BIOCORP MERCK smartdot User manual

Instructions for Use

Part 1 · Safety information 3
Part 2 · What’s in the box 5
Part 3 · Your smartdot™ transmitter 6
Part 4 · smartdot™ light signals 7
Part 5 · Preparing 8
Part 6 · Injecting 13
Part 7 · Storing 16
Part 8 · Frequently asked questions 17
Part 9 · Troubleshooting guide 21
Part 10 ·Regulatory information on radio communication 26
Part 11 · Regulatory information on electronic waste 27
Part 12 · Technical specications 28
Part 13 · Symbols and information on the packaging 32
SUMMARY
2

• The purpose of the smartdotTM transmitter is to store and transfer
injection data when administering growth hormone treatment.
• The smartdotTM transmitter can only be used when injecting Saizen®
(somatropin) with the Merck pen injector.
• Injection data are transferred to the smartdot™ compatible mobile
Application (App) via Bluetooth®technology. Your healthcare
professional 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 pen user only.
• The smartdot™transmitter does not change the pen injection
process. Please read your pen injector instructions before starting to
use the transmitter.
• Keep your transmitter out of the reach of small children. Small
parts could be inhaled or swallowed and may lead to choking. If
the smartdot™ transmitter is being used by a child, they should be
supervised by an adult.
Part 1 Safety information
IMPORTANT:
Please read all the instructions in this manual before using the smartdot™
transmitter.
3

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.
• The smartdot™ transmitter is an electronic product. Do not throw
it away as household waste. Dispose of it in accordance with local
regulations.
Do not use smartdot™transmitter while it is charging.
Do not use smartdot™transmitter in the case of visible damage.
Contact your healthcare professional for further assistance.
Do not attempt to modify or repair smartdot™ transmitter. It
may damage the transmitter or cause you harm. Please note, the
smartdot™transmitter does not require any special maintenance
during its lifespan.
4

smartdot™
transmitter
Compliance
information
Quick Start Guide USB cable
Part 2 What’s in the box
Note:
USB charger is not included.
5

Light signal
Dial wheel
Injection
button
Micro-USB port
(charging)
Part 3 Your smartdot™ transmitter
6

The blinking blue light shows that smartdot™transmitter
is charging. The smartdot™ transmitter will show no light
after it is fully charged and before it is activated. See ‘Part 5:
Preparing <A. Charging your smardot™transmitter.’
Blinking blue
The red light means smartdot™ transmitter is defective.
See ‘Part 9: Troubleshooting guide <red light.’
Red
The blinking red light means that a reset is in progress.
See ‘Part 9: Troubleshooting guide <red light <What should I
do?’
Blinking red
If the smartdot™ transmitter is paired and activated, a light
signal should be shown anytime the injection button is pressed.
If no light is shown the battery might be empty. See ‘Part 9:
Troubleshooting guide <no light’ for more details.
No signal
The green light shows that smartdot™ transmitter is success-
fully activated and ready to use. The green light will disappear
after few seconds of inactivity. To see the light again, press
the injection button. See ‘Part 5: Preparing <E. Activating your
smartdot™transmitter.’
Green
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
Troubleshooting signals
7

ACharging your smartdot™ transmitter
1. Connect smartdot™ transmitter 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 the transmitter is fully charged, the blinking blue light will
disappear, and no light is shown.
5. Remove the charging cable. smartdot™ transmitter is now ready to
be paired.
You must charge your transmitter before using it for the rst time.
The smartdot™ transmitter will automatically switch on when you plug in
the USB cable.
After initial charging, your transmitter will need to be recharged
approximately every 2 weeks.
Do not use smartdot™ transmitter while it is charging.
2h
Part 5 Preparing
8

1. Your healthcare professional will create an account for you in the
associated web-based application. You will receive an invitation email
with instructions to download the compatible App.
2. Once installed the compatible App on your smartphone, you can log
in with the temporary password shared in the invitation email.
Install the compatible App on your smartphone and log in with your
details.
Downloading the App
Part 5: Preparing
B
9

