page 37: ...he flow of blood Remember that the opening where the lancet comes out is not in the center of the cap 9 Keep steady pressure on the area and press the yellow release button Don t be afraid to apply pressure to the area with the lancet device to assist the flow of blood Continue to press the cap against the site for a few seconds to allow blood to come to the surface TIP Rub the skin prior to lanci...

Page 38: ...low window of the test strip Do not put blood on top of the test strip 11 When you see flash you have enough blood in the test strip If you applied blood but do not see the flashing you may reapply more blood within five seconds Running a Blood Sugar Test non fingertip continued ...

Page 39: ...l event leave the test strip in the meter See Flagging Test Results Otherwise throw the used test strip away 13 For virtually pain free testing we recommend that you advance to a new sterile lancet after each test To load the next lancet twist the plunger one quarter turn forward until it stops then twist it back all the way ...

Page 40: ...other than your fingertip please contact our ACCU CHEK Customer Care Service Center at 1 800 858 8072 for assistance We will guide you through the testing procedure step by step If you continue to have difficulty we can also offer you free of charge our ACCU CHEK Softclix lancet device Because the ACCU CHEK Softclix lancet has a thicker diameter needle than the ACCU CHEK Multiclix lancet you may h...

Page 41: ...isk to mark a special result When you review your results in memory this flag can help you remember what was different about the result Here is how to flag a result 1 Run a test 2 With the test result on the display and the test strip STILL IN THE METER press or once The appears just below the date 3 Remove and throw the test strip away Chapter 3 Testing Your Blood Sugar 39 flag ...

Page 42: ...er meals the blood glucose range for an adult without diabetes is less than 140 mg dL 2 For people with diabetes please consult your doctor for the blood glucose range appropriate for you Unusual Test Results If your blood sugar result doesn t match the way you feel follow these steps 1 Run a control test Chapter 2 Control Testing 2 Repeat a blood sugar test Chapter 3 Testing Your Blood Sugar with...

Page 43: ... or thirst frequent urination blurred vision headache general aching or vomiting Low blood sugar hypoglycemia sweating trembling blurred vision rapid heartbeat tingling or numbness around mouth or fingertips If you are experiencing any of these symptoms test your blood sugar If your blood sugar result is displayed as LO or HI and you have symptoms of low or high blood sugar contact your doctor imm...

Page 44: ... If you want to compare your meter result to the lab result you must be fasting Take your meter to the doctor s office and test yourself by fingerstick within five minutes of having blood drawn from your arm by a healthcare professional Keep in mind that the lab uses different technology than the meter and that blood glucose meters for self testing generally read somewhat lower than the lab result...

Page 45: ...esult causes the oldest one to be deleted Hold or down to scroll through the results faster The control results are not displayed in memory They are not included in the 7 14 and 30 day averages Chapter 4 Meter Memory Setup and Downloading Memory Storing Test Results Your meter automatically stores up to 500 test results with the time and date of the test You can review them at any time Test result...

Page 46: ...sult Most recent result Viewing Test Results 1 Press either or to enter memory Your most recent result appears 2 Press to view previous results in order 3 OR press to look at your 7 14 or 30 day averages in that order You see an n with a number in the upper left corner of the display This tells you how many test results are included in that average ...

Page 47: ...tyle Here are the features you can customize Time and Date set the time and date Beeper select on or off Test reminders select 1 4 times a day for a reminder to test Hypoglycemic Hypo indicator select on or off If you choose on choose the level of the indicator Throughout this section the purple progress bar helps guide you through the setup process ...

Page 48: ... off on level You are here 1 Press to turn the meter on The flashing test strip symbol appears 2 To enter the set mode press and hold for about four seconds Set flashes on the display The hour flashes 3 Press and release or to increase or decrease the hour Press and hold or to scroll faster 4 Press and release to set the hour The minutes flash decrease increase ...

Page 49: ... the minutes am pm day month and year The flashing field is the one you are changing 6 If you want to set up more options press and release If you want to exit press and hold until the flashing test strip appears Note You can press and hold or to scroll faster decrease increase ...

Page 50: ...lution to the test strip When enough blood or control solution is drawn into the test strip When the test is complete When a button is pressed When it is time to test if you set test reminders If an error occurred while testing even if the beeper is set to OFF it still beeps for an error 1 Press to turn the meter on The flashing test strip symbol appears TIME DATE hrs min am pm month day year BEEP...

Page 51: ... four seconds Set flashes on the display 3 Press and release repeatedly until you reach the display with the flashing beeper symbol and On 4 Press or to select On or OFF 5 If you want to set up more options press and release If you want to exit press and hold until the flashing test strip appears ...

