UCB Medical Devices AVA User Manual
User Manual
User
Manual
CIMZIA is a registered trademark of
the UCB Group of Companies
Ref: q-011957 v. 4.0, June 2016
Ref: q-011957 v. 4.0, June 2016
Contents
is affected by absorption and reflection from structures, objects and people.
Chapter 1: Important information about ava 5
Important information 6
ava set up 10
Additional important information 10
Chapter 2: Getting to know ava 11
ava 12
CIMZIA medication cassette 14
ava’s medication dosing 16
Changing your CIMZIA dosing 19
ava accessories 20
ava operating environment 23
Storing ava 23
Cleaning ava 24
Battery saving mode 25
Chapter 3: Learning to use ava 27
Training cassette 28
Using the training cassette 30
Chapter 4: Injecting CIMZIA with ava 43
Electromagnetic
environment - guidance
None
rms
performance criterion
10V
CT for transmitters, CR for
receivers
rms
10V
150kHz – 80 MHz
(AM, modulation depth 80%,
sinusoidal audio signal of 1
None
10 V/m
CT for transmitters, CR for
receivers
10 V/m
26 MHz -2700 MHz
(1 kHz, modulation depth
kHz)
80%)
Preparing your CIMZIA medication cassette 44
Setting up for your CIMZIA injection 46
Selecting and preparing your injection site 48
Giving your CIMZIA injection 50
Disposal of Used Medication Cassettes 59
Optional Actions During an Injection: 62
Pausing your injection 62
2
Immunity test Test level Compliance level /
Conducted RF
ETSI EN 301 489-1
ETSI EN 301 489-3
IEC 60601-1-2
IEC 61000-4-6
Radiated RF
ETSI EN 301 489-1
ETSI EN 301 489-3
IEC 60601-1-2
ISO 11608-1
ISO 11608-4
IEC 61000-4-3
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation
103
CIMZIA Injection speed settings 63
Chapter 5: More information about ava 65
Viewing the injection log 66
Charging the battery
70
Chapter 6: Troubleshooting 73
Removing a cassette if the needle cap
is lost or if needle is severely bent
What to do if ava has problems identifying
a cassette by the Radio Frequency Identification (RFID) 75
Warning message priority
High priority alarms
Medium priority alarms
Low priority alarms
Instructions
Cassette Warnings
Other Non-Alarm Screens
86
77
80
89
76
79
91
74
Chapter 7: Technical Information about ava 95
Technical data 96
Explanation of ava symbols
Electromagnetic Compatibility Tables
Guidance and manufacturer’s declaration
– electromagnetic emission
Guidance and manufacturer’s declaration
– electromagnetic immunity
97
98
99
101
3
This page is intentionally left blank.
4
Chapter 1:
Important
information
about ava
This section contains important
information you must be aware
of before starting to use ava.
1
1
Important information
Make sure you read and understand these ava instructions.
Read these instructions for use before you start using ava to
inject. However, only use ava to inject your medication after you,
or someone you know, has received training from your healthcare
provider.
ava must only be used in the way described in these instructions.
Always follow the warnings and cautions in the instructions or on
the device itself.
ava is an electromechanical device and should be handled with care.
WARNING: ava is an injection device for delivering a fi xed dose of
CIMZIA. It is for use by one person only.
or allow anyone else to inject themselves with it, as doing so may
result in injury.
properly and
ava must only be used with pre-fi lled cassettes of CIMZIA as
prescribed by your healthcare provider.
CIMZIA medication cassettes are single-use only and must be
discarded in a biohazards (sharps) container immediately after use.
DO NOT re-use a cassette.
6 Chapter 1: Important information about ava
DO NOT use ava if it does not appear to be working
DO NOT attempt to repair a faulty ava.
DO NOT share the device
Contact your healthcare provider when you need more CIMZIA
medication cassettes.
Be sure to store the CIMZIA medication cassettes properly:
• Store CIMZIA medication cassettes in the refrigerator between
36ºF to 46ºF ( 2ºC to 8ºC).
• Keep this medication out of sight and reach of children.
DO NOT freeze CIMZIA.
•
• Protect CIMZIA medication cassettes from light. Store CIMZIA
medication cassettes in the carton they came in.
• The CIMZIA medication cassette contains a glass syringe.
DO NOT drop or crush the cassette.
DO NOT use CIMZIA medication cassette if:
• Any name other than CIMZIA is on the carton and/or cassette
label.
• The expiration date on each cassette or its outer carton has
passed.
• The carton is torn or the tamper evident seal is missing or broken
when you receive it.
• The cassette has been frozen or if it has been left in direct
sunlight.
• The CIMZIA solution in the cassette is not clear to colorless to
light yellow, if it looks cloudy, or if it has large or colored particles
in it.
