User Manual
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PROFESSIONAL MEDICAL PRODUCTS Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy gima@gimaitaly.com - export@gimaitaly.com www.gimaitaly.com
A200 INFRARED NON CONTACT THERMOMETER
System Owner Thank you for purchasing the A200 Infrared Thermometer. Please read this instruction manual first, so you can use this thermometer safely and correctly. Please keep this instruction manual for future reference. This innovative medical device uses advanced infrared (IR) technology to measure temperature instantly and accurately on the forehead or object.
IMPORTANT SAFETY INSTRUCTIONS READ BEFORE USE
The following basic safety precautions should always be taken. 1. Close supervision is necessary when the thermometer is used by, on, or near children, handicapped persons or invalids. 2. Use the thermometer only for the intended use described in this manual. 3. Do not use the thermometer if it is not working properly, or if it has suffered any damage. KEEP THESE INSTRUCTIONS AT A SAFE PLACE
CONTENTS
Please note: This medical instrument must be used according To instructions to ensure accurate readings.
BEFORE YOU BEGIN... 2 Cautions and Warnings... 2 Restrictions of Use... 3 Intended Use... 3 How does it work... 4 Highlighted Features... 4 Meter Overview... 4 Display Screen... 5 Display Mode... 5 Select the Temperature Unit... 5 Turn ON/OFF the Led Light... 6 Replacing the Battery... 6 DETAILED INFORMATION... 7 About Normal Body Temperature & Fever... 7 PERFORM THE TEST... 8 As a Body Measurement Thermometer... 8 As an Object Measurement Thermometer... 10
How does it work The thermometer measures the infrared heat generated by the surface of the skin over the vessel and its surrounding tissue. The thermometer then converts it into a temperature value.
Cautions and Warnings • As with any thermometer, proper technique is crucial to obtaining accurate temperature readings. Please read this manual thoroughly and carefully before using. • Always operate the thermometer in an operating temperature range 10°C to 40°C (50°F to 104°F), and relative humidity15 to 95%. • Always store the thermometer in a cool and dry place -25°C to 55°C (-13°F to 131°F) and relative humidity 15% to 95%. • The device requires no calibration. The product has been calibrated before the factory inspection. • The device contains no user serviceable parts. • The user must check that the equipment functions safely and see that it is in proper working condition before being use • The manufacturer does not require such preventive inspections by other persons. • No modification of this equipment is allowed. • The device is not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide. • Manufacturer will provide circuit diagrams, component part lists, descriptions, calibration
instructions to assist to SERVICE PERSONNEL in parts repair. • Do not clean or maintenance the device is in use. • Avoid direct sunlight. • Avoid dropping the thermometer, if it happens and you think the thermometer may be damaged, please contact customer services immediately. • Do not touch the lens. • Do not disassemble the thermometer. • Basic safety precautions should always be observed, especially when the thermometer is used on or near children and disabled persons. • This thermometer is not intended to substitute for a consultation with your physician. • This thermometer and the subject must remain in a stable environment for at least 30 minutes before measuring the temperature. • When the measured temperature falls within the fever temperature range of ≥37.8°C (100.04°F) and <42.9°C (109.22°F), as indicated by the red LED on display, please consult with your physician immediately. Restrictions of Use This thermometer is clinically proven to produce accurate temperature measurements. However, please be advised that the accuracy can not be ensured when the thermometer is not clean. Check that the probe is clean before taking a measurement. Intended Use A200 Infrared Thermometer is intended for the intermittent measurement and monitoring of human body temperature from forehead measurement at home, clinics and hospital. A control measurement using a conventional thermometer is recommended in the following cases: 1. If the reading is surprisingly low. 2. For new-born infants, up to 100 days old. 3. For children under three years of age who have a weakened immune system or who react unusually in the presence or absence of fever.
