Sense-U SU501 Smart Thermometer User Manual

Sense-U® Smart Thermometer
User Manual SU501

Important Safety Notes

To ensure the correct usage of the product, basic safety measures should always be followed, including the precautions listed below.The patient is considered the intended operator, and all functions can be safely utilized.
WARNINGS

• Never use the thermometer for purposes other than those it has been intended for.
• Carefully read and follow the enclosed instructions to ensure accurate temperature readings.
• Keep out of reach of unattended children.
• Please keep still during measurement. Do not allow children to walk or run while taking a temperature.
• A prolonged period of high temperature requires medical attention. Contact a doctor when necessary.
• Do not attempt measurements when the thermometer is wet as inaccurate readings may result.
• Use of this Device adjacent to or stacked with other device should be avoided because it could result in improper operation. If such use is necessary, this Deivce and the other device should be observed to verify that they are operating normally.
• Please dispose of waste in accordance with national regulations on environmental protection.
• If the product will not be used for a long time, please remove the battery and place it properly.
• This thermometer uses Bluetooth Low Energy 4.0 technology. Keep the Device away from sources of high levels of electromagnetic field (in excess of 30 A/m) to reduce the likelihood of interference. Movement from external sources such as being pushed in a bassinet or traveling in a vehicle may be detected by the Device.
• The monitored child must sleep in their own separate bed as the Device may detect the movement of any other person sharing the bed with the child and may introduce false reading as long as it detects movement.
• During the warranty service, if necessary, the circuit diagram and necessary materials can be provided. If there are any problems with the maintenance of the electrical circuit, please contact the manufacturer

CAUTION

• Do not bite the thermometer. Doing so may lead to breakage and/or injury.
• Do not share the thermometer among individuals.
• Do not attempt to disassemble or repair the thermometer. Doing so may result in inaccurate readings.
• Do not attempt to incinerate the battery. It may burst.
• Pay attention to polarity (+ / ‒) when replacing the battery. Failure to do so may lead to fluid leakage, heat generation or bursting, resulting in damage to the unit.
• Do not use the thermometer in places where strong static electricity or electromagnetic fields are present. Doing so may lead to inaccurate readings and may contribute to instrument failure.
• Do not step on the unit or the hard case.
• Do not attempt to disinfect the probe sensor of the thermometer by immersing in alcohol or in hot water (water over 50°C).

GENERAL SAFETY PRECAUTIONS

• The is suitable for home healthcare environments.
• Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
• Do not use the thermometer to measure anything other than human body temperatures.
• Avoid taking the temperature until after 30 minutes has lapsed after exercise, bathing or eating/drinking.
• Dispose of the thermometer when its service life is reached. Follow local regulations regarding the disposal of such product.
• When the performance changes (such as: inaccurate temperature measurement, inaccurate temperature measurement or abnormal display), please stop using it immediately and contact the after-sales service personnel in time.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of the this device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

What’s in the Package

Introduction

The Sense-U Smart Thermometer Device tracks your child’s armpit temperature, and chest movements as a sleep quality indicator, and sends the real-time health data to the App.
The App notifies when something happens, based on the data sent from the Thermometer Device.
Your smartphone is your primary notification device in the event of an alert notification and should be
placed in a location where you can hear it if it sounds. The communication distance is up to 50 feet (15 meters) in open space. Brick wall or obstacles in between may affect the distance dramatically.

Indications for Use

The Sense-U Smart Thermometer is a wearable thermometer that safely and conveniently monitors your child’s armpit temperature and chest movements during sleep, and alerts you when something happens to your child, from anywhere.
The Device can be used by adults and children over the age of 6 months old.

CONTRAINDICATION

It is forbidden for patients allergic to stainless steel and PC plastic.

