BIOCORP smartdot User manual

smartdot™ transmitter
for aluetta™ pen injectors 6, 12 and 20
Instructions for Use

Please read all the instructions in this manual before using the
smartdot™transmitter.
• The smartdot™transmitter can only be used with the aluetta™ pen injector
(6, 12, 20).
• The purpose of the smartdot™transmitter is to store and transfer injection
data when administering Saizen®(somatropin) injections with the aluetta™
pen injector.
• Injection data are transferred to the growlink™ compatible mobile
application (app) via Bluetooth®technology. Your healthcare provider has
access to those data.
• The smartdot™transmitter is reusable and has a rechargeable battery.
• Do not share your transmitter with any other person. smartdot™is intended
for use at home by one aluetta™ pen user only.
• The smartdot™transmitter does not change the aluetta™ pen injection
process. Please read your aluetta™ pen injector instructions before starting
to use the transmitter.
• Keep your transmitter out of the reach of children. Small parts could be
inhaled or swallowed and may lead to choking. If smartdot™ is being used
by a child, they should be supervised by an adult.
Part 1 Safety information
2

Part 1: Safety information
To preserve the performance and lifespan of the smartdot™transmitter, please
adhere to the following environmental conditions:
• Do not use in an environment containing ammable substances or oxygen.
• Store the smartdot™transmitter in a safe place. Do not leave it unattended
in the presence of children due to the risk of serious injury (swallowing or
choking), or damage to the device.
• Do not use smartdot™while it is charging.
• Do not use smartdot™in the case of visible damage. Contact your
healthcare professional for further assistance.
• Do not attempt to modify or repair smartdot™. It may damage the
transmitter or cause you harm. Please note, smartdot™does not require
any special maintenance during its lifespan.
• smartdot™is an electronic product. Do not dispose of it as household waste.
3

smartdot™Compliance informationQuick Start Guide USB cable
Part 2 What’s in the box
4

Light signal
Dial wheel
Injection
button
Micro-USB port
(charging)
Part 3 Your smartdot™ transmitter
5

The blinking blue light shows that smartdot™is charging.
Blinking blue
The red light means smartdot™ is defective.
See ‘Part 9: Troubleshooting guide <red light.’
Red
The blinking red light means that a reset is in progress.
Blinking red
No light is displayed when smartdot™is sleeping, or the battery
is empty. You can check the status of smartdot™by pressing the
injection button. See ‘Part 9: Troubleshooting guide <no light’ for
more details.
No signal
The white light shows that smartdot™ is ready to use.
White
The orange light appears when the battery is low.
See ‘Part 9: Troubleshooting guide <orange light.’
Orange
The purple light appears when activation or deactivation is in
progress.See ‘Part 5: Preparing >E. Activating your smartdot™
transmitter’.
Purple
Part 4 smartdot™ light signals
6

ACharging your smartdot™ transmitter
1.Connect smartdot™ to the supplied USB cable.
2.Connect the cable to a powered USB wall charger.
3.The transmitter will display a blinking blue light to indicate that it is
charging. A full charge can take up to 2 hours to complete.
4.When smartdot™ is fully charged, the blinking blue light will disappear, and
no light is shown.
5.Remove the charging cable. smartdot™ is now ready to be paired.
You must charge your transmitter before using it for the rst time. smartdot™
will automatically switch on when you plug in the USB cable.
After initial charging, your smartdot™ will need to be recharged approximately
every 2 weeks.
Do not use smartdot™ while it is charging.
2h
Note:
There will be no light signal until the pairing process has nished.
Part 5 Preparing
7

1.Your healthcare provider will create an account for you in the growlink™ app.
You will receive an email with instructions to complete the registration process.
2.When you complete the registration, you will receive a second email to
activate your account and a link to download the growlink™ app. You can also
download the app by scanning the QR code below. You can also nd this QR
code in the Quick Start Guide.
Install the growlink™ app on your smartphone and log in with your details.
Downloading the growlink™ app
PLACEHOLDER
Part 5: Preparing
B
8

Pairing your smartdot™ with the growlink™ app
1.Activate Bluetooth on your smartphone.
2.Place the smartdot™ transmitter near your smartphone. You can do this
while the transmitter is charging.
3.Open the growlink™ app and follow the onscreen instructions to pair it
with your smartdot™.
4.After successful pairing, smartdot™ will display a white light. Your
growlink™ app will also conrm that the pairing was successful.
Part 5: Preparing
C
9