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MEMORY... 11 Recalling the Memory... 11 Clear the memory... 11 MAINTENANCE... 12 Care & Cleaning... 12 FAULT INDICATION... 12 SYMBOL INFORMATION... 13 SPECIFICATIONS... 14 DISPOSAL OF DEVICE... 15 REFERENCE OF STANDARDS... 15 Device Standards:... 15 Classification:... 15 Electromagnetic Compatibility:... 15 WARRANTY... 17 MANUFACTURER’S DECLARATION OF THE EMC... 21
BEFORE YOU BEGIN
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Long-press the Measurement Button for 5 seconds until the signal -- °C or °F displayed on the LCD panel as figure shown. Re-press the Measurement Button to select °C or °F unit.
Turn ON/OFF the Led Light This meter provides Led Light to help users placing the thermometer at the correct position. Be sure the thermometer is OFF before turn ON/OFF the Led Light.
1. Long-press the Measurement Button for seconds until Signal -- °C or °F displayed on the LCD panel. 2 Release the measurement button, then short-press the ON/OFF Button, the signal -- Led or OFF will displayed on the LCD panel as figure shown. 3 Quick press the measurement button, and select Led or OFF to turn ON/OFF the Led Light. Replacing the Battery The meter will display “ ” to alert you when the meter power is getting low, please follow the steps below to replace new batteries immediately. 6
1. Remove the battery cover as the arrow direction accordingly. 2. Remove the old batteries and replace with two 1.5V AAA size alkaline batteries. Taking care to match the Positive ( + ) and Negative ( - ) indications 3. Close the battery cover as the arrow direction accordingly. NOTE: 1. Although the thermometer works when “ ”, appearing, we still recommend that you change the batteries to obtain an accurate result. 2. Remove the batteries if stored for a long period of time. 3. The batteries should be kept away out of children’s reach. If they are swallowed, promptly see a doctor for help.
DETAILED INFORMATION
About Normal Body Temperature & Fever The temperature in the forehead and temple area differs from the internal temperature, which is taken orally or rectally. Vasoconstriction, an effect which constricts the blood vessels and cools the skin, can occur during the early stages of a fever. In this case, the temperature measured by the A200 Infrared thermometer may be unusually low. If the measurement therefore does not match the patient’s own perception or is unusually low, repeat the measurement every 15 minutes. As a reference, you can also measure the internal body temperature using a conventional oral or rectal thermometer. Body temperature can 7
vary from one individual/person to next. It also varies by location on the body and time of day. Below shows the statistical normal ranges from different sites. Please keep in mind that temperatures measured from different sites, even at the same time, should not be directly compared. Fever indicates that the body temperature is higher than normal. This symptom may be caused by infection, overdressing or immunization. Some people may not experience fever even when they are ill. These include, but are not limited to, infants younger than 3 months old, persons with compromised immune systems, persons taking antibiotics, steroids or antipyretics (aspirin, ibuprofen, acetaminophen), or persons with certain chronic illnesses. Please consult your physician when you feel ill even if you do not have fever. Table*1 Normal Temperature Range of various body sites Oral
0.6°C (1°F) or more above or below 37°C (98.6°F)
Rectal/ear
0.3°C to 0.6°C (0.5°F to 1°F) higher than oral temperature
Axillary (armpit)
0.3°C to 0.6°C (0.5°F to 1°F) lower than oral temperature
PERFORM THE TEST
As a Body Measurement Thermometer Press “ON/OFF” Button to turn on the thermometer first.
Push the Mode switch to select Body mode. The temperature unit flashes.
