Abbott Diabetes Care LIB01 Freestyle Libre Glucose Monitoring System User Manual

DO NOT PRINT FROM THIS FILE

-

FOR REFERENCE

ONLY

Reader Symbols

. . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . .

.

1

Important Safety Information

. . . . . . . . . . . . .

.

3

Indications

for

Use . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . .

.

3

Contraindications . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . .

.

4

Getting

to

Know Your System

. . . . . . . . . . . . . . . . . . . . . . . . . . .

8

Reader

Kit

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9

S

ensor

Kit . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . .

.

10

F

r

eeS

t

yle

Libre

S

of

t

w

are

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13

Setting up

Your Reader for

the

First

Time

. . . . . . . . . . . . . .

14

Using Your Sensor

. . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . .

.

17

Applying Your

S

ensor

. . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . .

18

S

tar

ting

Your

S

ensor

. . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . .

22

Checking Your Glucose

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23

Adding Notes

. . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . .

.

29

C

on

t

en

ts

Reviewing Your

History

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

31

Logbook

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

33

Daily

Graph . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . .

.

34

Other History

Options

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

35

Removing Your Sensor

. . . . . . . . . . . . . . . .

.

37

Replacing

Your Sensor

. . . . . . . . . . . . . . . .

.

38

Using Reminders

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

39

Using

the

Built-in

Meter . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

.

41

Blood Glucose Testing

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

43

Blood Ketone Testing

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

47

Control

S

olution

Testing . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

.

52

Using

the

R

apid-

A

c

ting

Insulin

C

alcula

t

or

. . . . . . . . . . . . . . . .

56

Charging

the

Reader

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

63

Changing

the

Reader Settings

. . . . . . . . . . . . .

. . . . . . . . . . .

.

64

Living

With Your FreeStyle Libre System

. . . . . . . . . . . . . . .

67

Maintenance and Disposal

. . . . . . . . . . . . . .

.

69

Troubleshooting

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

70

Reader Does

Not

Power

On

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

70

Problems

at the

S

ensor

Application

Site . . . . . . . . . . . . . . . . .

.

71

Problems

S

tar

ting

Your

S

ensor

or

R

ec

eiving

S

ensor

R

eadings

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

72

Blood Glucose

or

Ketone Error Messages . . . . . . . . . . . . . . . .

.

75

Problems Checking Your Blood Glucose

or Ketone . . . . . . .

.

79

Perform a Reader Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.

81

Customer

S

er

vic

e

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

81

Professional

Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. .

.

82

Changing Dose Increments

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

83

S

etting up the

Insulin

C

alcula

t

or

. . . . . . . . . . . . . . . . . . . . . . . . .

84

Easy

S

etup of the

Insulin

C

alcula

t

or

. . . . . . . . . . . . . . . . . . . . . .

86

Advanced

S

etup of the

Insulin

C

alcula

t

or

. . . . . . . . . . . . . . . . .

90

Changing

the

Insulin

C

alcula

t

or

S

ettings

. . . . . . . . . . . . . . . .

101

System Specifications

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

102

Rapid-Acting Insulin Calculator Specifications

. . . . . .

. .

106

Labeling Symbols

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

108

Electromagnetic Compatibility

. . . . . . . . . . . . . . . . . . . . . .

. .

109

DOC28687_rev-E_manual.indd 2-3 3/30/14 2:52 PM

S

ymbol

What

It M

eans

Blood glucose

or

ketone

test

S

ettings

Control solution test

result

R

apid-ac

ting

insulin

calculator

Details

of

your suggested insulin

dose

Estima

t

ed

rapid-acting insulin remaining

in body

Low

battery

Ba

tt

er

y

charging

S

e

n

s

or

too cold

S

ensor

too hot

Reader

Symbols

S

ymbol

What

It M

eans

Active

sensor

Direction your glucose is going

.

See Checking

Your

Glucose section

for

more

information

C

aution

View

previous/next

screen

Notes

+

Add more

information to notes

Food

note

R

apid-ac

ting

insulin

note

Time changed

on

R

eader

R

eminders

1

2

DOC28687_rev-E_manual.indd 1-2 3/30/14 2:52 PM

Important

Safety

Inf

orma

tion

Indications

for Use

The

F

r

eeS

t

yle

Libre Flash Glucose

Monitoring

S

y

st

em

is

indicated

for

measuring

interstitial fluid

glucose levels

in

adults aged 18

years

and

older

.

It

is designed

to

replace

blood

glucose

testing

in the

self-managemen

t

of

diabetes

with the

exceptions listed

belo

w

.

Under

the following

circumstanc

es

,

use a

blood

glucose

meter

to

check

the

current

glucose readings

from the

F

r

eeS

t

yle

Libre

F

lash

Glucose

Monitoring

S

y

st

em

S

ensor

:

•

During times

of

rapidly changing glucose lev

els

,

interstitial glucose

levels as measured

by the

S

ensor

and reported

as

current may

not

ac

cur

a

t

ely

reflect

blood

glucose

lev

els

.

When glucose levels are

falling

rapidly

,

glucose readings

from the

S

ensor

may

be

higher

than blood

glucose

lev

els

.

Conversely when glucose levels are rising

rapidly

,

glucose readings

from the

S

ensor

may

be

lower

than blood glucose

lev

els

.

•

In order

to

confirm hypoglycemia

or

impending hypoglycemia as

reported

by the

S

ensor

.

•

If

symptoms

do not

match

the

F

r

eeS

t

yle

Libre Flash

Glucose

Monitoring

S

y

st

em

r

eading

.

Do

not

ignore symptoms

that

may

be

due

to low blood

glucose

or high blood

gluc

ose

.

C

on

tr

aindic

a

tions

The

F

r

eeS

t

yle

Libre Flash Glucose

Monitoring

S

y

st

em

must

be removed

prior to

Magnetic

R

esonanc

e

Imaging

(MRI)

.

W

A

R

NIN

G:

•

The

F

r

eeS

t

yle

Libre Flash Glucose

Monitoring

S

y

st

em

contains

small parts

that

may

be

dangerous

if

sw

allo

w

ed

.

•

During times

of

rapidly changing glucose (more

than 2 mg/dL

per minute),

interstitial fluid

glucose levels as measured

by the

F

r

eeS

t

yle

Libre Flash Glucose

Monitoring

S

y

st

em

S

ensor

may

not

ac

cur

a

t

ely

reflect

blood

glucose

lev

els

.

Under these circumstanc

es

,

check

the

S

ensor

glucose readings

by

conducting a fingerstick

test

using a

blood

glucose

met

er

.

•

In order

to

confirm hypoglycemia

or

impending hypoglycemia

as

reported

by the

F

r

eeS

t

yle

Libre Flash Glucose

Monitoring

S

y

st

em

Sensor,

conduct

a

fingerstick test using

a

blood

glucose

met

er

.

•

Do

not

ignore symptoms

that

may

be

due

to low or high blood

gluc

ose

.

If

you have symptoms

that do not

match

the

F

r

eeS

t

yle

Libre Flash Glucose

Monitoring

S

y

st

em

reading

or

suspec

t

tha

t

your reading may

be

inac

cur

a

t

e

,

check

the

reading

by conducting

a

fingerstick test using

a

blood

glucose

met

er

.

If

you

are

experiencing symptoms

that

are

not

c

onsisten

t

with

your

glucose

r

eadings

,

consult your health care professional

.

3

4

DOC28687_rev-E_manual.indd 3-4 3/30/14 2:52 PM

C

A

UTION:

•

On rare

oc

casions

,

you may

get

inac

cur

a

t

e

S

ensor

glucose

r

eadings

.

If

you believe your glucose readings are

not correct

or

are

inconsisten

t

with how

you

f

eel

,

perform a

blood

glucose

test

on

your finger

to

confirm your gluc

ose

.

If the

problem

c

on

tinues

,

remove

the

current

S

ensor

and apply

a

new

one

.

•

Performance

of the

S

y

st

em

when used

with other

implan

t

ed

medical devic

es

,

such as

pacemakers

,

has

not been

evalua

t

ed

.

•

The Reader is

for

use

by

a single

person

.

It

must

not be used

on

more

than

one person

including other

family

members

due

to the

risk

of

spreading

inf

ec

tion

.

All

parts

of the

R

eader

are considered biohazardous and can

potentially transmit

infectious

diseases, even

after performing

the cleaning

pr

oc

edur

e

.

System-Related

Information

• The

F

r

eeS

t

yle

Libre Flash Glucose

Monitoring

S

y

st

em

is designed

to be

used

only with

F

r

eeS

t

yle

P

r

ecision/F

r

eeS

t

yle

Optium blood

glucose

and

blood

ketone test

strips and MediSense

control

solution

.

•

Avoid

getting

dust

,

dir

t

,

blood

,

control

solution,

w

a

t

er

,

or other

substances

in the

Reader’s USB

and test

strip por

ts

.

•

Physiologic differences between

the interstitial fluid

and capillary

blood

may result

in

differences

in

glucose

r

eadings

.

Differences

in glucose

readings between

interstitial fluid

and capillary

blood

may

be observed

during

times

of

rapid change

in blood

gluc

ose

,

such as

after

ea

ting

,

dosing insulin,

or

e

xer

cising

.

• Severe

dehydration and

excessive

water

loss may cause

inaccurate

r

esults

.

If

you believe you are suffering

from

dehydration, consult

your

health care professional

imm

e

dia

te

l

y

.

Confirm Precision

or Optium

test strip

as

appropriate

for

mar

ket

.

Change MediSense

to Optium for

A

ustr

alia

.

5

6

DOC28687_rev-E_manual.indd 5-6 3/30/14 2:52 PM

•

If

you have a medical

appointment that

includes strong magnetic

or

electromagnetic radiation,

for

example an X-ray, MRI

(Magnetic

R

esonanc

e

Imaging),

or

CT

(Computed Tomography)

scan, remove

the

S

ensor

you are wearing and apply a

new one after

the

appointmen

t

.

The

effect

of

these

t

ypes

of

procedures

on the

performance

of the

system has

not

been

evalua

t

ed

.

• The

F

r

eeS

t

yle

Libre Flash Glucose

Monitoring

S

y

st

em

has

not been

evalua

t

ed

for

use

in

pregnant women,

persons

on

dialy

sis

,

or people

less

than

18 years

of

age

.

Getting to

Kno

w

Your

System

The

F

r

eeS

t

yle

Libre Flash Glucose

Monitoring

S

y

st

em

has

two

main parts:

a

handheld

Reader and a disposable

Sensor, which you wear

on

your

body

.

You use

the

Reader

to

wirelessly scan

the

S

ensor

and

get

your

glucose

r

eadings

.

The Reader also has a

built-in blood

glucose and ketone

met

er

,

which works

with

F

r

eeS

t

yle

P

r

ecision/F

r

eeS

t

yle

Optium blood

glucose

and

blood

ketone test str

ips

.

IMPORTANT:

S

af

et

y

information about

th

e

S

y

s

t

e

m

is

in

thi

s

User’s

M

a

nu

a

l

.

Read all

o

f

the information in the

User’s Manual and

the

Fr

ee

S

t

y

l

e

P

re

c

i

s

i

on

/

F

re

e

S

t

y

l

e

Optium b

l

ood

glucose

and ketone

te

s

t

s

tr

ip in

s

tr

u

c

t

i

on

s

for

use before

u

s

i

n

g

your

S

y

s

t

e

m

.

Your

S

y

st

em

comes

in

a

Reader Kit

and a

Sensor

K

i

t

.

When opening

your

k

its

,

check

that the

contents

are undamaged and

that

you have all

parts

list

ed

.

If

any parts are missing

or

damaged

,

contact

Customer

S

er

vic

e

.

7

8

DOC28687_rev-E_manual.indd 7-8 3/30/14 2:52 PM

Reader

Kit

The Reader

Kit

includes:

•

1

F

r

eeS

t

yle

Libre

R

eader

•

1

USB C

able

USB

P

o

r

t

Used

to

charge

the

R

eader

and connect

it to

a c

o

mpu

t

e

r

.

Test Strip

P

o

r

t

•

1

Power

Adapter

• User’s

Manual

•

Quick

S

tar

t

Guide

T

ou

c

hsc

r

ee

n

Home

Bu

tt

o

n

Turns

the

Reader

o

n/off

and takes you

to

the

Home screen

from

a

n

y

Sensor

Kit

The

S

ensor

Kit

includes:

•

1

S

ensor

P

ack

•

1

S

ensor

Applicator

Sensor

Pack

Used

with the

S

ensor

Applicator

t

o

prepare

the

S

ensor

for

use

.

•

1

Alcohol

wipe

•

P

roduc

t

insert

Sensor

Applicator

Applies

the

S

ensor

to

your

body

.

I

n

s

e

r

t

a

test

strip

here

to use

the built-in

me

t

e

r

.

other

sc

r

een

.

The

S

ensor

measures and stores glucose readings when

worn on your

body

.

It initially

comes

in two

parts: one

part

is

in the

S

ensor

Pack

and

the other part

is

in the

S

ensor

A

pplica

t

or

.

By

following the

instruc

tions

,

you prepare and apply

the

S

ensor

on the

back

of your

The Reader is used

to get

glucose readings

from

your

S

ensor

.

It

can

store

approximately

90-days

of

glucose

history and notes you enter

about

ac

tivities

,

such as taking insulin, eating

f

ood

,

or

e

xer

cising

.

This

information

can

help

you understand

how

these activities aff

ec

t

your

gluc

ose

.

upper

ar

m

.

The

S

ensor

has a

small

,

flexible

tip that is

inser

t

ed

just under

the

sk

in

.

The

S

ensor

can

be worn

for up to

14

day

s

.

S

ensor

Measures your

g

lu

c

o

se

while on

y

our

body

(

on

l

y

visible

after appl

i

ed

).

9

10

DOC28687_rev-E_manual.indd 9-10 3/30/14 2:52 PM

92

The Reader Home

S

creen

provides access

to information about your

glucose and

the

S

y

st

em

.

You can press

the

Home Button

to get to the

Home

S

creen

.

Home

S

cr

een

The

S

ensor

Glucose

R

eadings

screen appears

after you

use

the

R

eader

to

scan your

S

ensor

.

Your

R

eading

includes your

C

urr

en

t

Glucose,

a

Glucose Trend Arrow

indicating

which way your glucose is going

,

and

a

graph

of

your current and stored

glucose

r

eadings

.

Sensor Glucose

Readings

Time

C

urr

e

n

t

time

s

e

t

on

the

R

e

ad

e

r

.

Sensor

S

t

a

t

u

s

Information

about your

current

S

en

so

r

.