• The red medication level indicator is not right at the top of the
cassette.
7
DO NOT shake the cassette before use.
!
Device
is nearing
end of life!
Keep your ava and CIMZIA medication cassettes out of the sight
and reach of children.
Be sure to store ava properly:
• Store ava in its closed storage case to limit exposure to dirt, dust,
liquid and other substances.
• Keep ava at room temperature between 68ºF to 77ºF
(20ºC to 25ºC).
• DO NOT freeze ava or place it in the refrigerator.
WARNING: Do not operate ava near strong electromagnetic sources
like an x-ray machine in a medical facility or a security machine
at an airport. However, using your ava near common-household
electronic devices should not be a problem.
The expected lifetime for ava under normal
use is up to 3 years, after which it must be
replaced. When it is nearing its end of life, ava will
automatically show the message ‘Device is nearing
end of life!’. As soon as you see this message,
contact your healthcare provider or local helpline
for a replacement device.
8 Chapter 1: Important information about ava
!
Device at
end of life!
!
Error!
Do not use.
Helpline code
xxxx
After another 10 injections when the message
above first appears, ava will stop working and
display the warning ‘Device at end of life!’.
ava contains no harmful or toxic components. The device does not
contain any personal information.
However, ava is considered biohazardous waste and must not be
disposed of in household waste.
Dispose of your used ava according to your community guidelines,
observing all Federal, State and local regulations or contact the
helpline for information on safe disposal of ava.
WARNING: ava should be handled with care.
DO NOT drop. If ava is dropped, check that no
broken parts are visible. Turn ava on. If you see
an ‘Error! Do not use. Helpline code’ warning
message digit Helpline Code number and contact your local
helpline for support.
CAUTION: Avoid spilling liquid on your ava. Never rinse or put ava
under water. If ava has been exposed to liquid, wipe it with a clean,
dry cloth, turn it on and check for error messages.
DO NOT use it. Make a note of the four
9
ava set up
Your new ava device needs to be set up by your healthcare
provider. Please make sure to schedule an appointment with
your healthcare provider to have your medication dose set up
in ava. You should also receive training on the correct use at
the same time.
DO NOT forget to bring ava to your appointment.
You can practice using ava even before your healthcare provider
has set up ava for you. The training cassette can be used at any
time before or after the medication dose has been set up.
Additional important information
The use of ava is not approved or recommended for the following
circumstances:
• users less than 18 years of age
• users who are legally blind
• users who are unable to self-inject as determined
by a health care provider
Your healthcare provider will determine if you are able to use ava.
Ask your health care provider if you are not sure.
10 Chapter 1: Important information about ava
Chapter 2:
Getting to
know ava
This section is a guide to ava and
CIMZIA medication cassettes, showing
the controls and the names of the main
parts. You will also fi nd information on
how to take care of your ava and
CIMZIA medication cassettes.
2
2
ava
Use this illustration to identify the controls and the names of
ava’s parts.
Information
Screen
Scroll wheel
Micro-USB
Port
On/Off
(Power)
Button
Start/Pause
Button
Skin Sensor
12 Chapter 2: Getting to know ava
Cassette/
Injection Port
Information screen
ava’s screen will display step-by-step instructions and any advice
or warning messages.
Scroll wheel
This wheel lets you adjust the speed of your injection.
Skin sensor
The skin sensor detects when the injection port is fully in contact
with your skin.
Micro-USB Port
This is where you connect the battery charger or your computer
to view your injection log.
On/Off (Power) Button
Use this button to turn ava on or off.
Start/Pause button
Pressing this button will begin administering an injection. It can
also be used to pause and re-start the delivery of CIMZIA during
an injection.
Cassette/Injection port
This is where the CIMZIA, or training cassette, is loaded and
where the needle comes out during a CIMZIA injection.
13
CIMZIA medication cassette
This illustration shows a CIMZIA medication cassette for
use with ava.
Top view
End cap
Side view
Medication
level indicator
Cassette body
Needle
(inside cap)
Syringe
Medication
information
chip
Needle cap
14 Chapter 2: Getting to know ava
Cassette body
This plastic cassette body contains the glass syringe of CIMZIA.
Needle (inside cap)
The single-use needle is safely covered by the needle cap until you
are ready to inject.
Medication level indicator
This red plastic indicator enables you to see the level of CIMZIA in
a cassette. When the syringe is full the indicator is at the top of the
syringe. When the syringe is empty the indicator is at the bottom of
the syringe.
Medication information chip
This microchip enables ava to identify the type of cassette and
check other information about it.
Needle cap
This part covers the needle whenever it is not inside ava ready for
an injection.
Keep the needle cap to remove the cassette after an injection.
