American Diagnostic Corporation – Core Medical Device Manufactur Adtemp Mini 432 Non-Contact Infrared Thermometer Instruction Manual

American Diagnostic Corporation – Core Medical Device Manufactur Adtemp

Mini 432 Non-Contact Infrared Thermometer

Thank you for choosing an ADC® AdtempTM Mini Non-Contact Infrared Thermometer. Your new thermometer is designed to provide accurate body temperature measurements. Adtemp thermometers meet or exceed all relevant international performance standards.

Product Instructions for Use

The Adtemp 432 Non-Contact Thermometer is a clinical-grade device designed for the intermittent measurement of human body temperature in patients of all ages. It uses infrared technology to measure temperature without the need for physical contact, making it a hygienic and convenient way to monitor body temperature.

Device Description and Intended Use

The Adtemp 432 Non-Contact Thermometer is intended for use in clinical settings and at home. It is designed to measure body temperature in patients of all ages, including infants and adults. The device can measure temperature from a distance of 1 cm to 2 cm from the patient’s forehead, providing accurate readings that can help diagnose illness or monitor fever.

Contraindications

While the Adtemp 432 Non-Contact Thermometer is safe for most patients, there are some contraindications to be aware of. Do not use the thermometer on scarred or compromised tissue, or with patients in trauma or those being treated with medications that affect skin temperature. Additionally, do not use the thermometer when the measuring site has been exposed to direct sunlight or extreme temperatures.

Product Parts and Assembly

The Adtemp 432 Non-Contact Thermometer comes with several parts that are essential to its operation. These include:

• LCD Display
• USB Port for Charging
• Sensor Lens
• Multifunction Button
• Memory Indication Measure Value
• Low Battery Indication
• Forehead Measurement Measuring Scale
• Micro USB Cable
• Extendable Lanyard

Product Symbol Definitions

The following symbols are used in the user manual to provide additional information about the thermometer:

• Important warning/caution
• LATEX
• Phthalate-free
• Keep dry
• Manufacturer’s information
• Authorized European representative’s information
• Device is off
• Meets essential requirements of European 0197 Medical Device Directive 93/42/EEC
• Lot number
• Multifunction button
• Forehead measuring/measurement complete
• MEM Memory indication
• Low battery indication

Product General Warnings

Before using the Adtemp 432 Non-Contact Thermometer, familiarize yourself with the general safety instructions provided in the user manual. Failure to use the device properly could result in patient injury, illness, or death. The following general warnings should be observed:

• The thermometer is designed for intermittent measurement of body temperature and can be used on patients of all ages.
• Stop using the device if malfunctions appear or if it operates abnormally.
• Components may be harmful if swallowed. Keep out of reach of unsupervised children.
• Some medications may cause a rise in skin temperature, which can lead to incorrect measurements.
• Only use the thermometer indoors. Do not use this device close to strong electromagnetic fields, such as mobile phones.
• Unauthorized modifications to the device are not permitted. Do not modify the product in any way without the manufacturer’s prior authorization.
• In order to avoid incorrect measurements, make sure that the thermometer’s infrared sensor lens is clean and intact prior to use. Avoid touching the infrared sensor lens directly with your fingers.
• Do not expose the thermometer to extreme temperatures or humidity levels. Do not expose to direct sunlight.

Product Usage Instructions

To use the Adtemp 432 Non-Contact Thermometer, follow these steps:

1. Press the multifunction button to turn on the device.
2. Aim the thermometer at the patient’s forehead from a distance of 1 cm to 2 cm.
3. Press the multifunction button again to take a measurement.
4. The LCD display will show the patient’s temperature reading.
5. If desired, use the memory function to store up to 32 temperature readings for later reference.
6. When finished, turn off the device by pressing and holding the multifunction button for 3 seconds.
7. The device can be charged using the included micro USB cable and should be stored in a cool, dry place when not in use.

Device Description and Intended Use

• The Adtemp 432 Non-Contact Thermometer is a clinical-grade device intended for the intermittent measurement of human body temperature in patients of all ages.

Contraindications

• Do not use on scarred or compromised tissues.
• Do not use with patients in trauma or those being treated with medications that affect skin temperature.
• Do not use when the measuring site has been exposed to direct sunlight or extreme temperatures.

Parts and Assembly

Symbol Definitions

The following symbols are associated with your thermometer.

General Warnings

A warning statement in this manual identifies a condition or practice which, if not corrected or discontinued immediately, could lead to patient injury, illness, or death. The thermometer is safe for patient and clinicians when used in accordance with the instructions and with the warning and caution statements in this manual. Before using the thermometer, familiarize all operating personnel with the general safety instructions provided in this manual.