Placing smartdot™ on your aluetta™ pen
1.Hold the aluetta™ pen in one hand, so that you can see the aluetta™ dose knob.
2.In your other hand, hold the smartdot™ transmitter by the dial wheel.
3.Place the transmitter onto the aluetta™ dose knob and push the dial wheel down
until the aluetta™ knob is completely covered by smartdot™, and you cannot push
anymore.
Do not hold or push the injection button when placing it onto the aluetta™ pen.
smartdotTM transmitter should
cover the pen button entirely
Part 5: Preparing
D
10

Step 2a
Step 1a Step 1b
Activating your smartdot™ transmitter
1.Press the smartdot™ injection button, until you see a purple light.
2.Now release the button. smartdot™ will display a white light. When
the white light turns off, smartdot™ has been successfully activated.
Note:
You need to activate smartdot™ to use it. This will allow your transmitter
to record injection data when you perform your injection.
Middle of
the button
Purple
Light
Step 2b
White
Light
Part 5: Preparing
E
11

Step 1
1.Prepare your aluetta™ pen, as shown in the aluetta™ Instructions for Use. If
stored in the refrigerator, open the storage box and wait ve minutes before use.
2.Turn the smartdot™ dial wheel until your intended dose is visible in the
dose window.
3.Perform your injection as described in the aluetta™ Instructions for Use.
Note: A white light will appear when you are performing your injection. It will
disappear when you release the button.
4.Remove the needle from your skin.
5.Release the button. The white light will stay for few seconds.
Note:
Your smartdot™ transmitter does not change the injection process for your
aluetta™ pen. Please follow the aluetta™ instructions for use to prepare and
perform your injection. The steps below only cover the use of smartdot™.
Note:
If the smartdot™ battery is low, the white light will turn orange for few
seconds after the button is released. See ‘Part 9: Troubleshooting guide
<orange light’ for more details.
Always set your dose
according to your prescription.
Part 6 Injecting
Before removing the aluetta™ pen injector from the skin, make sure you
see “0.0” in the dose window to ensure you injected the full dose.
12

Step 3cStep 3b
Step 2a
Step 2c
Hold while slowly
counting to 10
Step 2b Press and hold the button
all the way down
Middle of
the button
Step 3a
Make sure the number “0.0”
appears in thedose window to
ensure you injected the full dose.
Part 6: Injecting
13

Place your pen and attached smartdot™ transmitter in the aluetta™ storage
case. Store it according to the Saizen® patient information leaet.
Part 7 Storing
14

How do I check the status of my smartdot™ transmitter?
Once smartdot™ has been connected to the growlink™ app, you
can press the injection button at any time. This will wake up the
transmitter and a light will switch on for few seconds. This light
can be white, orange or red. See ‘Part 9: Troubleshooting guide’
if you see a red or orange light, or no light at all.
Do not play with your pen or smartdot™. Only dial the pen when
you are about to perform an injection.
How do I clean my smartdot™ transmitter?
• Attached to the aluetta™ pen – to clean the external surfaces
• Removed from the aluetta™ pen – to clean internal and external surfaces.
In this case, you need to deactivate smartdot™ before removing it from
the aluetta™ pen. See ‘Part 8: Frequently Asked Questions <C. How do I
deactivate and remove the smartdot™ transmitter?’.
Do not clean smartdot™ while it’s connected to external power source. Unplug
the transmitterbefore cleaning it.
Do not immerse smartdot™ in water. It is not waterproof, and you may
damage the transmitter.
Do not leave your smartdot™ or its accessories in a dusty location.
You can clean your transmitter when it is:
Wipe the surfaces with a slightly damp, soft lint-free cloth, with a small amount
of neutral detergent if needed.
Dry the surfaces with a soft cloth.
If you removed smartdot™ from the aluetta™ pen:
1.Place your transmitter back on your pen. See ‘Part 5: Preparing <D. Placing
smartdot™ on your aluetta™ pen’.
2.Reactivate your transmitter. See ‘Part 5: Preparing <E. Activating your
smartdot™ transmitter’.
Part 8 Frequently asked questions
A
B
15