15
ava’s medication dosing
ava delivers your medication from CIMZIA medication cassettes
as shown below.
This illustration also shows the labels you will see on your CIMZIA
medication cassettes.
CIA79917A
certolizumab pegol
Store at 36° to 46°F (2° to 8°C).
Do not freeze. Protect from
light. Single use.
Mfd. by UCB Inc.,
Smyrna, GA, USA
LOT:
CIA79918A
EXP:
Part#
xxxxxx
NCD 50474-xxxx-xx Rx Only
certolizumab pegol
Each medication cassette contains 1mL of
Cimzia. For subcutaneous injection use only.
Use only with the Cimzia ava device.
injection 200mg/mL cassette
16 Chapter 2: Getting to know ava
CIA79919A
ava can only be used with CIMZIA
!
Consult your
physician to
set device
dosage!
medication cassettes. However, before
ava accepts CIMZIA medication cassettes
it must be set up by your healthcare
provider according to your prescribed
dose of CIMZIA. This is indicated by the
following screen.
If you have not done so already, take an appointment with
your healthcare provider to have your new ava set up for
you. Remember to bring ava to your appointment.
In the meantime, you can practice using ava with the training
cassette that is provided in your ava storage case. See Chapter 3
for more information.
Your healthcare provider will set up ava according to your
prescription.
If your healthcare provider prescribes the loading doses, ava
is programmed to deliver your loading dose injections at weeks
0, 2 and 4 and then automatically switches to the maintenance
dosing regimen which has been selected by your healthcare
provider for you.
The loading dose regimen consists of two injections given every 2
weeks at the start of your CIMZIA treatment (week 0) and then at
week 2 and the final loading dose injections are given at week 4.
17
Once the last injection of your
Loading dose
complete.
You are on
maintenance
dose 2 inj.
every 4 weeks.
You are on
maintenance
dose 1 inj.
every 2 weeks.
loading dose has been delivered
at week 4, ava indicates this by
displaying the message ‘Loading
dose complete.’.
This message will be followed by either ‘You are on maintenance
dose 1 inj. every 2 weeks.’ or ‘You are on maintenance dose 2 inj.
every 4 weeks.’ depending on which maintenance dose has been
selected for you.
18 Chapter 2: Getting to know ava
Changing your CIMZIA dosing
In case your healthcare provider needs to change your dose,
ava will need to be set up again. Please make sure you bring ava
to your next appointment where your healthcare provider will
set up ava for your new medication dosing.
19
ava accessories
LBL4_CIM_
PS6
ava is supplied with a storage case containing additional items
you will fi nd useful. When not in use, keep ava and accessories
securely inside the storage case to protect them from dust or
accidental damage. Keep ava with all accessories out of the sight
and reach of children. All of ava’s accessories are designed for
the life of the product.
Storage Case
The storage case has an internal compartment which is
covered by a lid. To open the lid, slide a fi nger under the
small lever and lift. The charger, USB cable and spare
needle caps are placed under this internal lid.
20 Chapter 2: Getting to know ava
The Storage Case contains
An electrical battery charger
Charge ava only with this battery
charger. When charging ava
make sure to keep the cable
out of reach of children and
keep it secure to avoid the
risk of tripping over it.
A USB cable
Use this USB cable to connect
ava to your computer to view
your injection log. When viewing
the injection log make sure to
keep the cable out of reach of
children and keep it secure to
avoid the risk of tripping over it.
ava welcome booklet
A booklet introducing you to ava.
21
ava Training Cassette
For training purposes o nly.
Contains no needle or medication.
LBL4_CIM_
PS6
ava Training Cassette
For training purposes o nly.
spare
needle
cap
x2
A training cassette
Use this training cassette to help
you practice injections with ava.
The training cassette is reuseable
and does not contain a needle or
medication. It can be used at any
time and as often as you like,
even before ava has been set up
for your medication dose.
CAUTION: Never replace the
training cassette by a CIMZIA
medication cassette! Your
medication cassettes must be
stored between 36°F to 46°F
(2°C - 8°C) and must never
be transported inside of the
Two spare needle caps
These are extra caps to remove
used cassettes from ava in case
you dispose of the needle cap
from the medication cassette.
The helpline support number
is 1-800-xxx-xxxx.
storage case.
22 Chapter 2: Getting to know ava
ava operating environment
When operating ava make sure you observe the following
environmental requirements.
Operating
temperature
Humidity 15 – 90% relative humidity, non-condensing
Atmospheric
Pressure
It is recommended to avoid using ava in direct sunlight as the
display may be more difficult to read.
WARNING: This medical equipment is not intended for use in
oxygen-rich environments.