How to Use

5.1 Requirements

1. The Bluetooth on your smart device needs to be turned on to connect.
2. The communication distance is up to 50 feet (15 meters) in open space. Brick wall or obstacles in between may affect the communication distance dramatically.
3. One Sense-U Device can only connect to one smart device directly at any one time. To pair to another smartphone, you need to log out of the Sense-U App on the paired smart device first, then log on the Sense-U App on the other smart device. An optional Base Station supports twins and multiples.
4. For Android devices, please make sure Location is enabled for the Sense-U App in Settings-> Connections->Location and Settings->Apps-> Sense-U->Permissions. If Location is not enabled it may not be able to pair to the Device.
5. Pull out the battery separator to power on the Device.

5.2 Download the Sense-U App

1. Download the free Sense-U App, available for iOS and Android from the Apple App Store and Google Play.
2. Allow all requested permissions for the Sense-U App, e.g. Location, Bluetooth, no optimization of battery usage, etc.
3. Create a free Sense-U account.

5.3 Pair the Device
Follow the in-app instructions to pair the Device.
Pairing: double shake the  Device, until the Device flash BLUE 3+ times (waiting for pairing)

5.4 How to Wear and Measure
Step 1: Remove the liner from the other side of stripe A, and adhere the Device to strip A with the Sense-U logo on the top.
Step 2: Stick the Device with stripe A to the right chest area and ensure the probe tip reaches armpit area.
Step 3: Peel off the upper liner from strip A.
Step 4: Repeat steps 1-3 for strip B, covering the probe tip and sticking it to the underarm.

Step 5: Wait for 5 plus minutes, until the App shows a stable temperature reading.
NOTE:
A fever is defined as body temperature that is elevated above the normal for that person. It is important to determine what is normal for an individual before determining if a fever is present.
Tracking an individual’s temperature on a consistent basis, at the same body site and at the same time every day when the person is well or healthy will help determine an individual’s normal temperature.

Sense-U App at a Glance

Home Screen

again. Make sure that your environment is in the operating range and that the thermometer is placed as described in the diagram in the ‘5.4’ section
Temperature Too High| Above 109°F (43.0°C)| Try measuring the temperature again. Make sure that your environment is in the operating range and that the thermometer is placed as described in the diagram in the ‘5.4’ section
—| There is no temperature reading| Check whether the Device is disconnected; check whether the switch Button is turned off.

Me

1. Account: Update my profile, Child Profiles, Dark Mode, Language, log out, etc
2. Messages: News & Savings and System notifications
3. Help: User manuals
4. Contact Us: Have questions about your Sense-U products? Contact us here and include your device / app info, which will greatly expedite the diagnosis process.
5. Manage Devices: Change notification settings, check device information, update firmware, delete device, etc
6. Widget: Real-time data in lock screen for easy access
7. Family Sharing: Share with family members
8. Love the Product? Rate it Like our product? Support us with a review
9. Refer: Refer a friend and earn
10. Buy: Find exclusive deals available in the Sense-U official store (www.sense-u.com)

Device Setting

1. Device Name: Please name your device

2. Assigned To: A child or another child

3. Firmware Update

4. Smart Thermometer: Device Switch

5. Chest Movement Alerts: Alert when movement gets out of preset range

6. Temperature Alert: Alert when temperature gets out of preset range

7. Wearing Detection (Beta)
   Stop detecting movement automatically when the device is not worn.

8. Device Information

To receive audible alarms, notifications need to be switched on for the Sense-U App from Settings->Notifications->Sense-U.
For Android devices, make sure Media Volume is switched on in Settings->Sounds and Vibration->Volume. Make sure your smart device is not in Do Not Disturb mode.

