SureLife ThinTemp AET-R1F1 - Infrared Thermometer Manual

Intended use

This Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring the human body temperature of individuals three months of age and older by detecting infrared heat from the center of the forehead.

• For safe and proper use of this product, be sure to read and fully understand Safety Precautions contained in this user manual.
• Keep this manual with you for a convenient reference.
• Keep this manual in a proper way and avoid any loss.
• If you need other information that is not listed in the instructions-for-use packet, please contact MHC Medical Products at (877) 358.4342.

The correct measurement method to follow:
Measure forehead.
Distance 0.59" to 1.97" (15mm to 50mm)

Correct measurement method

1. Turn the thermometer on by pressing the "" button. Choose mode by pressing the "" button on the shutoff mode. A beep sound will be heard following which the screen will indication with ---˚F (˚C), indicating the unit is ready for use.
   
2. Place the thermometer probe point near the forehead and press the "" button and release after ~1 second and the thermometer will beep and display the accurate temperature. Whenever consecutive readings are required, please wait for at least 5 seconds. The above procedure can be repeated as many times as required.
   
3. To turn off the device press and hold the "" button for 5 seconds. The thermometer will turn off automatically after 60 seconds of not being in use.
   

Unit description

Display information

Measuring location symbol: The icon indicates the correct measuring position.

Temperature data indicator: The temperature reading is displayed after measuring.

Temperature unit indicator: Unit of measuring temperature shows ˚F or ˚C.

Low battery symbol: The icon prompts you to replace the battery when the power is low.

Memory symbol: It shows in memory query mode currently.

Load and replace batteries

When the battery symbol "" appears, please replace with new batteries immediately. The steps are as follows:

Please take out the battery if you do not use the thermometer for a long time. Please refer to the relevant laws and regulations for the disposal of waste batteries.

Before take a measurement

Correct position to measure

Forehead temperature mode
The correct measurement method to follow:
Measure the forehead.
Distance 0.59" to 1.97" (15mm to 50mm)

Instructions for Use

Recalling Readings from Memory

Changing Temperature Scales

Disposal

Do not dispose of electrical appliances as unsorted municipal waste, use separate collection facilities. Contact you local government for information regarding the collection systems available. If electrical appliances are disposed of in landfills or dumps, hazardous substances can leak into the groundwater and get into the food chain, damaging your health and well-being.

Explanation of Marks or Symbols

The following symbols may appear on the manual, Infrared Thermometer and its accessories.

	MUST OBSERVE Means Obligatory with detailed items expressed in words or figures within or beside the mark. Left one means General Compulsory.
	Follow instructions for use.
	IMPLICATION OF SYMBOL Type-BF applied part.
	CE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC.
	Consult accompanying documents.
	Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary.
	Transport package shall be kept away from rain.
	Transport package shall not be exposed to sunlight.
	Indicates correct upright position of the transport package.
	Contents of the transport package are fragile therefore it shall be handled with care.
	Indicates temperature limits within which the transport package shall be stored and handled.
	Non-ionizing electromagnetic radiation
	Do not roll
	Lot number
	Production date
	The device should not be used after the expiration date listed on the retail box.
	Protected against solid foreign objects of 12.5mm dianeter and greater. protected against vertically falling water drops when the device is tilted up to 15˚.
	Manufacturer
	Authorized Representative in the European Community

Do not use the thermometer under temperature extremes (below 16˚C/60.8˚F or over 35˚C/95˚F) or humidity extremes (below 15%RH or over 80%RH). *Failing to do so may cause inaccuracy.

Do not expose the thermometer to temperature extremes (below -20˚C/-4˚F or over 55˚C/131˚F) or humidity extremes (below 15%RH or over 93%RH). *Failing to do so may cause inaccuracy.

Temperature probe has been shocked and lax. *Contact MHC Medical Products immediately.

It is dangerous for patients to perform a self-evaluation and self-treatment based on the measuring results. Be sure to follow doctors' instruction. *A self-evaluation may cause a disease to worsen.

Don't touch or blow infrared sensor. *A contaminated or broken infrared sensor may cause inaccuracy.

