CareTouch MFT-9 User Manual

MFT-9 Multi-function Infrared Thermometer
Real Time Clock
The real time clock will be recorded with the memory function and help you to recognize each measurement result. (It includes the 12/24 Format_Hour_Minutes_Date.)
Room Temperature
Suitable ambient temperature is important for the baby and patient, the thermometer always help you recognize the room temperature. Setting Real time clock first to enable this function. After power off, room temperature will be shown on the screen with icon. Please see the Use of the thermometer section to learn how to get the correct room temperature.
Ear / Forehead Temperature
The thermometer has been designed for practical use. Its not meant to replace a visit to the doctor. Please also remember to compare the measurement result to your regular body temperature. Please
consult with doctor if you have health concerns.
Please see the Use of the thermometer section to learn how to measure the body temperature.
Surface Mode
The surface mode shows the actual, unadjusted surface temperatures, which is different from the body temperature. It can help you to monitor if the object temperature is suitable for the baby or patient, for example the babys milk. Please see the Use of the thermometer section to learn how to measure the object temperature.
Stopwatch
The thermometer built the stopwatch function to help you to monitor the heartbeat since heartbeat is one of the healthy indexes for people. Please see the Use of the Stopwatch section to learn how to measure the heartbeat result.
Temperature Alarm
If thermometer detects a body temperature 99.5°F (37.5°C), there will be a long beep sound followed
by three short beep sound to warn the user for the temperature is above 99.5°F (37.5°C).
Zone Indicator
Under ear or forehead mode, if thermometer detects a body temperature <99.5°F (37.5°C), there will be " Green" light signal; if temperature 99.5°F (37.5°C) and <100.4°F (38.0°C), there will be" Yellow" light
signal; if temperature 100.4°F (38.0°C), there will be" Red" light signal.
RED: Warning - Immediate response by the OPERATOR is required. Suggest continually monitoring
the body temperature. If in doubt about the person’s condition, seek medical assistance.
YELLOW: Caution - Prompt response by the OPERATOR is required.
GREEN: Ready for use.
Memory Locations
There are total 9 sets memories for body temperature. Each memory also records the measurement date/time/mode icon and site location. When in power on, press the ON/MEM button to see the temperature stored with icon.
°F / °C Switch
In “power off mode (The LCD only shows the date, time and room temperature). Press and hold the “FOREHEAD” button, then immediately press and release the ON/MEM” button. After 3 seconds, icon °F” will be switched to icon “°C”. (You may use the same way to switch back to “°F”)
Intended use:
The infrared ear/forehead thermometer can measure the infrared heat generated
by eardrum/central forehead area 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:
Ear / Forehead mode: 93.2~108°F (34~42.2°C), Surface mode: -7.6~176°F (-22~80°C)
Operating temperature range: 50~104°F (10~40°C), 15%~85% RH Storage temperature range: It should be stored at room temperature between -4~122°F
(-20~+50°C), RH85%
Transportation temperature shall be less than 158°F (70°C), RH95%
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:
For ear / forehead mode: ±0.4°F (0.2°C) within 95~107.6°F (35~42°C),
±0.5°F (0.3°C) for other range.
For surface mode: ±0.5°F (0.3°C) within 71.6~108°F (22~42.2°C), others ±4% or ±4°F (2°C) whichever is greater.
Temperature alarm & Memory locations under Ear/Forehead mode
(with each measurement date/time/mode icon)
3 color LED Zone Indicator Real time clock, °F / °C Switch mode Battery: one lithium cell battery (CR2032 *1pcs) Battery life: around 3,000 continuous readings. Expected Service Life: 4 years This thermometer converts the ear/forehead temperature to display its “oral equivalent.”
(according to the result of the clinical evaluation to get the offset value)
Enclosure Rating: IP22 Dimensions: 146.4 x 38.3 x 54.8 mm
Weight: 63.3 grams including battery
The device should not submerge into any liquids and expose it to direct moisture.
There is no gender and age limitation for using infrared thermometer. This is not an AP or APG product.
Before the measurement, please make sure the selected
button accords with the measured position.
Functions
Figure 4.1.1
Figure 4.1.2
Real time clock setting
Remarks:
a. It is recommended that you measure 3 times with the same ear. If the 3 measurements are different, select the highest temperature. b. To avoid the risk of cross contamination, please clean the probe according to “Care and cleaning” section after each use. c. The different temperature varies in healthy persons between different parts of the body can be between 32.4~33.8°F (0.2~1°C) d. The “Clinical Bias” is 31.1 ~ 30.7°F (-0.5 ~ -0.7°C). e. The “Limits of Agreement is 1.02. f. The "Repeatability" is 32.3°F (0.19°C).
4.1.1 Gently pull the ear back to straighten the ear canal (Fig.4.1.1) and snugly position the probe into the ear canal, aiming towards the membrane of the eardrum to obtain an accurate reading (Fig.4.1.2).
