Chicco Smart Touch - Infrared Contact Thermometer Manual

PLEASE READ THESE INSTRUCTIONS CAREFULLY BEFORE USE AND KEEP THEM FOR FUTURE REFERENCE.

Dear Customer, thank you for choosing our product!
All Artsana thermometers are high-tech products and are subject to rigorous quality tests in compliance with EU regulations to guarantee quality and accuracy. Do not use this device in decisions of life & death or Safety related applications. In case of doubts or increased body temperature, consult a physician.

Utilising infrared technology, this thermometer takes temperatures in seconds by measuring heat generated by the surface of the skin on the forehead. This product conforms to the provisions of the EC directive MDD(93/ 42/ EEC). Its benefits include:

1. Measuring Body Temperature on the Forehead
2. 10 User Memory
3. °C/°F Switch-able Function
4. One-second Reading
5. Auto power off for power saving
6. Low-battery Indicator. Indications for battery condition and measuring range.
7. Large LCD Display
8. Instant Measurement. By using our unique technology, users can get their precise body temperature instantly and accurate.

IMPORTANT INFORMATION BEFORE USE

When using this product, please be sure to follow all the notes listed below. Any action against these notices may cause injury or affect the accuracy.

1. Do not disassemble, repair, or remodel the thermometer.
2. Be sure to clean the thermometer lens each time after usage.
3. Avoid touching the measurement sensor with your fingers.
4. No modification of this equipment is allowed.
5. It is recommended that user may take 3 temperatures. If they are different, use the highest reading.
6. Do not expose the thermometer to extreme temperature, very high humidity, or direct sunlight.
7. Avoid extreme shock or dropping the device.
8. Before the measurement, the patient and thermometer should be at room temperature and in a steady state for at least 30 minutes.
9. Avoid measuring temperature in 30 minutes after exercise, bathing, or returning from outdoor.
10. To protect the environment, dispose of empty batteries at appropriate collection sites according to national or local regulations.
11. It is ill-advised to disassemble the thermometer.
12. Please use the thermometer solely for its intended purpose.
13. Carefully hold the device when in use to avoid dropping the device.
14. Wait at least 1 minute between measurements. Repeated measurements may cause incorrect temperature readouts. Use average temperatures instead.
15. There are no absolute body temperature standards. Keep reliable records of your personal temperature to serve as a reference for judging a fever.
16. Under any circumstances, the temperature taking result is ONLY for reference. Before taking any medical action, please consult your physician.
17. It is recommended calibrate the device every 1 year.
18. 
    Please keep this device away from pets, pests, and children.
19. 
    Danger of explosion if battery is incorrectly replaced. Replace only with the same type recommended by the manufacturer, discard used batteries according to the manufacturer's instructions.

PRODUCT IDENTIFICATION

1. Sensor Tip with Lens
2. Memory Button
3. Battery Cover
4. Power/ Measure Button
5. LCD Display

1. Memory symbol
2. Smiling face Measurement<38°C (< 100.4°F)
3. Frowning face Measurement≥38°C (≥100.4°F)
4. Low battery Warning
5. Scan in Progress
6. Fahrenheit Scale
7. Celsius Scale
8. Degrees of Temperature

SWITCHING BETWEEN FAHRENHEIT OR CELSIUS

Your thermometer can display results in either degrees Celsius (°C) or degrees Fahrenheit (°F).

To change from degrees Celsius to Fahrenheit, press the "Power/Measure" button and "Memory" button at the same time with the thermometer in standby mode. The selected unit of measurement will be saved for all following measurements. The same procedure can be used to change the unit of measurement from °F to °C.

TIPS FOR MEASURING HUMAN TEMPERATURE

Bear in mind that the thermometer needs to have been in the room in which the measurement is taken for at least 30 minutes before use.

NOTE:

• Attempting to take temperature readings from sites on the body other than the forehead may produce inaccurate results.
• The patient should remain still while the reading is being taken.
• Infrared forehead temperature readings are equivalent to oral temperature readings. In all of these cases, please consult your doctor.
• Readings taken while asleep should not be compared directly to readings taken while awake, as body temperature while asleep is typically lower.
• Do not take body temperature readings within 30 minutes of being outdoors, exercising or bathing.
• This thermometer may be used by children only under adult supervision.
• Use of the thermometer on different persons can be inappropriate in the event of certain acute infectious diseases because of the possible spread of germs despite cleaning and disinfection. If you have any doubts, please consult your doctor.

MEASURING HUMAN TEMPERATURE

Taking a Measurement
Please note that the forehead must be free from sweat and cosmetics and that taking medication and skin irritations can distort the result when measuring temperature on the forehead.

1. Press the Power/Measure Button for 1 second to switch the thermometer on. Following a successful self-test, the device emits beep sound.
   