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Move the probe close to the forehead and take measurements Make sure the probe is flat and close to the forehead, not at an angle. Perform a forehead measurement with a distance within 3 cm. Read the result. The measurement result will be done in 1 second. The reading is shown together with LED lighting and one long beep informs about the temperature measurement, and after a while another short beep, confirming the saving of the result to the memory and readiness for the next measurement. Press the “ON/OFF” button to turn off the unit, or leave it idle for 30 seconds the unit will switch off automatically. NOTE: • As the forehead measurement temperature is likely to be affected by sweat, oil and the surroundings, the reading shall be taken as a reference only. • If the probe is placed at an angle close to the forehead measurement, the reading will be affected by surrounding temperature. Babies’ skin reacts very quickly to the ambient temperature. Therefore, do not take their temperature with the A200 Infrared thermometer during or after breastfeeding, because the skin temperature may then be lower than the internal body temperature. • If the measured temperature is < 32°C (89.6°F), the display will show with LO symbol. • If the reading is≥ 37.8°C (100.04°F) and < 42.9°C (109.22°F), the display will show together with red LED and six short beeps. 9
NOTE: The thermometer does not emit any infrared energy. Highlighted Features • Measurement that does not require probe cover, thereby saving cost of replacement. • Automatically power off if left idle for 30 seconds. • Memory function allows you to recall previous results up to 25 previous results. • Easy to read LCD with green backlight in a dark environment. • Color visible of fever (red) and measurement in progress (green). Meter Overview
Display Screen
1. Body mode indication 2. Object mode indication 3. Memory indication 4. Temperature reading 5. Temperature unit 6. Battery indication Display Mode Two modes can be selected. 1.Body Mode This mode is used to measure the forehead temperature. 2.Object Mode This mode is used to measure the object temperature. Select the Temperature Unit This meter provides two measurement units used for indicating the body/object temperature, °C or °F, for your preferred selection.
1. nfrared Sensor 2. Led Light 3. Display Screen 4. Measurement / Memory Button 5. ON/OFF Button 6. Mode Switch 7. Battery Cover
Be sure the thermometer is OFF before selecting the temperature unit.
• The thermometer will automatically turn off if left idle for 30 seconds. As an Object Measurement Thermometer Press “ON/OFF” Switch to turn on the thermometer first.
Push the Mode switch to select Object mode. The temperature unit flashes. Move the probe close to the object and take measurements. Make sure the probe is flat and close to the object, not at an angle. Perform a measurement with a distance within 3 cm. When ready, push measurement button to take measurements. Read the result. The measurement result will be done in 1 second. The reading is shown together with LED lighting and one long beep informs about the temperature measurement, and after a while another short beep, confirming the saving of the result to the memory and readiness for the next measurement. Press the “ON/OFF” button to turn off the unit, or leave it idle for 30 seconds, the unit will switch off automatically.
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MEMORY
Recalling the Memory This thermometer stores 25 most recent readings Be sure the thermometer is OFF before recalling this memory. Press to enter the memory mode. Each time you press the Memory Button, a result will be displayed in the order of dates (latest result shown first), together with “MEM” and number (from 1 to 25). LED in green or red will appear according to the memory reading. When the memory is full, the oldest result is deleted as the new one added. When the last record displayed in the display, press Memory Button again to return the first record.
Exit the memory. Press ON/OFF Button to exit the memory or keep the meter in idle for 30 seconds to switch off automatically. Clear the memory Delete the record by unplugging the battery and power off.
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Care & Cleaning • The probe is not waterproof. Please wipe with a clean and dry cotton swab to clean the probe on the inside. • The body of the thermometer is not water-resistant. Never put the thermometer under a running tap or submerge it into water. Use a soft and dry cloth to clean it. Do not use abrasive cleaners. • Store the thermometer in a cool and dry location. Free from dust and away from direct sunlight.
FAULT INDICATION FAULT OR FAULT SYMBOL
FAULT DESCRIPTION
CORRECTIIVE MEASURE
No display On the LCD pane
The battery has run out. Incorrect battery polarity.
Replace the battery. Please note: The (+) side of the battery must face upwards.
Measurement The thermometer not possible is not ready. (or an abnormal value is displayed)
Wait until the °C symbol is displayed.
An abnormal temperature value is displayed.
Clean the probe tip or get it repaired. Wait until you hear the beep before removing the thermometer from the ear or forehead
The probe tip is dirty or damaged. Did you hear the beep after pressing the ON button?
LO or HI symbol is displayed
The temperature measured is outside the measuring Range. LO-temperature <32°C (89.6°F). HI-temperature ≥42.9°C (109.22°F).
