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. With Medical Health Tags all you need to do is get dressed and go! Spire, Inc. Instructions for Use Confidential & Proprietary Page 1 of 20 IFU002 Rev C.
IFU002 Rev C.0 RELEASED Effective Date: 2019-10-17 Setting Up the Spire Health App 1. Download the Spire Health App by going to www.spirehealthapp.com on your iPhone or Android device. 2. Next open your App and tap on “Create Account”. 3. Follow the instructions in the App to create your account and start using your Medical Health Tags. Important Notes for App Setup: • You’ll need your Medical Health Tags and undergarments you wear most frequently ready for this step.
IFU002 Rev C.0 RELEASED Effective Date: 2019-10-17 Attaching Medical Health Tags Instructions for attaching your Medical Health Tags are included in the Spire Health App. They are also included below for your reference: 1. 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 from center on the front waistband Bras: place ½ inch from bra cup on the inside wing of your bra 2.
IFU002 Rev C.0 RELEASED Effective Date: 2019-10-17 Understanding the App It is important that you wear a Medical Health Tag as often as possible. Use your app to confirm that your device is being worn correctly. The different screens you may see are shown below: This screen indicates that your Medical Health Tag is working correctly. Spire, Inc. Instructions for Use This screen means your Medical Health Tag is still processing. This is normal and may take up to 15 minutes.
IFU002 Rev C.0 RELEASED Effective Date: 2019-10-17 The error message “Medical Health Tag is worn incorrectly” means you need to adjust how your Medical Health Tag is being worn. The error message “No Medical Health Tag is worn or currently connected” means there is no Tag currently connected to your mobile device. Make sure the soft side of the Medical Health Tag is in contact with your skin. Make sure you are wearing a Medical Health Tag.
IFU002 Rev C.0 RELEASED Effective Date: 2019-10-17 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 your App to replace your device(s) Make sure your Medical Health Tag is worn so that the soft side is in contact with your skin Spire, Inc.
IFU002 Rev C.0 RELEASED Effective Date: 2019-10-17 Replacing Medical Health Tags 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. To replace the device, go to your app and tap on Settings. The Settings tab shows the device(s) that need to be replaced. Follow the instructions on the screen to replace your device.
IFU002 Rev C.0 RELEASED 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. The Medical Health Tag adhesives are a special type of double-sided tape. To use a replacement adhesive: 1. First, take a replacement adhesive strip and remove one side of the backing. Both sides are identical, so either side is OK. 2.
IFU002 Rev C.0 RELEASED Effective Date: 2019-10-17 Important Notes 1. For best care of your Medical Health Tags, wash clothing in warm water and dry with low heat. Do not wash or dry on high heat. Do not use bleach or fabric softeners. 2. Once your Medical Health Tags are ready to wear, be sure to only wear one Tag at a time. 3. To be monitored most effectively, be sure to keep your mobile device charged and in close proximity to you. 4.
IFU002 Rev C.0 RELEASED Effective Date: 2019-10-17 Frequently Asked Questions How do Medical Health Tags work? Medical Health Tags monitor your breathing, pulse rate, steps and sleep throughout the day and night. Health Tags are able to share this data with your care team through your app. Do I need to turn on my Medical Health Tags? No, the Medical Health Tags turn on automatically when you wear them. The green light may flash on and off; this is normal.
RELEASED IFU002 Rev C.0 Effective Date: 2019-10-17 WARNINGS ● For any medical concerns or a medical emergency contact your doctor or call 911. ● Stop wearing garments with Medical Health Tags immediately if you experience any discomfort. ● Do not use Medical Health Tags on broken or wounded skin. ● Do not adhere the adhesive of the Medical Health Tag directly on skin. ● Do not use Medical Health Tags if you have a known allergy to suede or adhesives.
IFU002 Rev C.0 • • • • • • • RELEASED Effective Date: 2019-10-17 degradation of adhesive performance causing the 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. Expired or faulty Medical Health Tag devices should be properly disposed with a certified electronics recycler or returned back to the manufacturer.
IFU002 Rev C.0 RELEASED Effective Date: 2019-10-17 DETAILED DEVICE DESCRIPTION Spire’s Remote Patient Monitor (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data and share this data with healthcare providers with a view to improving patient health and outcomes. The RPM is intended for longitudinal monitoring of pulse rate, respiratory rate, sleep/wake behavior, and activity associated with movement.
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 Spire, Inc.
IFU002 Rev C.0 RELEASED Effective Date: 2019-10-17 MHT DEVICE SPECIFICATIONS – Model MHT900100 PERFORMANCE CHARACTERISTICS Memory Capacity 48 hours Useful Life 3 months Shelf Life 14 months Respiration Rate Range 8-35 breaths per minute Pulse Rate Range 40-190 beats per minute ELECTRICAL CHARACTERISTICS Sensor Sampling Rate 25 Hz Nominal Battery Voltage 3V Bluetooth Version 4.0 Bluetooth Frequency Band/Bandwidth 2.4-2.
RELEASED IFU002 Rev C.
RELEASED IFU002 Rev C.0 Effective Date: 2019-10-17 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.
IFU002 Rev C.0 RELEASED Effective Date: 2019-10-17 less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1—At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a.
RELEASED IFU002 Rev C.0 Effective Date: 2019-10-17 Table 3: Recommended separation distances between portable and mobile RF communications equipment and the Medical Health Tag The Medical Health Tag is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
IFU002 Rev C.0 RELEASED Effective Date: 2019-10-17 REGULATORY Spire Medical Health Tag 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. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
