FORA TM10 Wearable Temperature Monitor Instruction Manual

Wearable Temperature Monitor
Operation Instruction
311-1035100-021
ver 2.0 2021/06

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**Dear FORA TM10 System Owner:

**

Thank you for purchasing FORA TM10 Wearable Temperature Monitor. For safe and correct use of the device, please read this operation instruction carefully before use and keep it for future reference. The product incorporates Bluetooth temperature monitor with temperature detection and low- ltage display to provide accurate and in stand axillary temperature measurement. If you have any other questions regarding this product, please contact your local customer service or place of purchase.

**INTENDED USE

**

FORA TM10 Wearable Temperature Monitor is a thermometer equipped with Bluetooth unction for underarm temperature measurement and monitoring. It  s a home-use device intended for infants and children younger than 3.

**SAFETY INFORMATION

**

1. As with any temperature monitor, proper technique is crucial to training ccurate temperature readings. Please read this instruction oroughly and carefully before use.
2. Always operate the monitor in the  perating temperature ranging from  °C  o 40°C (41°F to 104°F) and the relative humidity ranging from 15% to 93%.
3. Always store the thermometer in a cool and dry place. Storage conditions:  emperatures from -25°C to 70°C (-13°F to 158°F); relative humidity between 10% and 95%.
4. Avoid direct sunlight.
5. Avoid dropping the monitor, if it happens and you think the monitor may  e damaged, please contact customer services immediately.
6. Do not disassemble the monitor.
7. Basic safety precautions should always be observed, especially when the  onitor is used on or near children and disabled persons.
8. This monitor is not intended as a substitute for the advice provided by your physician.
9. The battery is well sealed inside the monitor to reduce the risk of being swallowed by children.
10. If you experience any serious incident that occurred in relation to the use of this product, please report it to the manufacturer and the competent authority of medical devices in your country. A serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:
    (a) the death of a patient, user, or other people,
    (b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health,
    (c) a serious public health t hreat.

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

PRODUCT OVERVIEW (a )

1. ON/OFF Button
2. Battery Cover
3. Sensor
   Applicable measuring range of upper arm: 4.7” to 6.3” (12 cm to 16 cm)

METER DISPLAY (b)

1. Battery Indicator
2. Bluetooth Symbol
3. Temperature Unit
4. Temperature Reading

**WHAT IS A “NORMAL” TEMPERATURE?

**

Body temperature is a complex, non-linear data point, subject to many sources of internal and external variations. A normal body temperature mean and range (males and males combined) for axillary is 36.3°C (35.5°C – 37.0°C) / 97.3°F (95.9°F – 98.6°F). Source: Gregory Kelly, ND. Alternative Medicine Review 006;11(4): 278-293.

Note:

• Please consult your physician when your baby’s temperature is out of the above normal range.
• Axillary temperatures are generally 0.5°C /1.0°F lower than oral readings.

BLUETOOTH PAIRING

You can transmit your data from the monitor to your devices via Bluetooth. lease contact your local customer service or place of purchase for assistance. lease note that you must complete the pairing between the monitor and the Bluetooth receiver before transmitting the data.

Pairing with your mobile device

1. Install the software (iFORA BM) to your device with an iOS or Android system. (c)

2. Turn on the Bluetooth function on your mobile device.

3. Press ON/OFF button to turn on the meter.

4. Make sure your FORA TM10 is already paired with your device with an iOS, Android system or PC by following the instructions below. (d)
   Note: This step is recommended when the user needs to pair this meter to a Bluetooth receiver for the first time, or when the user needs to pair this meter to another new Bluetooth receiver.

5. After successfully pairing the APP with the device, the Bluetooth function on the meter should be on before transmitting the data to your APP.

Bluetooth indicator on the meter

Note:

• Make sure Bluetooth is turned on or enabled on your device before transmitting the data and that the meter is within the receiving range. As for the requirements for the OS version, please refer to App Store or  Google Play when you download the app.
• As Bluetooth functionality may differ from one mobile phone to another, compatibility issues may occur between your mobile phone and the thermometer.

HOW TO TAKE YOUR TEMPERATURE?

Firstly, remove the battery protection tab. (e)

1.  Wipe the underarm with a dry towel before wearing the temperature monitor.
   Note: The temperature monitor can be positioned on either arm.

