THERMODISTANCE - Medical thermometer TERRAILLON - Free user manual and instructions

USER MANUAL THERMODISTANCE TERRAILLON

Power supply:	DC 3V (2 x AAA battery)
Body measuring range:	32.0°C ~ 42.9°C (89.6°F ~ 109.3°F)
Forehead measuring accuracy:	±0.2°C(±0.4°F) for 35.0°C (95.0°F) ~ 42.0°C (107.6°F) ±0.3°C (±0.5°F) for other range
Object measuring range:	-22°C ~ 80.0°C (-7.6°F ~ 176.0°F)
Object measuring accuracy:	±2.0°C(±4.0°F)
Displayed room temperature range:	5.0°C ~ 59.9°C (41.0°F~139.8°F)
Room temperature accuracy:	±1°C (±2°F)
Measure time:	1 second
Measure interval:	1 second
Dimension:	130.1(L)x45.0(W)x50.3(D)mm
Weight:	About 72.0g (without battery)
Forehead and object operating condition:	15.0°C~40.0°C (59.0°F~104.0°F) with a relative humidity of 15%~85% Atmosphere pressure: 700hPa-1060hPa
Storage and transport condition:	-20°C~55°C (-4°F~131°F) with a relative humidity of 15%~90% Atmosphere pressure: 700hPa-1060hPa

Service life: 2 years
Service life of the battery: With a new battery (Carbon) approx. 6 months based on the use frequency at 5 times/day

Caution:

This thermometer has been thoroughly tested and inspected to assure proper performance and operation!

A	Applied part of type BF (The applied part is the probe tip)
B	Disposal in accordance with Directive 2012/19/EU (WEEE)
CE0197	Complies with the European Medical Device Directive (93/42/EEC) and amended by directive 2007/47/EC requirements. Notified body TÜV Rheinland (CE0197)
	The name and the address of the manufacturer
EC REP	The name and the address of the Authorized EC-representative in Europe
	Caution
	Refer to Instruction Manual
IP22	The first number 2: Protected against solid foreign objects of 12,5 mm Φ and greater. The second number: Protected against vertically falling water drops when enclosure titled up to 15°. Vertically falling drops shall have no harmful effects when the enclosure is titled at any angle up to 15°, on either side of the vertical.

IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY(EMC)

With the increased number of electronic devices such as PC's and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation. Medical devices should also not interfere with other devices.

In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the EN60601-1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices. Medical devices manufactured by Shenzhen Dongdixin Technology Co.,Ltd. conform to this EN60601-1-2:2007 standard for both immunity and emissions. Nevertheless, special precautions need to be observed: The use of accessories and cables other than those specified by manufacturer, with the exception of cables sold by manufacturer as replacement parts for internal components, may result in increased emission or decreased immunity of the device.

• The medical devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in which it will be used.
• Refer to further guidance below regarding the EMC environment in which the device should be used.

Guidance and manufacturer's declaration - electromagnetic emissions
The thermometer are intended for use in the electromagnetic environoment specified below. The customer or the user of these thermometer should assure that it is used in such environment.
Emissions test	Compliance	Electromagnetic environment - guidance
RF emissions CISPR 11	Group 1	The thermometer use 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 thermometer are 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.
Harmonic emissions IEC 61000-3-2	Not applicable
Voltage fluctuations/ flicker emissions IEC61000-3-3	Not applicable

Guidance and manufacturer's declaration - electromagnetic immunity
The thermometer are intended for use in the electromagnetic environment specified below. The customer or the user of these thermometer should assure that it is used in such environment.
Immunity test	IEC 60601 Test level	Compliance level	Electromagnetic environment - guidance
Electrostatic discharge (ESD) IEC 61000-4-2	±6 kV contact ±8 kV air	±6 kV contact ±8 kV air	Floor should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical fast transient/burst IEC 61000-4-4	Not applicable	Not applicable	Not applicable
Surge IEC 61000-4-5	Not applicable	Not applicable	Not applicable
Voltage dips, short interruptions and voltage variations on power supply IEC 61000-4-11	Not applicable	Not applicable	Not applicable
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8	3 A/m	3 A/m	Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
The thermometer are intended for use in the electromagnetic environment specified below. The customers or the users of these thermometer should assure that it is used in such environment.
Immunity test	IEC 60601 Test level	Compliance level	Electromagnetic environment - guidance
Conducted RF IEC 61000 -4-6	Not applicable		Portable and mobile RF communications equipment should be used no closer to any part of the thermometer including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter. Recommend separation distance d = 1.2 √P d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 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,
Radiated RF IEC 61000-4-3	3 V/m 80 MHz to 2.5 GHz	3 V/m
			a. should be less than the compliance level in each frequency range. b. Interference may occur in the vicinity of equipment marked with he following symbol:
Note1: At 80 MHz and 800 MHz, the higher frequency range applies. Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted the oretically 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 thermometer are used exceeds the applicable RF compliance level above, the thermometer should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the thermometer. bOver the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.
Recommended separation distance between portable and mobile RF communications equipment and the thermometer
The thermometer are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customers or the users of these thermometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the thermometer as recommended below, according to the maximum output power of the communications equipment.
Output Power of Transmitter in Watt	Separation distance according to frequency of transmitter in meter
	150 kHz to 80 MHz d = 1.2 √P	80 MHz to 800 MHz d = 1.2 √P	800 MHz to 2.5 GHz d = 1.2 √
0.01	0.12	0.12	0.23
0.1	0.38	0.38	0.73
1	1.2	1.2	2.3
10	3.8	3.8	7.3
100	12	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: At 80MHz and 800MHz, the separation distance for the higher frequency range applies Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Model: TH1009N / THERMO DISTANCE

Shenzhen Dongdixin Technology Co., LTD.

No.3 Building XiliBaimang Xusheng Industrial

Estate 518108,Nanshan Shenzhen, China.

EC

REP

Shanghai International Holding Corp. GmbH (Europe)

EiffestraBe 80, 20537 Hamburg Germany

Terrailion SAS France & Headquarters

1, rue Ernest Gouin

78290 Croissy-sur-Seine - France

Quarry Bay - Hong Kong

Tel: + 852 (0)2960 7200

[e-mail]

Terrailon Corp USA