Tucky-21 Wearable Axillary Thermometer Instructions

**Tucky-21 Wearable Axillary Thermometer Instructions

**

Product Overview

1. Measurement sensor
2. On-off button
3. Micro USB port strip-cap
4. On-off LED / Led On-Of
5. USB port
6. Charger lead
7. Double-sided adhesive

INSTRUCTIONS FOR USE

Tucky-21 is a non-invasive and reusable electronic device for home use and a non-invasive and single patient use in the hospital. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

Tucky-21 also allows position monitoring of patient from ages 29 days and older (this is however not part of its medical intended use). It is positioned under the right armpit, as high as possible, with a dedicated doublesided adhesive (ADH-21) and transmits data to the “Tucky” smartphone application.

Temperature monitoring
The thermometer is set in direct mode: it takes the actual axillary temperature, without making adjustment calculations. You should thus wait about 15 minutes after placing Tucky under the armpit for the temperature to stabilize. The temperature is displayed with a color code, indicating whether it is normal or not.

Colour / axillary temperature correlation table:

Green
normal temperature| Orange
high temperature| Red (alert)
Very high temperature| Grey
Temperature not representative
From 34.7 to 37.3 °C (93.2 to 98.6 °F)| From 37.3 to 38.4 °C (98.6 to 100.4 °F) default value| Above 38.4 °C (100.4 °F) default value| E.g.: opened arm*
Note: rectal temperature is usually 0.7 °C (1.3 °F) higher than axillary temperature

The arm must be closed so that the measurements are less disturbed by the environment. The normal temperature varies according to the individual (age, sex, type, skin thickness), the time of day and external factors (ambient temperature, clothing, etc.) [1]. It is therefore normal to notice temperature variations caused by changes in the environment or arm position. In this case, the trend can be interpreted by following the  highest values of the last few hours.

An alert is issued when the temperature exceeds the “very high temperature” value. This threshold can be modified by the user in the application.

Position monitoring

The device also allows position monitoring, especially for babies. An icon on the application indicates whether the baby is in one of the following 4 positions: standing or sitting, lying on his back, lying on his stomach, lying on his side.
An alert is issued when the child turns over on his or her stomach. This alert can be deactivated in the application.
Note: to ensure this functionality, the product must be placed under the right armpit.
[1] KELLY, Greg. Body temperature variability (Part 1) : A review of the history of body temperature and its variability due to site selection, biological rhythms, fitness, and aging. Alternative medicine review, 2006, vol. 11, no 4, p. 278.

WARNINGS AND PRECAUTIONS FOR USE

Before using the product, please read these instructions for use carefully and completely to ensure reliability of the data.

• Tucky is a measurement tool but is not a diagnostic tool. It is not a substitute for monitoring symptoms or consulting a physician.
• Do not use this thermometer to interpret hypothermia temperatures.
• Tucky should only be applied with the double-sided adhesive provided (ADH-21), on clean and creamfree skin. Adhesives are single-use and  non-repositionable. During use, ensure that the probe remains in continuous contact with the skin.
• If axillary hairs are present, shave the area to maximize contact between Tucky and the skin.
• In case of heavy sweating or use during sport activities, a single-sided medical adhesive may be added over the device to improve its hold. A list of recommended adhesives is available on the manufacturer’s website.
• Do not apply the device on irritated or damaged skin or if an allergy to plastics (elastomer or silicone type) and/or adhesives has been detected in the patient.
• The adhesive should be changed every 24 hours or more frequently depending on skin sensitivity. If the skin shows redness, wait until it disappears before putting the product back on. If irritation occurs, remove the product immediately and seek advice from a health care professional.
• Tucky and adhesives should be used under normal conditions of temperature and humidity (see “Technical data”). Otherwise, measurements accuracy cannot be guaranteed.
• The thermometer and adhesives must be transported, stored and put in dry locations, away from direct sunlight, fire, contamination and within the specified temperature and humidity ranges (see “Technical data”).
• It must not be immersed in water: remove Tucky before bathing or showering.
• The product has been designed to follow the curvature of the body. Do not twist it by hand and do not try to open, repair or modify it. Do not use if damaged.
• Do not use Tucky near strong wave emitting devices (MRI scanners, scanners, portable or mobile RF communication devices) that may interfere with its operation (see “Electromag. testing”).
• Do not use Tucky and adhesives beyond their lifespan (see “Technical Specifications”).
• Be sure to keep Tucky and its accessories (adhesives and charger cable) away from children’s mouth. They must be used by adults.
• The device must never be worn during charging. Its functions are then deactivated.
• Check that your device (smartphone or tablet) is compatible with the application and has Bluetooth® and internet connectivity (see “Technical data” and list of recommended devices).
• Before using Tucky, check the time on your phone as the application is based on it.
• Make sure your smartphone or tablet has enough memory to store data.
• The phone paired with Tucky using Bluetooth® must remain within signal range to receive information (see “Monitor data wherever you are”).
• The manufacturer may change this manual and product specifications without notice. Refer to the digital version available on the manufacturer’s website.