Symbol The battery has run out. is displayed
Symbol is displayed
± 8 kV contact
± 8 kV contact
± 15 kV ± 15 kV air air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrostatic transient / burst IEC 61000-4-4
± 2 kV for power supply lines ± 1 kV for input/ output lines
N/A
Surge IEC 61000-4-5
± 1 kV differential mode ± 2 kV common mode
N/A
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 610004-11
0% UT; N/A 0,5 cycle g) At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0% UT; 1 cycle and 70% UT; 25/30 cycles at 0° 0% UT; 250/300 cycle
Mains power quality should be that of a typical commercial or hospital environment. If the user of the A200 Infrared Thermometer requires continued operation during power mains interruptions, it is recommended that the A200 Infrared Thermometer be powered from an uninterruptible power
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
30 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
30 A/m
Mains power quality should be that of a typical commercial or hospital environment.
SPECIFICATIONS
REFERENCE OF STANDARDS
Model
A200
Measurement range
Body/Forehead: 32.0~42.9°C (89.6°F~109.22°F) Object: 0.0°C to 99.9°C (32°F to 211.8°F)
Display resolution
0.1°C / 0.1°F
Device Standards: Device Corresponds to the requirements of the standard for infrared thermometers IEC 60601-1-2: 2014 IEC 60601-1: 2012 ISO 80601-2-56: 2017
Accuracy
For body mode: ±0.2°C (±0.4°F) from36.0°C (96.8°F) to 39.0°C (102.2°F) ±0.3°C (±0.5°F) from 32.0°C (89.6°F) to 35.9°C (96.6°F) and from 39.1°C (102.4°F) to 42.9°C (109.22°F)
To ensure accurate measurement, let the thermometer rest at operating temperature for 30 minutes prior to use.
SYMBOL INFORMATION Caution: read instructions (warnings) carefully
Medical Device complies with Directive 93/42/ EEC
Keep in a cool, dry place
Keep away from sunlight
Manufacturer
Date of manufacture
Product code
Lot number
Follow instructions for use
Type BF applied part
Serial number
WEEE disposal
Authorized representative in the European community
For object mode ±4°C (±7.2°F) from 0°C (32°C) to 4.9°C (40.8°F) ±1°C (±2°F) from 5°F (41°C) to 60°C (140.0°F) ±4°C (±7.2°F) from 60.1°C (140.1°F) to 100°C (212°F) Indicator light
Green light for temperature lower than 37.8°C(100.4°F) Red light for temperature higher than 37.8°C(100.4°F)
Voice
Power on and ready for working: a short beep. Measurement finished: 1 long beep equal or lower than 37.8°C (100.4°F) 6 short beeps higher than 37.8°C (100.4°F)
Memory
Storage of 25 measurements
Operating conditions
10°C to 40°C (50°F to 104°F), Humidity: 15 to 95% R.H.
Air pressure
86Kpa-106Kpa
Storage and transport environment
Temperature: -25°C to 55°C (-13°F to 131°F)F Storage humidity: 15% to 95% RH
Auto shut-off
About 30 seconds after no using
Battery
2pcs 1.5V AAA Alkaline Battery
Size
170 x 47 x 53 mm
Weight
75g
Classification: Anti-electric Shock Type: Internally powered equipment Applied part: Type BF Mode of operation: Continuous Operation EMC: type B class I Enclosure Degree of ingress protection: IP22 IP22 means shell of this product can withstand the water dropping to the surface when the shell deviate 15 degree from horizontal surface. Electromagnetic Compatibility: Device fulfills the stipulations of the standard IEC 60601-1-2 The stipulations of EU-Directive 93/42/EEC for Medical Devices Class II a have been fulfilled. * Technical alterations reserved! Software identify no.: A200 V1.1.0
• This thermometer is guaranteed for 18 months from the date of purchase against any manufacturing defect, conditional upon normal household use. • The intended service life of the product is 24 months. • This product to be free of defects in workmanship and materials for a period on 18 months from the date of purchase. • During the warranty period, if this product is found to be defective, you may bring it together with the purchase receipt and Warranty Certificate on a carry-in basis to manufacturer’s office during normal business hours for warranty service.
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Guidance and manufacturer´s declaration – electromagnetic immunity
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reflection from structures, objects and people.
For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (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.
