Temptraq TT-100 User Manual

Page 1

User Manual

Model TT-100

Introduction to TempTraq™

Welcome to TempTraq™ , hands-free temperature monitoring.

This guide is for your beneﬁt to make sure you fully understand how to use the Tem pTra q™ system. Tem pTraq™ is a wearable, wireless, intelligent thermometer in the form of a one-time use, disposable patch. The patch senses, records and transmits body temperature for 24 hours via Bluetooth® Version 4.0. Temperature information from the patch is “read” using a smart device (Apple® or Android™ with Bluetooth® Version 4.0 capability running the TempTraq™ app). TempTraq ™ allows your child to rest when they are ill with an elevated temperature. There is no need to disturb your child to take a temperature measurement so your child can rest and you can have the peace of mind knowing your child’s temperature.

Important: Read instructions carefully before use. High, prolonged fever requires medical attention. If symptoms persist, contact your healthcare provider.

Warnings and Precautions

When using this product always follow these basic safety precautions to insure 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 Tem pTra q™ patch prior to application.

DO NOT immerse the patch in water. Patch may be removed for a bath or shower and then re-applied afterwards.

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 successive patches under the same arm. When removing one patch and starting another, place the second patch on the other side of the body.

Consult with your doctor before using on children under 2 years of age. Patch adhesive may irritate sensitive skin. Contact your doctor if irritation persists.

Clinical Temperature Information

Intended Use

The wireless thermometer, model TT-100, is a battery-operated electronic device with an intended use of measuring human body temperature precisely. This device is single-use and intended for armpit temperature measurement for persons of all age.

For Best Results

• Apply the patch to clean dry skin

• The sensor - the corner marked with “underarm” - must be positioned in the center of the armpit.

• The arm should be relaxed along the side of the body to enclose the Tem pTraq™ sensor in the armpit.

• Temperature measurements can be aected by ambient temperatures, particularly if the patch is exposed to cold ambient temperatures.

• Temperature data from the TempTra q™ patch can be read up to 40 feet away depending upon a number of factors, including obstructions between the patch and the smart device, and the position of the patch on the body. For improved performance, move the smart device closer to the Tem pTraq™ patch.

TempTraq Temperature Measurement

Normal body temperature is not a single temperature, but a range of temperatures inﬂuenced by age, time of day, and measurement site. We recommend that you take the temperatures of your family members when they are well to establish their normal body temperature. Many people may not have an elevated temperature when they are sick. These include, but are not limited to, infants under 90 days old, people on steroids, antibiotics or antipyretics (acetaminophen, ibuprofen, and aspirin), people with compromised immune systems (including the elderly and those having HIV/AIDS). See your doctor if you feel someone is ill even if their temperature is not elevated.

A doctor should be consulted in the following situations where fever is present: vomiting, diarrhea, changes in appetite, activity or breathing, or with children who are irritable, lethargic or unusually sleepy.

Troubleshooting Guide Speciﬁcations

Problem Troubleshooting Hints

Patch ID is not visible in the app when setting up a new proﬁle

App is showing "Out of Range" for a patch

Temperatures from the patch are lower than expected

Temperatures from the patch are higher than expected.

No audible alert is received from the smart device when the device is out of range or when a temperature alert is generated.

No alert is received when temperature measured by the patch exceeds the user set alert level.

• Patch may not be activated. Press button on patch to activate.

• Move the smart device running the TempTraq™ app closer to the patch. The patch can send temperature data up to 40ft. This distance is reduced by walls and objects between the patch and the smart device.

• 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 exposing the patch to cold ambient temperatures.

• Conﬁrm the patch is correctly reading temperature by measuring oral temperature with a digital thermometer.

• Check to insure that the phone volume is set to an audible level and is not set to mute.

• Check settings for the app to insure 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.

• 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 out of range of the patch.

• Check to insure that the app is running. No alerts will be generated if the app is not running.

TempTr aq™ measures under-the-arm "axillary" temperature and converts this temperature to display body temperature which is equivalent to a temperature measurement taken orally.

Fever Guidance

The TempTr aq™ app uses color coding to aid the user:

indicates a temperature is in the normal range.

GREEN

indicates a possible fever of 100.4°F (38.0°C) or higher.

ORANGE

indicates a temperature equal to or higher than the alert

RED

temperature that you selected.