41°F to 104°F (5°C to 40°C)
700 hPa to 1060 hPa
Storing ava
When you are not using ava or you are travelling, it is recommended
that you store it, together with the accessories, inside the storage
case. This will help prevent ava from being exposed to dust and dirt
and getting damaged. Use the handle to carry the storage case.
Be sure to store ava properly:
• Store ava in its closed storage case to limit exposure to dirt, dust,
liquid and other substances.
• Keep ava at room temperature between 68ºF to 77ºF
(20ºC to 25ºC).
DO NOT freeze ava or place it in the refrigerator.
•
23
Cleaning ava
If needed, you may clean the exterior surface of ava with a solution
of mild soap and water using a damp cloth. You may also clean it
with a commercially available, alcohol based, colorless disinfectant.
CAUTION: Do not use a scouring powder or an abrasive sponge as
it will damage the surface.
DO NOT attempt to clean the inside of the cassette port.
DO NOT insert your finger or any objects other than a cassette into
the cassette port.
DO NOT clean ava while there is a cassette inserted into the
cassette port.
CAUTION: Avoid spilling liquid on your ava. Never rinse or put ava
under water. If ava has been exposed to liquid, wipe it with a clean,
dry cloth, turn it on and check for error messages.
The helpline support Number is 1800-xxx-xxx.
24 Chapter 2: Getting to know ava
Battery saving mode
If ava is inactive for 60 seconds, the screen will dim automatically
to preserve battery. Pressing any button will restore the normal
screen brightness and you can continue the procedure.
If left inactive for 3 minutes, ava will automatically turn off,
unless you have not completed your injection. You will need to
re-start any procedure from the beginning, if the device turns off.
25
This page is intentionally left blank.
26 Chapter 2: Getting to know ava
Chapter 3:
Learning to
use ava
This section teaches you how to use
ava with a training cassette that does
not contain a needle or medication.
By using a ‘training cassette’, you
can get used to operating ava.
This section does not cover the safety
precautions you have to take when
injecting CIMZIA. You can fi nd that
information in Chapter 4, “Injecting
CIMZIA with ava”.
3
3
Training cassette
For training
purposes
only.
Contains no
needle or
medication.
CIA79970A
Batch no.:
xxxxxxxxxxxx
UCB Inc.
CIA79969A
1950 Lake Park Dr.
Smyrna, GA
ava Training Cassette
UCB Inc.
CIA79969A
1950 Lake Park Dr.
Smyrna, GA
ava Training Cassette
ava Training Cassette
For training purposes only.
LBL4_CIM_
PS6
ava Training Cassette
For training purposes only.
There is a training cassette included in your ava kit to help you
practice injections. The training cassette has no needle or
medicine. When it is time to inject your medicine, use the CIMZIA
medication cassettes only, not the training cassette.
Cassette body
Cap
Training
Cassette:
contains no
needle and no
medication
CIA79969A
UCB Inc.
1950 Lake Park Dr.
Smyrna, GA
ava Training Cassette
Body label 1
For training
CIA79970A
purposes
only.
Contains no
needle or
medication.
Batch no.:
xxxxxxxxxxxx
Body label 2
CIA79968A
ava Training Cassette
For training purposes only.
Contains no needle or medication.
Cap label
NOTE: The training cassette is reuseable. DO NOT discard.
28 Chapter 3: Learning to use ava
Your training cassette has
• no needle
• no medicine inside.
You can use it to practice injecting with ava. It can be used
• before your healthcare provider has set up your medication dose
on ava
• after your medication dose has been set up
• as often as you would like
• Make sure you keep the training cassette.
NOTE: When using the training cassette you are practicing the
DO NOT throw it away.
injection steps without actually injecting any medication. The
screens you will see on the display when using the training cassette
are the same you will see when using your cassettes containing
medication.
Using this training cassette will teach you how ava guides you
through the injection process.
The training cassette cap is colored bright green and the cassette
body is gray.
WARNING: See Chapter 4 for full injection instructions using a
CIMZIA medication cassette.
If you drop the training cassette, check the cassette to make sure
there are no broken parts before inserting into ava.
29
Using the training cassette
!
Low battery!
Please charge
battery.
!
Consult your
physician to
set device
dosage!
1
Turn on ava by holding down the
‘On/Off ’ button for 1 second, or until
the screen lights up and you hear a
sound.
NOTE: ava should arrive with the
battery charged, but, if ava does not
turn on, or it displays the message
‘Low battery. Please charge
battery.’, the battery
will need charging
before you start.
See Chapter 5 for
instructions on how
to re-charge the
battery.
If your healthcare provider has not
set up your device, you will see the
following message.
You can still insert the training
cassette to practice the injection
process.
30 Chapter 3: Learning to use ava
Loading...