IDION iTempShield Wearable Device for Senses Body Temperature and Communications User Guide

: June 12, 2024
: IDION

Table of Contents

iTempShield Wearable Device for Senses Body Temperature and
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

iTempShield Wearable Device for Senses Body Temperature and

Communications

Product
Information:
The IDION iTempShieldTM is a wearable device that senses body
temperature and communicates with a mobile app on your smartphone
or tablet. It is designed to provide accurate temperature
measurements. The device is equipped with iTempShieldTM technology,
which ensures reliable and consistent readings. The iTempShieldTM
can be worn for up to 60 days before needing to be replaced. The
IDION Shield app allows you to view current and historical
temperature measurements. If provided by a clinician, they may have
real-time access to your temperature data and can review all of
your readings. Product Usage
Instructions:
1. Install the IDION Shield app on your phone. You can do this by
scanning the QR code provided in the user manual with your phone’s
camera or by downloading it directly from the app store on your
phone. 2. Enable notifications and agree to the Terms and
Conditions in the app. 3. After viewing the brief iTempShieldTM
overview in the app, select “Enable” and then tap “OK” to allow the
device to connect with your phone. 4. Prepare your chest area where
you will be wearing the iTempShieldTM. 5. Peel off the adhesive
tape provided and apply it over the top of the device. Do not
remove the back of the device. 6. If you are an iPhone user, tap
the top area of the back of your phone to connect the device. If
you are an Android user, tap the middle of your phone to connect
the device. If the connection is not made, move the device across
the back of the phone and try again. 7. Keep Bluetooth enabled on
your phone at all times for seamless connectivity. 8. Use the IDION
Shield app to view your current and historical temperature
measurements. 9. If you have any concerns or questions about the
device readings, always consult your physician and do not
self-diagnose based solely on the device readings. Please refer to
the complete user guide available at www.idion.us/userguide for
detailed instructions and additional information.

iTempShieldTM
Patient Guide
CCR No:CR2022114 , DocFolder Id:Design-IFU-00006 , Revision:4 , Ver Effective Date:10-Nov-2022 Report generated by: JoshSape Copyright 2022 by Qualcy Systems Inc. A

Scan this QR Code to watch the
instructional video to set up your iTempShieldTM device:

iTempShieldTM
Patient Guide
Read these instructions fully before using the IDION iTempShield.TM
This Patient Guide provides important safety information about the IDION iTempShieldTM and its mobile application. For complete instructions go to www.idion.us/userguide. Please do not self-diagnose based solely on the device readings. Always consult your physician.
System Overview
The IDION iTempShieldTM is a wearable device that senses body temperature and communicates with a mobile app on your smartphone or tablet. When the iTempShieldTM is connected to your device, it sends all temperature measurements automatically.
The iTempShieldTM can be worn for 60 days before needing to be replaced. The IDION Shield phone application allows you to view current and historical temperature measurements.
If this device is being provided by a clinician they may have real-time access to your temperature data and may be able to review all of your readings.

CCR No:CR2022114 , DocFolder Id:Design-IFU-00006 , Revision:4 , Version:B , Current Status:Released and EFFECTIVE

1

iTempShieldTM
Patient Guide

System Contents

DO NOT REMOVE THE BACK OF THE DEVICE

IDION iTempShieldTM

There is no adhesive on the back of the iTempShield.TMAdhesive
tape is provided to be applied
over the top of the device.

Patient guide (this document)

iTempShieldTM
Patient Guide

Activating & Using Your iTempShieldTM
Getting started Install the IDION Shield app on your phone by scanning this QR code with the camera on your phone. You can also install the IDION Shield app by downloading it directly from the app store in your phone.
If you are an iPhone user, go to

Download IDION SHIELD APP

If you are an Android user go to

Type in IDION Shield and click on this image

CCSRiliNcoon:Ce RAd2h0e2s2iv1e1T4a,pDe ocFolder Id:DeSmsigarnt-IPFhUon- 0e0R0e0q6ui,reRdevision:4 , Version:B , Current Status:Released and EFFECTIVE

2

3

iTempShieldTM
Patient Guide

1. Enable “Allow notifications,” and select the box to agree to the Terms and Conditions.
2. After viewing the brief iTempShieldTM overview on the phone application, select “Enable” and then select “OK” to allow the device to connect with your phone.

Applying the iTempShieldTM

1

2

3 Inches

3. If you are an iPhone user, tap the top area of the back of your phone to

the device. If you are an Android user, tap the middle of your phone to the

device. If the connection is not made, move the device across the back of

the phone and try again.

Prepare chest

Adhere sensor to

4. Keep Bluetooth enabled on your phone at all times.

a. Select area on left or tape

5. Keep your iTempShieldTM device and your phone close together, with a maximum range of 32 feet (10 meters) and no physical obstacles (such as a wall) between them.

right upper chest.
b. If needed, trim hair to ensure good contact with skin.

a. Tear a three inch strip from the tape roll.
b. With the device logo visible and upright,

It will take up to 20 minutes for the device to adjust to your temperature.

c. Clean and dry skin. d. DO NOT apply

place the adhesive tape over the top.