2. All symbols appear in the display at first. The last temperature measured will appear.
3. Then press and hold the "Power/Measure Button" and move the thermometer smoothly over the forehead to the other temple.
4. Release the "Power/Measure Button". The end of the measuring time is signaled with a short beep and the measured value appears on the display with backlight for 5 seconds.
5. Read the recorded temperature from the LCD display.
   
6. After 1 Minute no button is pressed: device shows off for 2 seconds and turns off.
7. If the temperature measurement is below 38°C, a "Smiling Face " will be appear next to the reading. If the reading is 38°C or above, a "Frowning Face " will be displayed.
   

MEMORY FUNCTION

Memory Recall:
You can recall up to 10 measurements currently stored in memory to share with your physician or trained healthcare professional.

1. Press the "Memory Recall" button. The first reading displayed is the latest measurement stored in memory.
2. Continue to press the "Memory Button" to view the next previously stored measurement.

CLEANING AND DISINFECTING

• Probe and Tip:
  Clean the probe and tip with an alcohol swab before and after each measurement.
• Thermometer:
  Use a soft, dry cloth to clean thermometer body. Never use abrasive cleaning agents, thinners or benzene for cleaning. Do not scratch the surface of the probe lens or the display. Do not expose the thermometer to extreme temperatures, humidity, direct sunlight, or shock.
  

BATTERY INSTALLATION

Low battery warning:
When the battery power becomes low, the low battery symbol will appear on the display. The thermometer can still be used during this time, but the battery should be replaced as soon as possible. If the battery run out completely, "Lo" will be displayed along with the low battery symbol. In this case, the battery will need to be replaced before using the thermometer again.

Replacing the Battery:

1. Gently slide the battery cover back.
2. Carefully remove the old batteries and properly discard.
3. Insert a new battery (one 3V lithium CR2032 size) according to the proper polarity.
4. Slide the battery cover back on.
   

NOTE: Battery-operated

1. Please properly dispose of the batteries away from small children and heat.
2. It is recommended to remove the batteries if the unit will not be used for an extended period of time.
3. For long durations of non-operation, please remove all batteries from the device.
4. Batteries must be disposed of in accordance with local environmental and institutional policies.
5. Dispose of used batteries in accordance with the applicable legal regulations. Never dispose of batteries in the normal household waste.

APPLIED STANDARDS

This product conforms to the provisions of the EC directive MDD(93/42/EEC). The following standards apply to design and/or manufacture of the products:

• ISO 80601-2-56: Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
• IEC/EN 60601-1: Medical electrical equipment - Part 1: General requirement for safety
• IEC/EN 60601-1-2: Medical electrical equipment - Part 2: Collateral standard: Electromagnetic compatibility - Requirements and tests

CLINICAL ACCURACY VALIDATION METHOD

This device is an adjusted mode clinical thermometer. The validated information for clinical accuracy in each adjusted mode are:

GroupA1: Δcb=-0.01°C, LA=0.18, σr = ±0.08°C

GroupA2: Δcb= 0.06°C, LA=0.22, σr = ±0.08°C

GroupB: Δcb=-0.01°C, LA=0.20, σr = ±0.07°C

GroupC: Δcb=-0.01°C, LA=0.18, σr = ±0.07°C

Δcb: CLINICAL BIAS

LA: LlMITS OF AGREEMENT
σr: CLINICAL REPEATABILITY

ERROR CODES

When a malfunction or incorrect temperature measurement occurs, an error message will appear as described below (comes with backlight).

LCD Display	Cause		Solution
	The temperature measured is higher than 43°C (109.4°F)		Operate the thermometer only between the specified temperature ranges. If necessary, clean the sensor tip. In the event of a repeated error message, contact your retailer or Service.
	The temperature measured is lower than 34°C (93.2°F)
	The operating temperature is not in the range from 15°C to 40°C (from 59°F to 104°F)		Operate the thermometer only between the specified temperature ranges.