Check

G

lu

c

os

e

Touch

to

check

your

S

ens

or

g

l

u

cos

e

.

10:23pm

Ends

in 14 days

Check

Glucose

Review

History

Battery

Le

v

e

l

B

a

tt

e

r

y

charge

r

ema

i

n

i

n

g

.

S

etti

ng

s

Touch

to

change

t

h

e

Reader’s

sett

i

ng

s

.

Review

His

t

o

r

y

Touch

to

review

in

f

or

m

a

t

io

n

Message

Touch

for more

in

f

or

m

a

ti

on

.

Current

G

lu

c

os

e

Glucose

from your

l

a

t

e

st

scan

.

Food

Note

350

250

150

50

Glucose

Going

Low

mg

dL

Add

N

o

t

e

s

Touch

to

add

no

t

es

to the

glucose

r

ea

ding

.

G

lu

c

ose

Trend

Arrow

Direction

your

glucose is goi

n

g

.

Rapid-Acting

Insulin

Note

Reminder

Touch

to

se

t

or change

r

e

mi

n

d

e

r

s

.

about your past g

l

u

c

o

s

e

r

e

a

d

i

ng

s

.

2pm 6pm

10pm

Glucose

G

r

aph

Graph

of

your

current

and stored glucose

readings

.

11

12

DOC28687_rev-E_manual.indd 11-12 3/30/14 2:52 PM

Step

A

c

tion

1

Press

the

Home Button

to turn on the

R

eader

.

2

If prompt

ed

,

use

the

t

ouchscreen

to

selec

t

your

preferred language

for the

R

eader

.

Touch

OK

to

c

on

tinue

.

N

o

te

:

Use

the

pad

of

your

finger

.

Do NOT

use

your fingernail

or

any

other object on the

scr

een

.

3

Current Date

Set

the

Current Date

using

the

arrows

on the

t

ouchscreen

.

Touch

c

on

tinue

.

14 June

2014

back

Software

F

r

eeS

t

yle

Libre

sof

t

w

ar

e

can

be

used

to

view reports and change

R

eader

settings

.

The

sof

t

w

ar

e

is compatible

with

most

W

indow

s

and

Mac

operating

sy

stems

.

Go

to www

.

F

r

eeS

t

yleLibr

e

.

c

om

and

follow

onscreen

instructions

to

download and install

the

sof

t

w

ar

e

.

Setting up

Your Reader

for the

First

Time

Before using

the

S

y

st

em

for the

first time

,

the

Reader must

be

set up

.

INTENDED

U

SE

F

r

eeS

t

yle

Libre

sof

t

w

ar

e

is

intended

for

use

by

individuals

and

health care professionals

to

aid

in the

r

eview

,

analysis,

and

evaluation

of information

such as

S

ensor

glucose

r

eadings

,

blood

glucose

test

r

esults

,

blood

ketone test

r

esults

,

and

other

data uploaded

from the

F

r

eeS

t

yle

Libre Flash

Glucose

Monitoring

S

y

stem,

in

support

of

an effective diabetes

health

management pr

ogr

am

.

F

r

eeS

t

yle

Libre

sof

t

w

ar

e

is

not

intended

for the

diagnosis

of

or

screening

for

diabetes

mellitus

.

Users should

be

aware

tha

t

F

r

eeS

t

yle

Libre

sof

t

w

ar

e

is merely an

information management

tool

and

it

is therefore

not

intended

to

substitute

for the

support

of

a health care prof

essional

.

Individuals should alw

a

y

s

consult

their

health care professional

if they

have any queries

or

concerns

about

diabetes managemen

t

.

13

14

DOC28687_rev-E_manual.indd 13-14 3/30/14 2:52 PM

Step

A

c

tion

4

Current Time

Set

the

Current Ti

me

.

Touch

c

on

tinue

.

12 am 00

CAUTION:

It

is very

important to

set

the time

and date

c

orr

ec

tly

.

These values

aff

ec

t

the

Reader data and

settings

.

back

Target Glucose

?

Set

your

Target Glucose

R

a

nge

.

Work

with your

Range

health care professional

to

determine your

T

ar

get

Glucose

R

ange

.

Touch

c

on

tinue

.

80 to 140 dL

mg

N

o

te

:

Your Target Glucose

R

ange

is

displayed

on

glucose graphs

on the

Reader and used

t

o

back next

calcula

t

e

your Time In

T

ar

get

.

Step

A

c

tion

6

The Reader

now

displays

important information about two key

topics

to help

you use

the system:

•

How

to

understand

the

Glucose Trend Arrow included

on

the

Glucose

R

eading

scr

een

.

•

How

to return to the

Home

S

creen

from

any

other

scr

een

.

When you scan your Sensor

an

arrow

will

indicate your

recent glucose

trend:

Rising quickly While using the Reader, press

Rising the Home

button

to

return to

the Home screen.

Changing

slowly

Falling

Touch

move

to the

Falling

quickly

opic

.

At the

end

of the

back next

Reader

setup

,

touch

done

to

go to the

Home

S

creen

.

back done

N

o

t

e

:

Charge

the

Reader

if the

battery level

is

l

o

w

.

Only use

the

USB

cable

and power ad

a

p

t

er

included

with the

S

y

s

t

e

m

.

15

16

DOC28687_rev-E_manual.indd 15-16 3/30/14 2:52 PM

Step

A

c

tion

1

Apply Sensors

only on the

back

of

your

upper

ar

m

.

Avoid areas

with

scars,

moles

,

stretch mar

ks

,

or

lumps

.

S

elec

t

an area

of

skin

that

generally stays

flat

during

your normal daily activities (no

bending

or

f

olding)

.

Choose a site

that

is

at

least 2

.

5

cm

(1 inch) away

from

an insulin

injection

sit

e

.

T

o

prevent discomfort

or

skin

irritation,

you

should

selec

t

a

different

site

other than the

one

most

recently

used

.

2

Clean application site

with

an alcohol

wipe and

allow site

to dry

before proc

eeding

.

This

helps

the

S

ensor

stay attached

to

your

body

.

N

o

te

:

The area

MUST

be

clean and dr

y

,

or the

S

ensor

may

not

stick

to the

sit

e

.

Using Your

Sensor

Applying Your

Sensor

C

AU

T

I

O

N

S:

• The

S

ensor

Pack and

S

ensor

Applicator

are packaged as

a

set

(separ

a

t

ely

from the

Reader) and have

the

same

S

ensor

c

ode

.

Check

that the

S

ensor

codes

match

before using your

S

ensor

Pack and

S

ensor

A

pplica

t

or

.

S

ensor

Packs and

S

ensor

A

pplica

t

ors

with the

same

S

ensor

code

should

be

used

together

or

your

S

ensor

glucose readings may

be

inc

orr

ec

t

.

F

r

eeS

t

y

S

ensor

P

CODE XXX

XXXXXXX

X

YYY

Y/M

•

I

n

t

ense

exercise may cause your

S

ensor

to

loosen due

t

o

sw

ea

t

or

movement

of the

S

ensor

.

If

your

S

ensor

comes

loose

,

you may

get no

readings

or

unreliable

r

eadings

,

which may

not

match

how

you

f

eel

.

F

ollow the instructions

to

selec

t

an appropriate application sit

e

.

17

18

DOC28687_rev-E_manual.indd 17-18 3/30/14 2:52 PM

Step

A

c

tion

6

The

S

ensor

Applicator

is prepared and ready

t

o

apply

the

S

ensor

.

CAUTION:

The

S

ensor

Applicator

now

contains a

needle

.

Do NOT

touch

inside

the

S

ensor

Applicator

or put it

back

into the

S

ensor

P

ack

.

7

Place

the

S

ensor

Applicator over

the prepared

site and push

down firmly to

apply

the

S

ensor

t

o

your

body

.

CAUTION:

Do NOT push

down on the

S

ensor

Applicator

until

placed over prepared site

t

o

prevent unintended

results

or injur

y

.

Step

A

c

tion

3

Lid

Open

the

S

ensor

Pack

by

peeling

the lid off

c

omplet

ely

.

Unscrew

the

cap

from the

S

ensor

Applicator and

set

the

cap aside

.

CAUTION:

Do NOT use

if the

S

ensor

Pack

or

C

ap

the

S

ensor

Applicator

seem

to be damaged

or

already

opened

.

Do NOT use

if past

expiration

da

t

e

.

4

Line

up the

dark mark

on the

S

ensor

Applicator

with the

dark mark

on the

S

ensor

P

ack

.

P

r

ess

firmly down on the

S

ensor

Applicator

until

it

comes

to

a

st

op

.

5

Lift the

S

ensor

Applicator

out of the

S

ensor

P

ack

.

19

20

DOC28687_rev-E_manual.indd 19-20 3/30/14 2:52 PM

Step

A

c

tion

8

Gently

pull the

S

ensor

Applicator

away

from your

body

.

The

S

ensor

should

now

be attached

to your

Sensor

sk

in

.

Note:

Applying

the

S

ensor

may cause

bruising or

bleeding

.

If

there is bleeding

that

does

not

st

op

,

remove

the

Sensor, and apply a new one

at

a

different

sit

e

.

9

Make sure

the

S

ensor

is secure

after applica

tion

.

Put

the

cap back

on the

S

ensor

A

pplica

t

or

.

Discard

the

used

S

ensor

Pack and

S

ensor

Applicator according

to

local

r

egula

tions

.

6

Starting Your

Sensor

Step

A

c

tion

1

Press

the

Home Button

to turn on the

R

eader

.

2

10:23pm

No Active Sensor

Touch

Start New

S

e

n

s

o

r

.

Start

New

Sensor

Review

History

3

Hold

the

Reader

within 4

cm

(1

.

5

inches)

of the

S

ensor

to

scan

it

.

This starts your

S

ensor

.

If sounds

are

turned

on,

the

Reader beeps when

the

S

ensor

New

Sensor

OK

Starting Up

Sensor

can be

used

in:

mi

nutes

has been successfully ac

tiv

a

t

ed

.

The

S

ensor

can

be

used

to

check your glucose

after 60

minut

es

.

Note:

If the

S

ensor

is

not

successfully

scanned

within

15

sec

onds

,

the

Reader displays a pr

ompt

to

scan

the

S

ensor

again

.

Touch

OK

to return

t

o

the

Home

S

creen

and

touch

Start New

S

e

n

s

o

r

to

scan your

S

ensor

.

21

22

DOC28687_rev-E_manual.indd 21-22 3/30/14 2:52 PM

Step

A

c

tion

3

The Reader displays

your current

glucose

reading

Glucose Going

along

with

your glucose graph and an

arrow

Low

350 92

indicating

the

direction your glucose is g

o

i

n

g

.

mg

dL

250

150

50

2pm 6pm 10pm

Checking Your

Glucose

Step

A

c

tion

1

10:23pm

En ds

in

14 days

OR

Check

Glucose

Review

Histo ry

Turn

the

Reader

on by p

r

e

ss

i

n

g

the

Home

B

u

tt

on

or touch

Check Glucose

from the Home

Sc

r

ee

n

.

2

Hold

the

Reader

within 4

cm

(1

.

5

inches)

of your

S

ensor

to

scan

it

.

Your

S

ensor

wirelessly

sends

glucose readings

to the

R

eader

.

If

sounds

are

turned

on,

the

Reader beeps when

the

S

ensor

has been successfully

scanned

.

Note:

If the

S

e

n

s

or

is

not

successfully scanned

within 15

seconds,

the

Reader displays a

prompt to

scan

the

S

e

n

s

or

a

g

ai

n

.

Touch

OK

to return to the

Home

S

c

r

ee

n

and

touch

Check Glucose

to

scan your

S

ens

or

.

23

24

DOC28687_rev-E_manual.indd 23-24 3/30/14 2:52 PM

Glucose is rising

quickly

(more

than 2 mg/dL

per

minute)

Glucose is

rising

(between

1

and

2 mg/dL

per

minute)

Glucose is changing

s

l

o

w

l

y

(less

than 1 mg/dL

per

minute)

Glucose is

falling

(between

1

and

2 mg/dL

per

minute)

Glucose is falling

quickly

(more

than 2 mg/dL

per

minute)

92

Sensor Glucose

Readings

The Glucose Trend Arrow gives you an

indication

of the

direction

your

glucose is going

.

Glucose Going

Low

G

lu

c

ose

Trend

A

rr

o

w

Target

Glucose

Range

mg

dL

350

250

150

50

Current

G

lu

c

ose

2pm 6pm 10pm

N

o

t

e

s:

•

The graph displays glucose readings

up to

350 mg

/

d

L

.

G

lu

c

o

s

e

readings above 350

mg/dL

are displayed

at

350 mg

/

d

L

.

• The

s

y

mb

o

l

may

a

pp

e

a

r

,

indicating

the

Reader

time

was c

h

a

n

g

e

d

.

Gaps

in the

graph may

r

e

s

u

l

t

or

glucose readings may

be hidd

e

n

.

Note:

The Glucose Trend Arrow may

not

always appear

with

your r

e

a

d

i

n

g

.

25

26

DOC28687_rev-E_manual.indd 25-26 3/30/14 2:52 PM

Display

What To

Do

Glucose Going

Low

72

mg dL

350

250 Glucose Going

High

150

50

237

dL

350

250

150

50

2pm 6pm

10pm

If

your glucose is

projected

to be

higher

than

240

mg/dL or

lower

than

70

mg/dL within 15

minut

es

,

you

will

see a message

on the

scr

een

.

You can

touch the

message

button for more

information

and set a reminder

to

check

your

gluc

ose

.

Display

What To

Do

Low Glucose

LO

mg dL

350

250

150 High

Glucose

50 HI

mg

2pm 6pm

10pm

dL

350

250

150

50

2pm

6pm 10pm

If

LO

appears

on the

Reader, your reading is

lower

than

40

mg/dL

.

If HI

appears

on the

Reader,

your

reading is higher

than

500

mg/dL

.

You can

touch

the

message

button for

more

inf

or

ma

tion

.

Check

your

blood

glucose

on

your finger

with

a

test str

ip

.

If

you

get

a second

LO

or HI

r

esult

,

contact

your

health care professional

imm

e

dia

te

l

y

.

Low Glucose

63

mg dL

350

250 High Glucose

150

50

289

2pm 6pm 10pm mg

dL

350

250

150

50

2pm 6pm

10pm

If

your glucose is higher

than

240

mg/dL or lower

than

70 mg/dL, you

will

see a message

on the

scr

een

.

You can

touch the

message

button for

more

information

and set a reminder

to check

your

gluc

ose

.

The

following

table shows messages you may see

with

your

glucose

r

eadings

.

