Accu-Chek Softclix Plus lancing device Owner's Booklet

Owner’s Booklet for Self-Testing Only

Blood Glucose Meter

Manual del usuario únicamente

para autocontrol

Medidor de Glucemia

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Roche USA – xxxxx

V4/1 – 07699336001 – Black

Roche USA – xxxxx

V4/2 – 07699336001 – Cyan

Roche USA – xxxxx

V4/3 – 07699336001 – Magenta

Roche USA – xxxxx

V4/4 – 07699336001 – Yellow

ONR 00008754 – 4 ALL 4774 (2015) DE 07699336001_01

US 07699336001_0515

Format 105x148A-US

Compact-Plus-MIC-US_man_Version06_Master_Rev1, 13-May-2015

Reason for revision: Namen Change Project (master change DCNC-L), revisions as comments

man_07699336001_01_EN.indb 1 08.10.2015 10:07:14

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Contents

Introduction ...............................................................................................................................................7

The ACCU-CHEK Compact Plus System ...........................................................................................................8

Need Help? ...................................................................................................................................................... 9

Important Safety Information .........................................................................................................................10

About Testing Yourself or Others ....................................................................................................................11

Before You Start Testing ................................................................................................................................. 12

Chapter 1: Understanding Your New System.........................................................................................13

The ACCU-CHEK Compact Plus System .........................................................................................................13

Using the ACCU-CHEK Compact Plus System ................................................................................................15

Meter Setup ...................................................................................................................................................17

Setting the Beeper On/OFF ............................................................................................................................18

Setting the Brightness of the Display ............................................................................................................. 20

Setting the Year, Time, and Date ....................................................................................................................21

Setting the Test Reminders ............................................................................................................................ 23

Setting the Hypoglycemic (Hypo) Indicator .....................................................................................................26

Installing the Test Drum ................................................................................................................................. 28

Test Strip Count .............................................................................................................................................32

Chapter 2: Control Testing ......................................................................................................................33

Why Perform Control Tests .............................................................................................................................33

About the Control Solutions ...........................................................................................................................34

Performing a Control Test...............................................................................................................................35

Understanding Out-of-Range Control Results .................................................................................................41

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Chapter 3: Testing Your Blood Glucose .................................................................................................. 43

Using the ACCU-CHEK Softclix Plus Lancing Device .......................................................................................43

Inserting a Lancet .......................................................................................................................................... 45

Preparing the Lancing Device for Fingertip Testing ........................................................................................47

Detaching and Attaching the Lancing Device ................................................................................................. 48

Performing a Blood Glucose Test with Blood from Your Fingertip ...................................................................49

Performing a Blood Glucose Test with Blood from Your Palm (Alternate Site Testing, or AST) ......................... 56

Flagging Test Results ..................................................................................................................................... 67

Unusual Test Results ......................................................................................................................................68

Symptoms of High or Low Blood Glucose ......................................................................................................71

Comparing Your Meter Result to a Laboratory Result .....................................................................................72

Chapter 4: Meter Memory and Transferring Results .............................................................................73

Memory ......................................................................................................................................................... 73

Viewing Test Results ...................................................................................................................................... 75

Viewing Averages, Highest and Lowest Results ............................................................................................. 76

Transferring Your Results to a Computer ........................................................................................................ 78

Chapter 5: Cleaning and Disinfecting the Meter and Lancing Device .................................................81

Cleaning and Disinfecting the Meter ..............................................................................................................83

Cleaning and Disinfecting the Lancing Device ...............................................................................................88

Chapter 6: Maintenance and Troubleshooting ......................................................................................93

Display check ................................................................................................................................................93

Changing the Batteries ..................................................................................................................................94

Display and Error Messages ..........................................................................................................................96

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Chapter 7: Technical Information ......................................................................................................... 109

Product Limitations ......................................................................................................................................109

Specications ..............................................................................................................................................109

Product Safety Information ..........................................................................................................................111

Travel Documentation .................................................................................................................................. 111

Explanation of Symbols ................................................................................................................................113

Warranty ......................................................................................................................................................114

Limited License ...........................................................................................................................................116

Additional Supplies ......................................................................................................................................118

Index .......................................................................................................................................................119

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Dear ACCU‑CHEK System Owner,

Thank you for choosing the ACCU-CHEK Compact Plus system!