4.1.2 Press and hold the Ear” button until you hear a beep sound. Remove the probe from ear and read the temperature measurement on the LCD. After each ear measurement, wait the ear icon stop flashing to be ready for next measurement.
Remarks:
a. Forehead temperature is displayed in oral mode. This mode converts the forehead temperature to display its “oral-equivalent” Value. b. Before the measurement, please stay in a stable environment for 5mins and avoid exercise, bath for 30mins. c. Remember to keep the forehead area clean and away from sweat, cosmetics and scar while taking temperature.
d. The “Clinical Bias” is 29.5 ~ 28.9°F (-1.4 ~ -1.7°C). e. The “Limits of Agreement” is 0.98.
f. The "Repeatability" is 32.4°F (0.20°C).
Figure 5
You can hold the thermometer within 1 cm from the central forehead (See Figure 5) and press the "FOREHEAD" button to get the forehead measurement. While scanning, you will hear a beep sound, which indicates you the newest measurement is taking place. Measurement has been completed after a long beep is heard and the forehead icon stops flashing. The time consuming for measurement might be 1 second. After
two short beeps are heard, the forehead icon stops flashing to be ready for next measurement.
Figure 1 Figure2 Figure 3 Figure 4
1. Power on: Press the ON/MEM button. The thermometer is ready for use after hearing two beep sounds.
2. Press and hold the ON/MEM button for 5sec. When you see the Set icon starts flashing, it indicates that you are in the setting screen.(see the following figure.)
3. Press the “FOREHEAD” button to make the 24 icon flash. This indicates that you are in the 12/24-hour setting screen. Press the “FOREHEAD” button to set
12/24-hour Format from 24(24-hour) to 12(12-hour).
4. Press ON/MEM button to move the flashing in the sequence shown below to select our settings:
hour minutesyearmonthdayleave the setting screen.
5. While the hour, minutes, year, month, day setting is flashing, use “FOREHEAD” button to change it.
Use of the thermometer
Note: The device must stay in stable ambient (room) temperature for 15 minutes before operating.
1. Always make sure the probe is clean, and without damage.
Warning: Choking from swallowing small parts and batteries by children or pets is possible,
please keep small parts and batteries at places where children and pets can’t reach.
2. Power on: Press ON/MEM button.(see figure 1)
3. Mode selection:
3.1 Ear mode: Press the Ear button, you can get the body temperature by ear measurement after
hearing two beep sounds. (see figure 1)
3.2 Forehead mode: Press the “FOREHEAD” button, you can get the body temperature by forehead measurement after hearing two beep sounds. (see figure 2)
3.3 Surface mode: Press and hold the ON/MEM button, and press the “FOREHEAD” button one time, you can see the icon on your LCD display(see figure 3). In this mode,
press the “FOREHEAD” button to get the target surface temperature.
3.4 Stopwatch: Press and hold the ON/MEM button, and press the “FOREHEAD” button twice,
you can see the icon on your LCD display(see figure 4). In this mode, press the “FOREHEAD” button to count by 0.01sec to 3 minutes.
4. Temperature taking:
4.1 Ear temperature measuring, points for attention:
4.2 Forehead temperature measuring, points for attention:
4.3 Measuring temperature under surface mode:
4.3.1 When you press the “FOREHEAD” button, you will get the real time temperature immediately. If you press and hold the “FOREHEAD” button, the reading of measurement will be continuous updated.
4.3.2 Applications include temperature measurements for Water, Milk, Cloth, Skin or other object.
* Note: This mode shows the actual, unadjusted surface temperatures, which is different from the body temperature.
4.4 Get the room temperature
4.4.1 Setting Real time clock first to enable this function. After power off, room temperature will be shown on the screen with icon.
4.4.2 For room temperature, the thermometer should be placed on the table and avoid the direct sunshine or air conditioner flow on.
4.4.3 The room temperature can be reference after 15min later.
5. After measurement:
5.1 Power off: Device will automatically shut off if left idle for more than 1 minute to extend battery life. The LCD will only show the date, time and room temperature.
5.2 Clean the probe after each use to ensure an accurate reading and avoid cross contamination. (See the section of Care and Cleaning for details.)
5.3 Remember to put on the Probe Cap when not in use.
Use of the Stopwatch
1. Press and hold the ON/MEM button, and press the “FOREHEAD” button twice for stopwatch mode.
2. For start or stop counting, press the “FOREHEAD” button; for reset counting, press the ON/MEM button.
3. Press and hold the ON/MEM button, and press the “FOREHEAD” button to enter the forehead mode.
4. How to measure the heartbeat? If you count out the number of beating is 18 in 15sec, then you can calculate the heartbeat of patient is 72 times in 1min.