2pm 6pm 10pm mg

N

o

t

e

:

If

you are

not

sure

about

a message

or

r

e

a

d

i

n

g

,

contact

your

health

care professional before you

do

a

n

y

t

h

i

ng

.

27

28

DOC28687_rev-E_manual.indd 27-28 3/30/14 2:52 PM

Step

A

c

tion

1

Glucose Goi ng

From

the

Glucose

R

eading

screen, add

not

es

Low by touching the

symbol

in the

upper r

igh

t

92

mg

corner

of the

t

ouchscreen

.

If

you

do not want

t

o

dL

350

250

add

not

es

,

you can press

the

Home Button

to go

150 to the

Home

S

creen

or hold the

Home Button

t

o

50

2pm 6pm

10pm

turn the

Reader

off

.

2

S

elec

t

the

checkbox

notes you

would

like

to

add

.

Touch

the down

arrow

to

view

other

Insulin

Note

options

.

Long-Acting

Insulin

Food

1

/ 4

+

Adding

Notes Step

A

c

tion

Notes can

be

saved

with

your glucose

r

eadings

.

You can add a

note at

the time of

your glucose reading

or within

15 minutes after your

reading

was

obtained

.

You can track

f

ood

,

insulin, exercise, and any

medication

you

take

.

3 Add Notes

Rapid-Ac

ting

Insulin

Long-Acting

Insulin

Food

OK

+

+Enter Rapid-Acting OK

Insulin

+

1

/ 4

After you

check

the box for food and

insulin

not

es

,

the +

symbol

appears

to the right of the

Not

e

.

You can

touch

it to

add more specific

information

t

o

your

not

e

.

Then

touch

O

K

.

•

Insulin notes:

En

t

er

the

number

of

units

taken

.

•

Food notes:

En

t

er

grams

or serving

inf

or

ma

tion

.

Note:

Food

and rapid-acting

insulin

notes are

shown

on

your glucose graphs and

in

your Logbook

as

symbols

.

Add Notes OK

Rapid-Ac

ting

4 Add Notes OK

Rapid-Acting

Insulin

Long-Acting

Insulin

Food +

Touch

OK

to

save your

Not

es

.

1

/

4

You can review your Notes

from the

L

ogbook

.

See Reviewing Your

History

section

for

more

inf

or

ma

tion

.

29

R

emov

e

magenta

content for

F

r

ance

.

30

DOC28687_rev-E_manual.indd 29-30 3/30/14 2:52 PM

Step

A

c

tion

3

Review History

Use

the

arrows

to

view

the

available

options

.

Logbook

Daily

Graph

Daily Patterns

Average Glucose

Time In

T

ar

get

1

/ 2

Low

Glucose

Events

Sensor

Usage

IMPORTANT:

Work

with

your health care professional

to

understand your glucose

histor

y

.

2

Reviewing Your

History

R

eviewing

and understanding your glucose history can

be

an impor

tan

t

tool for improving

your glucose

c

on

tr

ol

.

The Reader stores

about

90

day

s

of information

and has several ways

to

review your past glucose

r

eadings

,

not

es

,

and

other inf

or

ma

tion

.

Step

A

c

tion

1 Che ck Glucose

Sc an

Sensor to check

gluco se.

Press

the

Home Button

to turn on

the

R

eader

.

Press

the

Home

Button

again

to go to the

Home

S

creen

.

10:23pm

En ds

in

14 days

Touch

the

Review History

ic

on

.

Chec k

Glucose

Revie w

Hist ory

31

32

DOC28687_rev-E_manual.indd 31-32 3/30/14 2:52 PM

143

108

98

The

Logbook and Daily Graph show detailed information,

while other

history options show summaries

of information

over a number

of

day

s

.

Daily Graph

Logbook

Logbook OK

E

n

t

r

i

e

s

for

each

time

you scanned your

S

ensor

Daily Graph OK

(mg/dL)

350

250

150

A graph

of

your

S

e

n

s

or

glucose readings

by d

a

y

.

The graph shows your

T

a

r

g

e

t

Glucose Range

and

symbols

for food or

rapid-acting

i

n

s

u

li

n

no

t

e

s

you

have

en

t

er

e

d

.

or

performed a

blood

glucose

or

ketone

t

est

.

50

12 6 12 6 12

23

Feb

10:23am

23

Feb

6:37a

m

If

you entered

Notes

with

a glucose

r

eading

,

the

symbol appears

in that

ro

w

.

For

more

am a m pm pm

am

22 Feb

Wednesday

N

o

t

e

s:

• The

graph

displays glucose readings

up

t

o

22

Feb

11:09pm

mg/dL

information about the

symbols

,

see Reader

S

ymbols

sec

tion

.

Touch

the

entry

to

review

the

detailed

information,

including

any Notes you

en

t

er

ed

.

You can add

or

edit

(change) Notes

for the

most r

ec

en

t

Logbook

en

tr

y

,

provided your glucose reading was

within

the

last 15 minutes and you have

not used

F

r

eeS

t

yle

Libre

sof

t

w

ar

e

to

cr

ea

t

e

repor

ts

.

350 mg

/

d

L

.

Glucose readings above 350

mg/dL

are displayed

at

350

mg/dL

.

•

You

might

see gaps

in the

graph

during

times when you have

not

scanned

at least

once

in 8

hours

.

• The

s

y

mb

o

l

may appear indicating

the

Reader

time

was

ch

a

n

g

e

d

.

Gaps

in the graph

may

r

e

s

u

l

t

or

glucose readings may

be hidd

e

n

.

33

34

DOC28687_rev-E_manual.indd 33-34 3/30/14 2:52 PM

5

Other History

Options

Use

the

arrows

to

view

information about

your last 7, 14, 30,

or

90

day

s

.

Time In Target OK

A graph showing

the p

e

r

ce

n

t

a

g

e

of time your

S

e

n

s

or

glucose readings were

a

b

o

v

e

,

b

e

l

o

w

,

or

Average Glucose OK

Information

about the

average

of

your

S

e

n

s

or

Above

In

T

arget

Below

12%

34%

54% within

your

T

a

r

g

e

t

Glucose

R

a

n

g

e

.

Average: 119 mg/dL

152 134

glucose

r

e

a

d

i

n

g

s

.

The overall average

for the

ti

m

e

is displayed above

the g

r

a

p

h

.

The average is

a

l

s

o

Target Range

80-140 mg/dL

Last 7 Days

121

12

69

6 12 6

12

shown

for four different

6-hour

p

e

r

i

o

d

s

of the d

a

y

.

Time

In

T

arget

am a m pm pm

am

Last 7

Days

A

v

erage

Glucose

R

e

a

d

i

n

g

s

above

or below

your

T

a

r

g

e

t

G

lu

c

o

s

e

Range are

or

a

n

g

e

,

while

readings

in

range are

blu

e

.

Low Glucose OK

Events

Total Events: 10

6

3

Information

about the

number

of low glu

c

o

s

e

v

e

n

t

s

measured

by

your

S

e

n

s

or

.

A

low glu

c

o

s

e

event

is recorded when your

S

e

n

s

or

glu

c

o

s

e

reading is lower

than

70

mg/dL for longer

1 0

12 6 12 6

12

than

15 m

i

nu

t

e

s

.

The

total

number

of

e

v

e

n

t

s

Daily Patterns OK

(mg/dL)

350

250

150

50

A graph showing

the pattern

and variability

of your

S

ensor

glucose over a

typical

day

.

The

thick black

line

shows

the

median

(midpoint) of

your

glucose

r

eadings

.

The gray shading represents a

range

am a m pm pm

am

Last 7

Days

Low

Glucose

E

v

ents

is displayed above

the g

r

a

p

h

.

The bar

graph

displays

the low

glucose

e

v

e

n

t

s

in four different

6-hour

p

e

r

i

o

d

s

of the d

a

y

.

12 6 12 6 12

(10-90 percentiles)

of

your

S

ensor

r

eadings

.

Information

about how often

you scan your

S

e

n

s

or

.

am a m pm pm

am

Last 7

Days

D

ail

y

P

a

tt

erns

N

o

t

e

:

Daily

P

a

tt

e

rn

s

needs

at

l

e

a

s

t

5

days

o

f

glucose

d

a

t

a

.

Sensor Usage OK

Scans Per

Day

Sensor Data

The Reader

r

e

p

or

t

s

an average

of how many

ti

m

e

s

you scanned your

S

e

n

s

or

each

d

a

y

,

and

the

Captured 100

%

Last 7

Days

p

e

r

ce

n

t

a

g

e

of

possible

S

e

n

s

or

d

a

t

a

the

R

e

a

d

e

r

recorded

from

your

s

c

a

n

s

.

Sensor

Usage

35

36

DOC28687_rev-E_manual.indd 35-36 3/30/14 2:52 PM

Removing Your

Sensor

Step

A

c

tion

1

Pull

up the

edge

of the

adhesive

that

keeps

your

S

ensor

attached

to

your

sk

in

.

Slowly peel

away

from

your skin

in

one

motion

.

N

o

t

e

:

Any remaining adhesive residue

on the

skin can

be

removed

with

warm soapy

water

or

isopropyl

a

l

c

oho

l

.

2

Discard

the

used

S

ensor

according

to

local

r

egula

tions

.

S

ee

Maintenance and Disposal

sec

tion

.

When you are ready

to

apply a new Sensor,

follow the

instructions

in the

Applying Your

S

ensor

and Starting Your

S

ensor

sec

tions

.

If

you removed your last

S

ensor

before 14 days

of

use

,

you

will be prompted to

confirm

that

you

would

like

to

star

t

a

new

S

ensor

when you first scan

it

.

Replacing

Your

Sensor

Your

S

ensor

automatically stops

working

after

14 days

of

wear

and

must

be

r

eplac

ed

.

You should also replace your

S

ensor

if

you notice

any

irritation or

discomfort

at the

application site

or if the

Reader reports

a

problem

with the

S

ensor

currently

in

use

.

Taking action early can

keep

small problems

from turning into

larger

ones

.

CAUTION:

If the

glucose readings

from the

F

r

eeS

t

yle

Libre

F

lash

Glucose

Monitoring

S

y

st

em

do

NOT seem

to

match

with

ho

w

y

ou

f

eel

,

check

to

make sure

that

your

S

ensor

has

not come

loose

.

If the

S

ensor

tip

has come

out of

your skin,

or

your

S

ensor

is coming loose

,

remove

the

S

ensor

and apply a new

one

.

37

38

DOC28687_rev-E_manual.indd 37-38 3/30/14 2:52 PM

Step

A

c

tion

4

Set

the

reminder

Time

using

the

arrows

on the

t

ouchscreen

.

Touch

s

av

e

.

5

Reminders

From

the

R

eminders

screen, you can

turn the

reminder

On/Off

or

add new

r

eminders

.

8:30am On

Touch

done

to return to the

Home

S

creen

.

12:30pm Off

00:00:00 On

add new done

Step

A

c

tion

1

10:23pm

Ends in 14 days

From

the

Home Screen,

touch the

symbol

.

Check Review

Glucose History

2

Set Reminder

Touch

to

selec

t

which

Type

of

reminder you

want

to

set: Check Glucose, Take Insulin,

or

A

lar

m

.

Type Alarm

Repeat Daily

Time XX:XX

cancel save

3

Touch

to

selec

t

how often

you

want the

reminder

to

R

e

pe

a

t

:

Onc

e

,

Daily

,

or

T

imer

.

N

o

te

:

You can set

the

reminders

for

a specific

time

(e

.

g

.

8:30

am)

or

as a

timer

(e

.

g

.

3

hours

from the

current time)

.

Using

Reminders

You can use

R

eminders

to help

you remember

to

check your

gluc

ose

,

take

insulin,

or

as a general

alar

m

.

Reminder

8:30am

Alarm

snoo

ze

15 min

OK

When reminders are On,

the

next reminder

time

appears

reminder symbol

on the

Home

S

creen

.

For

example, 8:30am

Your reminder comes

on

even

if the

Reader

is

turned off

.

Touch

OK

to

dismiss your reminder

or

snooze

to be

reminded again

in

15

minut

es

.

N

o

te

:

R

eminders

will not

appear

if the

Reader

is

c

onnec

t

ed

to

a

c

omput

er

.

39

40

DOC28687_rev-E_manual.indd 39-40 3/30/14 2:52 PM

Using

the

Built-in

Met

er

The Reader has a

built-in

meter

that

can

be

used

to

test your

blood

glucose and

blood

ket

one

,

or to

test

the

meter and strips

with control

solution

.

WARNING:

Do NOT use

the built-in

meter

while the

Reader

is

c

onnec

t

ed

to

an electrical

outlet or

a

c

omput

er

.

IM

P

O

RT

A

N

T

:

•

Use

the

Reader

within the

test

strip

operating

temperature

range as

blood

glucose and ketone results obtained

outside

the

range may

be

less

ac

cur

a

t

e

.

•

Use

only

F

r

eeS

t

yle

P

r

ecision/F

r

eeS

t

yle

Optium

test str

ips

.

• Use a

test

strip

immediately after removing

from its

f

oil

packet

.

•

Only use a

test

strip

onc

e

.

•

Do

not

use

expired test

strips as

they

may cause

inaccurate

r

esults

.

•

Do

not

use a

w

et

,

ben

t

,

scra

t

ched

,

or

damaged test str

ip

.

•

Do

not

use

the

test

strip if the foil

packet has a hole

or

is

t

orn

.

• Results

from the built-in

meter are shown

only in your

Logbook and

not in other

history

options

.

• Refer

to

your lancing device instructions

for

use

for how

t

o

use your lancing

devic

e

.

41

42

DOC28687_rev-E_manual.indd 41-42 3/30/14 2:52 PM

Step

A

c

tion

2

D5

Check

the

test

strip

expiration

da

t

e

.

13758

2016/03

E

.

g

.

Expiration

date:

March 31,

2016

3

Open

the foil

test

strip

packet

at the notch and

t

ear

down to

remove

the

test str

ip

.

Use

the test

strip

immediately after removing

from the

f

oil

packet

.

4

I

nser

t

the

test

strip with the

three black lines

at

the

end facing up

.

Push

the strip in until it

stops

.

5

Apply Blood

Use your lancing device

to obtain

a

blood drop

and apply

blood to the white

area

at the

end

of

the

test str

ip

.

If

sounds are

turned

on,

the

Reader beeps

once

to let

you

know

you have applied enough blood

.

N

o

te

:

See

t

e

s

t

s

t

r

i

p

i

n

s

t

ru

c

ti

on

s

for

use

for

re-application

i

n

s

t

ru

c

t

i

on

s

.