Step 2Step 1
Step 3
How do I deactivate and remove the smartdot™ transmitter?
1.Press smartdot™ for 5s until the white light turns to purple.
2.Release the button as soon as you see the purple light.
3.The light will turn off. smartdot™ is now deactivated, and injections will no
longer be recorded.
You can now remove the transmitter from the aluetta™ pen.
To reactivate smartdot™, see ‘Part 5: Preparing <E. Activating your smartdot™
transmitter’.
• Cleaning smartdot™ or your aluetta™ pen
• Charging smartdot™ when the room temperature is above 25°C.
• Moving smartdot™ to a new aluetta™ pen
smartdot™ must be deactivated before you can remove it from the aluetta™
pen. This will prevent data being recorded in error.
You need to deactivate the transmitter before carrying out the following actions:
White
light
Purple
Light
No light
Part 8: Frequently asked questions
C
16

How do I travel with the smartdot™ transmitter?
How does smartdot™ transfer the injection data?
How do I pair smartdot™ with a new smartphone?
• Transmitter is paired with your growlink™ app. See ‘Part 5: Preparing <C.
Pairing your smartdot™ with the growlink™ app.’
• Smartphone is near the transmitter.
• Smartphone’s Bluetooth®is enabled.
• growlink™ app is open.
Place your pen and attached smartdot™ transmitter in the aluetta™ storage
case. Store it according to the Saizen® patient information leaet.
smartdot™ automatically transfers data to your growlink™ app if your:
Once paired with growlink™, you can perform 100 injections
with smartdot™ without opening the app. The data will
synchronize at least once a month, when there is an
established connection with the app as specied above.
If you want to pair your transmitter with a new smartphone:
1.Open the growlink™ app and ensure all your injection data is synchronized.
You can manually synchronize your data through the smartdot™ settings
page in the app.
2.Reset the transmitter. See ‘Part 9: Troubleshooting guide <A. Reset your
smartdot™ transmitter’.
3.Download the growlink™ app on your new smartphone. See ‘Part 5:
Preparing <B. Downloading growlink™ app’.
4.Follow steps A-E in ‘Part 5: Preparing’.
Part 8: Frequently asked questions
D
E
F
17

When would I reset the smartdot™ transmitter?
How do I dispose of the smartdot™ transmitter?
smartdot™ has been built to last 3 years after rst use.
The smartdot™ transmitter is an electronic product. Do not throw it away as
household waste. Dispose of it in accordance with local regulations.
Before disposing your smartdot™ transmitter, perform a factory reset to delete
your personal medical data. ‘Part 9: Troubleshooting guide <A. Reset your
smartdot™ transmitter’.
• It displays a red light.
• You want to pair it with a new smartphone.
• You want to delete smartdot™ injection data.
You need to reset your smartdot™ if:
To reset your transmitter, see ‘Part 9: Troubleshooting guide <A. Reset your
smartdot™ transmitter’.
Part 8: Frequently asked questions
G
H
18

smartdot™ is defective and cannot record your injections.
It needs to be reset.
The red light can appear when the button is pressed.
A. Reset your smartdot™ transmitter.
Please note: Resetting deletes the data stored in the smartdot™, deactivates
the transmitter and unpairs it from the growlink™ app.
1.Open the growlink™ app and ensure that all your data has been synchronized.
You can manually synchronize your data through the smartdot™ settings in
the app.
2.Open ‘smartdot™ settings’ in your app and select ‘Reset smartdot™’. The
transmitter will display a blinking red light during the reset.
3.Switch smartdot™ on by plugging in and unplugging the USB cable. Then see
steps C-E in ‘Part 5: Preparing’.
Continued on the next page
What do I see?
What should I do?
When does this light signal appear?
What does it mean?
Red light
Part 9 Troubleshooting guide
19

Note: You can also reset smartdot™ without the growlink™ app. To do this:
1.Connect the transmitter to a powered USB wall charger through the
supplied USB cable.
2.Quickly unplug it from the cable.
3.Repeat this action three times. You will see a blinking red light.
4.Switch smartdot™ on by plugging and unplugging it once. See steps C-E in
‘Part 5: Preparing’.
x3
If the red light remains, your smartdot™ is still defective. Remove it from your
pen and contact your healthcare professional for further assistance.
Note: You can still perform your injections without using your transmitter.
Part 9: Troubleshooting guide
20