TEMP TRAQ TT-100 User manual

Introduction to TempTraq
Welcome to TempTraq®, continuous temperature monitoring.
Intended Use
TempTraq®is a Bluetooth®continuous temperature monitor in the form of a one-time use,
disposable patch. The patch senses, records and transmits body temperature via Bluetooth®
Version 4.0. Temperature information from the patch is monitored using a smart device
(Apple®or Android™ with Bluetooth®Version 4.0 capability running the TempTraq app).
TempTraq measures under-the-arm “axillary” temperature and this is converted to an oral
temperature which is displayed in the TempTraq app.
Indications for Use
The wireless thermometers are battery-operated electronic devices with intended use of
measuring human body temperature precisely. These devices are single-use and intended
for armpit temperature measurement for persons of all ages.
For Best Results
• Clean and dry skin to remove deodorants or lotions, which can reduce adhesion of the
patch.
• The sensor - marked “underarm” - must be positioned high and in the center of the
armpit. Hold the arm at a 45° angle when applying the patch so that the center of the
armpit is easy to identify.
• Wait 8 minutes for the patch to warm up to body temperature.
• Maintain the placement of your arm along the side of your body to ensure an accurate
temperature reading. Temperature measurements can be aected by cold or hot
ambient temperatures if the arm is not at the side.
• Communication from the patch to the smart device is possible up to a distance of 40
feet (12 meters) but may be aected by objects between the patch and smart device.
• Individuals with high BMI may inadvertently cover the patch antenna with their arm
reducing the read range of the patch.
• For improved reception of temperature data from the patch, keep the phone awake,
and try moving it closer to the patch.
Troubleshooting Guide
Problem Troubleshooting Hints
Patch ID is not visible
in the Select Patch
list when adding the
patch
• Patch may not be activated. Press button on patch to activate.
• TempTraq only requires a single press of the “ON” switch to start operation.
Avoid repeated pressing of the “ON” switch which may damage the circuit
and cause TempTraq to fail.
App is showing "No
temperature data
received in last 60
minutes...”
• Move the smart device running the TempTraq app closer to the patch. The
patch can send temperature data up to 40 feet (12 meters). This distance is
reduced by walls and objects between the patch and the smart device.
• For improved reception of temperature data from the patch, keep the phone
awake, and try moving it closer to the patch.
Temperatures from
the patch are lower
than expected
• Check to make sure that the patch is properly positioned with the sensor
- marked “underarm” - correctly positioned in the armpit as shown in the
instructions for use.
• Lower than expected temperature readings can also be caused by exposure
to cold ambient temperatures, for example, when the arm is raised.
• Confirm the patch is correctly reading temperature by measuring oral
temperature with a digital thermometer.
Temperatures from
the patch are higher
than expected.
• Confirm the patch is correctly reading temperature by measuring oral
temperature with a digital thermometer.
No audible alert is
received from the
smart device when
there is an alert.
• Check to ensure that the phone volume is set to an audible level and is not set
to mute.
• Check settings for the app to ensure that notifications are enabled and sound
is enabled for notifications.
• Note that the audible alert only sounds for a short period. The visual
notification remains active in the app until canceled by the user.
No alert is received
when temperature
measured by the
patch exceeds the
user set alert level
• Check to make sure that the smart device running the app is in range of the
patch. A temperature alert will not be generated if the smart device is not
receiving data from the patch.
• Check to ensure that the app is running. No alerts will be generated if the app
is not running.
App displays "Patch
Error"
• Patch is not functioning correctly and needs to be replaced. Contact
Customer Care at 1 [phone] for return instructions.
App displays “Rapid
temperature drop
detected...”
• Can be caused by the arm being raised, exposing the patch to ambient
temperatures. For best results the arm should be down and relaxed at the
side. Dismiss this alert, or Disable to permanently silence this alert for this
patch.
TempTraq Temperature Measurement
TempTraq measures under-the-arm “axillary” temperature and this is converted to an oral
temperature which is displayed in the TempTraq app.
Fever Guidance
The TempTraq app uses color coding to aid the user:
indicates a temperature is in the normal range.
indicates a possible fever of 100.4°F (38.0°C) or higher.
indicates a temperature equal to or higher than the alert
temperature that you selected.
GREEN
ORANGE
RED
Important: Read instructions carefully before use.
High, prolonged fever requires medical attention.
If symptoms persist, contact your healthcare provider.
Model Number TT-100 TT-200 TT-300
Operating Time (hrs.) 24 48 72
User Manual
Warnings and Precautions
When using this product always follow these basic safety precautions to ensure that the
patch accurately reads temperature and to avoid skin irritation. Failure to follow these
precautions could result in inaccurate temperature readings resulting in delay in treatment,
or could result in skin irritation and mild discomfort.
DO NOT use the patch for any other purpose besides measuring human body
temperature.