WARNING

• The thermometer is designed for the intermittent measurement of the human body’s temperature and can be used upon people of all ages. The following recommendations must be carefully observed during the product’s use. Any activities that are inconsistent with or do not take into account these recommendations, could result in personal injury or could affect the accuracy of the thermometer.
• Stop using the device if malfunctions appear or if it operates abnormally.
• Components may be harmful if swallowed. Keep out of reach of unsupervised children.
• Some medications may cause a rise in skin temperature which can consequently lead to incorrect measurements.
• Only use the thermometer indoors. Do not use this device close to strong electromagnetic fields, such as mobile phones.

CAUTION

• Proper measurement distance between 1 cm and 2 cm from the patient’s forehead is essential to the accuracy of the temperature measurement determined.
• Unauthorized modifications to the device are not permitted. Do not modify the product in any way without the manufacturer’s prior authorization.
• In order to avoid incorrect measurements, make sure that the thermometer’s infrared sensor lens is clean and intact prior to use. Avoid touching the infrared sensor lens directly with your fingers.
• Do not expose the thermometer to extreme temperatures or humidity levels. Do not expose to direct sunlight.
• The thermometer is NOT waterproof.
• Avoid dropping the device.
• Do not autoclave or clean with chemical solvents. Follow only the cleaning procedures described in this manual.
• Avoid taking temperature measurements for at least 30 minutes after physical activity, bathing, swimming, consuming food or beverages, or spending time outdoors.
• Avoid pointing the infrared sensor at any heat source other than a patient. This might affect patient measurement.
• If possible, measurements should always be taken by pointing the infrared sensor at the same area of the forehead. Temperature measurement at different locations on the temples or on opposite sides of the head can vary considerably.
• Holding the thermometer in your hands for too long or exposing the device to external heat sources could result in distorted temperature readings. For this reason, the body temperature reading could result as being higher or lower than the actual value.
• Dispose of the device and battery in accordance with locally applicable regulations.
• The device is not intended for field-based emergency medical use.
• For maximal performance of the device, we recommend a calibration check every two years.

Changing the Measurement Scale

1. Press and release the multifunction button to turn on.
2. While self-check screen is displayed, press and hold the multifunction button. When °C or °F mode has changed, release the button.
3. Thermometer will switch to measurement mode in about two seconds.

How to Use

NOTE: Charge thermometer for two hours before first use.

1. Clean the unit before using.
2. Make sure the site is clean and dry prior to taking measurement.
3. Press and release the multifunction button to turn on. You will hear a short beep and the unit will perform a self check. A second beep will indicate that the unit is ready to use.
4. Aim probe at the measuring site at a distance of 1-2 cm.
5. Press the multifunction button to take measurement.
6. When measurement is complete, the unit will beep and the color-coded temperature will appear (see Figure 1).
7. The unit will power off automatically in about 10 seconds.

Memory Function

The unit retains the last nine readings.

To recall previous readings:

1. While the unit is off, press and hold the multifunction button for about three seconds, until the unit enters memory mode.
2. Release the button. The reading number will appear first, then the corresponding measurement value. These numbers will toggle three times.
3. Press and release the multifunction button again to recall each earlier reading.
4. The unit will switch to measurement mode about three seconds after the last button push.

To delete all readings in memory:

1. While in-memory mode, press and hold the multifunction button for about three seconds, until the “del” code appears on the display.
2. Release the button.
3. Press and release the multifunction button once more to confirm the deletion. All readings will be deleted and the unit will power off.

Charging the Battery

Warning

• Charge the unit when the low-battery indication appears.
• Do not dispose of the battery in a fire. The battery may explode.

1. When the low-battery indication shows, charge it via micro USB cable.
2. During charging, the low-battery icon lights with yellow; once charging is completed, the low-battery icon lights with green.
3. Unplug when charging is complete.

Cleaning and Disinfecting

The thermometer can be cleaned, and an intermediate level of disinfection can be achieved using the following method.

CAUTION

• Never use abrasive cleaning agents, thinners, or benzene for cleaning and never immerse the instrument in water or other cleaning liquids.
• Never insert a sharp object into the sensor lens area or any other open surface on the thermometer.
• Do not use unapproved cleaning or disinfection agents. Use of these agents may cause damage to components.
• Do not use chemicals other than isopropyl or ethyl alcohol on the sensor lens.

Cleaning the sensor lens

• Slightly moisten a cotton swab or cloth with isopropyl or ethyl alcohol and gently wipe the surface of the sensor lens using a side-to-side (not circular) motion.
• Avoid touching the sensor lens except when cleaning is required.