OPERATING INSTRUCTIONS

Charge Tucky
Before using Tucky for the first time, charge Tucky with the supplied cable 6 by connecting it to a computer 5V USB port until the LED turn off (about 2 hours). The autonomy after a full charge is 5 days.

Install the application and create an account

• Download the «Tucky» application from the Apple Store or Google Play Store.
• Create an account by following the instructions, then create one profile per patient.
  Note: the data are stored in a certified health data cloud.

Associate Tucky with a patient profile

• Turn on Tucky by pressing the On/Off 2 button; LED 4 will blink for 2 seconds (6 times).

• In phone / tablet settings, activate the Bluetooth® function.
  Notes: on iPhone, Tucky may not appear in the list of detected Bluetooth® devices. Simply enable Bluetooth®, then exit from iPhone settings.

• In the application, select a profile, approach Tucky to the phone / tablet, press the “Associate” button and accept authorization requests. A temperature is displayed in the banner.
  Note: once associated, Tucky reconnects as soon as it’s within signal range.

Apply ADH-21 adhesive to Tucky

Remove the small part of the paper backing and peel the adhesive 7 from the remaining part. Stick it on Tucky’s front side, making sure probe edges are covered. Then remove both parts of the clear film.

Place Tucky under the armpit

• To place Tucky, observe the following points:

  • The micro-USB port 5 must be oriented downwards, with strip-cap 3 closed and sensor 1 facing the skin,
  • Tucky must be positionned as high as possible under the right armpit.
    Notes: if axillary hairs are present, shave the area before applying the device. In case of heavy sweating, it is possible to improve Tucky hold by adding a single-sided adhesive strip over it.

• For a better temperature measurement, wear light clothing and wait about 15 minutes with the arm closed until the temperature stabilizes.

Monitor the data wherever you are (2 use cases)

• Below 10m, use the phone / tablet connected to Tucky via Bluetooth®.
  Notes: if Bluetooth® connection is lost, the application tries to reconnect automatically. Tucky will continue to record the temperature (for 8 hours maximum) and will synchronize with the application as soon as the connection is re-established.

• Above 10m, two phones / tablets connected to the same account are required.

  • One must be connected to Tucky via Bluetooth®. It automatically relays information via Internet to the cloud (see “Data Protection”), making them accessible to other devices.
  • The other one displays data from the cloud without distance limit. A cloud icon on the app indicates this.
    Notes: verify that alerts work and are audible by activating “Test alert” on the application.
    There is no limit concerning the number of people which can monitor remotely data of the same account.

Turn off Tucky

To turn off Tucky, press the On/Off button; the LED will lit during two seconds. Otherwise, Tucky will automatically turn off 30 minutes after being removed from the body.

Cleaning and maintenance

• After each use, remove the adhesive and clean Tucky with a cotton soaked with medical alcohol. Do not use water, abrasive cleaners, or dishwashing products on Tucky. Not intended to be sterilized.
• To avoid battery issues, charge Tucky at least once a year.

TECHNICAL CHARACTERISTICS

TUCKY-21O, TUCKY-21P, TUCKY-21B & TUCKY-21N – ADH-21-E1
Storage / transport conditions| For complete product (including adhesives) or for adhesives only: Temperature: +10 to 27 °C (+50 to 80 °F); Relative humidity: 40 to 60 %.
For thermometer only:
Temperature: -20 to +55 °C (-4 to 131 °F); Relative humidity: 15 to 95 %
Normal conditions of use| Temperature: +15 to 40 °C (59 to 104 °F); Relative humidity: 15 to 95 % (non-condensing)
Atmospheric pressure: 76 to 106 kPa
Display resolution| 0,1 °C (0.2 °F)
Displayed temperature range| +24 to 44 °C (75 to 111 °F)
Accuracy (maximum laboratory error within the display temperature range)| ±0.1 °C (0.2 °F) from 37 to 39 °C (98 to 102 °F);
±0.2 °C (0.3 °F) from 32 to 37 °C (90 to 98 °F) and from 39 to 42 °C (102 to 107 °F);
±0.3 °C (0.5 °F) beyond these ranges.
Power supply| Rechargeable internal Lithium battery not accessible. Capacity: 35 mAh
Charger cable| USB 2.0 Type A male to Micro USB Type B male cable
Charging voltage| 5V
Alerts and information| High temperature: >38.4 °C (101.1 °F) (modifiable), Rollover on the belly (deactivated), Battery discharged (<6 %), Tucky detached, Long connection loss (>15min), Error
Bluetooth® technology| BLE 4.2; very low output power (1.35 mW)
Protection class IP22| Protected against solid bodies larger than 12 mm Protected against dripping water up to 15° from vertical
Supplied accessories| Instruction for use, charger cable, double-sided adhesive tape ADH-21
Lifespan| Thermometer: 5 years (500 charge cycles); Adhesives: 5 years
Required equipment| Smartphone or tablet with Bluetooth and internet connectivity. A list of recommended equipment is available on the manufacturer’s website
Compatibility| From iPhone 4S, iPad 3 and Android 4.3
The device is intended for use in the electromagnetic environment defined below