DO NOT place the patch over wounds, sores or abrasions.
DO NOT excessively bend or twist the TempTraq patch.
DO NOT immerse the patch in water. Patch may be removed for a bath or shower
and then re-applied afterwards.
1. Download and Install App
The TempTraq app can be downloaded from
the App StoreSM or Google Play™ store.
2. Activate Patch
Squeeze the ( ) symbol between the thumb
and forefingers to activate the patch. You
will feel the switch “click” when you have
successfully activated the patch. Add your
patch to the TempTraq app.
SENSOR ACTIVATION
SWITCH
PATCH
RUN TIME
PATCH ID &
EXPIRATION DATE
3. Clean the Area
Clean and dry skin to remove deodorants or
lotions.
4. Remove Backing
Remove the backing from the patch just prior
to application.
Key for obtaining accurate temperature measurements
5. Apply Patch
Apply the patch directly under the arm on either
side of the body with the sensor - the corner marked
“underarm” – high and in the center of the armpit
( ) . Hold the arm at a 45 degree angle away from
the side when applying the patch so that the center of
the armpit is easy to identify. If applied correctly the
TempTraq logo will be in an upright position. Patch
may be removed and re-applied if needed to position
the patch correctly.
Key for obtaining accurate temperature measurements
DO NOT use the patch if it has been damaged or immersed in water.
DO NOT attempt to take apart the patch; there are no user serviceable parts.
DO NOT wear TempTraq during an MRI scan. TempTraq has not been evaluated for
safety and compatibility in the MR environment. It has not been tested for heating,
migration, or image artifact in the MR environment. The safety of TempTraq in the
MR environment is unknown. Scanning a patient who has this device may result in
patient injury.
DO NOT wear TempTraq during an X-ray scan. Wearing a TempTraq patch during
an X-ray scan may block visualization in the application area.
Patch adhesive may irritate sensitive skin or cause allergic reactions. Contact your doctor if
irritation or allergic reactions persist.

Additional User Information
IMPORTANT: Read instructions carefully before use.
Type BF Applied Part
User should contact Blue Spark Technologies, Inc. for assistance in using TempTraq when
needed, or to report unexpected operation or events.
WARNING: No modification of this equipment is allowed.
WARNING: Do not modify this equipment without authorization of the
manufacturer.
WARNING: If this equipment is modified, appropriate inspection and testing must
be conducted to ensure continued safe use of equipment.
Warranty
TempTraq warrants each new TempTraq patch against defects in materials or workmanship
until the expiration date of the product, and agrees to replace any defective product without
charge.
IMPORTANT:
This warranty does not cover damage resulting from accident, misuse or abuse, or lack of
reasonable care. No responsibility is assumed for any special, incidental or consequential
damages. To obtain warranty replacement, simply call TempTraq Customer Care at 1 (440)
249-5440 for return instructions, or email [email protected].
NOTE:
No other warranty, written or verbal is authorized by TempTraq. This warranty gives you
specific legal rights and you may also have other rights which vary from state to state. Some
states do not allow the exclusion or limitation of incidental or consequential damages, so the
above exclusion and limitations may not apply to you.
TempTraq Connect Troubleshooting Guide
(Applies to Models TT-100 and TT-200 only)
FCC Statement and Legal Notices
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 maycause undesired
operation.
FCC WARNING: any changes or modifications not expressly approved bythe party responsible for compliance could void the user’s
authority to operate this equipment under FCC regulations.
NOTE: this equipment has been tested and found to complywith the limits for a Class B digital device, pursuant to part 15 of the
FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment o and on, the useris encouraged to try to correct the interference by one or more ofthe
following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit dierent from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
P/N: TT-100-201 Rev 2
© 2017 Blue Spark Technologies, Inc.
TempTraq® and other related marks are owned by Blue Spark Technologies, Inc. All other trademarks are property oftheir
respective owners.
Protected by U.S. Patent Nos. 8,029,927; 8,268,475; 8,722,235. Otherforeign patents pending.
Specifications
Model Numbers (Patch
Operating Life) TT-100 (24 hrs.), TT-200 (48 hrs.), TT-300 (72 hrs.)
Patch Dimensions Length: 3.90 in (99.2mm), Height: 1.94 in (49.2mm), Thickness: 0.10 in
(2.5mm)
Patch Weight 0.16 ounces (4.5 grams)
Patch Environmental Conditions
• Transport and Storage
• Use
-4 to 122 °F (-20 to 50 °C) / 15 - 95% RH (non-condensing)
61 to 104 °F (16 to 40 °C) / 15 - 95% RH (non-condensing)
Temperature Measurement
Location
Axillary (under the arm) - TempTraq measures under-the-arm "axillary"
temperature and this is converted to an oral temperature which is
displayed in the TempTraq app.