Cleaning the thermometer

• Use a pre-moistened wipe or cloth slightly moistened with an approved cleaner to gently clean the thermometer.

Disinfecting the thermometer

• Use a pre-moistened wipe or cloth slightly moistened with an approved disinfectant to disinfect the thermometer..
• After cleaning or disinfecting, wait at least 10 minutes before taking another measurement. Follow the manufacturer’s recommendations.

Calibration Testing

The thermometer is calibrated at the time of manufacture. If the thermometer is operating according to these instructions, periodic readjustment is not required. ADC recommends checking calibration every two years or whenever clinical accuracy of the thermometer is in question. ADC can perform these tests for a nominal fee.

Care and Storage

• Do not drop or crush; this device is not shock proof.
• Do not dismantle or modify device.
• Do not store the device in an extreme environment with direct sunlight or high/low temperatures, or in a location with high humidity or severe dust.

Trouble Shooting and Error Messages

• The reading is higher than measuring range, please repeat the measurement.
• The reading is lower than measuring range, please repeat the measurement.
• Out of operating condition.
• Device self-diagnostic error, please contact customer service.
• Low battery indication, please charge it via USB cable.

Specifications

• Measuring Site: Forehead
• Measuring Distance: Within 0.7 in (2 cm)
• Measuring Time: 1 second
• Measuring Range: 71.6°F to 109.9°F (22.0°C to 43.3°C)
• Accuracy: 71.6°F to 109.9°F :≤0.5°F (22.0°C to 43.3°C :≤0.3°C )
• Measuring Unit: Dual (°F / °C)
• Resolution: 0.1°F
• Memory Sets: 9 sets
• Operating Conditions: 60.8°F to 104°F (16°C to 40°C), 15 to 95% RH (non-condensing)
• Storage Conditions: -4°F to 122°F (-20°C to 50°C), 15 to 95% RH (non-condensing)
• Battery: Rechargeable Lithium Ion battery
• Battery Life: At least 300,000 measurements within warranty
• Auto Shut Off: After 10 seconds of inactivity
• Dimensions: 3.48”x 1.02” x 1.02” (88.5mm x 26mm x 26mm)
• Weight: Approximately 1.59 oz (including battery)
• Standards: ISO 13485, IEC 62133, UN 38.3, ASTM E1965-98,
  • ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2

Limited Warranty

ADC warrants its products against defects in materials and workmanship under normal household use and service as follows:

1. Warranty service extends to the original retail purchaser only and commences with the date of delivery.
2. Your Adtemp Mini Thermometer is warranted for two years from date of purchase.

What Is Covered: Replacement of parts, and labor.

What Is Not Covered: Transportation charges to ADC. Damages caused by abuse, misuse, accident, or negligence. Incidental, special, or consequential damages. Some states do not allow the exclusion or limitation of incidental, special, or consequential damages, so this limitation may not apply to you.

To Obtain Warranty Service: Send item(s) postage paid to ADC, Attn: Repair Dept., 55 Commerce Dr., Hauppauge, NY 11788. Please include your name and address, phone no., proof of purchase, and a brief note explaining the problem.

Implied Warranty: Any implied warranty shall be limited in duration to the terms of this warranty and in no case beyond the original selling price (except where prohibited by law). This warranty gives you specific legal rights and you may have other rights which vary from state to state.

For Australian Consumers: Our goods come with guarantees that cannot be excluded under the Australian Consumer Law. You are entitled to a replacement or refund for a major failure and compensation for any other reasonably foreseeable loss or damage. You are also entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a major failure.

Read the instruction manual carefully before using this device, especially the safety instructions, and keep the instruction manual for future use.
Batteries and electronic devices must be disposed of in accordance with the locally applicable regulations, not with domestic waste.
Type BF applied part

Contact

K-JUMP HEALTH CO., LTD.

• No. 56, Wu Kung 5th Road
• New Taipei Industrial Park
• New Taipei City 24890, Taiwan

POLYGREEN GERMANY GmbH

• Ruhlsdorfer Straβe 95, D-14532, Stahnsdorf, Brandenburg, Germany

Dist. by: ADC®

• 55 Commerce Drive
• Hauppauge, NY 11788 Inspected in the U.S.A.
• Made in China
• tel: 631-273-9600
• toll free: 1-800-232-2670
• fax: 631-273-9659
• www.adctoday.com
• email: [email protected]

Printed in China

References

• American Diagnostic Corporation - Core Medical Device Manufacturer. Stethoscopes, Blood Pressure, Thermometry, and EENT

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