Roche Diagnostics Diabetes Care GW Accu-Chek Solo micropump User Manual Part 2

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Document ID	3771845
Application ID	SGfkO6u+LsSBDKZT/aToRg==
Document Description	User manual Part 2
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	456.02kB (5700267 bits)
Date Submitted	2018-03-07 00:00:00
Date Available	2018-03-07 00:00:00
Creation Date	2017-09-26 10:12:08
Producing Software	Adobe PDF Library 15.0
Document Lastmod	2017-09-26 10:12:17
Document Title	User manual Part 2
Document Creator	Adobe InDesign CC 2015 (Windows)

Overview
Insertion device
Micropump
Positioning aid
Inserted cannula
assembly
Detach button
Release button
Pump base with mounted
reservoir
Pairing code
Priming handle
Notch for attaching the
micropump holder
Cannula assembly slot
Safety release
Pump shield
Ventilation opening
Lock
Cannula opening
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Quick bolus buttons
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Putting the Micropump Into Operation
w WARNING
jj The reservoir, cannula and micropump holder are intended
for single use and are sterile packaged. They must not be
used if their sterile packaging was previously opened or
damaged or if the use by date has expired.
jj Check at regular intervals that the micropump holder and
cannula are tightly connected to each other. Make sure that
the micropump holder does not detach itself from the
infusion site and that the adhesive pad is not wet. Insulin
delivery may be interrupted by a loose fitting or displaced
cannula.
jj Check your blood glucose level at least four times a day and
once within a period of 1 to 3 hours if the micropump was
exposed to any mechanical impact.
Note
jj The micropump holder must not be attached to sites on the
body with scars, birthmarks and moles, tattoos, injuries,
bruises or rashes.
jj Before you attach the micropump holder to the body, the
infusion site must be completely dry.
jj A new infusion site must be at least 5 cm away from the
last infusion site.
jj If the micropump holder frequently becomes detached from
the skin, consult your healthcare team to find a method that
may improve adhesion to the skin.
jj If the infusion site becomes inflamed, replace the infusion
assembly immediately and choose a new infusion site.
jj Check the micropump system for possible damage or leaks
regularly.
jj Check your blood glucose level after changing the infusion
assembly once within 1 to 3 hours.
jj Check the micropump system for damage or leaks if you
can smell insulin.
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Recommended Infusion Sites
4.2 Recommended Infusion Sites
Choose a suitable infusion site before inserting a new infusion
assembly. Consult your healthcare team for advice. Sites with
sufficient subcutaneous tissue are the most suitable. For example:
Infusion site
Characteristics
Abdominal
region
Common infusion site with good insulin
absorption.
Upper arm
Slower insulin absorption compared to the
abdominal region.
Thigh
Slower insulin absorption compared to the
abdominal region.
Slower insulin absorption compared to the
Hip, lower back, abdominal region. Also suitable for physically
active users or if not much subcutaneous
buttocks
tissue is available.
Note
If the infusion site becomes inflamed, replace the infusion
assembly immediately and choose a new infusion site.
Blue areas: Recommended infusion sites
Grey areas: Possible infusion sites
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Putting the Micropump Into Operation
4.2.1 Attaching the Infusion Assembly
w WARNING
Before using the insertion device for the first time or if it has
been stored for a longer period, before inserting the cannula,
you must push down the safety release on the insertion device
and press the release button on the insertion device to check
that it does not contain a cannula. There is a risk that the
cannula may not be inserted under the skin correctly due to
insufficient spring tension in the insertion device.
After setting up the diabetes
manager (see Chapter 3), the
Prepare micropump display
appears.
Tap OK.
Read the instructions shown
on the Prepare micropump
display.
If you want to see the steps as
an animated video, tap Help.
Note
If there is an unexplained rise in your blood glucose level or
an occlusion alarm occurs, check the micropump and the
infusion assembly for occlusions and leaks. If you are unsure
whether the infusion assembly is working properly, replace it
immediately.
Once you have performed all 3
steps, tap Done.
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Recommended Infusion Sites
4.2.2 Step 1: Attaching the Infusion Assembly to the Body
Wash your hands with warm
water and soap and dry them
thoroughly.
Select a suitable site on the
body.
Remove the micropump holder
from the packaging.
Attach the hook of the
micropump holder to the
bottom of the insertion device.
Disinfect the site on the body
by wiping it with an alcohol
wipe, for example. Then let the
skin dry completely.
Press on the micropump
holder lightly until it engages
with the lock at the front of the
insertion device.
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Putting the Micropump Into Operation
Insert the cannula assembly
diagonally into the cannula
assembly slot.
Push the cannula assembly
into the slot until you hear it
click into place.
Prime the insertion device by
rotating the priming handle
clockwise in the direction of
the arrow by approximately
half a turn.
When the insertion device is
fully primed, you will hear a
click.
