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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
1
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Related Manuals for Lilly Tempo Smart Button
Summary of Contents for Lilly Tempo Smart Button
- Page 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.
- Page 2 Button Light Ring Dose Knob Dose Indicator Tempo Pen 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”.
- Page 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).
- Page 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.
- Page 5 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.
- Page 6 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...
- Page 7 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:...
- Page 8 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).
- Page 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.
- Page 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.
- Page 11 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.
- Page 12 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.
- Page 13 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.
- Page 14 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.
- Page 15 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 Tempo Smart Button Use Life: 8 months, assuming: • 4 injections (with priming) per day, •...
- Page 16 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 Effective Radiated Power (ERP): 0 dBm Electromagnetic Compatibility RF Emission Test Compliance Electromagnetic environment guidance RF emission CISPR Group 1, Class B...
- Page 17 Degree of Protection 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.
- Page 18 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...
- Page 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 By prescription only Caution Warning Single Patient - multiple use Patient information...
- Page 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.
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Questions and answers
Is the app accessible for those who are visually impaired and use Apple’s VoiceOver Screenreader on iPhone?