Temperature Range 87.0 °F - 109.3 °F (30.6 °C - 42.9 °C). Temperatures below this range will
be displayed in the app as “Lo”. Temperatures above this range will be
displayed in the app as “Hi”.
Temperature Indications Less than 100.4 °F (38.0 °C) – GREEN
Equal to or greater than 100.4 °F (38.0 °C) – ORANGE
Equal to or greater than the user defined alert temperature – RED
Accuracy Conforms with ASTM E1112-00 (2011); +/- 0.1 °C or +/- 0.2 °F over the
temperature range of the device
Display Resolution 0.1 °F (0.1 °C)
Response Time Once applied to the underarm, the patch requires up to 8 minutes to
reach a stable reading
Transmission Distance Patch will transmit up to 40 feet (12 meters) when applied to the
underarm
Compatible Smart Devices Smartphones and tablets with Bluetooth® 4.0 running Apple® operating
system iOS 8.0 or later or Android™ operating system 4.3 or later. Visit
temptraq.com for a list of compatible devices.
Standards ASTM E1112-00 (2011) standard for electronic thermometers
IEC 60601-1 Medical Design Standards, 3rd Edition
IEC 60601-1-2 Electromagnetic Compatibility
Bluetooth® Version 4.0
Radio Regulations FCC Part 15
Industry Canada License exempt RSS standard(s)
ISO/IEC 60601-1-2 Electromagnetic Compatibility
CISPR 11 Group 1, Class B Radiated Emissions within 30 – 1,000 MHz
Water Ingress Protection IP24 - Protected from damage due to water splashing on the product.
This thermometer conforms to all requirements established in ASTM standard E1112-00. Full
responsibility for conformance of this product to the specification is assumed by Blue Spark
Technologies, Inc., 806 Sharon Drive, Suite G, Westlake, Ohio 44145
Problem Troubleshooting Hints
Unable to access Connect
within the app
• User must be logged into Connect to access features of
Connect. Select “Log In” in the Hamburger menu to log into
Connect.
Unable to view a shared
patch
• Check to ensure that the latest version of the app is installed
on the device
• Check to ensure that you are logged into Connect on your
phone
Unable to change the
“Temperature Alert” setting
or “Name” when viewing a
shared patch
• Only the user monitoring the patch locally and sharing the
patch can change the “Alert Temperature” or “Name”
Not receiving alerts when
viewing a shared patch
• Only the user monitoring the patch locally and sharing the
patch will receive alerts on their phone
A shared patch is no longer
visible in the app
• Check with the person who shared the patch to ensure that
they are still sharing the patch with you
• Check to ensure that you are still logged into Connect
No longer receiving
temperature data updates
for a shared patch. App
displays “No temperature
data received in last 60
minutes….”
• The person that shared the patch may no longer be
receiving updates from the patch. This could occur if they
are too far from the patch or have closed the TempTraq app.
• Check to ensure that your phone is connected to the internet
via cellular or WiFi
TempTraq Connect
(Applies to Models TT-100 and TT-200 only)
TempTraq Connect enables you to invite anyone anywhere in the world to view temperature
data from a patch that you are monitoring on your smart device.
• Sign into TempTraq Connect within the TempTraq app.
• Select the patch that you wish to share.
• From the Patch Detail screen select the TempTraq Connect cloud icon.
• Enter the e-mail address for the user that you wish to share the patch with.
• The TempTraq Connect screen for that patch will show who you have shared the patch
with. You can share the patch with multiple Connect users, and you can add and delete
users from this list.
When someone invites you to view a patch using TempTraq Connect you may view the data
available for that patch.
• Sign into Connect within the TempTraq app to view a patch that has been shared with
you.
• Patch Name, Current Temperature, Temperature History, Temperature Alert Setting, and
Notes will be available to view, but cannot be changed.
• When viewing a shared patch, no alerts are generated on your device for that patch.
Alerts only occur on the device that is within 40 ft. of the patch and that is receiving data
from the patch via Bluetooth 4.0.
• You may delete the patch from the Patch List screen.
• If you log out of Connect, shared patches will no longer be visible on your phone.
Performance of this device may be degraded should one or more of the following occur:
• Operation outside of the manufacturer’s stated temperature and humidity range
• Storage outside of the manufacturer’s stated temperature and humidity range
• Mechanical shock
The device or its components are not intended to be serviced, replaced, or repaired.
Device is powered by a 3V non-rechargeable battery. Not intended to be recharged,
serviced, replaced, or repaired.
The device is single use only. Do not reuse.
May be safely applied to self or used on others.
May be discarded in common household waste.
Need More?
VISIT TEMPTRAQ.COM
CALL 1 [phone]
EMAIL [email protected]
Blue Spark Technologies, Inc.
806 Sharon Drive, Suite G
Westlake, OH 44145