Use the positioning aid to
check whether the cannula
assembly has the correct
position.
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Recommended Infusion Sites
10
11
12
Remove both parts of the
protective film from the
adhesive pad.
Press the insertion device
firmly against the selected site
on the body so that the
adhesive pad is applied evenly
to the skin. Make sure the
surface of the skin is taut.
Smooth over the adhesive pad
around the infusion assembly
so that the infusion assembly
is in good contact with the
skin.
Press the blue release button
to insert the cannula under the
skin.
Do not touch the adhesive
surface of the adhesive pad.
This could impair the adhesive
properties.
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Putting the Micropump Into Operation
13
14
15
16
Press the detach button and
detach the insertion device
from the infusion assembly.
Press the infusion assembly
and the edges of the adhesive
pad against the skin so that
the adhesive pad is smooth on
the skin.
Check whether the grey
cannula head is visible in the
opening of the cannula support
and is flush with the cannula
support.
Remove the used cannula
casing from the insertion
device.
The infusion assembly is now
safely attached to the site on
the body.
If the grey cannula head is not
visible, the cannula was not
inserted. Remove the
micropump holder and repeat
Steps 2 to 15.
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Recommended Infusion Sites
17
w WARNING
During disposal, ensure that no third party could injure
themselves and risk an infection.
Dispose of the used cannula
casing according to local
regulations.
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Putting the Micropump Into Operation
4.2.3 Step 2: Filling the Reservoir with Insulin
In addition to the reservoir assembly, you need an insulin vial with
U100 insulin and a form of disinfectant, such as a sterile alcohol
wipe.
jj Use and store insulin in compliance with the manufacturer
specifications and pay attention to the use by date.
jj Make sure that the insulin is at room temperature before using
it in the micropump. Use the reservoir immediately after filling
it.
jj Occlusions may occur if the temperature of the insulin or
micropump system is too low.
jj You can also use a 3 ml pen cartridge to fill the reservoir. To do
so, place the top of the cartridge onto the filling aid and press
the seal stopper of the cartridge down with a pen or similar
device.
jj During filling, make sure you remove any air bubbles from the
reservoir.
w WARNING
jj Use only permitted U100 insulin types to fill the reservoir.
jj If you connect an empty reservoir to the micropump (for
example, for training purposes), insulin delivery (basal rate
and bolus delivery) is nevertheless displayed, although no
insulin is delivered because of the empty reservoir.
jj Never fill the micropump while it is connected to an infusion
assembly attached to your body. There is a risk of
uncontrolled insulin delivery.
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Recommended Infusion Sites
Filling a new reservoir with insulin
Disinfect the top of the insulin
vial with a sterile alcohol wipe.
Allow the disinfected top of the
vial to dry.
Remove the new reservoir
assembly from the packaging.
Carefully pull out the battery’s
protective film downwards in
the direction of the arrow to
activate the battery.
Hold the round part of the
handle firmly and pull it
downwards in the direction
of the arrow.
Fill the reservoir with the
volume of air that you later
want to fill with insulin.
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Putting the Micropump Into Operation
Note
jj The reservoir must always
be filled with a minimum of
80 U for the electronics to
detect that the reservoir is
filled.
jj The reservoir has a
maximum holding capacity
of 200 U (2.0 ml).
jj Take care not to touch the
reservoir needle. You might
injure yourself.
Place the insulin vial on a flat
and solid surface (for example,
a table top) and hold it firmly.
Place the filling aid onto the
vial. Push the filling aid
downwards until you hear it
click into place.
Press the handle all the way
down in the direction of the
arrow to fill the insulin vial
with air.
Turn the reservoir assembly
together with the insulin vial
upside down so that the vial
is above the reservoir.
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Recommended Infusion Sites
10
11
Slowly pull the handle
downwards in the direction of
the arrow to fill the reservoir
with insulin.
Gently flick your finger against
the reservoir to release any air
bubbles from the reservoir.
Push the handle upwards
slightly in the direction of the
arrow to push air bubbles out
of the reservoir.
Compress the corrugated part
of the handle such that the
upper end of the handle opens.
Try to ensure that no air
bubbles form in the reservoir.
Then pull the handle
downwards again to fill the
reservoir with the desired
amount of insulin.
Remove the handle from the
piston rod to the side.
Dispose of the handle.
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Putting the Micropump Into Operation
4.2.4 Step 3: Connecting the Reservoir to the Pump Base
12
Detach the filling aid from the
reservoir by removing it
sideways in the direction of
the arrow.
Remove the blue reservoir cap
from the pump base.
Align the piston rod of the
filled reservoir such that you
can insert it into the piston rod
opening of the pump base
Hold the pump base with one
hand and the reservoir with
the other.
Dispose of the filling aid.
Push the filled reservoir onto
the pump base until both parts
are tightly connected.