Indicator Lights

| Pairing| Green| Double shakes detected
---|---|---|---
Blue (flashing)| Waiting for Bluetooth pairing
Green (3 times)| Paired successfully
Red (3 times)| Pairing timeout
Interaction
( tap on / off button )| Green (1 sec)| Battery level normal
Red(1 sec)| Battery level low (< 20%)
Updating| Blue (solid)| Updating firmware

Battery

The battery life is up to 1 month when used for 8 hours per day.
Battery Replacement

1. Use a warping piece to take off the battery cover
2. Remove the battery
3. Insert the new battery with the “+” pole facing up
4. Put the battery cover back

Care and Maintenance

1. Keep the thermometer clean.Do not use strong jets of water to clean the thermometer or leave it immersed in water for long periods of time.

2. Wipe the thermometer with a soft clean cloth and sterilize the probe with ethyl alcohol.

3. For stubborn stains, wipe the thermometer with a cloth that has been dampened with water or a neutral detergent solution and then wring thoroughly. Finish by wiping with a soft dry cloth.

4. Observe the following to prevent damage to the thermometer.
   • Do not use benzene, thinner, gasoline or other strong solvents to clean the thermometer.
   • Do not soak the sensing section in alcohol for long periods of time or attempt to sterilize it using hot water (water at a temperature of 50°C (122°F) or higher).
   • Do not use ultrasonic washing to clean the thermometer.
   • Do not soak the display in water.

5. Do not store the thermometer in the following types of places. Doing so may damage the thermometer.
   • Wet locations.
   • Locations with high heat and humidity or those that are exposed to direct sunlight. Areas close to heating equipment, dusty locations, or environments where there are high salt concentrations in the air.
   • Locations where the unit will be subjected to leaning, shock or vibration.
   • Pharmaceutical storage areas or locations where corrosive gases are present.

6. When the performance changes (such as: inaccurate temperature measurement, inaccurate temperature measurement or abnormal display), please stop using it immediately and contact the after-sales service personnel in time.

7. The thermometer is IP22 rated:
   • The first digit (2 in IP22) refers to protection against solid objects. In this case, it means the equipment is protected against solid objects greater than 12.5mm in diameter, such as fingers or large tools.
   • The second digit (2 in IP22) refers to protection against water. In this context, it means the equipment is protected against water droplets when tilted up to 15 degrees from its normal position.

8. Maintenance should be done by the operator as suggested.

9. No maintenance or servicing is required for the thermometer in use.

Technical Specifications

30-85%RH
Atmospheric pressure: 70 KPa-106 KPa
Storage and Transport Conditions| Temperature: -4 to +131°F (-20 to +55°C) Humidity:10%-93%RH
Atmospheric pressure: 70 KPa-106 KPa
Safety Classification Infor- mation (anti-electric shock)| Anti-electric shock type: Internal power supply Anti-electric shock degree for applied part: Type BF
Waterproof Rating| IP22
Accessories| Battery
Weight & Dimension| Approx. 23g (with battery installed), 120x35x9mm
Measurement Time| 5 minute
Battery life
.| up to 1 month (8 hours per day) .,

EMC Information

Electromagnetic Emissions
Guidance and manufacturer’s statement – Electromagnetic emission

Electromagnetic Immunity

Guidance and manufacturer’s declaration – Electromagnetic Immunity

Immunity Test| IEC 60601-1-2 Test level| Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2| 1-8 kV contact
-±2 kV, -±4 kV, ±8 kV, -±15 kV air| -±8 kV contact
-±2 kV, -±4 kV, -±8 kV, -±15 kV air
Electrical fast transient/burst IEC 61000-4-4| Not applicable| Not applicable
Surge IEC 61000-4-5| Not applicable| Not applicable
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| Not applicable
Not applicable|
Power frequency magnetic field IEC 61000-4-8| 30 A/m 50Hz/60Hz| 30 A/m 50Hz/60Hz
Conducted RF IEC61000-4-6| Not applicable| Not applicable
Radiated RF IEC61000-4-3| 10 V/m, 80 MHz – 2,7 GHz 80 % AM at 1 kHz| 10 V/m, 80 MHz – 2,7 GHz 80 % AM at 1 kHz
NOTE UT is the a.c. mians voltage prior to application of the test level.

