HTD8813 - Thermometer BabyOno - Free user manual and instructions

USER MANUAL HTD8813 BabyOno

INTENDED USE The Non Contact Infrared Body Thermometers are designed to be used for intermittent measurement and monitoring of human body temperature by consumers in the home setting and primary care setting as screening tool.

DESCRIPTION OF THE NON-CONTACT INFRA-RED THERMOMETER

The Babyono non-contact infrared-red thermometer is a manual, battery-powered device for measuring human body temperature (on the forehead). The device uses an infrared-red sensor to measure the temperature. The IR sensor generates various signals when measuring temperatures of dierent objects or when placed in ambient with varying temperature. The ASIC transforms the infra-red signal into a digital value and shows on the device’s LCD display. DESCRIPTION OF CONTROL ELEMENTS, INDICATORS AND SYMBOLS Fig. 1: infrared-red thermometer, part no. 613

8. Surface temperature measurement mode

9. Body temperature measurement mode

1. The colour codes only work in body temperature measuring mode.

2. The backlight is always green when measuring the temperature of surfaces.

3. In body mode 34.0-35.4°C is with green backlight.

Automatic power off time ≤ 18 s Measuring time ≤ 2 s Measuring distance 1 cm - 5 cm Memory slots 50 Power supply requirements Batteries 1.5 V (AAA) alkaline x 2 (IEC Type LR03) Operating voltage range 2.6 V ~ 3.6 V Ambient conditions Operating conditions Operating temperature: 15 °C ~ 40 °C (59 °F ~ 104 °F), relative humidity ≤ 85%, atmospheric pressure: 70 kPa -106 kPa Transport and storage conditions Storage temperature: - 20 °C to + 55 °C / - 4 °F to + 131 °F, relative humidity ≤ 93%, atmospheric pressure: 70 kPa - 106 Pa Dimensions and weight Weight (w/o batteries) 90 g Dimensions L: 138 mm X W: 95 mm X H: 40 mm Compliance Item Compliance with Device classification Safety standard EN 60601-1: 2006+A1:2013, EN 60601-1-2: 2015 Protection type Internally (battery) powered equipment Type of protection Internally powerd equipment (on battery power) Degree of protection: Non Applied part Front panel and case labeling: EN ISO15223-1:2016 Temperature: EN ISO80601-2-56:2017 Home healthcare environment: EN 60601-1-11:2015 Safety classification of ME EQUIPMENT Protection against electric shock Internally powered ME equipment Applied part Non Applied part Protection against harmful ingress of water or particulate matter IP22 Mode of operation Continuous operation Note: Not intended to be sterillized. Not for use in an OXYGEN RICK ENVIRONMENT4 CALCULATED VALUES OF THE INDICATORS ACCORDING TO ISO 80601-2-56 Forehead mode: Group A1 Group A2 Group B Group C Bias 0,015 0,0000 -0,042 -0,040 Standard Deviation 0,123 0,121 0,121 0,137 Limits of Agreement 0,245 0,243 0,243 0,274 Clinical Repeatability (for All Group) 0,071 Note: the above value is calculated from clinical data of HTD8818A

Caution: A non-contact infrared body thermometer with discharged batteries will not operate. New batteries must be installed in such a case.

1) Pull down and open the battery cover in the thermometer’s bottom part.

2) Place two AAA batteries inside, observing the “+” and “-” polarity marks.

3) Close the battery cover.

2.2 OPERATING METHOD

Please read the warnings in the manual before operating the device.

• To measure human body temperature, aim the thermometer at the middle of the forehead, (between the eyebrows above) maintain the distance and press the On/O button - the measurement will take place immediately.

• The ambient temperature where the device is being used should be stable - do not approach large ventilators, AC vents, etc.

• When moving from a place with lower ambient temperature to a place with a higher temperature, remain for at least 5 minutes in the new place to allow the temperatures to balance out.

• Wait at least 1 second between measurements. When taking 5 (or more) consecutive measurements, wait at least 30 seconds between such series.

• The green backlight means the device is ready to use. The yellow backlit range of temperatures from 37.4 °C to 38,0 °C means slight fever warning. Please take relevant steps if this body temperature is in this range. The red backlit temperature of over 38.1 °C means a fever. Please take relevant steps to lower body temperature or consult a doctor.

• Do not use the thermometer in places with excessive sunlight.

• If the measurement taken on the forehead is too low, measure the temperature behind the ear.

2.3 GENERAL CONFIGURATION AND OPERATION

• Starting the measurement 1. Use the On / O button to activate the thermometer. After activation, the thermometer will take 2 seconds to perform a self-test. 2. Aim the thermometer at the forehead of the examined person, maintain the distance, press the On / O button to measure the temperature and read the value on the LCD display. Caution: 1) Once the display is o, the device makes a beep to signal the end of the measurement. At the same time, the LCD display will show the measured value and the background will highlight in either red, yellow or green.