Congratulations on your decision to take control of your diabetes. We have designed your new ACCU-CHEK

Compact Plus system with comfort, convenience, and control in mind to help make living with diabetes a

little easier.

This booklet will help you get the most from your ACCU-CHEK Compact Plus system.

To start testing quickly, refer to the First Time Guide.

For questions, visit our web site at www.accu-chek.com/support or call the ACCU-CHEK Customer Care

Service Center at 1-800-858-8072. We offer assistance in many languages. You can also visit

www.accu-chek.com for diabetes management tools and product demonstrations.

Thanks again for choosing the ACCU-CHEK Compact Plus system.

WARNING

Before using the system, please read the Important Safety Information section on the following

pages.

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The ACCU‑CHEK Compact Plus System

The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended to be used for the quantitative

measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the ngertips or palm.

The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended to be used by a single person

and should not be shared.

The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended for self testing outside the body

(in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes

control. The ACCU-CHEK Compact Plus Blood Glucose Monitoring System should not be used for the

diagnosis of or screening of diabetes or for neonatal use. Alternate site testing should be done only during

steady-state times (when glucose is not changing rapidly).

The ACCU-CHEK Compact Plus test strips are for use with the ACCU-CHEK Compact Plus Blood Glucose

Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the

ngertips or palm.

This system is intended to be used by a single person and should not be shared.

NOTE

In this Owner’s Booklet the term “blood glucose” is used when referring to “blood sugar.”

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Need Help?

For questions, visit our web site at www.accu-chek.com/support or call the ACCU-CHEK Customer Care

Service Center at 1-800-858-8072. We offer assistance in many languages. You can also visit

www.accu-chek.com for diabetes management tools and product demonstrations.

Please complete your warranty card and mail it, so you receive the best customer service possible and

product update news.

The system includes:

•ACCU‑CHEK Compact Plus meter with batteries and attached

ACCU‑CHEK Softclix Plus lancing device

+

(with a black cap for fingertip testing and an AST cap* for alternate site testing)

•ACCU‑CHEK Compact Plus test drum (17 tests)*

•ACCU‑CHEK Compact Plus clear control solution*

•ACCU‑CHEK Softclix lancets*

+

Lancing device replacements are available by calling the ACCU-CHEK Customer Care Service Center at

1-800-858-8072 or visiting www.accu-chek.com.

*sold separately

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Important Safety Information

WARNING

• During normal testing any blood glucose meter or lancing device may come in contact with

blood. All parts of the kit are considered biohazardous and can potentially transmit infectious

diseases from bloodborne pathogens, even after you have performed cleaning and disinfection.

1,2

• Cleaning and disinfecting the meter and lancing device destroys most, but not necessarily all,

bloodborne pathogens.

3

• The meter and lancing device should never be used by more than one person. Do not share the

meter and lancing device with anyone, including family members, due to the risk of infection

from bloodborne pathogens.

1,2

• If the meter is being operated by a second person who is providing testing assistance to the

user, the meter and lancing device should be cleaned and disinfected prior to use by the second

person.

• Disinfect the meter and lancing device before allowing anyone else to handle them. Do not allow

anyone else to test with the meter or lancing device.

• It is important to keep the meter and lancing device clean and disinfected. For instructions on

how to clean and disinfect the meter and lancing device, see Chapter 5 “Cleaning and

Disinfecting the Meter and Lancing Device.”

• Wash hands thoroughly before and after handling the meter, lancing device, or test strips.

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About Testing Yourself or Others

WARNING

• If you are very dehydrated or urinating frequently, you may get an inaccurate test result. If you

think you are dehydrated, contact your healthcare professional right away.

• DO NOT CHANGE YOUR TREATMENT BASED ON A SINGLE RESULT THAT DOES NOT MATCH HOW

YOU FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT.