Blo

S

Abbott Di a b et es C ar e L

t

d.

Range Road

Witney,

Oxon, OX 29 0YL

Made in UK .

Blood Glucose

Testing

You can use

the built-in

meter

to

check your

blood

gluc

ose

,

whether

you

are wearing a

S

ensor

or not

.

You can perform a

blood

glucose

test

on

your

fingertip or

approved alternate sit

e

.

Be sure

to

read

the

test

strip

instructions

for

use

prior to

using

the built-in

met

er

.

Step

A

c

tion

1

CAUTION:

If

you

think

you have lo

w

glucose (hypoglycemia)

or

you suffer

from

hypoglycemia una

w

ar

eness

,

test

on your

fingers

.

Wash your hands and

the

test site

with warm

soapy

water

for

ac

cur

a

t

e

r

esults

.

Thoroughly

dry

your hands and

the

test sit

e

.

To warm

the

sit

e

,

apply a warm

dry

pad

or rub

vigorously

for

a

few

sec

onds

.

N

o

te

:

Avoid areas near bones and

areas

with

l

o

t

s

of

h

a

i

r

.

If

you

get

a

b

ru

i

s

e

,

consider

s

e

l

ec

t

i

n

g

another

s

i

t

e

.

43

44

DOC28687_rev-E_manual.indd 43-44 3/30/14 2:52 PM

Display

What To

Do

Low Glucose

LO

mg dL

High

Glucose

HI dL

If

LO

appears

on the

Reader, your result is

lower

than

20

mg/dL

.

If HI

appears

on the

Reader,

your

result is higher

than

500

mg/dL

.

You can

touch the

message

button for

more

inf

or

ma

tion

.

Check

your

blood

glucose again

with

a

test str

ip

.

If

you

get a

second

LO

or HI

r

esult

,

contact your health

care

professional

imm

e

dia

te

l

y

.

Low Glucose

63

mg

dL

High Glucose

289

mg

dL

If

your glucose is higher

than

240

mg/dL or lower

than

70 mg/dL, you

will

see a message

on the

scr

een

.

You can

touch the

message

button for

more

information

and set a reminder

to check

your

gluc

ose

.

dL

Step

A

c

tion

You

will

see a

butterfly on the

screen

while you

wait for

your

r

esult

.

If

sounds are

turned

on,

the

Reader beeps once when your result is

r

eady

.

6

After reviewing your

r

esult

,

remove and discard

the

used

test

mg

strip

according

to

local

r

egula

tions

.

10:23pm

IMPORTANT:

After performing

a

blood

glucose

t

est

,

wash your hands and

the

test site

with

soap and

water

and

thoroughly dry

them

.

Your Blood Glucose

Results

Blood glucose results are marked

on the

results screen and

in the

Logbook

with the

143

mg

symbol

.

N

o

te

:

C

on

tac

t

your health care

p

ro

f

e

ss

i

on

a

l

if

you have symptoms

that do not

match

your

test

r

es

u

lt

s

.

45

46

DOC28687_rev-E_manual.indd 45-46 3/30/14 2:52 PM

Step

A

c

tion

2

D5

Check

the

test

strip

expiration

da

t

e

.

13758

2016/03

E

.

g

.

Expiration

date:

March 31,

2016

3

Open

the foil

test

strip

packet

at the notch and

t

ear

down to

remove

the

test str

ip

.

Use

the test

strip

immediately after removing

from the

f

oil

packet

.

4

N

o

te

:

Use

only blood

ketone test str

ips

.

Do

not

put

urine

on the

test str

ip

.

I

nser

t

the

test

strip with the

three black

lines

facing up

.

Push

the strip in until it

stops

.

Blo

S

Abbott Di a b et es C ar e L

t

d.

Range Road

Witney,

Oxon, OX 29 0YL

Made in UK .

After you

get

your

blood

glucose

r

esult

,

you can add Notes

by touching

the

symbol

.

If

you

do not want to

add a

Not

e

,

press

the

Home

Button

to go to the

Home

S

creen

or hold the

Home Button

to turn the

Reader

off

.

Blood Ketone

Testing

You can use

the built-in

meter

to

check your

blood ketone

(β

-hy

dr

o

x

ybut

yr

a

t

e)

.

It

is

important to

consider

doing

this

when:

•

You are

sick

•

Your glucose is higher

than

240

mg/dL

•

You and your health care professional decide you

should

N

o

te

:

Be sure

to

read

the

t

e

s

t

s

t

r

i

p

instructions

for

use

prior

t

o

performing a

ketone

t

e

s

t

.

Step

A

c

tion

1

Wash your hands

with

warm soapy water

for

ac

cur

a

t

e

r

esults

.

Thoroughly

dry

your

hands

.

To warm

the

sit

e

,

apply a warm

dry

pad

or rub

vigorously

for

a

few

sec

onds

.

N

o

te

:

Use

only fingertip

samples

for blood

ketone

t

esting

.

47

48

DOC28687_rev-E_manual.indd 47-48 3/30/14 2:52 PM

Step

A

c

tion

5

Apply Blood

Ketone

T

est

Use your lancing device

to obtain

a

blood drop

and apply

blood to the white

area

at the

end

of

the

test str

ip

.

If

sounds are

turned

on,

the

Reader beeps

once

to let

you

know

you have applied enough blood

.

N

o

te

:

See

test

strip

instructions

for

use

for

re-application instruc

tions

.

You

will

see a

butterfly on the

screen

while you

wait for

your

r

esult

.

If

sounds are

turned

on,

the

Reader beeps once when your result is

r

eady

.

6

After reviewing your

r

esult

,

remove and discard

the

used

test

strip

according

to

local

r

egula

tions

.

IMPORTANT:

After performing

a

blood

ketone

t

est

,

wash your hands

with

soap

and water and

thor

oughly

dry

them

.

10:23pm

0

.

4

mmol

Your Blood Ketone

Results

Blood ketone results are marked

on the results

screen and

in the

Logbook

with the word

K

e

t

on

e

.

L

Ketone

T

est

N

o

te

s:

•

Blood ketone is e

xpec

t

ed

to be

lower

than

0

.

6

mmol/L

.

•

Blood ketone may

be

higher when you are sick,

fasting

,

have

exercised

har

d

,

or if

glucose levels are

not

c

on

tr

olled

.

•

If

your

blood

ketone result remains

high or

becomes higher

than

1

.

5

mmol/L, contact your health

care professional

imm

e

dia

te

l

y

.

49

50

DOC28687_rev-E_manual.indd 49-50 3/30/14 2:52 PM

Display

What To

Do

High

Ketone

1.7

mmol

L

Ketone

T

est

If

your

blood

ketone is high, you

will

see

a

message

on the

scr

een

.

You can

touch the

message

button for

more

inf

or

ma

tion

.

High Ketone

HI

mmol

L

Ketone

T

est

If HI

appears

on the

Reader, your ketone result

is

higher

than 8

mmol/L

.

You can

touch the

message

button for

more

inf

or

ma

tion

.

R

epea

t

the ketone

test

with

a

new test str

ip

.

If

you

get

a

second

HI

r

esult

,

contact your health

care

professional

imm

e

dia

te

l

y

.

Control Solution

Testing

You should

do

a

control

solution test when you

are

not

sure

of

your

test

strip

results and

want to

check

that

your Reader

and test

strips are

working

pr

operly

.

You can

do

a

control

solution test

with

a

blood

glucose

or ketone

test str

ip

.

IM

P

O

RT

A

N

T

:

•

Control solution results should

fall within the control

solution range

printed on the

test

strip

instructions

for

use

.

•

Do NOT use

control

solution past

the

expiration

da

t

e

.

Discard

control

solution

3

months after

opening

.

• The

control

solution range is a

target

range

for control

solution only

,

not for

your

blood

glucose

or

ketone

r

esults

.

• The

control

solution test

does

not

reflect your

blood glucose

or

ketone lev

els

.

•

Use

only

MediSense glucose and ketone

control

solution

.

•

Check

that the

LOT

number

printed on the

test

strip

f

oil

packet and instructions

for

use

ma

t

ch

.

• Replace

the

cap securely

on the bottle

immediately after

use

.

•

Do NOT

add water

or other liquid to the control

solution

.

•

C

on

tac

t

Customer

S

er

vic

e

for information on how to obtain

control

solution

.

51

Change MediSense

to Optium for

A

ustr

alia

.

52

DOC28687_rev-E_manual.indd 51-52 3/30/14 2:52 PM

Step

A

c

tion

1

Ends in 14 days

From

the

Home Screen,

touch the

S

ettings

10:23pm

symbol

.

Touch

Control Solution Test

to do

a

control

solution

t

est

.

Check Review

Glucose History

Settings

Sounds

Target Range

Control Solution Test

1

/ 3

2

D5

Check

the

test

strip

expiration

da

t

e

.

13758

E

.

g

.

Expiration

date:

March 31,

2016

3

Open

the foil

test

strip

packet

at the notch and

t

ear

down to

remove

the

test str

ip

.

Step

A

c

tion

4

I

nser

t

the

test

strip with the

three black

lines

facing up

.

Push

the strip until it

stops

.

5

Apply Control Solution

Shake

the control

solution

bottle to mix the

solution

.

Apply a

drop of control

solution

to the

white

area

at the

end

of the

test str

ip

.

If

sounds are

turned

on,

the

Reader beeps

once

to let

you

know that

you have applied

enough

control

solution

.

You

will

see a

butterfly on the

screen

while you

wait for the

r

esult

.

If

sounds are

turned

on,

the

Reader beeps once when

the

result is

r

eady

.

Blo

S

Abbott Di a b et es C ar e L

t

d.

Range Road

Witney,

Oxon, OX 29 0YL

Made in UK .

2016/03

53

54

DOC28687_rev-E_manual.indd 53-54 3/30/14 2:52 PM

L

dL

10:23pm

100

mg

Control Solution

T

est

Blood

Glucose

C

ontr

ol

S

olution

T

est

10:23pm

0.4 mmol

Ketone

Control

Solution

T

est

Control Solution

Results

Compare

the control

solution result

to the

range

printed on the

test

strip instructions

for

use

.

The result

on

your screen should

be

in

this r

ange

.

Control solution results are marked

on

the

results screen and

in the Logbook

with a

symbol

.

N

o

te

:

R

epea

t

the control

solution test

if the

results are outside

of the

range

printed on

the

test

strip

instructions

for

use

.

S

t

op using

the built-in

meter

if the control solution

results are

r

epea

t

edly

outside

of the prin

t

ed

r

ange

.

C

on

tac

t

Customer

S

er

vic

e

.

Using

the

Rapid-Acting Insulin

C

alcula

t

or

This

optional

feature requires an understanding

of the

use

of

insulin

.

Misuse

or

misunderstanding

of

this feature and

the

suggested

dose

may lead

to

inappropriate insulin

dosing

.

The

calcula

t

or

suggests

doses

for

rapid-acting insulin only

.

The

calcula

t

or

is

only for

use

with

fingerstick

blood

glucose results

from the built-in

met

er

.

You

cannot

use

the

insulin

calcula

t

or

with

S

ensor

glucose

r

eadings

.

An access code is

required

to

set

up or

change

the rapid-acting

insulin

calcula

t

or

settings

.

This access code is available

only

to

your health care professional

.

Work

with

your health

care

professional

to

set

up or

change

the

calcula

t

or

for

y

ou

.

If

you are

not

sure

about the

calcula

t

or

’

s

suggested

dose

,

you can adjust

it

based

on

instructions

from

your health care professional

.

K

et

one

C

ontr

ol

S

olution

T

est

55

56

DOC28687_rev-E_manual.indd 55-56 3/30/14 2:52 PM

Step

A

c

tion

2

to log any rapid-acting

E

n

t

er

information about any

Have you

for

got

ten

insulin you have taken

rapid-acting insulin you may

have

since X:XX?

Enter any rapid-

?

forgotten to log

.

Touch

n

ex

t

.

acting insulin you

have

forgotten

to log.

no yes 2

units

How long ago was

?

back

ne

th

x

e

t

unlogged dose

of

rapid-acting insulin?

15

minutes or less

back next

Step

A

c

tion

1

10:23pm

Test your

blood

glucose

on

your

finger

.

T

ouch

143

mg

results

scr

een

.

You can also access

the insulin

calcula

t

or

by touching the

calcula

t

or

icon

Rapid-Acting Insulin

from the

Add

N

o

t

e

s

Insulin Calculator

scr

een

.

CAUTION:

The

rapid-acting insulin

calcula

t

or

cannot

account

for

all

the

fac

t

ors

that

may

aff

ec

t

your insulin

dose

.

These

include incorrectly entered

data, incorrectly set

date

or time

,

un-logged insulin, smaller

or

larger

meals

,

sickness,

e

xer

cise

,

et

c

.

It

is

important that

you review your suggested dose

and

acc

oun

t

for

these fac

t

ors

before

taking

insulin

.

If

you have added a rapid-acting insulin

note to

a glucose result

without

indicating how

much insulin you

t

ook

,

the

calcula

t

or

will not be available

for up to 8

hours

.

Insulin Calculator

from the blood glucose

dL

N

o

t

e

s:

•

You have

up to

15 minutes after testing your

blood

glucose

to

acc

ess

the

calcula

t

or

.

If the

Reader turns

off or if

you have navigated

away

from the

result screen, you can

go to the

Logbook and

touch

add

or

edit

notes

to

access

the

calcula

t

or

from

your last

blood

glucose

en

tr

y

.

•

If

your

blood

glucose result is

below

60 mg/dL,

the

calcula

t

or

is

not

a

vailable

.

•

Do

not

use

control

solution

to obtain

a suggested

dose

.

57

58

DOC28687_rev-E_manual.indd 57-58 3/30/14 2:52 PM

Step

A

c

tion

3

Breakfast If

your

calcula

t

or

was programmed

with

E

as

y

S

etup

,

touch the

meal you plan

to

ea

t

no

w

.

T

ouch

n

ex

t

.

Dinner

No meal

back

Enter Carbs

?

If

your

calcula

t

or

was programmed

with

Advanced

S

etup

,

enter

the

grams

of

20

car

boh

y

dr

a

t

es

or

servings

of carbohydrates

grams

you plan

to

ea

t

no

w

.

Touch

don

e

.

back done

Or

Enter Servings

?

2.0

servings

= 30g carbs

back done

R

emov

e

magenta

content for

F

r

ance

.

Step

A

c

tion

4

Suggested Dose

R

eview

your suggested

dose

.