2) To ensure accurate measurements, wait 30 seconds between making sets of ve consecutive measurements.

• Selecting the operating mode After activating the device, press the MODE button to select the body temperature measurement mode or the surface temperature measurement mode. The body temperature measurement mode is for measuring the temperature of human body and the surface temperature measurement mode serves to measure the temperature of objects. (By default, the device operates in the body temperature measurement mode).

• Restoring and deleting the saved data The 50-cell memory stores the result of the last measurement taken before deactivating the thermometer.

1) To display the stored measurements, briey press the MEMO button when the devices is being activated or deactivated.

2) An empty memory cell shows “---°C” or “---°F”.

3) The measured results can be stored in the device’s memory. The memory can store 50 results and once all cells are used, the oldest result is replaced with the latest result.5 4) To fully wipe the memory, press the MEMO button when the devices is being activated and keep it depressed, until “CLR” is shown on the LCD display.

2.4 CONFIGURING THE PARAMETERS

To satisfy the needs of various groups of patients or individual patients, the device’s colour codes can be customized. To modify measurement parameters, press and keep depressed the SET button.

1) Selecting the measuring units - F1

When the device is being activated, press and keep depressed the SET button, then select F1, press and keep depressed the MODE button to switch between Celsius and Fahrenheit degrees, and then press the SET button to conrm the selection (Celsius degrees are selected by default).

2) Light fever alarm - F2

After selecting F1, press the SET button to go to F2, then press the MODE button to decrease the value by 0.1 °C, or press the MEMO button to increase the value by 0.1 °C; to adjust the value more quickly, press and keep the relevant button depressed, then press the SET button to save the selected value. (The default value is 38.1 °C)

3) Changing sound signals - F3

After selecting F2, briey press the SET button to go to F3, then press the MODE button or the MEMO button to change the sound signal, and then press the SET button to conrm the new setting. (By default, there is a sound signal when the device is being activated).

4) Exiting the conguration mode

After selecting F3, press the SET button to deactivate the LCD display and leave the settings menu.

• Activating and deactivating the sound signal When the device is being activated, briey press the SET button to turn the sound signal on or o.

• Restoring default settings When the device is being activated, press and keep depressed the MODE button, until “rst” is shown on the LCD display. After 2 seconds, the defaults settings for positions F1 - F3 will be restored.6 Make sure the measurement is taken on the forehead, not on other body parts. The optimal measuring distance is 1 cm. The examined person should wait, in leisure, 15 minutes, before having their temperature measured. High temperature Go to a room where the temperature is within the specified limits and wait 30 minutes before taking measurements. Replace the batteries. Have the device repaired. Install new batteries. Wait until the ambient temperature is stabilized. (1) Press the On / Off button again. (2) Check battery polarization. (3) Replace the batteries. (4) Contact the manufacturer of the service. The measured temperature is outside the typical range of human body temperature. (34,0 ~ 43,0 °C / 93,2 °F ~ 109,4 °F). The measurement should be taken from a distance of 1- 5 cm. The examined person’s forehead is covered with hair, sweat, anti-fever pads, etc. Some individuals may have higher natural body temperature than the rest of the population. The operating temperature exceeds the specied limits. The LCD display is blinking and the device deactivates automatically. Discharged batteries. Temperature cannot be measured. Excessive ambient temperature changes. (1) Power supply deactivated. (2) Improperly installed batteries. (3) Discharged batteries. (4) No information shown on the LCD display.

1. Open and remove the battery cover, as shown on the cover. Make sure the device is o, before replacing the batteries.

2. Remove the discharged batteries and replace with two new AAA batteries. Make sure the batteries are inserted as shown on the cover.

4. Slide the battery cover back into place.

Do not throw away the used batteries together with domestic waste. Old batteries should be disposed of in specially designated collection places. 5. If the device is still not working after replacing the batteries, make sure that the batteries have been inserted properly. Remove the barriers, wait 30 seconds and reinstall them. WARNING The batteries must not be charged, disassembled or placed in re.

1. The typical life of new, fresh batteries is 2,000 measurements, each lasting 18 seconds.

2. Only the recommended batteries should be used. Regular batteries should not be recharged. No batteries should be

3. Remove the batteries from the device if you intend to store it for an extended time.7

5 - CLEANING, MAINTENANCE AND STORAGE

The sensor’s lens is very delicate. The lens must be protected from damage and dirt. A clean, dry piece of cloth should be used to clean the device and its LCD display. The device should not be cleaned with solvents or submerged in water or other liquids. The thermometer should be always stored in places where the ambient temperature and humidity are as specied in Item 1. Technical specication. The thermometer should be stored in a dry, dust-free place. The thermometer should not be exposed to direct sunlight, high temperature or humidity, because such conditions may adversely aect its operation. If the ambient temperature changes drastically, e.g. when moving the thermometer from a cold place to a hot place, or if the ambient temperature is from 15 °C to 40 °C, wait for 30 minutes before using the device.

