Lilly Tempo Smart Button User manual

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Instructions for Use
Before you use the Tempo Smart Button™, read all the information and carefully follow
all the step-by-step instructions.
Before Using your Tempo Smart Button (Smart Button)
1) Check that you have your Tempo Pen™ and your Smart Button. Your Smart Button
will only work with a Tempo Pen.
2) Check your Smart Button for physical damage before every use. Do not use if
damaged.
3) Make sure your Smart Button is clean before every use.
4) Make sure you are using a compatible application (App).
WARNING: When using your Tempo Smart Button, do not repeat or skip your insulin
dose which may result in severe low or high glucose. Monitor your blood glucose and consult
with your healthcare practitioner.
WARNING: Consult with your healthcare practitioner to make sure you have a
backup diabetes management plan if your Tempo Smart Button or App stops working. Having
a backup plan and supplies can help you avoid severe low or high blood glucose.
WARNING: The Tempo Smart Button is intended to help support the management of
your diabetes. You must continue to independently manage your blood glucose values and
your prescribed regimen with support from your healthcare practitioner.
CAUTION:Keep your Smart Button away from children. The Smart Button represents a
choking hazard. The Smart Button could be swallowed or inhaled which could lead to choking
or injury.
Parts of the Tempo Smart Button

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Attach to Tempo Pen
Your Smart Button must be attached to a Tempo Pen to record or transfer insulin dose-related
data.
1) Check your pen label to make sure that you have a Tempo Pen.
2) Make sure your dose indicator on your Tempo Pen is at “0”.
3) Push the Smart Button straight down on the dose knob until you hear a snap or feel the
Smart Button snap into place.
Light Ring
Button
Dose Knob
Dose Indicator
Tempo Pen

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Note: Do not twist the Smart Button while attaching to the Tempo Pen. Push the Smart Button
straight down.
Switching your Tempo Smart Button between Tempo Pens
You can switch your Smart Button between Tempo Pens (for example if your Tempo Pen runs
out of insulin or if you are using two types of insulin).
To remove: Pull the Smart Button straight away from your current Tempo Pen. Avoid twisting
while removing the Smart Button from your Tempo Pen.
To attach: Follow the instructions in the section “Attach to Tempo Pen.” Avoid twisting while
attaching the Smart Button to your Tempo Pen.
Connect to an App
Your Smart Button must connect (pair) to an App before it transfers your insulin dose-related
data.
Reminder: You should only have to connect (pair) your Smart Button to your App during initial
setup.

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1) Make sure the Dose Indicator on your Tempo Pen is at “0”.
2) Open the App on your mobile device in a location at least 9 feet (3 meters) away from
other mobile devices actively in use. To help prevent others accessing your data or
settings do not leave your Smart Button in an area that can be accessed by others.
3) Follow the instructions from your App to connect the Smart Button.
4) Press and hold the Smart Button down until you see one (1x) green flash (after about 10
seconds). Release the Smart Button after you see one green flash.
hold and wait
green flash
release
The one (1x) green flash will tell you that your Smart Button is ready to pair to your App.
5) Follow your App’s onscreen prompts to finish pairing your Smart Button.
6) The light ring on the Smart Button will flash green three times (3x) when the Smart
Button is connected (paired) with your App.
7) Check your App to make sure your Smart Button is connected (paired).
Give Your Insulin Dose
Reminder: Your Smart Button must be attached to a Tempo Pen to record or transfer insulin
dose-related data.
1) Place your mobile device within 9 feet (3 meters) of your Smart Button,
2) Make sure that your mobile device’s Bluetooth®wireless technology is enabled, then
3) Give your insulin dose as described in the Instructions for Use that come with your
Tempo Pen.

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IMPORTANT NOTE: After your insulin dose, the Smart Button will flash green three
times (3x) when it stores your insulin dose-related data.
: Be sure to push the Smart Button straight down when injecting the dose. If you do not
push the Smart Button straight down, you may get more or less insulin than was dialed.
: If you are not sure if you injected your insulin or the Smart Button does not flash three
times (3x), do not repeat your insulin dose or skip your dose which may result in severe low or
high glucose. Monitor your blood glucose and consult with your healthcare practitioner.
After Your Injection
Follow the “After your injection” section of the Instructions for Use included with your Tempo
Pen. You can leave your Smart Button on your Tempo Pen between uses.
IMPORTANT NOTE: Your Tempo Smart Button is REUSABLE. You should remove your Smart
Button before disposing of any Tempo Pen.
Need help with pairing your App?
Your Smart Button should remain connected (paired) to your App when switching between
Pens. You should not need to pair it to your App again.
If your App disconnects from your Smart Button, follow the section “Connect to an App”.

