chicco Flex Night Plus Clinical Thermometer Instructions

chicco Flex Night Plus Clinical Thermometer Instructions

FLEX NIGHT PLUS CLINICAL THERMOMETER

INSTRUCTIONS

Please read the safety instructions and instructions for use carefully be- fore use and keep them for future reference.

WARNINGS

Clean and sanitise the sensor before and after each use. Store in a safe place out of the reach of children and people with cognitive limitations, it’s not a toy. Never leave children alone while measuring temperature.
The thermometer contains small parts (batteries, etc.) that may be swallowed by children and cause suffocation or internal injuries. Any use by individuals with cognitive limitations or children must be supervised by an adult: the tip of the sensor could become dangerous when taking a temperature if it were to end up near the eyes. The thermometer is intended solely for the measurement of body tem- perature. In the case of knocking, falls or doubts about the operation of the product, contact the distributor. Do not try to fix the thermometer. If in doubt or if the temperature rises, contact your physician. After use put the thermometer away in a cool, dry place, away from dust. After being used for the first time and after any subsequent use, the thermometer must be stored at a temperature and humidity level that meets the specifications provided for storage and transportation. Positioning the thermometer correctly is essential to accuracy when measur-

ing temperature. Refrain from drinking hot or cold beverages, performing physical exercise, taking a bath or shower or smoking in the 15 minutes before temperature measurement. Thermometer for direct measurement, indicated for rectal and oral use; axillary use allowed with precautions. No recalibration required. To ensure correct measurement of temperature, follow the instructions below.

INSTRUCTIONS FOR USE:

• Switch on the thermometer by pressing the ON/OFF button
• Thedisplaywill show all the segments below in the following order: »“Last measurement taken” (e.g., 36.0°C M/96.8°F M) » “Lo°C/Lo°F” with flashing °C/°F to indicate that the measure- ment has started;
• Position the thermometer:
  1. Oral use (~10 sec.): position the tip of the probe in the lower part of the mouth, under the tongue, and close your
  2. Rectal use (~10 sec.): insert the tip of the sensor a few mm (no more than 15 mm) into the rectum. If you encounter resistance in doing so, stop immediately. To measure the temper- ature of a baby rectally, lay the baby on his side on a hard surface and lift his legs toward his chest holding him securely to keep him from turning during the measurement. Remember that internal body temperature is always slightly higher than the external body temperature (about 5°C). Do not use lotions or vaseline on the tip.
• A beep alerts you when the measurement is The display lights up a few sec- onds to favour the reading of the temperature. FEVER INDICATOR: if the temperature is ≥37.8 °C (≥ 100.0 °F) the buzzer will beep with a distinctive pattern and the frowning icon will be displayed .
• If the Lo°C/ Lo°F appears, the thermometer has measured a temperature below the minimum value of the measurement range. If the Hi°C/ Hi°F appears, the thermometer has measured a temperature above the maximum value of the measurement In these cases we suggest checking that the thermometer is positioned correctly and repeat the measurement. If “ERR” appears, the thermometer is not working correctly: contact our Customer Service.
• After measurement, switch the thermometer off by pressing the button (if you forget to switch the thermometer off, it will switch off automatically after about 10 minutes). If “ERR” appears, the thermometer is not working correctly: contact our Customer Service.

PRECAUTIONS IN THE CASE OF AXILLARY MEASUREMENT

Since the thermometer is for direct and rapid measurement, we recommend rectal and oral use. If you need to measure the axillary temperature, take these precautions to allow the axillary temperature to stabilise:

• make sure that the armpit is dry;
• with the thermometer still off, place the tip in the armpit and hold your arm tightly against the body staying in this position for about 60 seconds before measurement;
• proceed with the measurement as illustrated in the paragraph “Instructions for use”.

SELECTING SILENT MODE

To switch to Silent Mode, with the thermometer off, keep the ON/OFF button pressed for
approximately 2 seconds after which the Silent Mode selection menu is entered. Default se- lection is set to ‘On’. Release the button. Press the button to set Silent Mode between ‘On’ or
‘Off’. The thermometer will automatically shut off and save the Silent Mode configuration set.

SELECTING THE °C/°F SCALE

To change scale, with the thermometer off, keep the ON/OFF button pressed for at least 5 sec- onds after which the unit of measurement °C/°F selection menu is entered. Default selection is
set to °C. Release the button. Press the button to set unit of measurement between °C or °F. The
thermometer will automatically shut off and save the unit of measurement set.

CHANGING THE BATTERY

The thermometer is powered by a CR 2032 battery with an average life of about 1000 meas- urements. The symbol appears to indicate that the battery is low. Replace the battery immediately. To change the battery: open the battery compartment by turning the cover 45°
counterclockwise with the aid of a utensil. Remove the flat battery and insert a new one with the positive pole “+” facing up. Close the cover of the compartment turning it 45° clockwise.
Dispose of old batteries in differentiated waste collection containers, following the instructions at the end of this manual. Keep batteries and the battery compartment cover out of the reach of children: if ingested they may be toxic, cause internal injuries or cause suffocation.