Page 52: ... on to use this feature If you turn A 1 A 2 A 3 and A 4 on your meter is preset with the following times for your convenience You can adjust the times to suit your needs A 1 8 00 am A 3 6 00 pm A 2 12 00 pm noon A 4 10 00 pm Notes If you tested within 30 minutes of a test reminder the reminder does not occur If the meter is on at the test reminder time the reminder does not occur When the meter be...

Page 53: ...To enter the set mode press and hold for about four seconds Set flashes on the display 3 Press and release repeatedly until you reach the display with the beeper symbol OFF and the flashing set and A 1 When you are setting the time for test reminders the beeper symbol remains on the display and set flashes continuously ...

Page 54: ...lease or to select On or OFF Press and release to set your choice 5 If you select On the hour flashes A 1 remains on the display 6 Press and release or to select the hour Press and release to set the hour 7 The minutes flash Press and release or to select 00 15 30 or 45 These are the only choices ...

Page 55: ... on the display 9 Press or to switch between am and pm Press and release to set am or pm 10 The next test reminder A 2 and set flash on the display with OFF and the beeper symbol You can set additional test reminders or press and hold until you see the flashing test strip symbol to exit the set mode ...

Page 56: ...also select what blood sugar level you want this indicator to have 60 to 80 mg dL Before you set the indicator talk to your doctor to help you decide what blood sugar level is your hypo level Your meter is preset to OFF for the hypo indicator If you want to turn it On follow these steps TIME DATE hrs min am pm month day year BEEPER on off TEST REMINDERS A 1 A 2 A 3 A 4 HYPO off on level You are he...

Page 57: ...Press to turn the meter on The flashing test strip symbol appears 2 To enter the set mode press and hold for about four seconds Set flashes on the display 3 Press and release repeatedly until you reach the display with OFF and the flashing set and hypo ...

Page 58: ...ator On set and hypo flash The display shows 70 mg dL 6 Press and release or to select the level between 60 to 80 mg dL Press and release to set it 7 Press and hold until you see the flashing test strip symbol to exit the set mode This function is no substitute for hypoglycemia training by your doctor or diabetes team Setting the Hypoglycemic Hypo Indicator continued ...

Page 59: ... 800 858 8072 You can transfer your stored results to a computer to track identify patterns and print Transferring Data 1 Install the software according to the instructions 2 Run the software program and follow the instructions about how to download information Make sure the software is ready to accept data from the meter 3 Locate the infrared IR window on the top of the meter 4 Locate the IR wind...

Page 60: ... is transferring The two arrows continue flashing until the data transfer is complete 7 Follow the prompts on your computer screen 8 The software program may shut off your meter automatically when the data transfer is complete Notes If the data did not transfer successfully try again If you still have problems call the ACCU CHEK Customer Care Service Center at 1 800 858 8072 To make the most of th...

Page 61: ... up It doesn t snap into place but rests on the metal contact The door holds the battery down 3 Put the battery door back in place and snap it closed Notes The meter uses one 3 volt lithium battery type CR 2032 This type of battery can be found in many stores Always keep a spare battery on hand Be sure the battery goes in side up or facing you After you change the battery your meter prompts you to...

Page 62: ...ure the meter is turned off Gently wipe the meter s surface with a soft cloth slightly dampened with one of these cleaning solutions 70 rubbing alcohol Mild dishwashing liquid mixed with water 10 household bleach solution 1 part bleach plus 9 parts water made the same day Do Not Get any moisture in the code key slot or test strip slot Spray any cleaning solution directly onto the meter Put the met...

Page 63: ...n a control test To make sure the display is working properly turn off the meter then press and hold to see the complete display All the segments should be clear and look exactly like the picture to the left If not call the ACCU CHEK Customer Care Service Center at 1 800 858 8072 Cleaning Your Lancet Device To clean the ACCU CHEK Multiclix lancet device use a mild dishwashing liquid and a soft clo...

Page 64: ...858 8072 The meter won t turn on or the display is blank Battery is dead Insert new battery Display is damaged Call the ACCU CHEK Customer Care Service Center at 1 800 858 8072 Extreme temperatures Move the meter to room temperature The meter is in set mode waiting for you to change or confirm settings See Chapter 4 Meter Setup Battery power is low Change the battery soon See Chapter 5 Changing th...

Page 65: ...r than the measuring range of the system See Chapter 3 Understanding Your Test Results Result may be lower than the measuring range of the system See Chapter 3 Understanding Your Test Results This test result was flagged See Chapter 3 Flagging Test Results for more details Result is below the defined hypo low blood sugar level See Chapter 3 Understanding Your Test Results ...