• Some people with diabetes do not experience symptoms of low blood glucose (hypoglycemia).

Others, such as children or people who are unconscious or have certain disabilities, may not be

abletocommunicatetheirsymptomstocaregivers.Forthesereasons,donotchangeany

treatmentwithoutrsttalkingtoahealthcareprofessional.

• It is always a good idea to have a back‑up testing method available. Failure to test could cause

a delay in treatment decisions and lead to a serious medical condition. Examples of back‑up

testing methods include a back‑up meter or testing by a laboratory. Ask your healthcare

professional or pharmacist about other possible back‑up methods.

• If your blood glucose result does not match how you feel and you have followed the instructions

in this Owner’s Booklet, follow your healthcare professional’s instructions, or contact your

healthcare professional.

• If peripheral circulation is impaired, collection of capillary whole blood from the approved

samplesitesisnotadvisedastheresultsmightnotbeatruereectionofthephysiological

blood glucose level. This may apply in the following circumstances: Severe dehydration as a

result of diabetic ketoacidosis or due to hyperglycemic hyperosmolar non‑ketotic syndrome,

hypotension, shock, decompensated heart failure NYHA Class IV, or peripheral arterial occlusive

disease.

• Not to be used for patients who are critically ill.

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Before You Start Testing

About the Meter and Test Strips

WARNING

• Carefully read and follow the instructions in the Owner’s Booklet and Package Inserts for the

test strips and control solutions. It is very important to follow the instructions in order to prevent

a wrong result or improper treatment.

• Inspect the test drum container before using the test drum. If you see any damage to the

container cap or if anything prevents the cap from closing properly, do not use the test drum.

Contact the ACCU‑CHEK Customer Care Service Center. Damaged test strips can cause

inaccurate results, which could lead to improper treatment.

• The meter, test strips, and control solutions are only for use outside the body (in vitro). Do not

eat the test strips. Do not swallow or inject control solutions or use control solutions for any

purpose other than testing the ACCU‑CHEK Compact Plus system.

NOTE

• Set the time and date on your meter before you begin testing.

• Although you always apply fresh capillary whole blood to the test strip, your system has been calibrated

to deliver plasma-like values for easier comparison to lab results.

NOTE

• Perform a control test when you open a new box of test drums or if you think that your test result is

incorrect. Performing a control test lets you know that the meter and test strips are working properly.

• Refer to your Test Strip and Clear Control Solution Package Inserts for additional health-related information.

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Chapter 1: Understanding Your New System

The ACCU‑CHEK Compact Plus System

Infrared (IR)

Window –

Transfers data from

the meter to a

computer or PDA.

Display –

Shows results,

messages, and

results stored in

memory.

M Button –

Press to enter

memory, and scroll

through results in

memory.

Drum Door –

Covers the

compartment where

the test drum goes.

Test Strip Slot –

Test strips come out

of the meter here

.

Test/On/Off Button –

Slide and release this

button to turn on the

meter and advance a

test strip. Also, at the

completion of a test,

slide and release this

button to turn off the

meter and release

the test strip.

S Button –

Press to set the

beeper, year, time,

and date.

Drum Door Tab –

Lift up on this tab to

open the drum door.

Release Button –

Slide to release the

attached lancing

device. You can use

your lancing device

attached or

unattached.

Battery Door –

Slide the door to

unlock and open the

battery compartment.

Test Strip Count

Window – Shows

the number of test

strips remaining in a

test drum.

Front View Back View

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NOTE

Some items may be sold separately.

Test Drum –

The bar code on

the label is

automatically

read by the

meter.

Test Strip –

Apply a drop

of blood or

control solution

to the black

notch on the

end of the test

strip.

Protective

Cover

Lancet

Top View

Infrared (IR) Window

Cap –

Comfort Dial with

Depth Selection

Depth Indicator

Plunger

Lancing Device

AST Cap –

(for obtaining blood

from alternate sites)

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Using the ACCU‑CHEK Compact Plus System

• Only use ACCU-CHEK Compact Plus test strips. Using other test strips with this meter will produce

inaccurate results.