CLEANING AND DISINFECTION

The thermometer and the probe can be cleaned using a cotton wad soaked with alcohol or a disinfectant solution. The probe is waterproof. The instrument is not waterproof. Do not im- merse it in liquid or let water or other liquids penetrate inside. Never use abrasive detergents,
solvents or benzene: these may damage or contaminate the thermometer shell.

TECHNICAL SPECIFICATIONS

• Temperature measurement range: 32 °C (90.0 °F) – 42.9 °C (109.2 °F)

•  Accuracy: ±0.1°C (0.2°F) 35.5°C (95.9°F) – 42.0°C (107.6°F); ±0.2°C [0.4°F] <35.5°C >42.0°C

•  Power supply: CR 2032: 1.5V DC battery or equivalent – Estimated measurement time: 10 seconds in the test environment

•  Operating temperature: 5°C – 40°C (50°F – 104°F), humidity 15% – 95%RH not condensing, –
  Atmospheric pressure: 700 – 1060 hPa

•  Life expectancy 3 years or 10.000 measurements

IP 22 degree of protection against the penetration of solids and liquids (dripping – tilted at 15°).

Date of manufacture:

The date of manufacture of the product may be found from the batch coding: 10AAMMXXXX (where: YY=year; MM=month; XXXX= progressive number).
Compliant with MDD 93/42/EEC and Directive 2007/47/EC
Complies with standard 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.

ELECTROMAGNETIC COMPATIBILITY

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided. Electromagnetic/ Radio Frequency Interference (EMC/RFI): the readings may be subject to interference if the device is used in an electromagnetic field with a radio frequency of ≤ 10 Volts/meter, but the instrument’s effectiveness will not be compromised permanently. Keep the thermometer at a distance of at least 1 m from RF transmitters in order to avoid interference.

The FLEX NIGHT PLUS CLINICAL THERMOMETER     00009812000000 was

designed for use in an electromagnetic environment that meets the speci- fications provided below. The person who purchased or who uses the FLEX NIGHT PLUS CLINICAL THERMOMETER     00009812000000 is responsible

for ensuring that the device is used in an environment that complies with said specifications.

Guidelines and Manufacturer’s Declaration – Electromagnetic Emissions

Phenomenon

|

Professional healthcare facilities a)

| DOMESTIC ENVIRON- MENT a)
Conducted and radiated radio frequen- cy EMISSIONS|

a)

| CISPR 11

Group 1 Class B

Harmonic distortion and voltage fluctuations/ flicker|

Not applicable

a) The device was designed to be used in a domestic setting or in profes- sional healthcare facilities and can be used exclusively in hospital wards and rooms allocated for outpatient treatment/diagnosis in hospitals and clinics. The most restrictive acceptance limits established for Group 1 Class B (CISPR 11) have been applied.
Manufacturer’s declaration and guidelines – Electromagnetic immunity – Port: Enclosure

Phenomenon

|  | Immunity test levels
Professional healthcare facilities| DOMESTIC ENVIRON- MENT a)
ELECTROSTATIC DISCHARGES| IEC 61000-4-2| ± 8 kV contact

± 2 kV, ±4 kV, ±8 kV, ±15 kV air

Radiated, ra- dio-frequency electromag- netic fields|

IEC 61000-4-3

|

a)

| 10 V/m b)

80MHz – 2.7GHz

80% AM at

1 kHz

Fields located near RF wireless com- munication devices

|

IEC 61000-4-3

| COMPLIANT

NOTE: further information about the distances to be maintained between portable and mobile RF communications device (trans- mitters) and the FLEX NIGHT PLUS CLINICAL THERMOMETER

00009812000000 can be request- ed from Artsana S.p.A. using the contact information provided in this manual. It is nevertheless ad- visable to keep the thermometer at a suitable distance (at least 1 m) from mobile phones or other RF communication devices in order to reduce any potential interference.

Magnetic fields at NOMINAL grid frequency|

IEC 61000-4-8

| 30 A/m c)

50 Hz or 60 Hz

a) The device was designed to be used in a domestic setting or in profes- sional healthcare facilities and can be used exclusively in hospital wards and rooms allocated for outpatient treatment/diagnosis in hospitals and clinics. The most restrictive limits were applied for the immunity tests.

b) Before modulation.

c) This test level presupposes a minimum distance of at least 15 cm between the FLEX NIGHT PLUS CLINICAL THERMOMETER 00009812000000 and sources of magnetic fields at grid frequency.

WARRANTY

The thermometer is guaranteed against any manufacturing defect, when used under normal conditions in compliance with the user manual, for a period of two years from the date of pur- chase. This warranty does not apply in the event of damage stemming from improper use. For repairs covered by the warranty, send the thermometer with proof of purchase (to be shown) to the distributor who will repair or replace it free of charge. This warranty does not confer any spe- cial legal rights to the buyer. The rights of the buyer may vary from country to country or state to state. If the product is used and maintained in compliance with the instructions it does not have a limited lifespan. In the event of breakage or damage, dispose according to the instructions.

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References

• Official Corporate Chicco website

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