If

needed

,

use

the

arrow

buttons to

adjust your suggested dose

for

any planned

ac

tivit

y

,

a smaller

or

larger meal

,

12u

sickness,

et

c

.

Touch

the

symbol

to

see

details

User change: of what

is included

in

your suggested

dose

.

+2.0

back log dose

Insulin

to

cover your

meal

Dose

Details

OK

I

n

s

u

li

n

to

c

orr

e

c

t

for

your

current

For breakfast 9

glucose

level

For 143 mg/dL +2

Active insulin -1

I

n

s

ulin

remaining

in

your

body

User change +2

Total 12u

A change you have made

to the

s

u

gg

e

s

t

e

d in

s

ulin d

o

s

e

1

/

2

Your

total

suggested

dose

Lunch Adjust if needed

59

60

DOC28687_rev-E_manual.indd 59-60 3/30/14 2:52 PM

Step

A

c

tion

5

Touch

log dose

to

save

to

your Logbook and take your

dose

.

Your dose is

only

saved

to the

Logbook

if

you

touch

log d

o

se

.

CAUTION:

It

is

important to log

all your

rapid-acting

insulin doses so your Reader can acc

oun

t

for active

insulin when calculating your suggested

doses

.

F

ailur

e

to log

all your rapid-acting insulin doses may result

in a

suggested dose

that

is

too high

.

N

o

te

:

The

total

dose is rounded

up or down to the nearest

whole number unless your health care professional

has

changed your Reader

to count by

half

unit

st

eps

.

10:23pm

Ends in 3 days

Check

Glucose

8:30am

Review

History

If

your health care professional

turned on the Active

I

n

s

u

li

n

f

e

a

t

ur

e

,

the

s

y

mb

o

l

may appear

on your

Home

S

c

r

ee

n

.

It

shows an

e

s

ti

m

a

t

e

of the

amount o

f

rapid-acting

i

n

s

u

li

n

left in

your

body

and

how much

longer

it

may

be

a

c

ti

v

e

.

Touch

the

s

y

mb

o

l

to

s

ee

more

information about the

remaining

rapid-acting

i

n

s

u

li

n

from

your logged

d

o

s

e

s

.

Estimated percentage

of

active insulin remaining

in

your

body

No symbol

100-87% 86-62% 61-37% 36-12% 11-1% 0%

61

62

DOC28687_rev-E_manual.indd 61-62 3/30/14 2:52 PM

Step

A

c

tion

1

Ends in 14 days

To

get to the

S

ettings

menu

,

touch the

S

ettings

10:23pm

symbol on the

Home

S

creen

.

Check Review

Glucose History

Settings

Sounds

Target Range

Control Solution Test

1

/ 3

Charging

the Reader

A

fully

charged Reader

battery should

last

up to 7

day

s

.

Your

battery

life

may vary depending

on

your

usage

.

A

Low Battery

message

acc

ompanies

your result when you have enough charge remaining

for about

one day

of

use

.

Changing

the

Reader

Settings

You can

go to the

S

ettings

menu

to

change many settings

on the

R

eader

,

like Time &

Da

t

e

or

S

ounds

.

The

S

ettings

menu is also where you

go to do

a Control

S

olution

Test

or to

check

the

S

y

st

em

S

ta

tus

.

Char

ging

Plug

the

included

USB cable

into

an

electrical

outlet

using

the

included power adapt

er

.

T

hen,

plug the other

end

of the

USB cable

into the

USB

port on the

R

eader

.

CAUTION:

Be sure

to

selec

t

a location

for

charging

that

allows

the

power adapter

to be

easily

unplugged

.

N

o

t

e

s:

•

You must charge

the

Reader when

the battery

is

low to

keep using

the

R

eader

.

• To

fully

charge

the

ba

tt

er

y

,

charge

the

R

eader

for at

least

3

hours

.

•

Only use

the

USB

cable and power

adapter

included

with the

sy

st

em

.

•

Fully charge your Reader before storing

it for

more

than 3

mon

ths

.

63

64

DOC28687_rev-E_manual.indd 63-64 3/30/14 2:52 PM

Step

A

c

tion

2

(c

ont.)

•

View

E

ven

t

Logs: A

list of

events recorded

by the

Reader, which may

be

used

by

Customer

S

er

vic

e

to help

•

troubleshoot your

S

y

st

em

Perform a Reader Test: The Reader Test

will

perform

internal

diagnostics and allow you

to

check

that the

Display

is

showing all

pix

els

,

S

ounds

(including

both

t

ones

and

vibrations) are

w

or

k

ing

,

and the Touchscreen is

responding

when

touched

Calculator Settings

–

R

eview

the

currently

programmed

settings

(option only

available

if

your health care

professional

has ac

tiv

a

t

ed

your insulin

calculator)

Reader Basics

–

R

eview

the information

screens

shown

during the

Reader

setup

Professional Options

– Set

by

health care professionals

only

Touch

OK

when you are

d

on

e

.

Step

A

c

tion

2

Touch

the

setting you

want to change:

Sounds

– Set

t

ones

and

vibrations

Target

Range

– Set range displayed

on

R

eader

glucose

graphs

Control Solution Test

– Perform a Control

S

olution test

Time & Date

– Change the Time

or Date

Language

– Change

the

language

on the

Reader

(option only

available

on

Readers

with multiple languages)

System Status

– Check Reader

information

and

performance

•

View

S

y

st

em

Information:

The Reader

will

display

information

about

your

S

y

st

em

including:

-

C

urr

en

t

S

ensor

end date and

time

-

Reader serial

number and version

number

-

S

er

ial

numbers

of

most r

ec

en

t

Sensors

(up to three)

-

S

ensor

version

for

most r

ec

en

t

S

ensor

-

Number

of

Sensors

that

have been used

with

R

eader

-

Number

of

t

ests

that

have

been performed using test

strips

65

66

DOC28687_rev-E_manual.indd 65-66 3/30/14 2:52 PM

A

c

tivit

y

What You Need To

Know

Traveling by

Air

Check

with the

airline

prior to

departure

as

rules

and regulations may change

without notic

e

.

F

ollow

these guidelines when

traveling:

•

Notify

security personnel

of the

presence

of the

device when

going through

security

sy

stems

.

•

Do

not

scan your

S

ensor

or

power

on the

R

eader

using

the

Home Button

while flying

,

if restricted

by flight

r

egula

tions

.

You may inser

t

a

strip

t

o

perform a

blood

glucose

or

ketone

t

est

.

N

o

te

:

If

you are changing

time

z

ones

,

you

can

change

the time

and date settings

on the

R

eader

by touching the

S

ettings

symbol from the

Home Screen,

then

Time &

D

at

e

.

Changing

the time

and date

affects

the g

r

aphs

,

sta

tistics

,

and settings programmed

by time of

day

.

T

h

e

s

y

mb

o

l

may appear

on

your glucose

graph

indicating

the

Reader

time

was

ch

a

n

g

e

d

.

Gaps

i

n

the

graph may

r

e

s

u

l

t

or

glucose readings may

be

h

i

dden

.

Living

W

ith

Your FreeStyle Libre

System

Your

F

r

eeS

t

yle

Libre Flash Glucose

Monitoring

S

y

st

em

can

be

used

during

a

wide

variety

of

ac

tivities

.

A

c

tivit

y

What You Need To

Know

Bathing,

Showering,

and

S

w

i

mming

The Reader is

not w

a

t

er

-r

esistan

t

and

should

NEVER

be

submerged

in

water

or other liquid

.

Your

S

ensor

is

w

a

t

er

-r

esistan

t

and can

be worn

while

ba

thing

,

sho

w

er

ing

,

or

swimming

.

N

o

te

:

Do NOT take your

S

ensor

deeper

than

1

meter (3 feet)

or

immerse

it

longer

than 30

minutes

in w

a

t

er

.

Sleeping

Your

S

ensor

should

not

interfere

with

your

sleep

.

It

is recommended

that

you scan your

S

ensor

before

going to

sleep and when you wake

up

because your

S

ensor

holds

8

hours

of

data

at a

time

.

If

you have reminders set

to go off while

you

are

sleeping

,

place

the

Reader

near

b

y

.

67

68

DOC28687_rev-E_manual.indd 67-68 3/30/14 2:52 PM

Problem What It May Mean

What To

Do

Reader does

not

power

on after

you press

the

Home Button

or

inser

t

a

test str

ip

.

Reader

battery

is

too low

.

Charge

the

R

eader

.

Reader is outside

of

its operating

temperature r

ange

.

Move

the

Reader

to a

temperature

between

10 °C and 45 °C and

then

try to

power

it

on

.

Maintenance and

Disposal

C

leaning

You may clean

the

Reader using a

cloth

dampened

with

a mixture

of

1 part

household bleach

to 9

parts

w

a

t

er

.

Gently

wipe the

exterior

of

the

Reader and allow

to

air dr

y

.

CAUTION:

Do NOT place

the

Reader

in

water

or other

liquids

.

Avoid

getting

dust

,

dir

t

,

blood

,

control

solution,

w

a

t

er

,

or any

other

substance

in the

test

strip or

USB por

ts

.

Maintenance

The

F

r

eeS

t

yle

Libre Flash Glucose

Monitoring

S

y

st

em

has

no

ser

vic

eable

par

ts

.

Disposal

This

product

should

be

disposed

of in

accordance

with

all applicable

local

regulations

r

ela

t

ed

to the

disposal

of

electronic

equipmen

t

,

ba

tt

er

ies

,

sharps, and

ma

t

er

ials

potentially

exposed

to body

fluids

.

C

on

tac

t

Customer

S

er

vic

e

for further information on the appropriate

disposal

of

system

c

omponen

ts

.

Troubleshooting

This section lists problems

or

observations

that

you may

ha

v

e

,

the possible

cause(s),

and recommended

ac

tions

.

If the

Reader experiences an

er

ror

,

a

message

will

appear

on the

screen

with

directions

to

resolve

the

er

ror

.

Reader Does

Not

Power

On

If the

Reader

still

does

not

power

on

after

trying

these st

eps

,

contact

Customer

S

er

vic

e

.

69

70

DOC28687_rev-E_manual.indd 69-70 3/30/14 2:52 PM

Problem What It May Mean

What To

Do

The

S

ensor

is

not sticking

to

your

sk

in

.

The site is

not free

of dir

t

,

oil

,

hair

,

or

sw

ea

t

.

1

.

R

emov

e

the

S

ensor

.

2

.

Consider shaving

and/or

cleaning

the

site

with soap

and

w

a

t

er

.

3

.

F

ollow the

instructions

in

Applying and Starting

Y

our

S

ensor

sec

tions

.

Skin

ir

rita

tion

at the

S

ensor

application

sit

e

.

Seams

or other

constrictive

clothing

or accessories

causing

friction at

the

sit

e

.

Ensure

that nothing

rubs

on the

sit

e

.

You may

be

sensitiv

e

to the adhesive

ma

t

er

ial

.

If the irritation

is where

the

adhesive

t

ouches

skin,

contact

your health care professional

t

o

identify the

best

solution

.

Problems

at the

Sensor Application

Site

Problems Starting Your Sensor

or

Receiving

Sensor

Readings

Display What It May Mean

What To

Do

New

S

ensor

S

tar

ting

Up

S

ensor

is

not ready

to

read

gluc

ose

.

Wait

until the

60

minute

S

ensor

start-up period

has c

omplet

ed

.

S

can

T

imeout

The Reader is

not

held

close

enough

to the

S

ensor

.

Hold

the

Reader

within

4

cm

(1

.

5

inches)

of the

S

ensor

.

Bring

the

screen

of the

R

eader

close

to the

S

ensor

.

S

e

n

so

r

Ended

The

S

e

n

s

or

life

h

a

s

ende

d

.

Apply and

s

t

a

r

t

a new

S

e

n

s

or

.

71

72

DOC28687_rev-E_manual.indd 71-72 3/30/14 2:52 PM

Display What It May Mean

What To

Do

Glucose

R

eading

Una

vailable

Your

S

ensor

is

t

oo

hot or too

c

old

.

Move

to

a location where

the

temperature

is

appropriate

and

scan again

in

a

few minut

es

.

S

ensor

Already

in

Use

The

S

ensor

w

as

star

t

ed

by another

R

eader

.

A

S

ensor

can

only be scanned

by the

Reader

that

star

t

ed

it

.

Scan

the

S

ensor

again

with the

Reader

that

star

t

ed

it

.

Or,

apply

and

star

t

a new

S

ensor

.

Check

S

e

n

s

or

The sensor

tip may

not be

under

your

sk

i

n

.

Try

to

s

t

a

r

t

your

S

e

n

s

or

a

g

a

i

n

.

If

Reader displays “Check

S

e

n

s

or

”

a

g

a

i

n

,

your

S

e

n

s

or

was

no

t

applied pro

p

e

rly

.

Apply

and

s

t

a

r

t

a new

S

e

n

s

or

.

R

e

p

l

a

ce

S

e

n

so

r

The

S

y

s

t

e

m

h

a

s

detected

a

problem

with

your

S

e

n

so

r

.

Apply and

s

t

a

r

t

a new

S

e

n

s

or

.

Display What It May Mean

What To

Do

New

S

e

n

s

or

Found

You scanned a

new

S

e

n

s

or

before

your

pr

e

v

i

ou

s

S

e

n

so

r

ende

d

.

Your Reader can

only be

u

s

e

d

with

one

S

e

n

s

or

at

a

ti

m

e

.

If

you

s

t

a

r

t

a new Sensor, you

w

ill

no

longer

be

able

to

scan

your

old

S

e

n

s

or

.

If

you

would

like

t

o

begin

u

s

i

n

g the

new

S

e

n

s

or

,

s

e

l

ec

t

“

Y

es”

.

Scan

E

rror

The Reader

w

a

s

unable

t

o

communicate

w

ith

the

Se

n

so

r

.

Try scanning

a

g

a

i

n

.

N

o

te

:

You may need

to move

away

from potential

sources

of

electromagnetic

in

t

er

f

erenc

e

.

S

e

n

so

r

E

rror

The

S

y

s

t

e

m

i

s

unable

to

provide

a

glucose re

a

ding

.

Scan again

in

10 m

i

nu

t

e

s

.

73

74

DOC28687_rev-E_manual.indd 73-74 3/30/14 2:52 PM

Err

or

M

essage

What It May Mean

What To

Do

E-3

Blood

drop

is

t

oo

small

.

or

I

nc

orr

ec

t

test

pr

oc

edur

e

.

or

There may

be a

problem

with the t

est

str

ip

.

1

.

R

e

v

i

e

w the

t

e

s

ti

n

g

i

n

s

t

ru

c

t

i

on

s

.