Model Number TT-100 Patch Dimensions Length: 99.2mm, Height: 49.2mm, Thickness: 2.5mm Patch Weight 4.5 grams Patch Operating Life 24 hours

Patch Environmental Conditions

• Transport and Storage

• Use

Temperature Measurement Location Axillary (under the arm) - app converts axillary temperature to body temperature

Temperature Range 87.0 °F - 109.3 °F (30.6 °C - 42.9 °C). Temperatures below this range will be

Temperature Indications Less than 100.4 °F (38.0 °C) - GREEN

Accuracy Conforms with ASTM E1112-00 (2011); +/- 0.1 °C or +/- 0.2 °F over the temperature

Display Resolution 0.1 °F (0.1 °C) Response Time Once applied to the underarm, the patch requires up to 3 minutes to reach a

Transmission Distance Patch will transmit up to 40 feet when applied to the underarm Compatible Smart Devices Smartphones and tablets with Bluetooth® 4.0 running Apple® operating system

Standards ASTM E1112-00 (2011) standard for electronic thermometers

Radio Regulations FCC Part 15

Water Ingress Protection IP22 - Protected from damage due to water dripping on the product.

-4 to 122 °F (-20 to 50 °C) / 15 - 95% RH (non-condensing) / atmospheric pressure range of 700 hPA to 1,060 hPA

61 to 104 °F (16 to 40 °C) / 15 - 95% RH (non-condensing) / atmospheric pressure range of 700 hPA to 1,060 hPA

which is equivalent to temperature measurement taken orally

displayed in the app as "Lo". Temperatures above this range will be displayed in the app as "Hi".

Equal to or greater than 100.4 °F (38.0 °C) - ORANGE Equal to or greater than the user deﬁned alert temperature - RED

range of the device

stable reading

iOS 7.1 or later or Android™ operating system 4.3 or later. Visit temptraq.com for a list of compatible devices.

IEC 60601-1 Medical Design Standards, 3rd Edition IEC 60601-1-2 Electromagnetic Compatibility Bluetooth® Version 4.0

Industry Canada License exempt RSS standard(s) ISO/IEC 60601-1-2 Electromagnetic Compatibility

Additional User Information

IMPORTANT:

Read instructions carefully before use.

Type BF Applied Part

WARNING: No modiﬁcation of this equipment is allowed. 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.

Warranty FCC Statement and Legal Notices

TempTr aq™ warrants each new TempTraq™ patch against defects in materials or

workmanship for a period of one year from the date of purchase, 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. In order to obtain warranty replacement, simply call TempTra q™ Customer Care at 1 (440) 249-5440 for return instructions.

NOTE:

No other warranty, written or verbal is authorized by Tem pTraq ™. 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.

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. FCC WARNING: any changes or modiﬁcations not expressly approved by the 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 comply with 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 user is encouraged to try to correct the interference by one or more of the 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erence from that to which

the receiver is connected.

• Consult the dealer or an experienced radio/TV technician for help.

Protected by U.S. Patent Nos. 8,029,927;8,268,475;8,722,235. Other foreign patents pending.

All other trademarks are property of their respective owners.

Need More?

VISIT TEMPTRAQ.COM

CALL 1 440 2495440

Page 2

Get Started

1. 2. 3. 4. 5.

SENSOR

ACTIVATION SWITCH

ID NUMBER

DOWNLOAD AND INSTALL APP

The Tem pTraq ™ app can be downloaded from the App StoreSM or Google Play™ store.

Start App

Open the app on your smartphone. Please take time to review an in-depth video on the use of Tem pTraq™.

OPEN PACKAGING

When you are ready to use Tem pTraq ™, open the foil packaging and remove the patch. Be careful not to excessively bend the patch.

ACTIVATE PATCH

Squeeze the area marked by "Press to Start" between the thumb and foreﬁngers to activate the patch. You will feel the switch "click" when you have successfully activated the patch.

Add New Patch

As soon as the patch is started and applied to your child, it immediately begins monitoring body temperature. For accurate temperature readings, your child's arm should be relaxed at their side. The patch needs approximately 3 minutes to reach an accurate and stable temperature reading after it is applied to your child. To monitor your child's temperature with the app, you will need to add a new patch by selecting the "+" sign in the upper right of this screen.

Add a New Patch Patch List

REMOVE BACKING

Remove the backing from the patch just prior to application.