Technical Specifications

EMC Tables

Smart Touch Thermometer 00009903000000 is intended for use in the electromagnetic environment specified below. The customer or the user of Smart Touch Thermometer 00009903000000 must make sure that it is used in such an environment.
Guidance and manufacturer's declaration - Electromagnetic emissions
Phenomenon	Professional healthcare facility environment a)		HOME HEALTHCARE ENVIRONMENT a)
Conducted and radiated RF EMISSIONS	a)		CISPR 11 Group 1 Class B
Harmonic distortion	Not applicable
Voltage fluctuations and flickering	Not applicable
a) The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited to patient rooms and respiratory treatment facilities in hospital or clinics. The more restrictive acceptance limits of Group 1 Class B (CISPR 11) have been considered and applied. b) The test is not applicable in this environment unless the ME EQUIPMENT and ME SYSTEM used will be connected to the PUBLIC MAINS NETWORK and the power input is otherwise within the scope of the Basic EMC standard.
Guidance and manufacturer's declaration - Electromagnetic immunity - Enclosure port
Phenomenon	Basic EMC standard or test method	Immunity test levels
		Professional healthcare facility environment	HOME HEALTHCARE ENVIRONMENT
ELECTROSTATIC DISCHARGE	IEC 61000-4-2	± 8kV contact ± 2 kV, ±4kV, ±8 kV, ±15 kV air
Radiated RF EM fields	IEC 61000-4-3	a)	10 V/m ) 80MHz - 2.7 GHz 80% AM at 1kHz
Proximity fields from RF wireless communications equipment	IEC 61000-4-3	COMPLIANT NOTE: Further information about distances to be maintained between portable and mobile RF communications equipment (transmitters) and the Smart Touch Thermometer 00009903000000 can be requested from supplier using the contact information provided in this manual. However, it is advisable to keep the thermometer at an adequate distance of, at least, 0.5 m from mobile phones or other RF communications transmitters to minimize possible interference.
RATED power frequency magnetic fields.	IEC 61000-4-8	30 A/m c) 50 Hz or 60 Hz
a) The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited to patient rooms and respiratory treatment facilities in hospital or clinics. The more restrictive IMMUNI- TY acceptance limits have been considered and applied. b) Before modulation is applied. c) This test level assumes a minimum distance of at least 15 cm between the ME EQUIPMENT or ME SYSTEM and sources of power frequency magnetic fields.

EXPLANATION OF SYMBOLS

	The CE marking with the Registration Number of the Notified Body. This denotes the compliance of European Medical Device Directive 93/42/EEC.		Disposal information: Should you wish to dispose of the article, do so in accordance with current regulations. Details are available from your local authority.
	European Authorized Representative		Caution
	Manufacturer's name and address		Type of protection of applied part against electric shock, body floating.
	Consult the instruction for use		SN YYMWWWXXXXX SN: Product Serial Number YY: year, M: month, WWW: working sheet, XXXXX: serial no.
	This product meets the basic safety and essential performance requirements indicated in the IP22 conditioning test (protection against solid foreign objects of 12.5mm and greater and against vertically falling water drops when enclosure tiled up to 15°).		Product catalogue reference code or catalog number.
	Temperature limits		Lot Number
	Relative Humidity limit		Pressure limit

DECLARATION OF EC COMPLIANCE

Hereby, AVITA Corporation declares that the equipment type 00009903000000 is in compliance with Directive 1907/2006 (REACH) and its amendments and Directive 2011/65/EU (RoHS).

THIS PRODUCT COMPLIES WITH THE DIRECTIVE 2012/19/EU.
The crossed bin symbol on the appliance indicates that the product, at the end of its life, must be disposed of separately from domestic waste, either by taking it to a separate waste disposal site for electric and electronic appliances or by returning it to your dealer when you buy another similar appliance. The user is responsible for taking the appliance to a special waste disposal site at the end of its life. If the disused appliance is collected correctly as separate waste, it can be recycled, treated and disposed of ecologically; this avoids a negative impact on both the environment and health, and contributes towards the recycling of the product's materials. For further information regarding the waste disposal services available, contact your local waste disposal agency or the shop where you bought the appliance.

COMPLIANCE WITH EU DIRECTIVE 2006/66 CE
The crossed bin symbol on the batteries or product pack indicates that, at the end of their life, they must not be disposed of as urban refuse. They must be disposed of separately from domestic waste, either by taking them to a separate waste disposal site for batteries or by returning them to your dealer when you buy similar rechargeable or non-rechargeable batteries. The chemical symbols Hg, Cd, Pb, printed under the crossed bin symbol, indicate the type of substance contained in the batteries: Hg=Mercury, Cd=Cadmium, Pb=Lead. The user is responsible for taking the batteries to special waste disposal sites at the end of their life to allow for their processing and recycling. If dead batteries are collected correctly as separate waste they can be recycled, processed and disposed of ecologically; this avoids a negative impact on both the environment and human health, and contributes towards the recycling of the substances contained in the batteries. Improper disposal of the product by the user may harm the environment and human health. For further information regarding the waste disposal services available, contact your local waste disposal agency or the shop where you bought the appliance.

WARRANTY

The product is guaranteed against any conformity defect in normal conditions of use as provided for by the instructions for use. The warranty shall not therefore apply in the case of damages caused by improper use, wear or accidental events. For the duration of warranty on conformity defects please refer to the specific provisions of national laws applicable in the country of purchase, where provided.

In case of problems concerning settings, maintenance or use of the device, contact your local distributor or the Italian toll-free number 800 188 898. Warning! Do not service and/or repair the appliance.

MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany

AVITA Corporation
9F, No.78 Sec.1,
Kwang-Fu Rd., San-Chung District,
24158 New Taipei City, Taiwan

Distributed by:
ARTSANA S.p. A.,
Via Saldarini Catelli 1,
22070 - Grandate (CO) - Italia