1) Do not throw away the used batteries together with domestic waste. Old batteries should be disposed of in specially designated collection places. 2) Do not throw away the used device together with domestic waste. Please nd out where this device can be safely disposed of. The local legal regulations currently in force should be observed.

The non-contact infrared body thermometer is covered with the manufacturer’s 2-year warranty, starting from the date of purchase. The warranty is void in the following situations:

• The serial number has been removed from the device or becomes illegible.

• The device was damaged due to being improperly connected to other devices.

• The device was damaged in an accident.

• The device was modied by the user without the manufacturer’s previous consent.

• The batteries and the packaging are not covered by the warranty.

• When ling a warranty claim, the user shall present a warranty card indicating the date of purchase and the seller’s stamp (including their name and address). Please request to stamp your warranty card when purchasing the device. The defective product should be delivered to a service. Defective products not covered by warranty can be repaired at a fee. CAUTION: 1. If there are any problems with the device, e.g. when setting it up, maintaining or operating, please contact Babyono’s service department. The device should not be opened or repaired by the user.

2. All cases of non-standard operation should be submitted to Babyono’s service department.

3. The thermometer is initially calibrated at the time of manufacture. If this thermometer is used according to the use instructions, periodic re-adjustment is not required .If at any time you question the accuracy of temperature measurements ,please contact us timely. 4. The device was designed for use by patients. The patient may make measurements and replace batteries under normal operating conditions and may also maintain the device as indicated in this manual. WARNING

• A defective or improperly operating thermometer should not be used for any purpose.

• If the ambient temperature changes drastically, e.g. when moving the thermometer from a cold place to a hot place, or if the ambient temperature is from 15 °C to 40 °C, wait for 30 minutes before using the device.

• Remove the batteries from the thermometer if it is not going to be used for a longer time.

• The device is not waterproof and should not be submerged in water or other liquids. Follow the instructions under Item 5 when cleaning or disinfecting the device.

• The IR sensor should not be touched.

• The thermometer should not be used if anti-fever pads or other methods of reducing body temperature are used.

• The thermometer should not be moved close to strong electrostatic or magnetic eld, because this may aect the accuracy of measurements.

• To avoid damaging the device, old and new batteries should not be used simultaneously.

• If the examined person’s forehead is covered with hair, sweat or a headscarf, the measurement may be inaccurate.

• The results of measurements made with the device are only for reference purposes. If in doubt, other methods of measuring temperature should be used.

• The device should be stored out of reach of children and pets. If the device is not going to be used, it should be stored in a dry room, protected against excessive humidity, heat, dust and direct sunlight. No heavy items should be placed on the device.

• The device should not be dropped, disassembled or modied.

• The device should not be used if it is damaged or behaves abnormally.

• The device contains sensitive components and should be handled with care. The storage and operating conditions described in Item 1 “Technical specication” should be observed.

• No potential allergic reactions are known as per the current state of technical knowledge.

• This thermometer will irreplaceable the diagnostic in hospitals.8 Warning Non starile packaging Consult instructions for use Operating Temperature Operating Humidity This device compiles with Part 15 of FCC (Federal Communications Commission) Rules Manufacturer Recyclabe The rst number 2 : Protected against solid foreign objects of Ф 12.5 mmand greater. The second number: Protected against vertically falling water drops when enclosure titled up to 15°C Restriction of Hazardous Substances Batch code Compliance with WEEE Standard

Intended for multiple use Operating atmospheric pressure Indicates this device is in compliance with MDD 93/42/EEC. 0598 is the Notied Body Number Authorized Representative in the European community Serial number EQUIPMENT SYMBOLS EMC DECLARATION 1) This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS; This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be aected by portable and mobile RF communications equipment. 2)* Caution: Do not use a mobile phone or other devices that emit electromagnetic elds, near the unit. This may result in incorrect operation of the unit.

3) *Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!

4) * Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the conguration in which it will be used. Not servicing/maintenance while the thermometer is in use. When using, shall not touch battery and the patient simultaneously.

• Do not throw batteries into re. Only use recommended batteries. Do not use rechargeable batteries.

