Chicco Flex Night Plus Clinical Thermometer

Please read the safety instructions and instructions for use carefully before 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 is 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 temperature.
In 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 measuring 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

1. Switch on the thermometer by pressing the ON/OFF button.

2. The display will show all the segments below in the following order: “Last measurement taken” (e.g., 36.0°C M/96.8°F M) then “Lo°C/Lo°F” with flashing °C/°F to indicate that the measurement has started.

3. Position the thermometer:

a. Oral use (~10 sec.): Position the tip of the probe in the lower part of the mouth, under the tongue, and close your mouth.
b. 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 temperature 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 0.5°C). Do not use lotions or vaseline on the tip.
c. Axillary Use (with precautions): Since the thermometer is for direct and rapid measurement, rectal and oral use is recommended. 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”.

4. A beep alerts you when the measurement is finished. The display lights up for a few seconds to favour the reading of the temperature.

5. 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.

6. Error Indicators:

If “Lo°C/Lo°F” appears, the thermometer has measured a temperature below the minimum value of the measurement range.
If “Hi°C/Hi°F” appears, the thermometer has measured a temperature above the maximum value of the measurement range. In these cases, check that the thermometer is positioned correctly and repeat the measurement.
If “ERR” appears, the thermometer is not working correctly: contact Customer Service.

7. 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).

Selecting Silent Mode

To switch to Silent Mode, with the thermometer off, keep the ON/OFF button pressed for approximately 2 seconds. The Silent Mode selection menu will be entered. Default selection 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 seconds. The unit of measurement °C/°F selection menu will be entered. Default selection is set to °C. Release the button. Press the button to set the 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 measurements. The low battery 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 immerse 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

Specification	Value
Temperature measurement range	32 °C (90.0 °F) - 42.9 °C (109.2 °F)
Accuracy	±0.1°C (0.2°F) for 35.5°C (95.9°F) - 42.0°C (107.6°F); ±0.2°C [0.4°F] for <35.5°C or >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, 700-1060 hPa
Life expectancy	3 years or 10,000 measurements

Storage and Transportation Conditions

Temperature: -20°C / 55°C (-4.0°F / 131.0°F)
Humidity: 15% - 95%RH not condensing
Pressure: 700-1060hPa
IP Rating: IP 22 (degree of protection against the penetration of solids and liquids - dripping, tilted at 15°)

Electromagnetic Compatibility (EMC)

Medical Electrical Equipment needs special precautions regarding EMC and must be installed and put into service according to the EMC information provided.

Electromagnetic/Radio Frequency Interference (EMC/RFI): 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 to avoid interference.

The FLEX NIGHT PLUS CLINICAL THERMOMETER 00009812000000 was designed for use in an electromagnetic environment that meets the specifications provided below. The purchaser or user of 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 ENVIRONMENT a)
Conducted and radiated radio frequency EMISSIONS	CISPR 11 Group 1 Class B	CISPR 11 Group 1 Class B
Harmonic distortion and voltage fluctuations/flicker	Not applicable	Not applicable

a) The device was designed to be used in a domestic setting or in professional 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 ENVIRONMENT a)
ELECTROSTATIC DISCHARGES	IEC 61000-4-2	± 8 kV contact; ± 2 kV, ±4 kV, ±8 kV, ±15 kV air	± 8 kV contact; ± 2 kV, ±4 kV, ±8 kV, ±15 kV air
Radiated, radio-frequency electromagnetic fields	IEC 61000-4-3	10 V/m b) 80MHz – 2.7GHz 80% AM at 1 kHz	10 V/m b) 80MHz – 2.7GHz 80% AM at 1 kHz
Fields located near RF wireless communication devices	IEC 61000-4-3	COMPLIANT	COMPLIANT
Magnetic fields at NOMINAL grid frequency	IEC 61000-4-8	30 A/m c) 50 Hz or 60 Hz	30 A/m c) 50 Hz or 60 Hz

NOTE: Further information about the distances to be maintained between portable and mobile RF communications devices (transmitters) and the FLEX NIGHT PLUS CLINICAL THERMOMETER 00009812000000 can be requested from Artsana S.p.A. using the contact information provided in this manual. It is nevertheless advisable 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.

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 purchase. 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 special 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.

Product Information

Lot Number: [Not specified in text]

Catalogue Number: 00009812000000

Manufacturer: Artsana S.p.A., Via Saldarini Catelli, 1 - 22070 Grandate (CO) Italy

Website: www.chicco.com

Distributed by: Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany

Date of manufacture: Can be found from batch coding: 10AAMMXXXX (where: AA=year; MM=month; XXXX= progressive number).

Compliance: Compliant with MDD 93/42/EEC and Directive 2007/47/EC. Complies with standard ISO 80601-2-56.

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