2

.

R

epea

t

the

test using

a

new

test str

ip

.

3

.

If the

error

r

eappears

,

contact

Customer

S

er

vic

e

.

E-4

The

blood glucose

level may

be too high

to be

read

by the

sy

st

em

.

or

There may

be a

problem

with the t

est

str

ip

.

1

.

R

e

p

e

a

t

the

t

e

s

t

u

s

i

n

g

a

new

te

s

t

s

t

r

i

p

.

2

.

If the

error

r

eappears

,

contact

your health care

professional

imm

e

dia

te

l

y

.

Blood Glucose

or

Ketone Error

Messages

Err

or

M

essage

What It May Mean

What To

Do

E-1

The

temperature

is

too hot or too cold

for the

Reader

t

o

work

c

orr

ec

tly

.

1

.

Move

the

Reader and

t

e

s

t

s

t

r

i

p

s

to

a location where

the

temperature

is

within the

t

e

s

t

s

t

r

i

p

operating r

a

n

g

e

.

(

S

ee

t

e

s

t

s

t

r

i

p

i

n

s

t

ru

c

ti

on

s

for

u

s

e

for the

appropriate r

a

n

ge

)

.

2

.

Wait

for the

Reader and

test

strips

to

adjust

to the new

t

emper

a

tur

e

.

3

.

R

epea

t

the

test using

a

new

test str

ip

.

4

.

If the

error

r

eappears

,

contact

Customer

S

er

vic

e

.

E-2

Reader

er

ror

.

1

.

Turn

off the

R

e

a

d

e

r

.

2

.

R

epea

t

the

test using

a

new

test str

ip

.

3

.

If the

error

r

eappears

,

contact

Customer

S

er

vic

e

.

75

76

DOC28687_rev-E_manual.indd 75-76 3/30/14 2:52 PM

Err

or

M

essage

What It May Mean

What To

Do

E-7

T

e

s

t

s

t

r

i

p

may

be

d

a

m

a

g

e

d

,

u

s

e

d

,

or

the

Reader does

no

t

recognize

it

.

1

.

Check

that

you are

u

s

i

n

g

the

c

orr

ec

t

e

s

t

s

t

r

i

p for

the

R

e

a

d

e

r

.

(See

t

e

s

t

s

t

r

i

p

i

n

s

t

ru

c

ti

on

s

for

use

to verify

your

s

t

r

i

p

is compatible

w

ith

the

R

e

ader

)

.

2

.

R

epea

t

the

test using

a

test

strip for

use

with

your

R

eader

.

3

.

If the

error

r

eappears

,

contact

Customer

S

er

vic

e

.

E-9

Reader

er

ror

.

1

.

Turn

off the

R

e

a

d

e

r

.

2

.

R

epea

t

the

test using

a

new

test str

ip

.

3

.

If the

error

r

eappears

,

contact

Customer

S

er

vic

e

.

Err

or

M

essage

What It May Mean

What To

Do

E-5

Blood was

applied

to the

test

strip

t

oo

soon

.

1

.

R

e

v

i

e

w the

t

e

s

ti

n

g

i

n

s

t

ru

c

t

i

on

s

.

2

.

R

epea

t

the

test using

a

new

test str

ip

.

3

.

If the

error

r

eappears

,

contact

Customer

S

er

vic

e

.

E-6

The

test

strip

may

not

be

compatible

with

the

R

eader

.

1

.

Check

that

you are

u

s

i

n

g

the

c

orr

ec

t

e

s

t

s

t

r

i

p for

the

R

e

a

d

e

r

.

(See

t

e

s

t

s

t

r

i

p

i

n

s

t

ru

c

ti

on

s

for

use

to verify

your

s

t

r

i

p

is compatible

w

ith

the

R

e

ader

)

.

2

.

R

epea

t

the

test using

a

test

strip for

use

with

your

R

eader

.

3

.

If the

error

r

eappears

,

contact

Customer

S

er

vic

e

.

77

78

DOC28687_rev-E_manual.indd 77-78 3/30/14 2:52 PM

Problem What It May Mean

What To

Do

The

test

does

not

star

t

after

applying

the blood

sample

.

Blood sample is

t

oo

small

.

1

.

See

t

e

s

t

s

t

r

i

p

i

n

s

t

ru

c

ti

on

s

for

use

for re-application

i

n

s

t

ru

c

t

i

on

s

.

2

.

R

e

p

e

a

t

the

t

e

s

t

u

s

i

n

g

a

new

te

s

t

s

t

r

i

p

.

3

.

If the

t

e

s

t

s

ti

ll

does

not

s

t

a

r

t

,

contact

C

u

s

t

o

m

e

r

S

e

r

v

i

ce

.

S

ample

applied

aft

er

the

Reader

turned

off

.

1

.

R

e

v

i

e

w the

t

e

s

ti

n

g

i

n

s

t

ru

c

t

i

on

s

.

2

.

R

e

p

e

a

t

the

t

e

s

t

u

s

i

n

g

a

new

te

s

t

s

t

r

i

p

.

3

.

If the

t

e

s

t

s

ti

ll

does

not

s

t

a

r

t

,

contact

C

u

s

t

o

m

e

r

S

e

r

v

i

ce

.

Problem

with

Reader

or

test str

ip

.

1

.

R

e

p

e

a

t

the

t

e

s

t

u

s

i

n

g

a

new

te

s

t

s

t

r

i

p

.

2

.

If the

t

e

s

t

s

ti

ll

does

not

s

t

a

r

t

,

contact

C

u

s

t

o

m

e

r

S

e

r

v

i

ce

.

Problems Checking Your Blood Glucose

or Ketone

Problem What It May Mean

What To

Do

The

R

eader

does

not

star

t

a

test

after

inserting

a

test str

ip

.

Test

strip

is

not

inser

t

ed

correctly

or not

inser

t

ed

fully

into the strip por

t

.

1

.

With the 3

black lines

facing

up

,

inser

t

the

test

strip in

t

o

the strip port until it

stops

.

2

.

If the

Reader

still

does

not

star

t

a

t

est

,

contact

C

ust

omer

S

er

vic

e

.

Reader

battery

is

t

oo

l

o

w

.

Charge

the

R

eader

.

The

test

strip is

damaged

,

used

,

or

unrecognizable

by

the

R

eader

.

I

nser

t

a new

F

r

eeS

t

yle

P

r

ecision/

F

r

eeS

t

yle

Optium

test str

ip

.

Reader is outside

of

its operating

temperature r

ange

.

Move

the

Reader

to a

temperature between 10

°C

and

45 °C and

then try to

power

it

on

.

Reader is

in

a

power

saving

mode

.

Press

the

Home Button

then

inser

t

a

test str

ip

.

79

80

DOC28687_rev-E_manual.indd 79-80 3/30/14 2:52 PM

Professional

Options

Perform

a

Reader

Test

Professional

Options

System Status OK

System

Info

Reader Test

Event Log

If

you

think the

Reader is

not working p

ro

p

e

r

l

y

,

you

can check

the

Reader

by

performing

a Reader

T

e

s

t

.

Touch

the

O

p

ti

on

s

y

mb

o

l

from the Home

Screen,

selec

t

System Status

and

then

s

e

l

ec

t

Reader

T

e

s

t

.

N

o

te

:

The Reader Test

will

perform

internal

diagnostics and

will

allow you

to

check

that the

This section is

only

meant

for

health care prof

essionals

.

It

describes

the

access

code-protected

features

of the

R

eader

.

Health care prof

essionals

can change dose increments

or

set

up the

insulin

calcula

t

or

.

From

the

Home Screen,

touch

the

S

ettings

symbol

.

S

cr

oll

display

,

sounds

,

and

t

ouchscreen

are

working

pr

operly

.

System Status

Calculator

Set

tings

Enter Code to Unlock down

using

the

arrows and

touch

Professional

O

p

t

i

o

n

s

.

En

t

er

the

A

Reader

Basics

B

Professional Options

C

1 Professional OK

2 Options

Dose

Increment

3

Insulin Calculator

access

c

ode

.

cancel done

Customer

Service

Customer

S

er

vic

e

is available

to

answer any questions you may have

about

your

F

r

eeS

t

yle

Libre Flash Glucose

Monitoring

S

y

st

em

.

Please

go the back

cover

of

this manual

for

your Customer

S

er

vic

e

phone number

.

81

N

o

te

:

If

you are a health care professional

,

contact

Customer

S

er

vic

e

for

more

inf

or

ma

tion

.

82

DOC28687_rev-E_manual.indd 81-82 3/30/14 2:53 PM

Professional

Options

Professional

Options

+

Changing Dose

Increments

You can set

the

insulin dose increments

to

either

1

.

0

or

0

.

5

units

for use

with the

R

apid-ac

ting

insulin

calcula

t

or

and insulin

not

es

.

Setting

up the

Insulin

C

alcula

t

or

The insulin calcula

t

or

can

help

your patients

calcula

t

e

their rapid-acting

insulin doses based

on

meal and fingerstick

blood

glucose

level

inf

or

ma

tion

.

From

the

Professional Options

screen, selec

t

Insulin

Dose

Increment

?

1

unit

0.5

unit

done

From

the

Professional Options

screen,

select

Dose

In

c

rem

e

n

t

.

Then choose

1 unit or 0.5 unit

.

Touch

don

e

.

C

alcula

t

or

.

CAUTION:

This

feature requires an understanding

of the use

of

insulin

.

Misuse

or

misunderstanding

of

this feature and

the

suggested dose may lead

to

inappropriate insulin

dosing

.

T

he

calcula

t

or

suggests doses

for

rapid-acting insulin only

.

Complete

the

setup

to

store your pa

tien

t

’

s

individual

insulin settings

in

the

R

eader

.

The

calcula

t

or

uses

the

fingerstick

blood

glucose

r

esults

,

meal

information

and

the

stored settings

to

calcula

t

e

a suggested insulin

dose

based

on

this

formula:

Blood glucose

c

orr

ec

tion

(if

needed)

Meal

|

C

ar

b

ohy

dr

a

t

e

Intake

Active

Insulin

(if present)

T

otal

=

suggest

ed

dose

83

84

DOC28687_rev-E_manual.indd 83-84 3/30/14 2:53 PM

Step

A

c

tion

1

Choose Setup Option

Choose

the

Easy

option on the

slide bar

and

touch

n

ex

t

.

Easy

For

patients

who

star t with

a

N

o

te

:

You need

to know

your pa

tien

t

’

s

fixed

dose of

r

apid-acting

insulin at

meals.

meal-time insulin

doses,

target

glucose

r

ange

,

and correction

fac

t

or

.

back

Breakfast

?

En

t

er

the

meal-time rapid-acting insulin

doses

.

Touch

each

en

tr

y

.

4

units of

insulin

back

Correction Target

?

E

n

t

e

r

the blood

glucose

Correction

T

a

rge

t

.

T

his

is

the

desired

target

range

for blood glucose

mg

values before meals

.

Touch

n

ex

t

.

70 to 130 dL

N

o

te

:

If

you just

want to

set one

target instead

of

a

r

ange

,

set

both the low

and

high

values

t

o

back next the

same

number

.

Professional

Options

Professional

Options

You can set

up the

insulin

calcula

t

or

using

the

Easy

or Advanced

settings

.

The Easy

S

etup

is

for

patients

who

star

t

with

a fixed dose

of

rapid-acting insulin

for

meals

.

The Advanced

S

etup

is

for

patients

who

count

car

boh

y

dr

a

t

es

(in

grams

or

servings)

to

adjust

their rapid-acting

insulin dose

for

meals

.

You must complete all

of the

steps

in the

insulin

calcula

t

or

setup

in order

for the patient to

use

the

calcula

t

or

.

When you have finished setting up

the

insulin

calcula

t

or

,

you can review

the

settings

to

make sure

they are

c

orr

ec

t

for

your pa

tien

t

.

You can also review settings

at

a

later time

.

T

ouch

the

S

ettings

symbol from the

Home Screen,

then

selec

t

C

a

lc

ula

t

o

r

S

e

tt

i

n

gs

.

Easy Setup

of the

Insulin

C

alcula

t

or

IMPORTANT:

If the time on the

Reader is wr

ong

,

this may

lead

to

an incorrect suggested

dose

.

R

emov

e

magenta

content for

F

r

ance

.

85

86

DOC28687_rev-E_manual.indd 85-86 3/30/14 2:53 PM

10

Professional

Options

Professional

Options

Step

A

c

tion

Notes about

the

Easy

O

p

t

i

o

n

:

• The

calcula

t

or

estima

t

es

the amount of

rapid-acting insulin

still in the

4

Correction Factor

?

1 u

insulin

for

mg

dL

back

o

t

e

s:

En

t

er

the

Correction Factor

(for example:

if

1

unit

of

insulin lowers

blood

glucose 50 mg/dL,

then

the

correction factor

is

50)

.

If the blood

glucose

value

is outside

the blood

glucose

tar

get

,

the

calcula

t

or

will

use

the

correction target and

factor

t

o

calcula

t

e

a correction dose

.

body

and

how

much longer

it

may

be

active

(if the

correction factor

is

set

to “no

correction

insulin

”

,

active insulin is

not

calcula

t

ed)

.

The

active

insulin

estima

t

e

is based

on

a 4-hour insulin

duration

calcula

t

ed

from

the time

and

amount of the

last logged rapid-acting insulin

dose

.

•

Both meal and correction doses are included

in the

active

insulin

tr

ack

ing

.

•

Insulin doses

calcula

t

ed

0-2

hours after

a previously logged

dose

•

If

your

patient

does

not

take correction insulin,

touch the

down

arrow

to go below 1 to

set

“No correction

insulin

”

.

If you

set

“No correction

insulin

”

,

the

calcula

t

or

only

includes

meal

doses

.

A

dditionally

,

active insulin is

not

tracked

or

calcula

t

ed

.

• The

calcula

t

or

corrects a

blood

glucose value

to the single

target or the

average

of the target

r

ange

.

• The

calcula

t

or

will not

suggest a dose

that

is

estima

t

ed

t

o

drop the blood

glucose

below the

lower end

of the target

range

or

single

tar

get

.

Touch

n

ex

t

.

Then

touch

done

to

complete

the

setup

.

You

can

now

review

the

calcula

t

or

settings

.

Touch

OK

when

done

.

will only

include a meal dose

.

Active insulin

will not be subtracted

from the

meal

or

car

boh

y

dr

a

t

e

dose

,

and a correction dose

will not

be

included even

if the blood

glucose is outside

the

tar

get

.