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Recommended Infusion Sites
Setting the reservoir fill amount
Pay attention to whether a
rising sequence of tones is
issued after connecting the
reservoir and pump base. The
sequence of tones confirms
that the system components
are connected to each other
correctly and that the battery
has been activated.
Note
jj Make sure that there is no
gap between the reservoir
and the pump base.
jj Do not exert too much
force when connecting the
pump base to the reservoir.
jj Make sure that the
ventilation opening of the
micropump is always clear
so that the battery is fully
functional.
Read the reservoir level using
the reservoir scale.
Use and to set the
insulin units with which you
filled the reservoir.
With 2.0 ml (200 U), the
reservoir shown in the figure
above is full.
The set fill amount will be
saved as the default setting for
when the reservoir is filled the
next time.
Tap Save.
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Putting the Micropump Into Operation
4.2.5 Step 4: Pairing the Diabetes Manager and Micropump
To be able to operate the micropump using the diabetes manager,
you must pair the devices.
Once the diabetes manager and the pump have been paired, the
pairing settings are stored in both devices so that you do not have
to repeat this process.
If radio connection between the diabetes manager and the
micropump is stopped or interrupted, it will automatically be
restored once the devices are within an appropriate range of each
other.
You can simply use the camera on the back of the diabetes
manager and the pairing code on the pump base to pair the
devices. If this is not possible, you can enter the pump key into
the diabetes manager. If several micropumps are within the
communication range of the diabetes manager, you must select
the micropump serial number from a list that is displayed.
Note
Once a pump base is paired with a diabetes manager, it
cannot be paired with a different diabetes manager.
So if you are using a different diabetes manager than before,
for example, a replacement device, it cannot be paired with
the micropump that has been in operation so far. In this case,
you must use a new pump base.
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Recommended Infusion Sites
Hold the diabetes manager
close to the micropump to
establish the radio connection.
The diabetes manager
establishes the radio
connection to the micropump.
Tap Scan pairing code.
Tap Next.
Wait a moment.
Point the camera of the
diabetes manager at the
pairing code on the pump
base. Hold the diabetes
manager such that the pairing
code appears in the middle of
the screen.
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Putting the Micropump Into Operation
Note
You will find the pump key(s) on the inside of the packaging
lid (of the starter kit or micropump kit).
The pump serial number of the micropump is on the pump
symbol.
shield label and the packaging label next to the
Pump key example:
Pump base 1 and 2
GW00000254
If the pairing code has been
successfully scanned and
registered, a signal is issued
shortly afterwards.
If the pairing code cannot be
successfully scanned, you can
enter the pump key manually.
00000254
GW00000255
00000255
Tap Enter pump key.
The micropump and the
diabetes manager are now
paired with each other.
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Recommended Infusion Sites
4.2.6 Step 5: Filling the Reservoir Needle
w WARNING
Never fill the reservoir needle while it is connected to an
infusion assembly attached to your body. There is a risk of
uncontrolled insulin delivery.
If several micropumps are
within communication range:
Tap the pump serial number of
your micropump.
Enter the pump key using the
keyboard.
If pairing was successful, a
signal is issued.
Tap Done.
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Putting the Micropump Into Operation
The micropump is now ready
to fill the reservoir needle and
issues a signal.
The reservoir needle is filled.
Pay attention to the opening of
the reservoir needle during
filling.
If you can see a drop of
insulin at the tip of the needle,
tap OK.
When you see a drop of insulin
at the tip of the needle, the
reservoir needle is filled.
Continue with Step 1 of the
next section.
Tap Fill.
Wait a moment.
button is
The
deactivated.
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Recommended Infusion Sites
If you cannot see a drop of
insulin at the tip of the needle,
tap Repeat. The Repeat button
is only activated after approx.
2 minutes.
Tap Yes and follow the
instructions on the displays
that follow.
Note
If you do not see a drop of
insulin at the needle tip after
a maximum of two minutes,
there is still too much air in
the reservoir. If no insulin
drop is visible even after
refilling the reservoir, you
must use a new reservoir.
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Putting the Micropump Into Operation
4.2.7 Step 6: Attaching the Micropump
To attach the micropump correctly to the infusion assembly, you
must engage the notch on the micropump with the hook on the
infusion assembly.
First place the pump
onto the infusion assembly
using slight pressure.
Exert some pressure on the
pump shield so that the
micropump engages with the
hook at the front of the
infusion assembly.
Notch on the micropump
Hook on the infusion
assembly
When the micropump is
correctly attached to the
infusion assembly, you hear
a click sound.
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Recommended Infusion Sites
w WARNING
jj Check the site on the body with the adhesive pad of the
infusion assembly at least once a day.
jj Inserting the sensor under the skin or wearing the adhesive
pad can cause the site to become irritated or inflamed.
