Radiant Innovation TMS Series User manual

TMS Smart IR Thermometer
INSTRUCTION FOR USE:
Warning: Choking from swallowing small parts by children or pets is possible, please keep small parts at places where children and pets can’t reach.
1. Download “Radiant Forehead”APP from the App Store (TMS-51A, TMS-01A) / Google Play (TMS-51A). If the dialog box appears on the screen, please press ”OK”/
“ACCEPT”.
2. Start the APP.
3. Plug the device into the phone jack.
4. Press ”I” for basic operation
5. Switch temperature unit oC or °F
6. Simply aim the device within 1 cm from the central forehead and press the "MEASURE"
button to get the forehead measurement. The time consuming for measurement might be 1sec.
7. Fever Indicator
If thermometer detects a body temperature <37.5°C, there will be "Green Circle" signal;
if temperature ≧37.5°C and <38.0°C, there will be "Yellow Circle" signal; if temperature ≧38.0°C, there will be "Red Circle" signal.
RED: Continually monitor the body temperature. If in doubt about the person’s condition, must seek medical assistance.
YELLOW: Continually monitor the body temperature. If in doubt about the person’s condition, suggest seeking medical assistance.
GREEN: Normal body temperature.
8. History: Press for memories of body temperature. Each memory also records the measurement fever Indicator icon /date/time.
Press to measurement mode, Press and then select “Clear” to clear all records.
9. Cal: This mode is just for the laboratory test with cavity blackbody.
CLEANING AND STORAGE
The Probe Lens is the most delicate part of the thermometer. Use with care when cleaning the probe lens to avoid damage.
a. Use the 70% alcohol swab or the soft cotton moistened with the 70% alcohol to clean the probe lens.
b. Allow the probe to fully dry for at least 1 minute.
c. Keep the unit dry and away from any liquids and direct sunlight.
d. Storage temperature range: It should be stored at room temperature between -20~+50°C, RH≦85%
e. The Probe should not be submerged into liquids.
Important Notes:
1. If there is any temperature difference between the places where the device is stored and where you are going to measure, subject and the device
should stay in the same room for at least 15 minutes before measurement.
2. Before the measurement, the subject should stay in a stable environment for 5mins and avoid the exercise, bath for 30mins.
3. Remember to keep the forehead clean and away from sweat, cosmetics and scar while taking temperature.
4. During the measurement, please keep away from the direct sunshine and wind.
Intended Use:
The Smart Infrared Thermometer can measure the infrared heat generated by central
forehead and surrounding tissues to reflect patient's body temperature accurately.
Intended operator:
At least 11 years old (5 years intensive reading experience), no maximum.
Specifications
Temperature measurement range: Forehead Mode 34~42.2°C (93.2~108°F)
Operating temperature range: 10~40°C (50~104°F), 15%~85% RH
Storage temperature range: It should be stored at room temperature
between -20~+50°C, RH≦85%.
Transportation temperature shall be less than 70°C, RH≦95%
Atmospheric pressure: 800~1013 hPa
Comply with ASTM E1965-98, EN ISO 80601-2-56, IEC/EN60601-1-2(EMC),
IEC/EN60601-1(Safety) standards, ISO10993, RoHS.
Accuracy: ±0.2°C (0.4°F) within 35~42°C (95~107.6°F),
±0.3°C (0.5°F) for other range.
Fever indicator, history and °C/°F switch function
Battery:
TMS-51A: one lithium cell battery (CR1616*1pcs)
TMS-01A : Battery Free
Battery life: around 3,000 continuous times. (TMS-51A)
Expected Service Life: 4 years
This thermometer converts the forehead temperature to display its “oral
equivalent.” (according to the result of the clinical evaluation to get the offset value)
Enclosure Rating: IP22
Dimensions:
TMS-51A : 52.76*25.03*10.51mm; TMS-01A: 53.86*9*9.97mm
Weight: 7.8g (TMS-51A, including one battery); 3.4g (TMS-01A)
OS:
TMS-51A : Support iOS 8.0 / Android 4.1 or above
TMS-01A :Support iOS 7.0 or above
Electrical Interface: 3.5mm Phone Jack Plug
With the Specific APP (APP Name: Radiant Forehead)
The device should not submerge into any liquids and expose it to direct moisture.
There is no gender and age limitation for using the infrared thermometer.
This is not an AP or APG product.
** The thermometer is NOT water-proof. Please
keep the unit dry and away from any liquids.

