Lilly Tempo Smart Button User manual

1
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

2
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

3
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.

4
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.

5
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”.

6
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.

7
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

8
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).

9
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).

10
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.

11
IMPORTANT NOTE: Avoid the use of cleaning or disinfecting fluids to clean your Smart Button.
Storage and Handling
Keep your Smart Button away from strong electromagnetic fields, such as Magnetic
Resonance Imaging (MRI). This may cause you harm or damage your Smart Button.
When stored on your Tempo Pen, store your Smart Button at room temperature below
86 º F (30 ºC). Do not store your Smart Button in the refrigerator.
You may keep the Smart Button attached to your Tempo Pen in between doses.
Store in-use insulin pen injectors as described in the Tempo Pen Instructions for Use.
Keep your Smart Button away from excessive light, including sunlight.
Your Smart Button is not waterproof.
Disposal of your Smart Button
Your Tempo Smart Button is designed to work for up to 8 months. The Smart Button is
REUSABLE and can be changed between your Tempo Pens. When your Smart Button is no
longer working, remove your Smart Button and dispose of it in accordance with applicable
country, federal, regional, state, and/or local laws and regulations.
Due to the electronic components in the Smart Button, do not throw in household trash.
Record the date the Smart Button was first used here: __ / __ / __
Record the Use-by date from your carton here: __ / __ / __

12
Do not use your Smart Button for more than 8 months after the first use or past the use-by date
on the carton.
Commonly Asked Questions
Q. Will my data automatically transfer to my App?
A. Your Smart Button stores and will automatically transfer insulin dose-related data to your App
when:
•Your Smart Button is connected (paired) to your App. See “Connect to an App” of this
Instructions for Use,
•Your mobile device with the App running is within (9 feet) 3 meters,
•Your mobile device is on with Bluetooth® enabled, and
•You push the Smart Button straight down while giving the insulin dose and then release
the Smart Button.
Q. My data is not appearing in my App. How do I transfer stored insulin dose-related data
from my Smart Button to my App?
A. Make sure your Smart Button is attached to your Tempo Pen. Place your mobile device
within 9 feet (3 meters) of the Smart Button. Make sure your device is on with Bluetooth®
enabled.With the Dose Indicator at “0” press and hold the Smart Button down for 5 seconds,
then release the Smart Button after 5 seconds.
If your data still does not appear, wait 30 seconds and try to transfer again.
If your data still does not appear, contact Lilly at 1-855-LILLY-TEMPO (1-855-545-5983) or call
your healthcare practitioner for help.
Q. The underside of my Smart Button is dirty. What should I do?
A. You should try cleaning the underside of the Smart Button with a dry, lint-free cloth. Refer to
the “Cleaning Instructions” section in the User Guide.
Q. Can I use the Smart Button with any prefilled insulin pen?
A. No, you may only use the Smart Button with Tempo Pens (Basaglar®U-100 Tempo Pen,
Lyumjev®U-100 Tempo Pen, Humalog®U-100 Tempo Pen).
Q. How long will my Smart Button work?
A. It may be used for up to 8 months if you:

13
•Do not frequently press the Smart Button without dosing your insulin,
•Do not store the Smart Button with the button pressed,
•Do not use the Smart Button outside of room temperature 59 °F (15 °C) to 86 °F (30 °C),
•Do not store the Smart Button outside the temperature range of 5 °C to 40 °C (41 °F to
104 °F).
Q. Who do I call if I need help with my Smart Button?
A. Contact Lilly at 1-855-LILLY-TEMPO (1-855-545-5983) or call your healthcare practitioner for
help.
Q. How will I know when to get a new Smart Button?
A. You will know by the Smart Button blinking amber and green flashes about 2 weeks before
the end of the battery life. You should replace your Smart Button before it runs out of battery life.
If your Tempo Smart Button stops working, the light ring will no longer light up when you press
the Smart Button while attached to your Tempo Pen.
Q. Can I recharge, repair, or change my battery?
A. Your Smart Button battery is not rechargeable. If the Smart Button is no longer working, you
should replace your Smart Button. Do not try to recharge, repair or change the battery. Trying to
recharge, repair, or change the battery could cause you harm or damage your Smart Button.
If you have any questions or problems with your Smart Button, contact Lilly at 1-855-LILLY-
TEMPO (1-855-545-5983) or call your healthcare practitioner for help. Do not try to repair,
perform maintenance, or modify your Smart Button. This could cause you harm or damage your
Smart Button. For more information on Smart Button, go to www.lillytempo.com.
Report all MEDICAL DEVICE COMPLAINTS or UNDESIRABLE SIDE EFFECTS, including
SUSPECTED SERIOUS INCIDENTS, to Eli Lilly and Company, by contacting them at 1-800-
545-5979.
You are also encouraged to report all UNDESIRABLE SIDE EFFECTS, including
SUSPECTED SERIOUS INCIDENTS, to the U.S. FOOD & DRUG Administration (US FDA)
by:
•Visiting the MedWatch web page on reporting an adverse event or serious problem
to FDA at (https://www.fda.gov/safety/reporting-serious-problems-fda/how-
consumers-can-report-adverse-event-or-serious-problem-fda) or
•Calling FDA’s toll-free information line at 1-800-INFO-FDA (1-888-463-6332).
Marketed by: Lilly USA, LLC

14
Manufacturer:
Eli Lilly and Company
Pharmaceutical Delivery Systems
Lilly Corporate Center
Indianapolis, IN 46285, USA
UK Responsible Person (RP):
Eli Lilly and Company Limited
Lilly House, Basing View
Basingstoke
Hants, RG21 4FA
United Kingdom
Authorized representative in the European community:
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ UTRECHT
The Netherlands
Copyright © 2022, Eli Lilly and Company. All rights reserved
Tempo™, Tempo Smart Button™, and Tempo Pen™ are trademarks of Eli Lilly and Company.
The Bluetooth®word mark and logos are registered trademarks owned by the Bluetooth SIG,
Inc. and any use of such marks by Eli Lilly and Company is under license.
All other trademarks are the property of their respective owners.
Issued: 16 September 2022
TSB-0001-UG-20220916

15
1 General Properties
1.1 Name: Tempo Smart Button; Catalogue Number: MS6303
1.2 Manufacturer: Eli Lilly and Company Pharmaceutical Delivery System
1.3 Compatibility
1.3.1 Mobile Medical Applications
•Legally marketed Tempo Compatible applications
1.3.2 Prefilled Insulin Pen Injectors
•Humalog® U-100 Tempo Pen, Lyumjev® U-100 Tempo Pen, Basaglar®
U-100 Tempo Pen
1.4 Insulin Dose-Related Data Measurement; Data transferred to an App
1.4.1 Increment: 1 Pen Injector Dial Click
1.4.2 Accuracy: +/- 1 Dial Click
1.4.3 Tempo Pen Brand Color Identification: Performed via color detection
1.5 Tempo Smart Button Use Life: 8 months, assuming:
•4 injections (with priming) per day,
•Transferring insulin dose-related data after each injection,
•Use at room temperature, and,
•The module is attached and detached from the pen no more than twice
per day.
1.6 Approximate Size: 21 mm (height) x 25 mm (diameter)
1.7 Tempo Smart Button Software Version: 3.1.1
2Electrical Properties
2.1 Mode of Operation: Continuous Operation
2.2 Communication: Wireless Bluetooth®Low Energy (BLE)
2.2.1 Frequency: 2.40 GHz –2.48 GHz
2.2.2 Range: 3 meters
2.3 Memory: 5840 dose records; where a single dose record includes time of dose,
dose knob rotation increments, and dose knob color.