2. Wear the temperature monitor. Adjust the armband to make sure the temperature sensor is under the arm in the center of the armpit. Make sure the temperature sensor is properly positioned on your underarm. This location is important to obtain accurate temperature measurements. (f)

3.  Press ON/OFF button to turn on the temperature monitor. (g)

Monitoring the Child’s Body Temperature with iFORA BM

1. To monitor the child’s temperature with the app, you will need to enter iFORA BM on your device. (h)
2. When the thermometer is turned on and applied to the child, it begins monitoring the temperature and transmitting temperature information. The monitor measures and displays the detected temperature every minute. (i)
3. You may enter the target temperature range in the settings to determine when you want the app to alert you. This could be a temperature recommended by your doctor. (j)
4. If the child’s body temperature falls outside of the target temperature, your device will receive an alert notification. (k)

Note:

• The physiological temperature reading will be measured after wearing the monitor for 10 minutes.
• The distance between the monitor and your mobile device should be 10m without any barrier.

REPLACING THE BATTERY

The temperature monitor comes with one 3V CR2032 lithium battery. Replace it when “ ” appears. Please follow the steps to replace a new battery. To replace the battery, make sure that the meter is turned off.

1. Detach the meter from the armband. (l)
2. Prepare a new battery and a proper-sized coin to open the battery cover. (m)
3. Use the coin to twist the battery cover counterclockwise to open. (n)
4. Remove the cover and the battery. (o)
5. Insert the new battery and fasten the battery cover clockwise. (p)

CARE & CLEANING

Before and after each use, clean the thermometer casing and tip with a clean cloth slightly moistened with 70% isopropyl alcohol solution or COLD soapy water. Never use abrasive cleaning agents, thinners, or benzene for cleaning. The device is not water-resistant. Never immerse the device in water or cleaning liquids. Take care not to scratch the surface of the LCD.
Note: The attached armband is regarded as a consumable item. Please replace it with a new one if the hook-and-loop fastener no longer works properly due to repeated use.

SYSTEM TROUBLESHOOTING

If you follow the recommended action but the problem persists, please contact your local customer service.

Result Readings

20.00°C to 45.00°C (68.00°F to 113.00°F).
Hi-temperature ≥ 45.01°C (113.02°F)
Lo-temperature ≤ 19.99°C (67.78°F )
| ambient temperature is above or below system operation range, from 5°C to 40°C (41°F to 104°F).
L-temperature < 5°C (41°F)
H-temperature > 40°C (104°F)

Troubleshooting
If the monitor does not display a message after being turned on:

SPECIFICATIONS

Model No.: FORA TM10
Dimension & Weight: 40.5 (L) x 27.5 (W) x 11.7 (H) mm, 18 g
Power Source: 3V CR2032 lithium battery
Operating Time of Battery: 200 hours for continuous measurement
Measurement Range: 20.00°C ~ 45.00°C (68.00°F ~ 113.00°F)
Low Temperature Display: < 20.00°C  (68.00°F): display: Lo
High Temperature Display: > 45.00°C (113.00°F): display: Hi
Atmospheric Pressure Range: 700 hPa to 1060 hPa
Operation Altitude: 2000m
Display Resolution: 0.01°C (0.01°F)
Accuracy: ±0.10°C (±0.18°F) for the range of 20.00°C to 34.99°C (68.00°F to 94.98°F); ±0.05°C (±0.09°F) for the range of 35.00°C to 38.00°C (95.00°F to 100.40°F); ±0.10°C (±0.18°F) for the range of 38.01°C to 45.00°C (100.42°F to 113.00°F).
Temperature Unit: °C or °F
Operating Condition: 5°C to 40°C (41°F to 104°F), 15% to 93% R.H.
Storage/Transportation Conditions: -25°C to 70°C (-13°F to 158°F), 10% to 95% R.H.
International Protection Marking: IP22
Reference to Standards: EN ISO 80601-2-56:2012, clinical thermometers; ASTM E1112;
IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2 (EMC); EN 301 489-17, EN 300 328
Display: LCD
External Output: Bluetooth
Expected Service Life: 2 years

WARRANTY TERMS AND CONDITIONS

With respect to disposable products, ForaCare Suisse warrants to the original purchaser that, at time of delivery, each standard product manufactured by ForaCare Suisse shall be free from defects in material and workmanship and, when used for the purposes and indications described on the labeling, is fit for the purposes and indications described on the labeling. All warranties for a product shall expire as of the product expiration date, or if none, after two (2) year from the original date of purchase, as long as it has not been modified, altered, or misused. ForaCare Suisse warranty hereunder shall not apply if: (i) a product is not used in accordance with its instructions or if it is used for a purpose not indicated on the labeling; (ii) any repairs, alterations or other work has been performed by the buyer or others on such item, other than work performed with ForaCare Suisse’s authorization and according to its approved procedures; or (iii) the alleged defect is a result of abuse, misuse, improper maintenance, accident or the negligence of any party other than ForaCare Suisse. The warranty set forth herein is conditioned upon proper storage, installation, use and maintenance in accordance with applicable written recommendations from ForaCare Suisse. The warranty furnished hereunder does not extend to damaged items purchased hereunder resulting in whole or in part from the use of components, accessories, parts or supplies not furnished by ForaCare Suisse.