During

this

time

per

iod

,

the

previous dose has

not

reached peak action

and

additional correction

doses, referred

to

as `insulin

stack

ing

’

,

may

result

in

hypogly

c

emia

.

•

Insulin doses

calcula

t

ed

2-4

hours after

a previously logged dose

will

have active insulin

subtr

ac

t

ed

from the

suggested

dose

.

•

All

previously injected rapid-acting insulin should

be

logged

to

ensur

e

ac

cur

a

t

e

active insulin tracking and

calcula

tions

.

87

88

DOC28687_rev-E_manual.indd 87-88 3/30/14 2:53 PM

Professional

Options

Professional

Options

Calculator Settings

-

Easy

Option

This page can

be

used

to

record insulin

calcula

t

or

settings

.

Advanced Setup

of the

Insulin

C

alcula

t

or

Step

A

c

tion

Breakfast

Dose

units of insulin

Lunch

Dose

units of insulin

Dinner

Dose

units of insulin

This is

the insulin

required

to

cover

f

ood

.

1 Choose Setup Option

Advanced

For

patients

who

count

ca

rbs

(in

gra ms or servings) to a

djust

their rapid-acting insulin dose

at meals.

Choose

the

Advanced

option on the

slide

bar

and

touch

n

ex

t

.

N

o

te

:

You need

to know

your pa

tien

t

’

s

meal-

time

insulin

settings

,

target

glucose

r

ange

,

correction

fac

t

or

,

and insulin

dur

a

tion

.

0-50

0-50 0-50 back

Target

_

mg/dL mg/dL

70-180

Correction

Factor

This is

the

desired

range

for

before meal

blood

gluc

ose

.

This is

the estimated

2 Enter food by:

?

Grams of carbs

Servings

Touch

to

s

e

l

ec

t

how meal/carbohydrate

information will be

en

t

er

ed

.

Touch

n

ex

t

.

For

Grams

of

carbs

,

go to

S

t

ep

3

.

For

S

e

rv

i

n

gs

,

go to

S

t

ep

4

.

1 unit of insulin for

mg/dL

1-99

(or No

Correction)

amount blood glucose

will drop by taking one

unit of

insulin

.

back

to

these settings can

only be

made

by

a health care prof

essional

.

For France: remove

S

t

ep

2 & 4 and magenta

content in

S

t

ep

3

.

R

enumber

steps

.

89

90

DOC28687_rev-E_manual.indd 89-90 3/30/14 2:53 PM

Step

A

c

tion

4

Servings

Definition

?

If

you chose

to

enter Servings in Step 2:

T

he

1 serving =

rapid-acting insulin dose suggestion is based

on

10.0

ser

vings

.

grams carbs

En

t

er

the

Servings Definition

(10

to 15

Servings

Ratio

?

grams

of

carbs) and

touch

n

ex

t

.

En

t

er

the

back

Servings Ratio

(

units

of rapid-acting

1.5

insulin per

1

ser

ving)

.

Touch

units

insulin

c

omplet

e

.

Optional: by time

of day

back next

Servings ratio

?

2 u ins

N

o

te

:

If

you

want to

set

different serving

morning

ratios

for different

times

of

day

,

touch the

3 u ins 3 u ins

night midday option

by time

of

da

y

.

Touch each

time

4 u ins

evening

period

to

change

the

servings

r

a

tio

.

T

ouch

Servings Ratio OK

back done

OK

after

each entry

to

sa

v

e

.

Touch

done

.

For 1 serving:

2

Morning:

4am to 10am

Professional

Options

Professional

Options

Step

A

c

tion

3

Carbohydrate Ratio

?

If

you chose

to

enter Grams

of

carbs in Step

2

:

1 u

insulin

for

The rapid-acting insulin dose suggestion is

based

10 on

grams

of

car

bs

.

grams carbs

Optional: by time

En

t

er

the

Carbohydrate Ratio

(1

unit of rapid-

of day

acting insulin

for

grams

of

carbs)

.

T

ouch

back

when

c

omplet

e

.

Carbohydrate ratio

?

1 unit insulin for:

10g

Note:

If

you

want to

set

different

morning

15g 15g

car

boh

y

dr

a

t

e

ratios

for different times

night midday

20g of

day

,

touch the option

by time

of

da

y

.

eveniCnagrbohydrate OK

Ratio

Touch each

time

period

to

change

the

back done 1 u

insulin

for

10

car

boh

y

dr

a

t

e

r

a

tio

.

Touch

OK

after

each

grams carbs

entry

to

sa

v

e

.

Touch

done

.

Morning:

4am to 10am

Go

to

S

t

ep

5

.

Time

of

day blocks can

not be

adjusted

.

They correspond

to the

following times:

Morning

4:00 AM

-

9:59 AM (04:00

-

09:59)

Midday

10:00 AM

-

3:59 PM (10:00

- 15:59)

Evening

4:00 PM

-

9:59 PM (16:00

- 21:59)

Night

10:00 PM

-

3:59 AM (22:00

-

03:59)

for 1 serving:

units

insulin

91

92

DOC28687_rev-E_manual.indd 91-92 3/30/14 2:53 PM

Step

A

c

tion

5

How does your

?

S

elec

t

how

you

want

your

patient to

c

orr

ec

t

their

patient correct

their

glucose?

gluc

ose

.

Touch

n

ex

t

.

To a single

tar

get

To a target

r

ange

back

Correction Target

?

En

t

er

the

Correction Target

value

or

r

ange

.

T

his

100

is

the

desired

target

value

or

range

for blood

glucose values before meals

.

Touch

mg/dL

c

omplet

e

.

Optional: by

time

of day

back Corre

nc

e

t

x

io

t n Target

?

in mg/dL:

N

o

te

:

If the

Correction Target

is

100

morning

based

on time of

day

,

touch the

120 110

night midday option

by time

of

d

ay

.

Touch

each

100 time

period

to

change

the correction

evening

back Corr

d

e

o

cn

ti

e

on Target OK target for that

per

iod

.

Touch

OK

after

each entry

to

sa

v

e

.

Touch

don

e

.

100

mg/dL

Morning:

4am to 10am

10

Professional

Options

Professional

Options

Step

A

c

tion

7

Correction Factor

?

1 u insulin

for

mg

dL

En

t

er

the

Correction Factor

(for example:

if 1

unit of

insulin lowers

blood

glucose 50

mg/dL,

then the

correction factor

is

50)

.

If the blood

glucose reading is outside

the blood glucose

Optional:

Correction factor

by time

of day

?

tar

get

,

the

calcula

t

or

will

use

the correction

1 u insulin

f

b

oa

r

c:

k next

10 mg/dL

morning

target

and factor

to

calcula

t

e

a correction dose

.

Touch

c

omplet

e

.

20 mg/dL

night

20 mg/dL

midday

15 mg/dL

evening

back done

Correction Factor OK

1 u

insulin

for

mg

dL

Morning:

4am to 10am

N

o

t

e

s:

•

If the

Correction

F

ac

t

or

is based

on time of

day

,

touch the option

by time

of

da

y

.

T

ouch

each

time

period

to

change

the correction

factor

for that

per

iod

.

Touch

OK

after

each

entry

to

sa

v

e

.

Touch

done

.

• The

calcula

t

or

corrects a

blood

glucose

v

alue

to the

single

target or the

average

of the

target

r

ange

.

• The

calcula

t

or

will not

suggest a dose

that

is

estima

t

ed

to drop the blood

glucose

below

the

lower end

of the target

range

or single

tar

get

.

93

94

DOC28687_rev-E_manual.indd 93-94 3/30/14 2:53 PM

Step

A

c

tion

9

Do you want the

?

S

elec

t

whether

or not to

show

the

Active

Insulin

Active Insulin symbol

to be displayed on the symbol on the

Home

S

creen

.

Home Screen?

Yes

This symbol shows an

estima

t

e

of the

amoun

t

No of

rapid-acting insulin

still in the body

and

how

much longer

it

may

be

ac

tiv

e

.

If

you

selec

t

“No

”

,

back next

active insulin is

still

included

in the

suggested

dose calcula

tion

.

Touch

n

ex

t

.

Then

touch

done

to

complete

the

setup

.

You can

now

review

the

calcula

t

or

settings

.

Touch

OK

when

done

.

Professional

Options

Professional

Options

Step

A

c

tion

8

Insulin Duration

?

En

t

er

the

Insulin

Dur

a

tion

.

This is

the amount of

time that

rapid-acting insulin remains active

in

4:30 the

pa

tien

t

’

s

body

.

hrs:min

Touch

n

ex

t

.

back

In

gener

al

,

the

insulin

duration for rapid-

acting insulin ranges

from

3-5

hours

,

and can vary

for

each

person

1

.

The Reader allows an insulin

duration

from

3-8

hours

.

1

P

roduc

t

Inserts: HumaLog®, NovoLog®,

A

pidr

a®

95

96

DOC28687_rev-E_manual.indd 95-96 3/30/14 2:53 PM

Professional

Options

Professional

Options

% active insulin

Notes about

the

Advanced O

p

t

i

o

n

:

• The

calcula

t

or

estima

t

es

the amount of

rapid-acting insulin

still in

the body

and

how

much longer

it

may

be

ac

tiv

e

.

The active

insulin

estima

t

e

is

calcula

t

ed

from the

set insulin duration,

the time

,

and

amount of the

last logged rapid-acting insulin

dose

.

•

Both meal and correction doses are included

in the

active

insulin

tr

ack

ing

.

•

Insulin doses

calcula

t

ed

0-2

hours after

a previously logged

dose

will only

include a meal dose

.

Active insulin

will not be subtracted

from the

meal

or

car

boh

y

dr

a

t

e

dose

,

and a correction dose

will not

be

included even

if the blood

glucose is outside

the

tar

get

.

During

this

time

per

iod

,

the

previous dose has

not

reached peak action

and

additional correction

doses, referred

to

as `insulin

stack

ing

’

,

may

result

in

hypogly

c

emia

.

•

Insulin doses

calcula

t

ed

between

2

hours and

the

set insulin

duration

will

have active insulin

subtr

ac

t

ed

from the

suggested dose

(for

example

if

insulin

duration

is set

at 5

hours

,

active insulin

will be

subtr

ac

t

ed

from

doses

calcula

t

ed

between 2-5

hours)

.

•

All

previously injected rapid-acting insulin should

be

logged

to ensure

ac

cur

a

t

e

active insulin tracking and

calcula

tions

.

This graph shows

how the

insulin

calcula

t

or

estima

t

es

the amount of

active insulin as a

function of

logged insulin dose and insulin

duration

over time

.

It

also shows

the

relationship between

the

symbol

and

amount of

active

insulin

.

Active insulin curvilinear

model

100

90

80

70

60

50

40

30

20

10

0

10 20 30 40 50 60 70 80 90 100

% insulin

dur

a

tion

Adapted

from

Mudaliar

et

al

.

Diabetes Care,

Volume 22(9),

S

ept

1999,

pp 1501-1506

97

98

DOC28687_rev-E_manual.indd 97-98 3/30/14 2:53 PM

Professional

Options

Professional

Options

Calculator Settings

-

Advanced

Option

This page can

be

used

to

record insulin

calcula

t

or

settings

.

Correction

Factor

1 unit of insulin for

This is

the

estima

t

ed

amount blood

glucose

will drop by taking one

unit of

insulin

.

(Option

to

enter

by

Carbohydrate

Ratio

1 unit of insulin for

grams

of

carbs

OR

1-50

Servings

Definition

grams

of

carbs

10-15

This is

the

number

of

grams

of

carbs

that

one

unit of rapid-acting

insulin

will

cover OR

the number

of

units

of

rapid-acting insulin tha

t

will

cover one

ser

ving

.

(Option

t

o

enter

by time of

day

.

)

Servings Ratio

For

1

serving

take

units of insulin

0.5-15

mg/dL

1-99

Insulin Du

r

a

tion

Insulin is active

in the body

f

or

hours:mins

3-8

time of

day

.

)

This is

the amount of time

tha

t

a dose

of

rapid-acting

insulin

remains active

in the

body

.

Correction

Target

mg/dL

70-180

OR

Correction

Target

Range

to

This is

the

desired

target or range

for

before meal

blood

gluc

ose

.

(Option

to

enter

by time of

day

.

)

Active Insulin

f

ea

tur

e?

Yes

No

mg/dL mg/dL

70-180

99

R

emov

e

magenta

content for

F

r

ance

.

Changes

to

these settings can

only be

made

by

a health care prof

essional

.

100

DOC28687_rev-E_manual.indd 99-100 3/30/14 2:53 PM

Step

A

c

tion

1

From

the

Home Screen,

touch the

S

ettings

System Status symbol

.

S

cr

oll down

using

the

arrows

and

touch

Professional

Options

.

En

t

er

the

acc

ess

Calculator

Set

tings

c

ode

.

Touch

Insulin

C

alcula

t

or

.

Reader Basics

Professional Options

2

Calculator Settings

Touch

Turn Off Calculator

to turn off the insulin

calcula

t

or

Change Calculator Settings

t

o

Turn Off Calculator

change

the

insulin

calcula

t

or

settings

.

Change Calculator

Set

tings

N

o

te

:

If

you

turn off the

insulin

calcula

t

or

,

your

patient will no

longer see

the calculator

back button

after

a

blood

glucose

t

est

.

You can

tur

n

the

calcula

t

or

back

on by

repeating

the insulin

calcula

t

or

setup

.

Professional

Options

Changing

the

Insulin Calculator

Settings

System

Specifications

See

test

strip

and

control

solution instructions

for

use

for additional

specifica

tions

.

Sensor

Specifications

Sensor glucose

assa

y

method

Amperometric electrochemical

sensor

Sensor glucose

reading

range

40

to

500

mg/dL

Sensor

size

5 mm height

and 35

mm diameter

Sensor

weight

5 grams

Sensor power sour

c

e

One silver oxide

battery

101

102

DOC28687_rev-E_manual.indd 101-102 3/30/14 2:53 PM

Sensor

life

Up

to

14

day

s

Sensor

memory

8

hours (glucose readings stored

every

15

minutes)

Operating

temperature

10 °C

to

45 °C

Sensor Applicator

and

Sensor Pack

storage

temperature

4

°C

to

30 °C

Operating and

st

orage

relative

humidity

10-90%,

non-condensing

Sensor water

resistance

IP27: Can

withstand

immersion

in

t

o

one meter (3

ft) of

water

for up to 30

minutes

Operating and

st

orage

altitude

-381 meters (-1,250

ft) to

3,048

meters

(10,000

f

t)

Reader

Specifications

Blood glucose

assa

y

range

20

to

500

mg/dL

Blood ketone assay

range

0

.