Pairing your smartdot™ transmitter with the App
1. Activate Bluetooth®on your smartphone.
2. Place the smartdot™ transmitter near your smartphone.
3. Open the App and follow the onscreen instructions to pair it with
your transmitter.
4. After successful pairing, smartdot™ transmitter will display a
green light. Your App will also conrm that the pairing was
successful.
Part 5: Preparing
C
10

Placing smartdot™ transmitter on your pen injector
1. Hold the pen in one hand, so that you can see the dose knob.
2. In your other hand, hold the smartdot™ transmitter by the dial wheel.
3. Place the transmitter onto the dose knob and push the dial wheel down
until the dose knob is completely covered by smartdot™ transmitter, and
you cannot push anymore.
Do not hold or push the injection button when placing it onto the pen
injector.
smartdotTM transmitter should cover
the pen dose knob entirely
Part 5: Preparing
D
Note:
The smartdot™ transmitter can be placed on the pen in any
orientation. The transmitter intended use is to record the injection
data, it does not indicate how to inject.
11

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. The transmitter will show a green light, it
means the smartdot™ transmitter has been successfully activated.
Note:
You need to activate smartdot™ transmitter to use it. This will allow
your transmitter to record injection data when you perform your
injection.
Learn more about data transmission, see ‘Part 8: Frequently asked
questions <F. How does smartdot™ transfer the injection data?’
Middle
of the
button
Purple
Light
Step 2b
Green
Light
Part 5: Preparing
E
12
IMPORTANT:
If you do not see a green light when you release the injection button or
when you press the button after the activation steps, the activation was
not successful. Repeat the steps 1 and 2 and try again.
Do not repeat the activation steps if you see the green light. Repeating
the same steps, if the smartdot™ transmitter has been activated, will de-
activate it. For more information on when to de-activate the transmitter,
see ‘Part 8: Frequently asked questions, <C. How do I deactivate and
remove the smardot™ transmitter?’.

1. Prepare your pen injector, as shown in the pen instructions for use. Respect
the acclimatation time specied in the pen instructions 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 pen instructions for use.
4. Remove the needle from your skin and then release the injection button. The
green light will stay for few seconds.
Note:
Your smartdot™ transmitter does not change the injection process for your
pen injector. Please follow the pen instructions for use to prepare and perform
your injection. The steps below only cover the use of smartdot™ transmitter.
The green light will show when injection button is pressed, it means that the
transmitter is ready to record the injection. During injection, the green light
shown means that the injection data is being measured.
Do not watch the green light during injection, it does not indicate how to
inject. Always follow the pen injection steps.
Part 6 Injecting
IMPORTANT:
Before removing the pen injector from the skin, make sure the number “0.0”
appears in the dose window to ensure you injected the full dose.
Note:
Contact your healthcare professional if you have questions about your pen
injector or if you are unsure you have injected your prescribed dose.
If you have any doubts about the synchronization of the data with the
application or with the data displayed please contact your healthcare
professional.
13

Step 2a Step 2b Press and hold the
button all the way down
Middle
of the
button
Step 1
Note:
If the smartdot™ battery is low, the green light will turn orange for few
seconds after the injection button is released. See ‘Part 9: Troubleshooting
guide <orange light’ for more details.
Always set your dose
according to your
prescription.
14

Step 3cStep 3b
Step 2c
Hold while
slowly counting
to 10
Step 3a
Make sure the number “0.0”
appears in the dose window
to ensure you injected the
full dose.
Part 6: Injecting
15

Place your pen injector and attached smartdot™ transmitter in the
pen storage case. Store it according to the Saizen®patient information
leaet.
Part 7 Storing
Note:
Your smartdotTM transmitter is designed for storage between 2°C to 40°C.
16