You can use each device for up to 60 days.

iTempShieldTM to an

open wound or wet/

Apple and app store and google play are registered trademarks of Apple Inc and Google LLC.

moist skin.

Bluetooth word mark is registered trademark owned by Bluetooth SIG, Inc.
CCR No:CR2022114 , DocFolder Id:Design-IFU-00006 , Revision:4 , Version:B , Current Status:Released and EFFECTIVE

4

3
Adhere tape to chest a. Avoid stretching adhesive tape when applying it to skin. b. Place tape’s adhesive side on chest, then firmly press tape against skin to secure it.
5

iTempShieldTM
Patient Guide
Temperature screen (main screen)
The Temperature screen shows the latest temperature measurement and device battery level. When the iTempShieldTM first connects to the app, it sends temperature readings every 5 seconds. After the first 10 minutes, the device sends temperature readings approximately every 5 minutes.

iTempShieldTM
Patient Guide

How to track your temperature

To view your temperature history,

List view

tap the History tab. On the

history screen you can review the

temperature measurements as a List

( ) or as a Chart ( ).

Chart view

Temperature threshold
Your clinician may set up a threshold for your temperature measurements. When your core temperature exceeds the threshold value, the reading is marked with a red dot ( ) in the temperature history and your clinician is informed immediately.
Temperatures below the threshold will be marked with blue dots ( ).

CCR No:CR2022114 , DocFolder Id:Design-IFU-00006 , Revision:4 , Version:B , Current Status:Released and EFFECTIVE

6

7

iTempShieldTM
Patient Guide

How to care for your iTempShieldTM
Avoid… · Swimming. · Heavy exercise or contact sports. · Extreme heat or cold for more than a few minutes. · Do not bend or flex iTempShield.TM Bending the device can damage
it and prevent it from communicating with mobile devices. When you shower… · Pat dry when you dry off. · Do not aggressively scrub the tape and device. When you change clothes… · Take your time to avoid snagging the device. · Wear loose-fitting clothes when possible.

Battery level
· The iTempShieldTM must be replaced before the battery is depleted (after approximately 60 days of use).
· When you see the Battery is Low notification in the phone app, contact your healthcare provider for instructions.

CAUTION
Do not wear the iTempShieldTM during an MRI, X-Ray, or CAT Scan procedure as it may result in physical harm.

If you feel discomfort or pain from the tape or device, contact your doctor.

Do not apply the iTempShieldTM to an open wound or wet/moist skin. CCR No:CR2022114 , DocFolder Id:Design-IFU-00006 , Revision:4 , Version:B , Current Status:Released and EFFECTIVE

8

9

iTempShieldTM
Patient Guide
When to replace the iTempShieldTM Adhesive
Remove and replace adhesive every 2 days or every day as necessary. Move the device to the other side of the chest when replacing the adhesive tape. Always replace adhesive if: · Adhesive tape edges lift or loosen. · Device or adhesive tape has shifted.

iTempShieldTM
Patient Guide
How to Remove or Replace the Adhesive Tape
Slowly remove tape a. Slowly peel adhesive tape until fully removed from skin. b. For fragile skin: Use other hand to press down on and stabilize skin while removing tape. c. After removing adhesive tape from skin, lift iTempShieldTM off of adhesive tape. d. Clean any remaining adhesive residue from iTempShield.TM e. Use a new piece of adhesive tape to re-apply the iTempShieldTM (see instructions on Page 5).

CCR No:CR2022114 , DocFolder Id:Design-IFU-00006 , Revision:4 , Version:B , Current Status:Released and EFFECTIVE

10

11

iTempShieldTM
Patient Guide
Troubleshooting
If you see this screen…

Do this…

If you see this screen…

· If you do not connect to the shield and you a phone protective case, please remove the case on your phone and try again.

Do this…
· Make sure the phone and iTempShieldTM are within 32 feet (10 meters) of each other and without significant obstacles between them.

· Restart your phone.
· Make sure internet connection and Bluetooth are on and functioning.
· Try to connect your iTempShieldTM again. If it fails a second time, contact support at 203-208-8570 and replace the device.

· Make sure your phone is not in airplane mode and you have a cellular connection.

Need help?

If you have any questions about the iTempShieldTM system, call our customer

CCR No:CR2022114 , DocFolder Id:Design-IFU-00006 , Revision:4 , Versiosnu:Bpp,oCrtulirnreenatt:S20ta3t-u2s0:8R-8e5le70a.sed and EFFECTIVE

12

iTempShieldTM
Patient Guide
CCR No:CR2022114 , DocFolder Id:Design-IFU-00006 , Revision:4 , Ver Effective Date:10-Nov-2022 Report generated by: JosVh1S.0ape Copyright 2022 by Qualcy Systems Inc. A