ELECTROMAGNETIC EMISSION TESTS| COMPLIANCE| ENVIRONMENT
RF emission (CISPR 11)| Group 1| RF emissions are very low and are not likely to cause interference to nearby electronic equipment
Class B| Conform
Harmonic current emission| Not applicable| Battery powered
Voltage fluctuation, Emission of Flicker flicker| Not applicable| Battery powered
---|---|---
IMMUNITY TESTING| TEST LEVEL ACCORDING TO IEC 60601| CONFORMANCE LEVEL
---|---|---
Electrostatic discharge (ESD) IEC 61000-4-2| ± 8 kV on contact
± 2,4,8 and 15 kV in air| Compliant
Radiated RF IEC 60601-4-3| 10 V/m from 80 MHz to 2,5 GHz| Compliant
Magnetic field at mains frequency IEC 60601-4-8| 30 A/m| Compliant

DATA PROTECTION

Data are stored in a certified health data cloud (HADS) and are processed in accordance with applicable laws for the purpose of monitoring patient’s axillary temperatures. You have the right to access, rectify and delete your data, and the right to limit data treatment. For more information, please read the privacy and data protection policy on the manufacturer’s website.

AFTER-SALES SERVICE, WARRANTY & INSPECTION

If you have problems using the product, please refer to the troubleshooting section on the manufacturer’s website. If the problem persists, contact support and communicate the product serial number available on the packaging label and on the 2D barcode located under the product strip cap. Applications for reading 2D barcodes are available from the Apple Store and Google Play Store. Tucky thermometer is under warranty for 2 years from the date of initial purchase from the distributor by the end customer. It covers defects in material and workmanship under normal use in accordance with manufacturer’s recommendations. This warranty does not cover defects caused by abnormal or faulty use or resulting from a cause unrelated to the intrinsic qualities of the product. For more information, please refer to the general terms and conditions of sale on the manufacturer’s website. To guarantee the operation and accuracy of the product, it is advisable to have it inspected every 2 years. The cost of this service is defined on the manufacturer’s website.

REGULATORY COMPLIANCE

This device complies with european directives and regulations relating to medical devices, radio equipment and restriction of hazardous substances. A copy of the EU Declaration of Conformity is available on the manufacturer’s website. Any serious incidents with Tucky should be reported to e-TakesCare ([email protected]) and the health agency in charge of vigilance incidents.

INFORMATIONS TO USERS IN USA

Federal Communication Commission Interference Statement (FCC ID = 2AWDL- TUCKY21WAA) 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 off 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 different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

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

INFORMATIONS TO USERS IN CANADA

(IC : 26084-TUCKY21WAA)
This device complies with Industry Canada’s licence exempt RSSs. Operation is subject to the following two conditions: (1) This device may not cause interference; and (2) This device must accept any interference, including interference that may cause undesired operation of the device.

Radiation Exposure Statement

The product complies with the Canada portable RF exposure limit set forth for an uncontrolled environment and are safe for intended operation as described in this manual. The further RF exposure reduction can be achieved if the product can be kept as far as possible from the user body or set the device to lower output power if such function is available.

SYMBOL SIGNIFICATIONS

CE marking affixed in 2016

| Manufacturer:
e-TakesCare, 35, rue des Chantiers, 78000 Versailles, France www.e-takescare.com
---|---

| Direct current

| CE marking

| Follow the operating instructions

| Apparatus comprising BF-type applied parts

| Non-ionizing radiation

| Storage temperature:
+10 to 27 °C (+50 to 80 °F)

| The device, its accessories and its packaging must be recycled in the appropriate way at the end of their use. Please observe local regulations and rules

| Serial number

| Catalogue number

References

• HugeDomains.com

Read User Manual Online (PDF format)

Download This Manual (PDF format)

Download this manual  >>