Care TH838S - Thermometer Cresta - Free user manual and instructions

USER MANUAL Care TH838S Cresta

TH838 Ear-Type Thermometer Thank you for using this TH8 series thermometer. TH8 series thermometer is designed with advanced infrared and ambient temperature compensation technology as well as self- diagnoses functions for accurate and fast temperature measurements-without waiting.The Ear thermometer is an electronic thermometer using an infrared detector (thermopile detector) to detect the body temperature from the ear canal in people of all ages. Intented operator: Have eight years of education, no maximum.1. Gently squeeze on the side edges to pull off the probe cap. Do not force to open.2. Always use a clean, undamaged and new probe cover. Be sure ear canal is clean.(1) Attach the probe cover on the probe.(2) Use the "o" ring to press down the probe cover to the base of the probe until click sound is heard. The probe cover is now clipped in place and is ready for taking measurement.Warning: Install the probe cover well to ensure an accurate reading.** If the probe cover has not been attached firmly, the " " icon will be flashing on the LCD screen.3. Press "ON" button; When the LCD Display shows three icons and the ear icon stops flashing, and beeps twice, the thermometer is ready for use.

4. Measuring ear temperature: Use index finger to trigger

and hold Scan button then release when you hear a beep.5. Shutting off unit: To manually turn off the unit, press and hold ON/OFF button for about 5 seconds.

Unit Switch between Fahrenheit and Celsius To change LCD display from °C to °F: When the unit in Power off condition, press and hold Scan button, do not release, and press ON/OFF button and hold, until the LCD Display show ‘°F’. The same process can change LCD display from °F to °C. Memory Function If the reading of the thermometer is within the normal temperature range of 34°C to 42.2°C (93.2°F to 108.0°F), the data is saved into memory each time when power is turned off. ** Press the "ON/OFF Memory" button again to see the temperature stored. Changing the Battery This device is supplied with one lithium cell (CR2032 x 1). Remember that Power off the unit before replacing the battery. If power is on when the battery is replaced, a malfunction may occur. If a malfunction occurs, restart the device. Keep the battery away from children. Specifications: **Storage Range: -20°C~50°C (-4°F~122°F) 15% ~ 85% RH Compliance with ASTM E1965-98, Comply with ASTM E1965-98, EN ISO 80601-2-56, IEC/ EN60601-1-2(EMC), IEC/EN60601-1 (Safety) standards, ISO10993, RoHS. Operating temperature range: 10~40°C (50~104°F) RH 85% Transport conditions < 70°C, RH 95% a. The “Clinical Bias” is -0.2 ~ -0.4°C. b. The “Limits of Agreement” is 0.58. c. The ‘Repeatability” is 0.17°C. Accuracy:+/-0.2 °C (0.4 °F) during 35.5~42°C (95.9~107.6°F), +/-0.3 °C (0.5 °F) for other range. Atmospheric pressure: 800-1013hPa Dimensions: 141.4 x 40.4 x 43.5mm Weight: 67.3g. Battery Life: Approx. 3000 times measurementGB

Cleaning and storage The Probe Lens is the most delicate part of the thermometer. Use with care when cleaning Probe Lens to avoid damage. Clean gently with mild cleaner and do not submerge unit into liquid. Keep unit dry and away from direct sunlight. Store at a temperature of between 10°C to 40°C (50°F to 104°F). ** Replace or clean the probe cover after each use to ensure an accurate reading and avoid cross infection. Clean the probe cover with a cotton swab or soft cloth moistened with alcohol. Trouble Shooting Error Message Problem Solution Device stabilization on process Wait until stops flashing. Battery is low and no more measurements are possible. Replace the battery. Measurement before device stabilization. The device showing a rapid ambient temperature change. Wait until stops flashing. The ambient temperature is not within the range between 10°C and 40°C (50°F~104°F). Allow the thermometer to rest in a room for more than 30min at room temperature between 10°C and 40°C(50°F~104°F). Error5~9, the system is not function properly. Allow the thermometer to rest in a room for more than 30min at room temperature between 10°C and 40°C(50°F~104°F). Temperature taken is higher than 42.2°C (108.0°F). Unload the battery, wait for 1 minute and repower it. If the message did not disappear, contact the retailer for further service. Make sure of the integrity of the probe cover and take a new temperature measurement. Temperature taken is lower than 34°C (93.2°F). Make sure the probe cover and the lens are clean and take a new temperature measurement. ** If device is accidentally used without a probe cover, clean the probe lens as follows: a. Gently wipe lens surface with a cotton swab or soft moistened with water or medical alcohol. b. Allow lens to be fully dry for at least 1 minute or more before attaching a new probe cover.GB

Warranty: Contact your nearest retailer if service is needed.