0

to

8

.

0

mmol/L

Reader

size

95

mm x

60

mm x

16

mm

Reader

weight

65

grams

Reader power

sour

c

e

One

lithium-ion

rechargeable

battery

Reader battery

life

7

days

of

typical

use

Reader

memory

90 days

of

typical

use

Reader

operating

temperature

10 °C

to

45 °C

Reader

storage

temperature

-20 °C

to

60 °C

103

104

DOC28687_rev-E_manual.indd 103-104 3/30/14 2:53 PM

Operating and

st

orage

relative

humidity

10-90%,

non-condensing

Reader moisture

protection

Keep

dry

Operating and

st

orage

altitude

-381 meters (-1,250

ft) to

3,048

meters

(10,000

f

t)

Reader display

timeout

60 seconds (120 seconds when

test

strip

is

inserted)

Radio

Frequency

13

.

56

MHz

Data

port

Micro USB

Minimum

C

omputer

Requirements

S

y

st

em

must

only be

used

with

EN60950-1

rated

computers

Mean service

life 3

years

of

typical

use

Power

Adapter

Abbott

Diabetes

C

ar

e

PRT25612 (UK

plug)

PRT25613 (EU

P

lug)

PRT25847 (Australia

plug)

PRT25611 (Canada

plug)

Operating

t

emper

a

tur

e:

10 °C

to

40 °C

USB

C

able

Abbott

Diabetes Care

PR

T21373

Length: 94 cm (37

inches)

Rapid-Acting Insulin Calculator

Specifications

Parameter Unit

Range

or

Value

Correction

target

mg/dL

70

to 180

Carbohydrate

ratio

1

unit

per X

grams

of carbs

1

to 50

Servings

ratio

Units

of

insulin

per

serving

0

.

5

to 15

Servings

definition

Grams

of carbs

10

to 15

Mealtime insulin

doses

(breakfast, lunch,

dinner)

Units

of insulin

0

to 50

Correction

factor

1

unit

per X

mg/dL

1

to 99

Insulin

duration

(duration of insulin

action)

Hours

Easy:

4

Advanced: 3

to 8

105

106

DOC28687_rev-E_manual.indd 106 3/30/14 2:53 PM

Parameter Unit

Range

or

Value

Dose

increments

Units

of insulin

0

.

5

or 1

Maximum insulin

dose

Units

of insulin

50

Consult instructions

for

use

Use-by

date

Temperature

limit

Catalog

number

Manufacturer

S

er

ial

number

CE

Mark

Do

not

use

if

package

is

damaged

Ba

t

ch

code

Keep

dry

Type BF

applied

part

Non-ionizing

radiation

C

ODE

S

ensor

code

C

aution

Do

not re-use

S

t

er

iliz

ed

using

irradiation

This

product

must

not

be disposed

of

via municipal

waste

c

ollec

tion

.

S

epar

a

t

e

collection

for

electrical and

electronic

equipment

waste per Directive 2012/19/EC

in the

E

ur

opean

Union is

requir

ed

.

C

on

tac

t

the

manufacturer

for

details

.

Labeling

Symbols

R

emov

e

magenta

content for

F

r

ance

.

107

May

or

may

not be pr

esen

t

or

may vary per RA

requir

ements

.

108

DOC28687_rev-E_manual.indd 107-108 3/30/14 2:53 PM

Emissions

t

est

C

ompliance

E

lec

tr

omagnetic

environment

–

guidance

RF

emissions

CISPR

11

Group

1

T

he

System uses

RF

energy only

for its internal

func

tion.

T

her

efor

e

,

its

RF

emissions

ar

e

very low and are not likely

t

o

cause any interference in

nearb

y

electronic

equipmen

t

.

RF

emissions

CISPR

11

C

lass

B

T

he

S

yst

em

is

suitable

f

or

use

in all

establishments, including

domestic establishments

and

those directly connected to

the

public low voltage power supply

network that supplies buildings

used for domestic

purposes.

Harmonic emissions

IEC

61000-3-2

C

lass

A

V

oltage

fluc

tua

tions

/

flicker

emissions

IEC

61000-3-3

C

omplies

Include

for

C

anada

Electromagnetic

C

ompa

tibilit

y

•

T

he

S

yst

em

needs

special

pr

ec

autions

r

egarding

EMC

and

needs

t

o

be

installed

and

put

in

t

o

ser

vic

e

according to the

EMC

information provided in this

manual.

• Portable and mobile

RF

communications equipment can affect the

S

yst

em.

•

T

he

use

of

ac

c

essories

,

tr

ansducers

and

c

ables

other

than

those

specified

b

y

A

bbott

D

iabet

es

C

ar

e

may result in increased

EMISSIONS

or decreased

IMMUNITY

of the

S

yst

em.

•

T

he

System should not be used adjacent to or stacked with other equipment and that

if

adjac

en

t

or stacked use is necessary, the

System should be observed to

verify normal operation in

the

configuration in which it will be

used.

• This

device complies with part 15 of the

FCC

Rules.

O

per

a

tion

is

subject to the following

t

w

o

conditions: (1)

This

device may not cause harmful interference, and (2) this device must accept

an

y

interference received, including interference that may cause undesired

oper

a

tion.

•

C

hanges

or

modific

a

tions

not

appr

o

v

ed

b

y

A

bbott

c

ould

v

oid

the

user

’

s

authorit

y

t

o

oper

a

t

e

the

equipmen

t

.

Guidance and manufacturer’s declaration

–

electromagnetic

emissions

T

he

S

yst

em

is

in

t

ended

f

or

use

in

the

elec

tr

omagnetic

en

vir

onmen

t

specified

below.

T

he

c

ust

omer

or

the user of the System should assure that it is used in such an

en

vir

onmen

t

.

109

110

DOC28687_rev-E_manual.indd 109-110 3/30/14 2:53 PM

IMMUNIT

Y

t

est

IEC

60601

test le

v

el

C

ompliance

L

e

ve

l

E

lec

tr

omagnetic

environment

–

guidance

Surge

IEC

61000-4-5

±1 kV

diff

er

en

tial

mode

±2

kV

c

ommon

mode

±1 kV

diff

er

en

tial

mode

±2

kV

c

ommon

mode

Mains power quality should be

tha

t

of a typical domestic,

c

ommer

cial

,

or

hospital

en

vir

onmen

t

.

V

oltage

dips

,

shor

t

in

t

erruptions

and

voltage

v

ariations

on power supply

input lines

IEC

61000-4-11

<5 %

U

T

(>95

% dip in

U

T

)

f

or

0.5

cy

cle

40 %

U

T

(60

%

dip in

U

T

) for

5

cy

cles

70 %

U

T

(30

%

dip in

U

T

) for

25

cy

cles

<5 %

U

T

(>95 % dip

in

U

T

)

for

5

sec

onds

<5 %

U

T

(>95

% dip in

U

T

)

f

or

0.5

cy

cle

40 %

U

T

(60

%

dip in

U

T

) for

5

cy

cles

70 %

U

T

(30

%

dip in

U

T

) for

25

cy

cles

<5 %

U

T

(>95 % dip

in

U

T

)

for

5

sec

onds

Mains power quality should be

tha

t

of a typical domestic,

c

ommer

cial

,

or

hospital environment.

If

the user

of the System requires

c

on

tinued

operation during power mains

interruptions, it

is

rec

ommended

that the System be powered

fr

om

an

uninterruptible power supply or

a

ba

tt

er

y

.

Guidance and manufacturer’s declaration

–

electromagnetic

immunity

T

he

System is intended for use in the electromagnetic environment specified

below.

T

he

customer or

the user of the System should assure that it is used in such an

en

vir

onmen

t

.

IMMUNIT

Y

t

est

IEC

60601

test le

v

el

C

ompliance

L

e

ve

l

E

lec

tr

omagnetic

environment

–

guidance

E

lec

trosta

tic

discharge

(ESD

)

IEC

61000-4-2

±

6 kV

c

ontac

t

±

8 kV

air

±

6 kV

c

ontac

t

±

8 kV

air

Floors

should be wood, concrete or

ceramic tile.

If

floors are

c

o

v

er

ed

with synthetic material, the

r

ela

tiv

e

humidity should be at

least 30 %.

E

lec

trical

fast

tr

ansien

t/burst

IEC

61000-4-4

±

2 kV

f

or

power supply

lines

±

1 kV for

input/

output lines

±

2 kV

f

or

power supply

lines

±

1 kV for

input/

output lines

Mains power quality should be

tha

t

of a typical domestic,

c

ommer

cial

,

or

hospital

en

vir

onmen

t

.

111

112

DOC28687_rev-E_manual.indd 111-112 3/30/14 2:53 PM

IMMUNIT

Y

t

est

IEC

60601

test le

v

el

C

ompliance

L

e

ve

l

E

lec

tr

omagnetic

environment

–

guidance

C

onduc

t

ed

RF

IEC

61000-4-6

3

V

rms

150 kHz

t

o

80

MH

z

3

V

rms

Portable and mobile RF

communications

equipment should

be used no closer to any part of

the

System, including cables, than

the

recommended separation distanc

e

calculated from the

equa

tion

applicable to the frequency of

the

transmitt

er.

Recommended separa

tion

distance

d =

1.2

IMMUNIT

Y

t

est

IEC

60601

test le

v

el

C

ompliance

L

e

ve

l

E

lec

tr

omagnetic

environment

–

guidance

Power

fr

equenc

y

(50/60

H

z)

magnetic field

IEC

61000-4-8

3 A/m

Power frequency magnetic fields

should be at levels charac

t

eristic

of

a typical location in a

t

ypic

al

domestic, commercial, or

hospital

en

vir

onmen

t

.

NOTE

U

T

is the a.c. mains voltage prior to application of the test lev

el

.

113

114

DOC28687_rev-E_manual.indd 113-114 3/30/14 2:53 PM

IMMUNIT

Y

t

est

IEC

60601

test le

v

el

C

ompliance

L

e

ve

l

E

lec

tr

omagnetic

environment

–

guidance

R

adia

t

ed

RF

IEC

61000-4-3

3

V/m

80 MHz

t

o

2.5

GH

z

3

V/m

Recommended separa

tion

distance

d =

1.2

80 MHz

to 800

MH

z

d =

2.3

800 MHz

to 2.5

GH

z

a

Field strengths from fixed

transmitters, such as base stations

for radio

(

c

ellular/c

ordless)

telephones and

land mobile radios, amateur radio,

AM and FM

radio broadcast

and

TV

br

oadc

ast

cannot be predicted theoretically with accuracy.

To

assess the electromagnetic environment due

t

o

fixed

RF

transmitters, an electromagnetic site survey should be considered.

If

the measured field

strength in the location in which the

System is used exceeds the applicable

RF

compliance

lev

el

above, the System should be observed to

verify normal operation.

If

abnormal performance is

observed, additional measures may be necessary, such as re-orienting or relocating the

S

yst

em.

b

Over the frequency range 150 kHz

to 80

MHz,

field strengths should be less than

3

V/m.

P

is

the maximum output power rating of the transmitter in watts (W) according

to the transmitt

er

manufacturer and

d

is

the recommended separation distance in

meters (m).

Field strengths from fixed

RF

transmitters, as determined by

an electromagnetic site survey,

a

should

be less than the compliance level in each frequency r

ange

.

b

Interference may occur in the vicinity of

equipment marked with the following symbol:

NOTE

1

A

t

80 MHz and 800 MHz,

the higher frequency range

applies.

NOTE

2

T

hese

guidelines may not apply in all situations.

E

lec

tr

omagnetic

propagation

is

affected

b

y

absorption and reflection from structures, objects and

people.

115

116

DOC28687_rev-E_manual.indd 115-116 3/30/14 2:53 PM

Recommended separation distances between

por

table

and mobile RF

communications equipment and

the

System

T

he

System is intended for use in an electromagnetic environment in which radiated

RF

disturbances

are

c

on

tr

olled

.

T

he

customer or the user of the System can help prevent electromagnetic

in

t

er

f

erenc

e

by maintaining a minimum distance between portable and mobile

RF

communications

equipmen

t

(transmitters) and the System as recommended below, according to the maximum output power of

the communications

equipmen

t

.

For

transmitters rated at a maximum output power not listed above, the recommended separ

a

tion

distance

d

in meters (m) can be estimated using the equation applicable to the frequency of

the

transmitter, where

P

is

the maximum output power rating of the transmitter in watts (W)

ac

c

or

ding

to the transmitter

manufac

tur

er.

NOTE

1

A

t

80 MHz and 800 MHz,

the separation distance for the higher frequency range

applies.

NOTE

2

T

hese

guidelines may not apply in all situations.

E

lec

tr

omagnetic

propagation

is

affected

b

y

absorption and reflection from structures, objects and

people.

Ra

t

ed

maximum

output

power

of

transmitt

er

W

S

eparation

distance

according

to

frequency

of

transmitt

er

m

150

kHz

t

o

80

MHz

d =

1.2

80

MHz

t

o

800

MHz

d =

1.2

800

MHz

t

o

2.5

GHz

d =

2.3

0.01

0.12

0.23

0.1

0.38

0.73

1

1.2

2.3

10

3.8

7.3

100

12

23

117

118

DOC28687_rev-E_manual.indd 117-118 3/30/14 2:53 PM

Her

eby

,

Abbott

Diabetes Care

L

t

d

,

declares

that the

F

r

eeS

t

yle

Libre

Flash Glucose

Monitoring

S

y

st

em

is

in

compliance

with the essential

requirements and

other

r

elevan

t

provisions

of the

R&TTE

Dir

ec

tiv

e

.

A

copy

of the

original declaration

of

conformity may be obtained

from

Abbott

Diabetes Care

L

t

d

.

,

R

ange

Road, W

itney

,

Oxon, OX29 0YL, UK

.

F

on

t

License

bbott

Licensed

under the

Apache License, Version

2

.

0

(the “License”);

you may

not

use

this file

except

in

compliance

with the

License

.

You may

obtain a

copy

of the

License at:

http://www .

apache

.

or

g/lic

enses/LICENSE-2

.

0

Unless required

by

applicable law

or

agreed

to in wr

iting

,

software

distributed

under

the

License is

distributed on

an

“AS

IS

”

BASIS,

WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND,

either

express

or implied

.

See

the

License

for the

specific

language

governing permissions and limitations under

the

License

.

May

or

may

not be pr

esen

t

or

may vary per RA

requir

ements

.

119

Abbott Diabetes Care LIB01 Freestyle Libre Glucose Monitoring System User Manual

Abbott Diabetes Care Freestyle Libre Glucose Monitoring System

User Manual

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