The A200 Infrared Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the A200 Infrared Thermometer should assure that it is used in such an environment. Immunity test
IEC 60601 test level
Conducted 3 Vrms RF
Compliance level
Electromagnetic environment - guidance
N/A
Portable and mobile RF communications equipment should be used no closer to any part of the A200 Infrared Thermometer, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
IEC 61000-4-6
150 kHz to 10 V/m 80 MHz
Radiated RF
6Vrms in ISM banda between 150 kHz to 80 MHz
IEC 61000-4-3
80 MHz to 2.7 GHz
d=
3.5 √ P V1
d=
3.5 √ P E1
80 MHz to 800 MHz d=
7 √P E1
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 metres (m).b 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:
Guidance and manufacturer´s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING 19
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 can not 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 A200 Infrared Thermometer is used exceeds the applicable RF compliance level above, the A200 Infrared Thermometer should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re¬orienting or relocating the A200 Infrared Thermometer. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
• We will then repair or replace defective parts or exchange the whole product as we select, at no charge to the original owner. After such repair, replacement or exchange, the product will be warranted from the date of purchase. • This warranty is valid only if the Warranty Certificate and Warranty Registration Card are duly complete with date of purchase, serial number and dealer’s stamp, and if the Warranty Registration Card is sent to local distributor office not later than 14 days from the date of purchase. • This warranty is void if this product has been repaired or serviced by unauthorized person. This warranty does not cover defects caused by misuse, abuse, accident, tampering, poor maintenance, fire or any other acts beyond human control. • Except as stated in the above paragraphs, A200 Infrared Thermometer disclaims all other warranties, implied or expressed, including the warranties of merchantability of fitness for a particular purpose with respect to the use of this product. Manufacturer shall not be liable for any direct, consequential or incidental damages arising out of the use or inability to use product.
WARRANTY
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NOTE UT is the a. c. mains voltage prior to application of the test level.
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Replace the battery.
The ambient temperature is outside the operating temperature range or is changing too fast.
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Electrostatic discharge (ESD) IEC 61000-4-2
Check that the probe tip is clean and that the thermometer is properly placed on the forehead.
3.5 √ P V1
d=
/ / / / /
3.5 √ P E1
0.12 0.38 1.2 3.8 12
20
d=
Guidance and manufacturer´s declaration – electromagnetic emission The A200 Infrared Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of A200 Infrared Thermometer should assure that it is used in such an environment. Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
The A200 Infrared Thermometer 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
Harmonic emissions IEC 61000-3-2
N/A
The A200 Infrared Thermometer 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.
Voltage N/A fluctuations / flicker emissions IEC 61000-3-3
Guidance and manufacturer´s declaration – electromagnetic immunity The A200 Infrared Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the A200 Infrared Thermometer should assure that it is used in such an environment. Immunity test
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IEC 60601 Comtest level pliance level
Electromagnetic environment guidance
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Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing it to a specific recycling point for electric and electronic equipment.
Recommended separation distances between portable and mobile RF communications equipment and the A200 Infrared Thermometer The A200 Infrared Thermometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of theA200 Infrared Thermometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and theA200 Infrared Thermometer as recommended below, according to the maximum output power of the communications equipment Rated maxi- Separation distance according to frequency mum output of transmitter m of transmitter 150KHz 80MHz 800MHz W to 80MHz to 800MHz to 2.5GHz d=
Guidance and manufacturer´s declaration – electromagnetic emission – for all EQUIPMENT AND SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic immunity –for all EQUIPMENT and SYSTEMS
Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM -for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
0.01 0.1 1 10 100
MANUFACTURER’S DECLARATION OF THE EMC
M25582-GB-Rev.0-04.20
MAINTENANCE
0123
25582 / A200
7 √P E1
Shenzhen Aeon Technology Co., Ltd. RM6H02, Block 27-29, Tianxia IC Industrial Park, Majialong, No.133 of Yiyuan road, Nantou Street, Nanshan District, Shenzhen, China Made in China
0.23 0.73 2.3 7.3 23
Shanghai International Trading Corp GmbH Eiffestrasse 80, 20537 Hamburg, Germany 21
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