16
2.4 Battery:
2.4.1 Type: Manganese Dioxide Lithium Battery. Perchlorate Material - special
handling may apply. See
http://www.dtsc.ca.gov/hazardouswaste/perchlorate
2.4.2 Model Number: CR1616
2.4.3 Voltage: 3 V
2.4.4 Non-replaceable; non-rechargeable
2.5 Effective Radiated Power (ERP): 0 dBm
2.6 Electromagnetic Compatibility
RF Emission Test
Compliance
Electromagnetic environment
guidance
RF emission CISPR
11, IEC 60601-1-2
Group 1, Class B
The device RF emissions are
not likely to cause interference
in nearby electronic equipment.
Electromagnetic environment guidance: The device is suitable for use in domestic and home
healthcare environments.
Immunity test
Test level
Compliance level /
performance criterion
Electrostatic discharge (ESD)
ETSI/EN 301 489-1
ETSI/EN 301 489-17
IEC 60601-1-2
ISO 11608-1
ISO 11608-4
±2, ±4, and ±8 kV contact
discharge
±2, ±4, ±8, ±10, ±12 and ±15
kV air discharge
±8 kV contact discharge
±15 kV air discharge
Power frequency magnetic
field
IEC 60601-1-2
30 A/m
30 A/m
Radiated RF
ETSI/EN 301 489-1
ETSI/EN 301 489-17
EN/IEC 60601-1-2
ISO 11608-4
10 V/m
26 MHz –6 GHz
Immunity to proximity fields
from RF wireless
communication equipment as
defined in Table 9 of
IEC60601-1-2
10 V/m
CT for transmitters, CR for
receivers

17
Portable RF (radio frequency) communications equipment should be used no closer than 30 cm
to any part of the Smart Button; otherwise, degradation of the performance of the Smart Button
could result.
Smart Button is a Bluetooth®device using the 2.4GHz transceiver. In review of IEC 60601-1-2,
subclause 8.10 the testing requirements in table 9 for the test frequency 2,450 MHz are
acceptable for testing Smart Button with the minimum separation distance as 30 cm. There are
no foreseeable use cases that would require the Smart Button to be used within the 30 cm
separation distance.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
3 Degree of Protection
3.1 Ingress: IP22 –The Tempo Smart Button is not waterproof. IP22 is protection
against finger insertion and will not be damaged or become unsafe when
exposed to vertical or near vertical dripping water.
4 Storage and Handling for the Smart Button
4.1
Operating conditions
Storage conditions
Temperature
Room Temperature,
59 °F (15 °C) to 86°F (30 °C)
41 °F (5 °C) to 104 °F (40 °C)
Humidity
15% to 90%
Atmospheric pressure
700 hPa to 1060 hPa
4.2 Store away from pests, pets, and children.
4.3 Exposing the Smart Button to environmental conditions outside of those listed in
the User Guide may cause damage or the Smart Button to malfunction.
Note: Store in-use insulin pen injectors as described in the patient Information Leaflet.
No modification of the Smart Button is allowed.
5 Compliance
•Title 47 Part 15

18
o This device complies with part 15 of the FCC Rules. Operation is subject to
the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
•FCC ID: 2AS69LLY00043845100.
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
European Union and United Kingdom, compliance with Radio Equipment Directive
Hereby, Eli Lilly and Company Pharmaceutical Delivery Systems declares that the radio
equipment type Tempo Smart Button is in compliance with Directive 2014/53/EU and UK
Statutory Instruments 2017 No. 1206, The Radio Equipment Regulations 2017. The full text of
the EU and UK declaration of conformity is available at the following internet address:
www.lilly.com/eudeclarations
The Smart Button has no Member State and/or geographical restrictions of use as it relates to
the Radio Equipment Directive (Directive 2014/53/EU).
6 Symbols
Manufacturer
Batch Code
Do not dispose in
household waste
Temperature
limitation (5 °C to
40 °C)
Keep away from
heat and sunlight
Serial number
Authorized
representative in
the European
Community

19
Use-by Date
Atmospheric
Pressure
Limitations
(700 hPa to
1060 hPa)
Medical Device
Humidity Limit
(15-90%)
Do not use if
package is
damaged
Conformité
Européenne (CE)
Mark
UK Conformity
Assessed
Consult
instructions for
use
By prescription
only
Caution
Warning
Single Patient -
multiple use
Patient
information
website
Catalogue
number

20
Magnetic
Resonance (MR)
Unsafe. Keep
away from
magnetic
resonance image
equipment.
Country of Origin:
Austria
Refer to
instruction
manual
IP22 is protection
against finger
insertion and will
not be damaged
or become
unsafe when
exposed to
vertical or near
vertical dripping
water.