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Did you know your Smart Button stores your insulin dose-related data?
: If you are unsure if any App data is inaccurate or missing, do not repeat your insulin
dose or skip a dose. This may result in severe low or high blood glucose. Monitor your blood
glucose and consult with your healthcare practitioner or Lilly at 1-855-LILLY-TEMPO (1-855-
545-5983). There are potential Smart Button design limitations which could lead to inaccurate or
missing data.
Your Smart Button can store insulin dose-related data if your phone is not within 9 feet
(3 meters) while you are giving your insulin dose. To send this insulin dose-related data to your
App, follow these steps:
1) Place your mobile device with the App running within 9 feet (3 meters) of your Smart Button.
2) Make sure that your mobile device’s Bluetooth®is enabled.
3) With the Dose Indicator at “0” press and hold the Smart Button down for 5 seconds. Then,
release the Smart Button. You can look at your App to see your data.
Hold
count slowly
release
If you have questions about your Tempo Pen, refer to the Instructions for Use that came with
your Tempo Pen.
If you have questions about your App, refer to the Instructions for Use that came with your App.
: When using your Tempo Smart Button, do not repeat or skip your insulin dose which
may result in severe low or high glucose. Monitor your blood glucose and consult with your
healthcare practitioner.

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Error Flashes on your Smart Button
When your Smart Button is ready to pair during the “Connect to an App”step and you are
waiting for your Smart Button to pair to your App:
Light Ring Flashes
Three Amber Flashes
Meaning: Your Smart Button had a problem during pairing. If your Smart Button is not paired to
your App, repeat “Connect to an App” steps. See Commonly Asked Questions or contact Lilly at
1-855-LILLY-TEMPO (1-855-545-5983).
When you push and release the Smart Button:
Light Ring Flashes
Blinking Amber and Green Flashes
Meaning: Your Smart Button has less than 2 weeks of battery life left. Your Smart Button is not
rechargeable. Your Smart Button will blink amber and green after every use until the battery no
longer works.
When you push and release the Smart Button:
No Light Ring Flashes
No Flash
Meaning: There is no light ring flash after use while attached to your Tempo Pen. Your Smart
Button is not working. Your Smart Button will only flash if it has enough battery life, and it is

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attached to a Tempo Pen. Make sure your Smart Button is fully attached to a Tempo Pen. You
may need to replace your Smart Button or contact Lilly at 1-855-LILLY-TEMPO (1-855-545-
5983) for help.
: If your Smart Button stops working, do not repeat or skip your insulin dose which
may result in severe low or high glucose. Monitor your blood glucose and consult with your
healthcare practitioner. Continue to dose your insulin as instructed by your healthcare
practitioner.
Reminder: If you have questions about the meaning of the flashes on the light ring display,
please see the steps in this Instructions for Use or contact Lilly at 1-855-LILLY-TEMPO (1-855-
545-5983).

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User Guide
TEMPO SMART BUTTON™
Read the entire User Guide before you use your Tempo Smart Button (Smart Button) and each
time you get a new Smart Button. There may be new information. This information does not take
the place of talking to your healthcare practitioner about your medical condition or treatment.
About Your Tempo Smart Button
Intended Use:
The Smart Button is intended to detect, store, and transfer insulin dose-related data from a
Tempo Pen to a compatible application (App). The Smart Button is indicated for single-patient
use by patients 18 years or older who are:
diagnosed with type 1 or type 2 diabetes mellitus,
using prefilled insulin Tempo Pens [Basaglar®Tempo Pen (insulin glargine) injection
100 units/mL, Lyumjev®Tempo Pen (insulin lispro-aabc) injection 100 units/mL,
Humalog® Tempo Pen (insulin lispro injection) 100 units/mL],
using a compatible application (App).

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Device Description:
The Tempo Smart Button is a reusable data transmitter (or data transfer module) that detects
and stores information from a Tempo Pen™and then transfers insulin dose-related data to a
compatible application (App) via Bluetooth®wireless technology.
The insulin dose-related data is used by the App, which can display the brand of insulin, dose
amount, date, and time.
Tempo Smart Button Associated Benefit and Risks
As with any medical device, there are benefits and risks associated with the use of the Tempo
Smart Button. Before using the Tempo Smart Button, read all the information including the
warnings and cautions to help understand the risks. Consult with your healthcare practitioner if
you have questions regarding how to safely use your Tempo Smart Button.
Important Information
Only use your Smart Button with your Lilly Tempo Pens. Using any other pens
may lead to missing insulin dose-related data.
Keep your Smart Button away from children. The Smart Button represents a
choking hazard. If inhaled or ingested, the Smart Button may cause internal injury which
could require medical assistance.
Connect (pair) your Smart Button to an App in a private place. This helps keep
your Smart Button safe.
Your Smart Button is reusable.
Each Smart Button is for single-patient multiple use only.
Cleaning Instructions
Avoid the use of a dirty-appearing Smart Button. Your Smart Button should be cleaned
whenever it looks dirty.
To clean your Smart Button:
1. Use a clean dry cloth to wipe the outer surface of the Smart Button.
2. Inspect the Smart Button to make sure it is clean.
3. If the Smart Button still appears dirty, re-wipe the Smart Button with a clean dry cloth.
If Smart Button still appears dirty after multiple attempts to clean, contact Lilly for help.
Do not try to repair or replace the Smart Button battery. This may cause you harm or
damage the Smart Button.
Only press the Smart Button while in use, such as dosing or transferring insulin dose-
related data. Repeated pressing of the Smart Button can reduce the battery life.