APPLY PATCH

Apply the patch directly under the arm with the sensor - the corner marked "underarm" - in the center of the armpit. The patch can be placed on either side of the body. The Tem pTra q™ logo should be in an upright position.

Enter your child's name; then enter an alert temperature. The app indicates a possible fever for temperatures of 100.4 °F (38.0 °C) or higher. Enter an alert temperature for when you want the app to alert you. Next, select a patch by choosing the ID number that corresponds to the ID number on the front of the patch on your child. Selecting "Save" will set up the patch and take you to the next screen.

This is your patch list, which shows a status bar for each active patch. Tem pTraq ™ enables you to monitor multiple patches at one time. Within each status bar, you will ﬁnd the current temperature of each child, the child's alert temperature and the time remaining for the patch. Within the circle, the Bluetooth® symbol will pulse whenever new data is received from the patch. By swiping across a status bar from right to left you can access the option to edit or delete a patch. Patches that have completed their 24 hour monitoring period are also shown on this screen. These patches and their data are retained in the app until you delete them. By tapping on the status bar for your child, you can navigate to your child's dashboard.

NOTE: To switch between Celsius and Fahrenheit, choose the appropriate selection within settings for the Tem pTraq™ app.

Dashboard Alert Notiﬁcation and Alert Temperature

The dashboard shows your child's current temperature, the alert temperature, and time remaining for the patch. The graph at the bottom of the screen illustrates your child's temperature over time. The app uses colors to show the current temperature status for each child.

GREEN indicates a

temperature that is in

the normal range

ORANGE indicates a possible

fever of 100.4 °F (38.0 °C)

or higher

RED indicates a reading equal to or higher than the user alert

temperature (ex. 103.0 °F)

If your child's temperature is equal to the user selected alert temperature - 103.0 °F in this example - the background color within the circular display for current temperature will change to red and your device will receive an alert notiﬁcation. Select "Snooze" to snooze the alert for 30 minutes. If your child's temperature remains above the alert level at the end of the 30 minute snooze period, you will receive another alert. If your child's temperature falls below the alert temperature during this 30 minute snooze period, the alert notiﬁcation will be canceled. Choose "Dismiss" to cancel the alert until your child's temperature drops below the user selected alert level and then once again increases to the alert temperature.

The alert temperature can be changed by selecting the "Edit" button in the upper right corner of the dashboard screen to navigate to the "Add a New Patch" screen.

Patch Out of Range Adding Notes

When the patch is out of range of the smart device running the TempTraq™ app for more than 15 minutes, the app will notify you that the smart device is not receiving temperature data from the patch and you will not be able to monitor the current temperature or receive alerts based on your selected alert temperature. To correct an "Out of Range" condition, move your smart device running the app closer to the patch until you once again begin to receive current temperature data. When in range, the app shows the current temperature. When out of range the app displays the message "Out of Range" and no current temperature is displayed.

The TempTr aq™ app allows you to add notes to your child's temperature history. Access Notes by selecting the "Notes" button at the bottom of the Dashboard Screen. Select "+" to add a note. You can choose from three preset events - medication, bath, or feeding - or create a custom note. Select the date and time that corresponds to the event or note and then press "Save" to save the note. Notes will be listed on this screen for review and editing and can be exported by tapping the export icon. A note icon is also added to the temperature history graph for each new note. Tap a note icon on the graph at any time to see the details of a previously entered note.

Graph View and Table View Patch Done

When in the dashboard screen, turn your smart device horizontally to display an expanded graph. Use pinch and zoom to view portions of the graph in more detail. You may also tap on note icons in this view to review previously entered notes. Rotate your smart device back to vertical to return to the dashboard screen.

When in the dashboard screen monitoring an individual patch, select the "History" button to view a list of temperature measurements for a more detailed look at the temperature changes over time. You may also tap the icon in the upper right of this screen to export data via e-mail. The data is sent as a .csv ﬁle which can be viewed in Microsoft© Excel©.

The patch stops measuring after 24hrs at which point it no longer sends the current temperature to the app. It will continue to send temperature history for the 24 hour use period just completed for an additional 24 hour period. The app shows the word "Done" to indicate that the 24 hour period of monitoring is completed. Remove the patch from your child when ﬁnished and dispose of it in common household waste. The patch and the data for the patch are retained in the app until you delete them.