Page 66: ...ificially heat or cool the meter Battery is almost out of power Change the battery now See Chapter 5 Changing the Battery Your blood sugar may be extremely low or the test strip may be damaged or not properly inserted If you see this error message after you applied blood to the test strip see Chapter 3 Unusual Test Results If you see this error message before you applied blood to the test strip re...

Page 67: ...s drawn into the test strip for measurement or sample was applied after the test has started Discard the test strip and repeat the test An error occurred during the test Discard the test strip and repeat the test See Chapter 1 Understanding Your New System An electronic error occurred Turn the meter off and on Take the battery out for a few seconds and reinsert it If the problem persists call the ...

Page 68: ...ttery type CR 2032 Protection class III Meter type The ACCU CHEK Aviva meter is suitable for continuous operation Blood volume Refer to the test strip package insert Measuring range Refer to the test strip package insert Sample type Refer to the test strip package insert Measuring time Refer to the test strip package insert System operating conditions Refer to the test strip package insert Meter s...

Page 69: ...25 1 40 1 55 1 70 1 85 2 00 2 15 2 30 mm Product Safety Information Explanation of Symbols CAUTION Please refer to safety related notes in the manual accompanying this instrument 3 volt battery CR 2032 The ACCU CHEK Aviva meter has been listed by Underwriter s Laboratories Inc in accordance with UL 3101 and CAN CSA C22 2 No 1010 1 Store at Store at This product fulfills the requirements of Directi...

Page 70: ... including public e g Medicare Medicaid and private payers Consumers affected by this exclusion may instead request a different ACCU CHEK meter system This warranty does not apply to the performance of an ACCU CHEK Aviva meter that has been damaged by accident or has been altered misused tampered with or abused in any way Roche Diagnostics will handle meters that show damage or abuse according to ...

Page 71: ...ar product Replacement meters will be warranted for a period of 90 days from shipment under a limited warranty providing for replacement of parts and labor at no charge Warranty and Service Instructions All requests for return of ACCU CHEK Aviva meters under the above warranty or service policy must be made to ACCU CHEK Customer Care Service Center You will be mailed a return authorization label w...

Page 72: ...viva system Using the ACCU CHEK Aviva system indicates your acceptance of the restricted license to use the ACCU CHEK Aviva system only with ACCU CHEK Aviva test strips and the ACCU CHEK Aviva code keys If you do not agree to the terms and conditions of the restricted license you may return at the place of purchase the unused ACCU CHEK Aviva system for a full refund If you have any questions pleas...

Page 73: ... ACCU CHEK Multiclix device only with ACCU CHEK Multiclix lancet drums If you do not agree to the terms and conditions of the restricted license you may return at the place of purchase the unused ACCU CHEK Multiclix device for a full refund ACCU CHEK Multiclix lancet drums are high precision components that are produced to the close tolerances required for satisfactory operation with the ACCU CHEK...

Page 74: ... ct Retail test strips Cat No 04528662001 ACCU CHEK Aviva 100 ct Retail test strips Cat No 04538412001 ACCU CHEK Aviva 50 ct Health Network test strips Cat No 04528948001 ACCU CHEK Aviva 50 ct Mailorder test strips Cat No 04528654001 ACCU CHEK Aviva Starter test strips and level one control Cat No 04527364001 Control Solutions ACCU CHEK Aviva 2 level control solutions Cat No 04528638001 Lancets AC...

Page 75: ... test results The difference in capillary bed concentration and blood perfusion throughout the body can lead to sample site to site differences in glucose results These physiological effects vary between individuals and can vary within a single individual based upon his or her behavior and relative physical condition Our studies involving alternative site testing of adults with diabetes show that ...

Page 76: ...l Information 74 References 1 Stedman Thomas Lathrop Stedman s Medical Dictionary 27th Edition 1999 pg 2082 2 American Diabetes Association Clinical Practice Recommendations 2003 Diabetes Care Vol 26 Supplement 1 pg S22 ...

Page 77: ... messages 64 65 fatigue 41 frequent urination 3 41 high blood sugar 41 hyperglycemia 41 hypoglycemia 41 lancet drum 7 20 limited license 70 71 low blood sugar 41 maintenance meter 59 memory meter 43 numbness 41 patent information 70 71 product limitations 66 product specifications 66 professional caregivers 73 rapid heartbeat 41 screen messages 62 65 settings meter 45 supplies 72 sweating 41 symbo...

Page 78: ...troubleshooting 62 65 use by 12 13 warranty 68 69 Index 76 ...

Page 79: ......

Page 80: ...d 04447344002 0105 Assembled and distributed in the USA by Roche Diagnostics Indianapolis IN Roche Diagnostics 9115 Hague Road Indianapolis IN 46256 ACCU CHEK ACCU CHEK AVIVA and ACCU CHEK MULTICLIX are trademarks of a Member of the Roche Group Made in U S A ...

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