Ref No.：092018
Changing the Battery (TMS-51A)
This device is supplied with one lithium cell (CR1616x1pcs).
1. Loosen the screw on the battery cover by using small, pointed screwdriver with the “X” shaped.
2. Remove the battery cover and use the screwdriver to flip out the battery.
3. Insert a new battery under the hook and press the other side of the battery down.
4. Replace the battery cover and fasten the screw.
TROUBLE SHOOTING:
Error Message
Problem
Solution
No Device
Device not detected
Please plug the device into the phone jack.
Not TMS Device
TMS Device not detected
1. Please replug the device and confirm it is securely plugged into the phone
jack to the end.
2. Make sure the settings are correct.
For iOS (TMS-51A,TMS-01A)
(1) Settings Privacy Microphone : Radiant Forehead ON
(2) Settings General Accessibility : Mono Audio OFF
Adjust the audio volume balance to the middle or left channel.
(3) Settings Music : Volume Limit OFF (Adjust the volume balance to
the rightmost side.)
(4) Settings Music Sound Check OFF
For Android (TMS-51A)
Settings Apps Radiant Forehead PERMISSIONS Storage,
Microphone ON
Temperature taken is higher than +42.2oC (108°F)
Please select the target within specifications. If a malfunction still exists, please
contact the nearest retailer.
Temperature taken is lower than +34oC (93.2°F)
Er
Error 5~9, the system is not functioning properly.
Please contact the retailer for service.
WARRANTY: 12 months
Note: The thermometer is calibrated at the time of manufacture. If at any time you question the accuracy of temperature measurements, or meet any
unexpected event, please contact the dealers or nearest service address.
Warning: No modification of this equipment is allowed.
Please read the instructions for use
Radiant Innovation Inc.
Http://www.radiantek.com.tw
Add: 1F, No.3, Industrial East 9th Road,
Science-Based Industrial Park, HsinChu, Taiwan 300.
Medical Technology Promedt Consulting GmbH
Add: Altenhofstrasse 80, D-66386 St. Ingbert,
Germany

Symbol Descriptions
The CE mark and Notified Body
Registration Numbers, the
requirement ofAnnex II from Medical
Device Directive 93/42/EEC are met.
Indicates this device is subject to the Waste
Electrical and Electronic
Equipment Directive in the European Union.
To protect the environment, dispose of
useless device at appropriate collection sites
according to national or local regulations.
Authorized
representative in the
European community
Caution
Please read the instructions for use
Manufacturer
Battery Recycling
Paper Recycling
IP22
Classification for water
ingress and particulate
matter.
Manufacturer’s declaration-electromagnetic emissions
The TMS series is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the TMS series
should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –guidance
(for home healthcare environment)
RF emissions
CISPR 11
Group 1
The TMS series 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 TMS series 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.
Manufacturer’s declaration – electromagnetic immunity
The TMS series is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the TMS series
should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment –guidance
(for home healthcare environment)
Electrostatic discharge(ESD)
IEC 61000-4-2
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%
Power frequency(50, 60 Hz)
magnetic field IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz and 60 Hz
The TMS series power frequency magnetic fields should be at levels
characteristic of a typical location in a typical home healthcare
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Manufacturer’s declaration – electromagnetic immunity
The TMS series is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the TMS series
should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic environment –guidance
(for home healthcare environment)
Radiated RF
IEC 61000-4-3
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
Recommended separation distance:
d = 1,2 √P
d = 1,2 √P80MHz to 800 MHz
d = 2,3 √P800MHz 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).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site
survey, ashould be less than the compliance level in each frequency range.b
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.
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 TMS series is used exceeds
the applicable RF compliance level above, the TMS series should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the TMS series.
Recommended separation distances between
portable and mobile RF communications equipment and the TMS series
The TMS series is intended for use in an electromagnetic environment (for home healthcare) in which radiated RF disturbances are controlled. The
customer or the user of the TMS series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the TMS series 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
80 MHz to 800 MHz
d = 1,2
800 MHz to 2,7 GHz
d = 2,3
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.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 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 TMS series is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the TMS series
should assure that it is used in such an environment.
Test 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 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)
1 kHz sine
2
0,3
28
28
710
704–787
LTE Band 13,17
Pulse
modulation b)
217 Hz
0,2
0,3
9
9
745
780
810
800–960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 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
28
1845
1970
2450
2400–
2570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz
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.