• Perform a control test every time you open a new box of test strips.

• Refer to the test strip package insert for test strip storage and system operating conditions.

• Store the test drum in its original container with the cap closed. Moisture can damage the test strips and

produce incorrect results.

• Do not remove test drums from the drum container and put them into another container, such as a plastic

bag, pocket, purse, wallet, etc.

• Use only test drums on which the aluminum foil is intact on both sides.

• Discard the test drum if it is past the “Use by” date printed on the test drum container. If the “Use by” date

is missing or cannot be read, do not use the test drum. Visit our web site at www.accu-chek.com/support

or call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072.

• Never push any test strip back into the meter or the test drum. These test strips can produce incorrect

results.

• If you do not turn off the meter after a test, the meter turns off automatically after about 60 seconds. The

result is saved in the memory. The test strip then remains in the meter. When you slide and release

to

turn on the meter, it simply releases the test strip and turns itself off again.

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WARNING

• DO NOT expose test drums to heat, moisture or humidity. Temperatures outside the required

range, as well as moisture and humidity, can damage your test strips and lead to inaccurate

results.

• DO NOT bend, cut, or alter the test strips.

• DO NOT get dirt, food, or other material on the test strip.

Not following these precautions can lead to inaccurate results.

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Meter Setup

Your meter comes with the batteries already installed. The meter is preset with the time and date which may

need to be adjusted to the local time zone. Setting the correct time and date in the meter is important to

review the results in memory or to transfer the results to a computer.

Using the Setup Mode

The following features can be customized as required:

•Beeper – Select “On” or “OFF.”

•Brightness – Set the brightness of the display.

•Time and date – Set the time and date.

•Test reminders – Select “On” or “OFF.” If you choose “On,” select 1 to 3 reminders per day

•Hypoglycemic (Hypo) indicator – Select “On” or “OFF.” If you choose “On,” select the blood glucose

level for the indicator.

Throughout this section, the blue progress bar helps guide you through the setup process.

The following rules apply when changing settings:

• You can change any setting at any time.

• With the meter off, press and release

S

to enter the set mode. “set” is shown on the display.

• Press and release

S

repeatedly until you reach the setting you want to change. The ashing eld is the

one that is being changed.

• Press and release

M

to change a selection or to increase numbers. Press and hold

M

to scroll faster.

• To exit the set mode at any time and save your settings, slide and release

.

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BEEPER

(on/off)

BRIGHTNESS

(level)

TIME / DATE

(year, am/pm,

hrs, min, month, day)

TEST REMINDERS

(1, 2, 3)

HYPO INDICATOR

(off/on, level)

You are here

Setting the Beeper On/OFF

The meter beeper is preset to “On1.” This means the beeper is on. Setting the beeper to “OFF” does not

affect test results.

The beeper is helpful because it prompts you:

• To apply blood or control solution to the test strip

• When enough blood or control solution is drawn into the test strip

• When the test is complete

• When the hypo indicator is turned on and the result is below the level you have set

• If an error occurred

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1. With the meter off, press and

release

S

to enter the set

mode. The meter turns on and

briey shows the display

symbols.

2. “On1” ashes and the beeper

symbol is displayed. This

means the beeper is on. Press

and release

M

to switch

between “On1” and “OFF.”

3. Press and release

S

to set

your selection. The brightness

setting comes next.

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BEEPER

(on/off)

BRIGHTNESS

(level)

TIME / DATE

(year, am/pm,

hrs, min, month, day)

TEST REMINDERS

(1, 2, 3)

HYPO INDICATOR

(off/on, level)

You are here

Setting the Brightness of the Display

You can use this setting to adjust how bright you wish the displayed symbols and numbers to be. There are

three brightness levels: low, medium, and high. The brightness is factory-set to medium (shown by the

number “2” at the top right of the display).

Low brightness (level 1)

Medium brightness (level 2)

High brightness (level 3)

1. Press and release

M

to move

to the next brightness level.

The brightness of the display

changes.

2. Press and release

S

to set

your selection. The year setting

comes next.

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