• This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS. For further information contact: Manufacturer: Hetaida Technology Co., Ltd Adds: Room 801, 802, 803, 804, 901, 2# Building Scientic Research Center; Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, Dongguan City, Guangdong Province, P.R.China Company Name: Share Info Cnsultant Service LLC Reprasentanzburo. Company Address: eerdeter Lohweg 83, 40549 Dusseldorf Tel: [phone] Fax [phone] Email: [e-mail]; [e-mail]; [e-mail] IP229 The rst number 2 : Protected against solid foreign objects of Ф 12.5 mmand greater. The second number: Protected against vertically falling water drops when enclosure titled up to 15°C GUIDANCE AND MANUFACTURE’S DECLARATION – ELECTROMAGNETIC EMISSION The Non Contact Infrared Body Thermometer is intended for use in the electromagnetic environment specied below. The customer of the user of the Non Contact Infrared Body Thermometer should assure that it is used in such an environment. GUIDANCE AND MANUFACTURE’S DECLARATION – ELECTROMAGNETIC IMMUNITY The Non Contact Infrared Body Thermometer is intended for use in the electromagnetic environment specied below. The customer or the user of Non Contact Infrared Body Thermometer should assure that it is used in such an environment. EMISSION TEST RF emissions CISPR 11 RF emission CISPR 11 Harmonic emissions

Power frequency (50Hz/60Hz) magnetic eld IEC 61000-4-8

0.5 cycles for > 95% (sync angle (degrees):0,

45, 90, 135, 180,225, 270, 315) 1 cycles for >95% UT (sync angle (degrees):0) 25 (50Hz)/30 (60Hz) cycles for 30% U T (sync angle (degrees):0) 250 (50Hz)/300 (60Hz) cycles for >95% UT (sync angle (degrees):0) 30A/m COMPLIANCE LEVEL Contact: ±8 KV Air: ±2, ±4, ±8, ±15 KV Not applicable Not applicable Not applicable 30A/m COMPLIANCE Group 1 Class B Not applicable Not applicable NOTE UT is the a.c. mains voltage prior to application of the test level.10 GUIDANCE AND MANUFACTURE’S DECLARATION – ELECTROMAGNETIC IMMUNITY The Non Contact Infrared Body Thermometer is intended for use in the electromagnetic environment specied below. The customer or the user ofthe Non Contact Infrared Body Thermometer should assure that it is used in such an environment. IMMUNITY TEST Conducted RF

3 Vrms 150 kHz to 80 MHz Professional healthcare environment: 3 V/m Home healthcare environment: 10 Vm 80 MHz to 2700 MHz COMPLIANCE LEVEL Not applicable Professional healthcare environment: 3 V/m Home healthcare environment: 10 Vm 80 MHz to 2700 MHz 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 aected by absorption and reection from structures, objects and people. a) Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the Non Contact Infrared Body Thermometer is used exceeds the applicable RF compliance level above, the Non Contact Infrared Body 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 Non Contact Infrared Body Thermometer. b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.11 test frequency (MHz)

Guidance and manufacturer's declaration - RF wireless communication equipment immunity Band (MHz)

Distance (m) IMMUNITY test level (V/m) Body temperature 1) Body temperature varies from person to person and uctuates during the course of the day. For this reason, it is suggested to know one's normal, healthy forehead temperature to correctly determine the temperature. 2) Body temperature runs approximately from 35.5°C to 37.8°C (95.9°F-100°F). To determine if one has a fever, compare the temperature detected with the person's normal temperature. A rise over the reference body temperature of 1°C (1°F) or more is generally indication of fever. 3) Dierent measurement sites (rectal, axillary, oral, frontal, auricular) will give dierent readings. Therefore it is wrong to compare the measurement taken from dierent sites.

4) Here below are typical temepratures for adults, based on dierent measurement sites:

- Rectal: 36.6°C to 38°C/97.9°F-100.4°F - Axillary: 34.7°C to 37.3°C/94.5°F-99.1°F ASTM laboratory accuracy requrements in the display range of 37°C to 38.9°C (98°F to 102°F) for IR thermometers is ±0.2°C (±0.4°F), whereas for mercury in-glass and electronic thermometers, the requrement per ASTM Standards E667-86 and E1112-86 is ±0.1°C (±0.2°F). Caution: This infrared thermometer meets requirements established in ASTM Standard (E1965-98) Except of clause 5.2.2. It displays subject's temperature over a range of 34.0~43,0°C. Full responsibility for the conformance of this product to the standard is assumed by Hetaida Technology Co., Ltd Adds: Room 801, 802, 803, 804, 901, 2# Building Scientic Research Center; Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, Dongguan City, Guangdong Province, P.R.China.

5. Memóriagomb (MEMO)

2.2 LIETOŠANAS VEIDS

MELDING PROBLEEM OPLOSSING

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