Clean a contaminated infrared sensor with a soft dry cloth in a gentle manner. *Cleaning with toilet tissue or paper towel may scratch the infrared sensor, causing inaccuracy.

Install the battery in the right position according to the manual. *Incorrect replacement will cause battery heat.

Do not immerse the thermomter in liquids. *This instrument is not waterproof.

Do not use a mobile phone nearby when the thermometer is working. *Portable and mobile RF communications equipment can affect MEDICAL ELECTICAL EQUIPMENT. Falling to do so may cause inaccuracy.

The probe glass is made from special material which is not easy broken. *If there is any damage, stop using it and contact MHC Medical Products immediately.

Do not modify this equipment without authorization of the manufacturer. *Contact MHC Medical Products immediately.

The device is not repairable and contains no user serviceable parts. *If there is any problem, contact MHC Medical Products immediately.

The device requires no calibration. *If there is any problem, contact MHC Medical Products immediately.

No modification of this equipment is allowed. *If there is any problem, contact MHC Medical Products immediately.

If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. *If there is any problem, contact MHC Medical Products immediately.

The operator shall not touch the thermometer and the patient simultaneously. Keep the machine out of children's reach. *For accidental swallow of battery of protective film, please consult the doctor at once.

For temperature difference between storage area and measurement site, condition the thermometer for about 30 minutes in room temperature (measurement site). *Failing to do so may cause inaccuracy.

Ensure that children do not use the instrument unsupervised. *some parts are small enough to be swallowed.

Error Messages

Error Message	Problem	Solution
Hi	Temperature is higher than 42.2˚C (108˚F).	Operate the thermometer only between the specified temperature ranges. In the event of a repeated error message, contact MHC Medical Products.
Lo	Temperature is lower than 32˚C (89.6˚F).	Operate the thermometer only between the specified temperature ranges. In the event of a repeated error message, contact MHC Medical Products.
Err	Sensor not welded	Contact MHC Medical Products.
	Low power	Replace with new batteries
ErH	The temperature of the measuring environment is too high.	Decrease the temperature of the environment, keep it within 60.8˚F-95˚F (16˚C-35˚C).
ErL	The temperature of the measuring environment is too low	Increase the tmperature of the environment, keep it within 60.8˚F-95˚F (16˚C-35˚C).

Maintenance, storage and calibration

Maintenance:

1. Gently remove any dirt on the body using a soft and dry cloth.
2. Use a cotton swab or soft cloth absorbed with alcohol, and gently wipe the lens of the temperature measuring head. After using the product, the product can be sterilized with 70% medical alcohol on the soft towel or cotton sliver. If the probe tip is damaged, please contact MHC Medical Products.
3. Don't wash with water or detergent containing abrasive or benzene.
4. Do not immerse in liquids.

Storage:

1. The device must not be stored or used in locations that are excessively high or low temperature or humidity, in direct sunlight, or in close proximity to an electrical current or in dusty locations. Otherwise inaccuracies may occur.
2. Remove the battery if the thermometer is not used for longer than one month.

Calibration:
This thermometer is calibrated at the time of manufacture. If the thermometer is used according to the instruction, periodic recalibration is not required. If at any time you question the accuracy of the measurement, please contact MHC Medical Products immediately.
Don't attempt to modify or reassemble the thermometer.

Technical Specifications

Standard
The product is made under the ISO80601-2-56.

Guarantee

Two-year warranty is available from purchasing date, excluding user-caused failures listed below:

1. Failure resulted in unauthorized disassembly and modification.
2. Failure resulted in unexpected drop during application or transportation.
3. Failure resulted in operation away from proper instruction in User's Manual.

Included in delievery

• Infrared thermometer
• Instructions for use
• 2 x AAA batteries

Electromagnetic Compatibility

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare and hospital environments.

Do not use near active HF (high-frequency) surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

If any: a list of all cables and maximum lengths of cables (if applicable), transducers and other ACCESSORIES that are replaceable by the RESPONSIBLE ORGANIZATION and that are likely to affect compliance of the ME EQUIPMENT or ME SYSTEM with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE).

If any: the performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL PERFORMANCE and a description of what the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES (the defined term "ESSENTIAL PERFORMANCE" need not be used).

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer's declaration -electromagnetic emissions and Immunity.