Ref No.072017
Important Notes
Care and cleaning
The probe is the most delicate part of the thermometer. Use with care when cleaning the lens to avoid damage.
a. After the measurement, please use the cotton swab with the Alcohol (70% concentration) to clean the inside of the probe,
including lens and metal parts. b. Allow the probe to fully dry for at least 1 minute. c. Storage temperature range: It should be stored at room temperature between
-4~122°F (-20~+50°C), RH85%
d .Keep the unit dry and away from any liquids and direct sunlight. e. The Probe should not be submerged into liquids.
* Note: Please check the device if damaged once it falls. If you can’t make sure of it ,please send the complete device to the nearest retailer for recalibration.
Holding the thermometer too long may cause a higher ambient temperature reading of the probe.
This could make the body temperature measurement lower than usual.
Battery replacement
When the “Low Battery” icon indicates the battery is low, the battery should be replaced immediately with CR2032 *1pcs battery.
○1 Open the battery cover: Insert a pointed object, such as a pen, into battery cover pick hole.
At the same time, use thumb to push battery cover out.
○2 Hold the device and flip the battery out with a small screwdriver ○3 Insert the new battery under the metal hook on the left side and press the right side of the
battery down until you hear a click.
○4 Replace the battery cover
The positive (+) side up and the negative (-) side pointed down.
Error Message
Problem
Solution
Error 5~9, the system is not functioning properly.
Unload the battery, wait for 1 minute and repower it. If the message reappears, contact the retailer for service.
Measurement before device stabilization.
Wait until all the icons stops flashing.
The ambient temperature is not within the range between 50oF and 104oF (10oC ~ 40oC).
Allow the thermometer to rest in a room for at least 15 minutes at room temperature: 50oF ~104oF (10oC and 40oC).
(1) In ear/forehead mode: Temperature taken is higher than +108°F (42.2
o
C)
(2) In surface mode: Temperature taken is higher than +176°F (80
o
C)
Please select the target within specifications. If a malfunction still exists, please contact the nearest retailer.
(1) In ear/forehead mode: Temperature taken is lower than +93.2°F (34
o
C)
(2) In surface mode: Temperature taken is lower than –7.6°F (22
o
C)
Device cannot be powered on to the ready stage.
Change with a new battery.
Manufactured in China for Future Diagnostics LLC 266 47th Street, Brooklyn, NY11220 Package Design © 2017 CareTouch is a Trademark of Future Diagnostics LLC
Trouble shooting:
Warranty:
Warranty: 12 months
Manufacture Date: as the serial number (please open the battery cover, it is shown on the inside of the device.)
Ex.SN:E512A000001, the first “E” is External, the second number “5” is the last number of manufacture year, the third and the fourth number “12” is the manufacture
month, the others is the serial number.
Note: The thermometer is calibrated at the time of manufacture. If at any time you question the accuracy of temperature measurements, please contact the
dealers or nearest service address.
Warning: No modification of this equipment is allowed.
Please read the instructions for use BF type applied part
Symbol Descriptions
The CE mark and Notified Body Registration Numbers, the requirement of Annex 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
BF type applied part
Battery Recycling
Paper Recycling
IP22
Classification for water ingress and particulate matter.
Guidance and manufacturer’s declaration – electromagnetic emissions
The MFT-9 is intended for use in the electromagnetic environment specified below. The customer or the user of the MFT-9 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions CISPR 11
Group 1
The MFT-9 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 MFT-9 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
Guidance and manufacturer’s declaration – electromagnetic immunity
The MFT-9 is intended for use in the electromagnetic environment specified below. The customer or the user of the MFT-9 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 150 kHz to 80 MHz
3 V/m 80 MHz to 2,5 GHz
Not
applicable
3 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the MFT-9, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance d = 1,2 d = 1,2 80 MHz to 800 MHz d = 2,3 800 MHz to 2,5 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 meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range b.
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, 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.
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 MFT-9 is used exceeds the applicable RF compliance level above, the MFT-9 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MFT-9.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and manufacturer’s declaration – electromagnetic immunity
The MFT-9 is intended for use in the electromagnetic environment specified below. The customer or the user of the MFT-9 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 61000-4-2
6 kV contact 8 kV air
6 kV contact 8 kV air
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
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5
1 kV line(s) to line(s) 2 kV line(s) to earth
Not applicable
Mains power quality should be that of a typical commercial or hospital environment.
interruptions and voltage variations on power supply input lines
IEC 61000-4-11
<5 % UT (>95 % dip in UT) for 0,5 cycle
40 % UT (60 % dip in UT) for 5 cycles
70 % UT (30 % dip in UT) for 25 cycles
<5 % UT (>95 % dip in UT) for 5 sec
Not applicable
Mains power quality should be that of a typical commercial or hospital environment. If the user of the MFT-9 requires continued operation during power mains interruptions, it is recommended that the MFT-9 be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level.
Recommended separation distances between
portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM
The MFT-9 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MFT-9 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MFT-9 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 2,5 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.
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