Care TH838S - Thermometer Cresta - Free user manual and instructions

Product type	Infrared ear thermometer
Brand and model	Cresta Care TH838S
Dimensions	141.4 × 40.4 × 43.5 mm
Weight	67.3 g (with battery)
Power supply	1 CR2032 lithium battery (included)
Battery life	Approximately 3000 measurements
Measurement range	34 °C – 42.2 °C (93.2 °F – 108.0 °F)
Accuracy	±0.2 °C (±0.4 °F) between 35.5 and 42 °C; ±0.3 °C (±0.5 °F) outside
Display units	Celsius (°C) or Fahrenheit (°F) – switchable
Memory	Last measurement stored (displayed by memory button)
Operating temperature	10 °C – 40 °C (50 °F – 104 °F)
Storage temperature	-20 °C – 50 °C (-4 °F – 122 °F), 15 % – 85 % HR
Atmospheric pressure	800 – 1013 hPa
Main functions	Infrared ear measurement, self-diagnosis, °C/°F switching, memory
Care and cleaning	Clean the lens with a soft cloth moistened with alcohol; change the protective cover after each use
Safety	Do not immerse; keep out of reach of children (small parts and battery)
Spare parts and repairability	Protective covers (reusable); replaceable CR2032 battery
General information	Compliant with ASTM E1965-98, EN ISO 80601-2-56, CE, RoHS; use for all ages

Frequently Asked Questions - Care TH838S Cresta

How to use the Cresta Care TH838S thermometer?

Press the ON button. Wait until the ear icon stops flashing and a double beep sounds. Then place the probe in the ear and hold down the ON button until a beep. Release to get the measurement.

How to change the display from °C to °F?

Turn off the device. Press and hold the recall button, without releasing it press and hold the ON button. Release when the screen shows °F. The same procedure allows returning to °C.

What to do if the device displays 'Error 5 to 9'?

Remove the battery, wait one minute, then reinsert it. If the error persists, contact your dealer.

The displayed temperature is below 34°C or above 42.2°C. Why?

Check that the protective cover is correctly installed and in good condition. Clean the lens if necessary (with a soft cloth moistened with alcohol). Take another measurement.

How to replace the thermometer battery?

Turn off the device. Open the battery compartment cover (on the side), remove the old CR2032 battery and insert a new one respecting polarity. Close the cover.

What is the stabilization time before use?

The device must remain at stable room temperature (10-40°C) for at least 15 minutes before use. Wait until the ear icon stops flashing after turning on.

Is the protective cover mandatory?

Yes, a clean and properly attached protective cover is essential for accurate measurement and to avoid cross contamination. If the cover is not in place, a flashing symbol appears.

How to clean the probe lens?

Use a cotton ball or soft cloth moistened with water or alcohol. Gently wipe the lens surface, then let dry for at least 1 minute before putting on a protective cover.

Is the thermometer suitable for children?

Yes, the ear thermometer is suitable for people of all ages. However, keep small parts (covers, battery) out of reach of children and pets to avoid choking hazards.

What to do if the device does not turn on?

Check that the battery is correctly installed and sufficiently charged. Replace it if necessary. If the problem persists, contact your dealer.

USER MANUAL Care TH838S Cresta

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.

How to operate

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.

1. 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.
2. Measuring ear temperature: Use index finger to trigger and hold Scan button then release when you hear a beep.
3. 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^ to 42.2^ (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.

a. The "Clinical Bias" is -0.2 ~ -0.4°C.

b. The "Limits of Agreement" is 0.58.

c. The 'Repeatability" is 0.17^

Accuracy: + / - 0.2^ (0.4^) during 35.5-42^ (95.9-107.6^), + / - 0.3^ (0.5^) for other range.

Atmospheric pressure: 800-1013hPa

Dimensions: 141.4 × 40.4 × 43.5mm

Weight: 67.3g

Battery Life: Approx. 3000 times measurement

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^ to 40^ (50^ to 104^)

** 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.

** 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.

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.	Wait until stops flashing.
	The device showing a rapid ambient temperature change.	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).
	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.	Unload the battery, wait for 1 minute and repower it. If the message did not disappear, contact the retailer for further service.
	Temperature taken is higher than 42.2°C (108.0°F).	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.

Warranty: Contact your nearest retailer if service is needed.

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

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.

date of purchase. Shipping plus handling cost and recalibration service fee shall be charged accordingly.

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

Important /Note! Read the operating instructions.

The CE mark and Notified Body Registration Numbers, the requirement of Annex II from Medical Device Directive 93/42/EEC are met.

BF type applied part.

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

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.

Date of issue: 2020-08-20

Fabricant: Radiant Innovation Inc.

1F, No.3, Industrial East 9th Road,

Science-Based Industrial Park, HsinChu Taiwan

Medical Technology Promed, Consulting

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

1F, No.3, Industrial East 9th Road

Science-Based Industrial Park, HsinChu Taiwan

Medical Device Directive 93/42/EEC.

1F.No.3Industrial East 9th Road

Science-Based Industrial Park, HsinChu Taiwan

Manufacturer's declaration-electromagnetic emissions
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.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11	Group 1	The TH8xyz series uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11	Class B	The TH8xyz series is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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
Electrostatic discharge(ESD)IEC 61000-4-2			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 fieldIEC 61000-4-8	30 A/m50 Hz or 60 Hz	30 A/m50 Hz or 60 Hz	The TH8xyz series power frequency magnetic fields should be at levels characteristic of a typical location in a typical home healthcare environment.
Radiated RFIEC 61000-4-3	10 V/m80 MHz -2,7 GHz80 % AMat 1 kHz	10 V/m80 MHz -2,7 GHz80 % AMat 1 kHz	Recommended separation distanced = 1.2 √Pd = 1.2 √P 80 MHz to 800 MHzd = 2.3 √P 800 MHz to 2.7 GHzwhere 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 b.Interference may occur in the vicinity of equipment marked with the following symbol:
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.
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.
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.
Rated maximum output power of transmitter W	Separation distance according to frequency of transmitter m
	150 kHz to 80 MHz d = 1.2 √P	80 MHz to 800 MHz d = 1.2 √P	800 MHz to 2.7 GHz d = 2.3 √P
0.01	N/A	0.12	0.23
0.1	N/A	0.38	0.73
1	N/A	1.2	2.3
10	N/A	3.8	7.3
100	N/A	12	23
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.
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)	Band a) (MHz)	Service a) Modulation b)
385 380 -390		TETRA 400	Pulse modulation b) 18 Hz
450 430 - 470		GMRS 460, FRS 460	FM c) 35 kHz deviation 1 kHz sine
710	704 - 787	LTE Band 13, 17	Pulse modulation b) 217 Hz
745
780
810	800 - 960	GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5	Pulse modulation b) 18 Hz
870
930
1720	1700 - 1990	GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS	Pulse modulation b) 217 Hz
1845
1970
2450 2400 - 2570		Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7	Pulse modulation b) 217 Hz
5240	5100 - 5800	WLAN 802.11 a/n	Pulse modulation b) 217 Hz
5500
5785
Maximum power (W)	Distance (m)	IMMUNITY TEST LEVEL (V/m)	Compliance LEVEL (V/m)
1,8 0,3		27	27
2 0,3		28	28
0,2	0,3	9	9
2	0,3	28	28
2 0,3		28	28
2	0,3	28	28
0,2	0,3	9	9
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.
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.

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 appropriate collection point.

CRESTA INTERNATIONAL B.V.

Rolbrugweg 4 - 1332 AS - Almere - The Netherlands

[e-mail] - + 31 20 6 932 932

www.cresta-international.com