Symptoms include, amongst other things, redness, swelling,
pain, heat sensation or weeping. Remove the infusion
assembly if signs of inflammation or contamination are
visible. Place a new infusion assembly on a different suitable
site on the body.
Check whether the micropump
is securely attached to the
infusion assembly.
The micropump is now ready
for insulin delivery.
Tap Next.
A small amount of insulin is
delivered to fill the micropump
system.
Note
jj Check at regular intervals whether the adhesive pad with
the infusion assembly is securely attached to the body. A
loose infusion assembly may interrupt insulin delivery.
jj If there is an unexplained rise in your blood glucose level or
an occlusion alarm occurs, check the micropump and the
infusion assembly for occlusions and leaks. Replace your
infusion assembly if you are not sure whether it is working
properly.
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Putting the Micropump Into Operation
4.2.8 Activating the Basal Rate Profile
After having completed all preparatory steps for using the
micropump for the first time, you can activate the set basal rate
profile.
To confirm this step, press the
lit up in
insulin button
green, on the diabetes
manager.
The Status screen displays the
activated basal rate profile.
Once you have activated the basal rate profile, the micropump
system setup is complete. The basal rate is delivered and you can
use other system features.
Follow the setting for basal rate profiles you agreed on with your
healthcare professional. For more information on basal rate
profiles, see the chapter Basal Rate Profiles and Temporary Basal
Rates.
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Recommended Infusion Sites
4.2.9 Stopping and Starting the Micropump
With the Stop and Start
items in the Main menu, you can
interrupt or start insulin delivery again.
Stopping insulin delivery
Discuss with your healthcare professional when and for how long
insulin delivery may be interrupted.
If necessary, use a syringe or insulin pen to deliver insulin
according to the instructions of your healthcare team.
Note
If your insulin delivery is interrupted for any reason, check
your blood glucose level and deliver the missing insulin using
a syringe or pen, for example, when:
jj You stop or remove the pump for a longer period of time.
jj There is a technical problem with the pump.
jj There is an occlusion in the cannula/infusion assembly.
jj The reservoir or infusion assembly is leaking.
jj The infusion assembly has come loose at the infusion site.
Tap Stop
Tap Yes.
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Putting the Micropump Into Operation
While the micropump is in Stop mode, it emits a signal every hour
to remind you that no insulin is being delivered.
Starting or stopping insulin delivery
Note
Stopping the micropump cancels all ongoing boluses and the
Temporary Basal Rate.
or
On the Status screen, tap the
symbol to restart the
micropump.
In the Main menu, tap
Start .
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5
Testing Your Blood Glucose
5.1 Checking the Unit of Measurement
Diabetes manager
mmol/L
Mannheim,
Germany
Blood glucose results can be specified in two different units of
measurement (mg/dL and mmol/L). As a result, two versions of
the same diabetes manager are available. Check whether the
diabetes manager displays the unit of measurement familiar to
you. The unit of measurement your diabetes manager displays is
shown on the back of your diabetes manager 1. If you do not
know which unit of measurement is correct for you, contact your
healthcare team.
w WARNING
The unit of measurement that your diabetes manager displays
cannot be changed. Contact your Customer Support and
Service Centre if the wrong unit of measurement is printed on
the back. A wrong unit of measurement may lead to incorrect
interpretation of blood glucose results and therefore to wrong
therapy recommendations being made, thus resulting in
serious adverse health effects.
jj You need the diabetes manager, a test strip, a finger pricker
and a lancet drum.
jj Set up the diabetes manager before testing your blood glucose
for the first time.
jj Read the test strip package insert. In the package insert, you
will find further important information on storage and possible
causes of incorrect test results.
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Testing Your Blood Glucose
5.2 Performing a Blood Glucose Test
After inserting a lancet drum into the finger pricker and setting
the penetration depth, you can start the blood glucose test.
w WARNING
jj A blood glucose test that was performed incorrectly can
lead to incorrect test results and thus to wrong therapy
recommendations being made, which can result in serious
adverse health effects. Therefore, follow the notes on how to
perform blood glucose tests correctly, carefully.
jj A contaminated puncture site may lead to incorrect test
results. Wash your hands and the puncture site with warm
water and soap and rinse them well.
jj Test your blood glucose regularly, at least 4 times a day.
jj The micropump system is only intended for blood glucose
testing with fresh capillary blood from the fingertip.
Prior to the test
Note
jj When the diabetes
manager prompts you to
apply a drop, you have
approximately 2 minutes to
apply blood to the test
strip. If you do not apply
any blood during this time,
the diabetes manager
turns itself off.
jj Visually impaired persons
must always be supported
by a sighted person when
applying the blood drop.
jj The micropump system is
not suitable for testing
blood from alternative
sites.
Wash your hands with warm
water and soap and rinse
them well. Dry your hands
thoroughly with a clean towel
before obtaining blood.
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