ELECTROMAGNETIC COMPATIBILITY (EMC) INFORMATION

Manufacturer’s declaration-electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Emission test| Compliance| Electromagnetic environment-guidance
RF emissions CISPR 11| Group 1| The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Not applicable
Voltage fluctuations / flicker emissions IEC 61000-3-3| Not applicable

Manufacturer’s declaration-electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment-guidance
Electrostatic discharge (ESD) IEC 610004-2| Contact: ±8 kV
Air ±2 kV, ±4 kV, ±8 kV, ±15 kV| Contact: ±8 kV Air ±2 kV, ±4 kV, ±8 kV, ±15 kV| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical fast transient/ burst IEC 61000-4-4| ±2 kV for power supply lines ±1 kV for input/output lines| Not applicable
Not applicable| Mains power quality should be that of a typical home and professional healthcare environment.
Surge IEC 61000-4-5| ±0.5 kV, ±1 kV line(s) to line(s)
±0.5 kV, ±1 kV, ±2 kV line(s) to earth| Not applicable
Not applicable| Mains power quality should be that of a typical home and professional healthcare environment.
Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Voltage interruptions: 0 % UT; 250/300 cycle| Voltage dips: Not applicable Not applicable Not applicable
Voltage interruptions: Not applicable| Mains power quality should be that of a typical home and professional healthcare environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.
Power frequency (50, 60 Hz) magnetic field
IEC 61000-4-8 U| 30 A/m
50 Hz or 60 Hz| 30 A/m
50 Hz and 60 Hz| The device power frequency magnetic fields should be at levels characteristic of a typical location in a typical home and professional healthcare environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

Manufacturer’s declaration-electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment-guidance
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3| 3 Vrms:
0,15 MHz – 80 MHz
6 Vrms:
in ISM and amateur radio bands between 0,15 MHz and 80 MHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz 80 % AM at 1 kHz| Not applicable
Not applicable
10 V/m
80 MHz – 2,7 GHz 80 % AM at 1 kHz| Portable and mobile RF communications equipment should be used no closer to any part of the device including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1,2 √P
d = 1,2 √P 80MHz to 800 MHz
d = 2,3 √P 800MHz to 2,7 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distance between portable and mobile RF communications equipment and the device
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output
power of transmitter (W)| Separation distance according to frequency of transmitter  (m)
---|---
150 kHz to 80 MHz
d =1,2√P| 80 MHz to 800 MHz
d =1,2√P| 800 MHz to 2,7 GHz
d =2,3√P
0,01| N/A| 0,12| 0,23
0,1| N/A| 0,38| 0,73
1| N/A| 1,2| 2,3
10| N/A| 3,8| 7,3
100| N/A| 12| 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.

T+A4:H19est
frequency
(MHz)| Band a)
(MHz)| Service a)| Modulation b)| Maximum
power (W)| Distance
(m)| IMMUNITY TEST LEVEL
(V/m)| Compliance LEVEL
(V/m) (for home and professional healthcare)
---|---|---|---|---|---|---|---
385| 380 – 390| TETRA 400| Pulse
modulation
b) 18 Hz| 1,8| 0,3| 27| 27
450| 430 – 470| GMRS 460,
FRS 460| FM
c)
±5 kHz deviation
1 kHz sine| 2| 0,3| 28| 28
710| 704 – 787| LTE Band 13,
17| Pulse
modulation
b)
217 Hz| 0,2| 0,3| 0| 0
74 5
780
810| 800 – 960| GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5| Pulse
modulation
b)
217 Hz| 2| 0,3| 28| 28
870
930
1720| 1700 –
1990| GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS| Pulse
modulation
b)
217 Hz| 2| 0,3| 28| 8
1845
1970
2450| 2400 –
2570| Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7| Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7| 2| 0,3| 28| 28
5240| 5100 –
5800| WLAN 802.11
a/n| Pulse
modulation
b)
217 Hz| 0,2| 0,3| 9| 9
5500
5785

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

| • Consult instructions for use| | • CE mark
---|---|---|---
| • Manufacturer| | • Humidity limitation
| • Serial number| | • Authorised representative in the European Community
| • Caution, consult accompanying documents| | • Type BF applied part
| • Temperature limitation| | • Medical device
| • Type BF Equipment| | • Restriction of Hazardous Substances
| • Disposal of waste equipment| | • Date of manufacture
| • Ingress protection rating| |

ForaCare Suisse AG
Neugasse 55, CH9000,
St. Gallen, Switzerland
www.foracare.ch

MedNet EC-REP GmbH
Borkstraβe 10, 48163 Mϋnster, Germany

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