Warning: Keep the probe covers and connection ring away from children.

NOTE：The device must stay in stable ambient (room) temperature for 15 minutes before operating.

Warning: Choking from swallowing small parts and batteries by children or pets is possible, please

keep small parts and batteries at places where children and pets can’t reach. Proper installation of the probe cover and using the specific probe cover ensure accurate measurements. The device should not submerge into any liquids and expose it to direct moisture. There is no gender and age limitation for using infrared thermometer. This is not an AP or APG product.

Warning: No modification of this equipment is allowed.

This thermometer is an adjusted mode thermometer that converts the forehead temperature to display its “oral equivalent.” (according to the result of the clinical evaluation to get the offset value)

Subject to typing errors and/or intermediate changes. Ɣ To ensure precise measurement reading, recalibration of the device is recommended after 3 years from the date of purchase. Shipping plus handling cost and recalibration service fee shall be charged accordingly. Ɣ Please report to the manufacturer and the competent authority of the Member State in which you are established about any serious incident that has occurred in relation to this device. Manufacturer: Radiant Innovation Inc. 1F, No.3, Industrial East 9th Road, Science-Based Industrial Park, HsinChu Taiwan Authorized Representative in the European Community: Medical Technology Promedt, Consulting GmbH Altenhofstrasse 80, D-66386 St., Ingbert, Germany Importer: CRESTA INTERNATIONAL B.V. Rolbrugweg 4 - 1332 AS - Almere - The Netherlands [e-mail] + 31 20 6 932 932 The CE mark and Notified Body Registration Numbers, the requirement of Annex II from Medical Device Directive 93/42/EEC are met. Please do not dispose of the product in the household waste at the end of its useful life. Disposal can take place at appropriate collection points provided in your country. Caution BF type applied part. Paper recyclable To protect the environment, dispose of empty batteries at your retail store or at appropriate collection sites according to national or local regulations. Protected against foreign objects equal to or greater than 12.5mm in diameter and against drops of water falling at up to 15° from vertical. Important /Note! Read the operating instructions. Date of issue: 2020-08-20FR

Contact: r 8 kV Airr 2 kV, r 4 kV, r 8 kV, r 15 kV Contact: r 8 kV Airr 2 kV, r 4 kV, r 8 kV, r 15 kV Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Power frequency (50, 60 Hz) magnetic field

30 A/m 50 Hz or 60 Hz 30 A/m 50 Hz or 60 Hz The T H8xyz series power frequency magnetic fields should be at levels characteristic of a typical location in a typical home healthcare environment.20 Manufacturer’s declaration-electromagnetic immunity The TH8xyz series is intended for use in the electromagnetic environment specified below. The customer or the user of the TH8xyz series should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Radiated RF

10 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz 10 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz Recommended separation distance d = 1.2 d = 1.2 80 MHz to 800 MHz d = 2.3 800 MHz to 2.7 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 meters (m). 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

Interference may occur in the vicinity of equipment marked with the following symbol:

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 cannot 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 TH8xyz series is used exceeds the applicable RF compliance level above, the TH8xyz series should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the TH8xyz series. 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 affected by absorption and reflection from structures, objects and people.21 Recommended separation distances between portable and mobile RF communications equipment and the TH8xyz series The TH8xyz series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the can TH8xyz series help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the TH8xyz series as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter

Rated maximum output power of transmitter

150 kHz to 80 MHz d = 1.2 80 MHz to 800 MHz d = 1.2 800 MHz to 2.7 GHz d = 2.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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. PP P22 Manufacturer’s declaration-electromagnetic immunity Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment The TH8xyz series is intended for use in the electromagnetic environment specified below. The customer or the user of the TH8xyz series should assure that it is used in such an environment. Test frequency (MHz) 450 430 – 470 385 380 –390

0,3 0,3 2 0,3 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a. For some services, only the uplink frequencies are included. b. The carrier shall be modulated using a 50 % duty cycle square wave signal. c. As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.24

WEEE Directive & Product Disposal At the end of its serviceable life, this product should not be treated as household or general waste. It should be handed over to the applicable collection point for the recycling of electrical and electronic equipment, or returned to the supplier for disposal. Internal / Supplied Batteries The battery is to be collected separately. The battery is designed for separate collection at an appropriatecollection point.CRESTA INTERNATIONAL B.V. Rolbrugweg 4 - 1332 AS - Almere - The Netherlands [e-mail] - + 31 20 6 932 932 www.cresta-international.com