Spire Medical Health Tag Patient Instruction Booklet Download Page 1

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IFU002 Rev C.0

RELEASED

Effective Date: 2019-10-17

Spire, Inc.

Confidential & Proprietary

IFU002 Rev C.0

Instructions for Use

Page 1 of 20

Patient Manual

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!

Summary of Contents for Medical Health Tag

Page 1: ...nt 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 ...

Page 2: ... 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 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 You mu...

Page 3: ...back of the Medical Health Tag and position it on clothing as shown below 2 Press Medical Health Tag firmly into clothing massaging for a few seconds to ensure placement Medical Health Tags should be placed on your first layer of clothing e g underwear bra or pajamas such that the side with the Spire Health logo is snug against your skin 3 Once your Medical Health Tags are attached wait at least 2...

Page 4: ...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 This screen means your Medical Health Tag is still processing This is normal and may take up to 15 minutes ...

Page 5: ...mer support at 415 980 3858 The error message Medical Health Tag is worn incorrectly means you need to adjust how your Medical Health Tag is being worn Make sure the soft side of the Medical Health Tag is in contact with your skin 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 you are wearing a Medica...

Page 6: ... 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 ...

Page 7: ...ife 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 For help with device replacement contact Spire Health custom...

Page 8: ...dhesives 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 Attach the replacement adhesive to the back of the Medical Health Tag over the old adhesive is OK and apply pressure on it for 5 seconds with your thumbs 3 Remove the second backing to expose the ...

Page 9: ...gh 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 Important Medical Health Tags are designed to be attached to clothes Do not adhere to skin If you would like to re watch the video on how to install Health...

Page 10: ...d to charge my Medical Health Tags 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 Make sure the soft side of your Medical Health Tag is in contact with your skin If yo...

Page 11: ...e 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 PRECAUTIONS Safety and effectiveness of Medical Health Tags on pediatric patients younger than 18 years o...

Page 12: ...alth Tag if package is damaged Device may not perform as intended Keep device and packaging away from young children Contents may be harmful if swallowed Medical Health Tags contain button cell batteries that are not accessible during normal use but if exposed are known choking hazards and may cause severe tissue injury if ingested Registration errors may result in limited functionality or erroneo...

Page 13: ...o the cloud based application CBA and to present the information captured on the MHT back to the user in an easy to understand format The HPD is a web based software application accessed through an internet browser by a nurse doctor researcher or other clinical professional Data captured by MHTs for a population of users can be viewed by an associated professional in the HPD INDICATIONS FOR USE Th...

Page 14: ...Health 2030 Harrison Street San Francisco CA 94110 Tel 1 800 501 2256 USA Only SYMBOLS Manufacturer Date of Manufacture Use by date Type BF Applied Part Prescription Use Only Net Quantity of Contents Batch Code Catalog Number Serial Number Consult Instructions for Use Do not re use Separate Collection Temperature Limit Caution Water Resistance Rating IP27 ...

Page 15: ...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 5 GHz ISM Band 1MHz Frequency Modulation Method FSK CPU Clock Rate 48 MHz Maximum Radiated Power 4 82 dBm at 2402 2480 MHz frequency POWER SPECIFICATIONS Battery Type 1 Lithium Manganese Coin...

Page 16: ...ions equipment can affect medical electrical equipment WARNING The MHT device should not be used adjacent to or stacked with other equipment 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 u...

Page 17: ...dity should be at least 30 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical home healthcare environment Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the Medical Health Tag inclu...

Page 18: ...transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Medical Health ...

Page 19: ...output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 80 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation...

Page 20: ...f the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment to an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help Important Changes or modifications to this product not authorized by Spire could void the electromagneti...

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