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IFU002 Rev C.0
Welcome to Spire Health!
Medical Health Tags help your
doctor understand changes in
your health and wellness while
you're at home. Medical Health
Tags also promote healthier
habits like increased activity and
sleep which can contribute to
improvements in your condition.
With Medical Health Tags all you
need to do is get dressed and go!
Spire, Inc.
Instructions for Use
Patient Instruction Booklet
RELEASED
Confidential & Proprietary
Page 1 of 20
Effective Date: 2019-10-17
IFU002 Rev C.0
Patient Manual
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Table of Contents
Summary of Contents for Spire Medical Health Tag
- Page 1 RELEASED IFU002 Rev C.0 Effective Date: 2019-10-17 Patient Instruction Booklet Welcome to Spire Health! Medical Health Tags help your doctor understand changes in your health and wellness while you’re at home. Medical Health Tags also promote healthier habits like increased activity and sleep which can contribute to improvements in your condition.
- Page 2 • You’ll need your Medical Health Tags and undergarments you wear most frequently ready for this step. • You only need to pair (connect) one Medical Health Tag with the App. The rest of your Medical Health Tags in your pack will pair automatically.
- Page 3 Spire Health App. They are also included below for your reference: For each piece of clothing, remove the adhesive strip from the back of the Medical Health Tag and position it on clothing as shown below. Underwear: place 1-2 inches Bras: place ½...
- Page 4 IFU002 Rev C.0 Effective Date: 2019-10-17 Understanding the App It is important that you wear a Medical Health Tag as often as possible. Use your to confirm that your device is being worn correctly. The different screens you may see are shown below:...
- Page 5 Make sure the soft side of the Make sure you are wearing a Medical Health Tag is in contact Medical Health Tag. with your skin. If you cannot resolve these errors, contact Spire Health customer support at (415) 980-3858 Spire, Inc. Confidential & Proprietary IFU002 Rev C.0...
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Page 6: App Notifications
The App may send you notifications to make sure your Medical Health Tags and App are working correctly. The different notifications you may see and how to resolve them is shown below: Re-open your app by tapping the blue Spire Health icon on your mobile device Navigate to “Settings” in... - Page 7 Your Medical Health Tags have a long battery life that does not require charging. When a Medical Health Tag has reached the end of its battery life, you will need to remove it and replace it with a new device.
- Page 8 IFU002 Rev C.0 Effective Date: 2019-10-17 Replacement Adhesive If for any reason, your Medical Health Tag comes off of your garment before it is ready to be replaced, you can re-attach it using the Medical Health Tag adhesives included in your kit.
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Page 9: Important Notes
Do not adhere to skin. If you would like to re-watch the video on how to install Health Tags, or to learn more about attaching your Health Tags, visit support.spirehealth.com Spire, Inc. Confidential & Proprietary IFU002 Rev C.0 Instructions for Use... -
Page 10: Frequently Asked Questions
No, your Medical Health Tags have a long-lasting battery and do not require charging. Battery life will vary based on usage. What happens if my Medical Health Tag stops working? If your Medical Health Tag is not working correctly, you will see an error notification on your app screen. - Page 11 ● Do not launder Medical Health Tags on hot settings (>140°F) or with bleach or fabric softener or device may become damaged. ● Do not wear or use a Medical Health Tag that has been damaged. ● The Medical Health Tags are magnetic resonance (MR) unsafe! Do not expose Medical Health Tags to a MR environment.
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Page 12: Need Help
Medical Health Tag to slip or fall off during the patient wear duration. • The Medical Health Tag has a shelf-life date. Use of expired device may cause a degradation of signal quality and/or low battery condition. -
Page 13: Indications For Use
The RPM is intended for longitudinal monitoring of pulse rate, respiratory rate, sleep/wake behavior, and activity associated with movement. The RPM solution is comprised of four components - a Medical Health Tag (MHT), a Spire Mobile Application (App), a Cloud Platform (Platform), and a Healthcare Professional Dashboard (HPD). The patient facing components of the system (the MHT and Mobile App) are intended for daily use in the home, the workplace, and alternate care settings. - Page 14 RELEASED IFU002 Rev C.0 Effective Date: 2019-10-17 Spire Health 2030 Harrison Street San Francisco, CA 94110 Tel: +1-800-501-2256 (USA Only) SYMBOLS Date of Manufacturer Use-by-date Manufacture Type BF Prescription Net Quantity Applied Part Use Only of Contents Catalog Batch Code...
- Page 15 Battery Type 1 Lithium Manganese Coin Cell Battery Life Minimum of 500 hours of use PHYSICAL CHARACTERISTICS Dimensions 55mm x 34mm x 9mm Weight Spire, Inc. Confidential & Proprietary IFU002 Rev C.0 Instructions for Use Page 15 of 20 Patient Manual...
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Page 16: Environmental Characteristics
Table 1: Guidance and manufacturer’s declaration— electromagnetic emissions The Medical Health Tag device is intended for use in the electromagnetic environment specified below. The customer or the user of the Medical Health Tag device should assure that it is used in such an environment. - Page 17 Table 2: Guidance and manufacturer’s declaration— electromagnetic immunity The Medical Health Tag device is intended for use in the electromagnetic environment specified below. The customer or the user of the Medical Health Tag device should assure that it is used in such an environment.
- Page 18 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Medical Health Tag is used exceeds the applicable RF compliance level above, the Medical Health Tag should be observed to verify normal operation.
- Page 19 The Medical Health Tag is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Medical Health Tag can help prevent electromagnetic interference by maintaining a minimum distance between...
- Page 20 Trademarks Spire®, the Spire wave, and the Spire Medical Health Tag are registered trademarks of Spire, Inc. The Bluetooth® wordmark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Spire, Inc.
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