Electromagnetic Immunity

Guidance and manufacturer’s declaration – Electromagnetic Immunity| Compliance level Nam) m)
---|---
Radiated RF IEC61000-4-3 (Test specifications
for ENCLOSURE PORT IMMUNITY to RF wireless communications
equipment)| Test Frequency
(MHz)| Band (MHz)| Service| Modulation| Maximum Power eN)| Distance (m)| IEC 60601-1-2
Test Level (vfm)
385| 380-390| TETRA 400| Pulse modulation
18 Hz| 2.| 0.3| 27| 27
400| 430-470| GMRS 460
FRS 460| FM± 5 kHz deviation1 kHz
sine| 2| 0.3| 28| 28
710| 704 – 787| LTE Band 13,17| Pulse modulation
217 Hz| 0.2| 0.3| 9| 9
745
780
810| 800 – 980| GSM 800/900,
TETRA am,
IDEN 820,
CDMA 850,
LTE Band 5| Pulse modulation
18 Hz| 2| 0.3| 28| 28
870
930
810| 1700-1990| GSM 1800;
CDMA 1900;GSM 1900;
DECT; LTE Band 1, 3,4, 25; UMTS| Pulse modulation
217 Hz| 2| 0.3| 28| 28
870
930
2450| 2400-2570| Bluetooth, WLAN, 802.1 g/n 1 b/, RFID 2450,| Pulse
modulation 217 Hz| 2| 0.3| 28| 28
| | LTE Band 7| | | | |
810| 5100-5800| WLAN 802.11a/ n| Pulse
modulation
217 Hz| 0.2| 0.3| 9| 9
870
930

Symbols and Descriptions

collection point for recycling.
Caution| Incorrect use of the thermometer may cause injury to the person or damage to the device.
Warning| Incorrect use of the thermometer may cause injury to the person or damage to the device.
| Manufacturer
| Consult the instructions for use
****| Ingress Protection Rating

FCC ID: 2AB89SU301
MODEL: SU501
FCC Caution:
Any Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 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 RF Radiation Exposure Statement:

1. This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
2. This equipment complies with RF radiation exposure limits set forth for an uncontrolled environment.
3. The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction.
   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 nterference 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

Shenzhen AOJ Medical Technology Co., Ltd.
Add: Room 301&4F, Block A, Building A, Jingfa Intelligent
Manufacturing Park, Xiaweiyuan, Gushu Community,
Xixiang Street, Bao’an District, 518126 Shenzhen, CHINA

DISCLAIMER
Customers use this thermometer at their own risk and Sense-U Inc., its members, employees, agents, contractors, representatives, manufacturers, distributors and associates shall not be held liable for any loss, damage or injury suffered by the customer or any other person arising from, or in connection with, the use or manufacture of the monitor, including loss, damage or injury suffered by the customer or any other person as a result of any defects in respect of the monitor, and all warranties, and any other liability from whatsoever cause arising, are hereby excluded and the customer hereby indemnifies Sense-U Inc. in respect of any such liability.

GUARANTEE

Sense-U promises a 30-day Money Back Guarantee for this product and a 1-year Limited Warranty from the original date of purchase, verified by a sales receipt. Our warranty liability shall be limited to replacing the unit free of charge and does not include transport costs. Our guarantee extends to all countries in which this product is supplied. By the act of operating this product, the user accepts all resulting liability. We reserve the right to modify the provisions of this guarantee at any time without notice. This guarantee does not cover the battery, incorrect application, tampering, misuse or transport damage.

CONTACT US
For product questions, we recommend contacting us directly via in-app Feedback from the Sense-U App->Me->Contact Us for expedited diagnosis and response. For general questions, please email us at SUPPORT@SENSE-U.COM.

Date of Issue: March 2024
File No.: SU501_UI_3_1

References

• Sense-U Smart Baby Monitor: Abdominal Movement, Rollover, Temp, Video

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