How do I check the status of my smartdot™ transmitter?
Once smartdot™ transmitter has been connected to the
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 green, 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 injector or smartdot™ trans-
mitter. Only dial your dose when you are about to perform
an injection.
How do I take care of my smartdot™ transmitter?
• Attached to the pen injector – to wipe the external surfaces
• Removed from the pen injector – to wipe the internal surfaces. In
this case, you need to deactivate smartdot™ before removing it
from the pen. See ‘Part 8: Frequently Asked Questions <C. How
do I deactivate and remove the smartdot™ transmitter?’.
Do not wipe smartdot™ transmitter while it is connected to external
power source. Unplug the transmitter before wiping it.
Do not immerse smartdot™ transmitter in water. It is not waterproof,
and you may damage the transmitter.
Do not leave your smartdot™ transmitter or its accessories in a dusty
location.
Do not use any cleaning solutions, chemicals or alcohol wipes.
You can wipe your transmitter with a clean damp cloth whenever need-
ed, when it is:
If you removed smartdot™ transmitter from the pen:
1. Place your transmitter back on your pen. See ‘Part 5: Preparing <D.
Placing smartdot™ on your pen injector’.
2. Reactivate your transmitter. See ‘Part 5: Preparing <E. Activating
your smartdot™ transmitter’.
Part 8 Frequently asked questions
A
B
17

Step 2Step 1
Step 3
How do I deactivate and remove the smartdot™ transmitter?
1. Press smartdot™ transmitter for 5 seconds until the green light turns
to purple.
2. Release the button as soon as you see the purple light.
3. The light will turn off. The transmitter is now deactivated, and
injections will no longer be recorded.
You can now remove the transmitter from the pen.
To reactivate smartdot™ transmitter, see ‘Part 5: Preparing <E.
Activating your smartdot™ transmitter’.
• Wiping the internal surfaces of smartdot™ transmitter or your pen
injector
• Charging smartdot™ when the room temperature is above 25°C.
• Moving smartdot™ to a new pen injector
The smartdot™ transmitter must be deactivated before you can remove
it from the pen injector. This will prevent data being recorded in error.
You need to deactivate the transmitter before carrying out the following
actions:
Green
light
Purple
Light
No light
Part 8: Frequently asked questions
C
18

How do I travel with the smartdot™ transmitter?
How does smartdot™ transmitter transfer the injection data?
How do I pair smartdot™ transmitter with a new
smartphone?
• Transmitter is paired with your App. See ‘Part 5: Preparing <C.
Pairing your smartdot™ with the App.’
• Smartphone is near the transmitter.
• Smartphone’s Bluetooth®is enabled.
• App is open.
Place your pen injector and attached smartdot™ transmitter in the
pen storage case. Store it according to the Saizen®patient information
leaet.
The smartdot™ transmitter automatically transfers data to your App if
your:
IMPORTANT:
Once paired with App, you can perform 100 injections with smartdot™
transmitter without opening the App. You should open the App at least
once a month to allow data transfer to happen.
If you want to pair your transmitter with a new smartphone:
1. Open the App and ensure all your injection data is synchronized.
See `Part 8: Frequently asked questions <F. How does smartdot™
transfer the injection data?’ and refresh the home page by swiping
down the screen.
2. Reset the transmitter. See ‘Part 9: Troubleshooting guide <A. Reset
your smartdot™ transmitter’.
3. Download the App on your new smartphone. See ‘Part 5: Preparing
<B. Downloading App’.
4. Follow steps A-E in ‘Part 5: Preparing’.
Part 8: Frequently asked questions
D
E
F
19

When would I reset the smartdot™ transmitter?
How do I dispose of the smartdot™ transmitter?
The smartdot™ transmitter has been built to last 3 years after rst use.
The 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™ transmitter if:
To reset your transmitter, see ‘Part 9: Troubleshooting guide <A. Reset
your smartdot™ transmitter’.
Part 8: Frequently asked questions
G
H
20