The VisioFocus® MINI 06700 is an infrared medical thermometer designed for non-contact measurement of body temperature in children and adults. It can also be used to monitor the temperature of inflammations, ulcers, wounds (e.g., on diabetics and under medical supervision). This device is a Class IIa medical device, manufactured by Tecnimed srl in Italy, and complies with Regulation (EU) 2017/745 for medical devices and 2014/30/EU directive for non-medical use.
Function Description:
The VisioFocus MINI detects infrared radiation from the human body. It is designed to measure temperature without physical contact, by projecting the temperature reading onto the forehead. The forehead is considered an ideal site for temperature measurement due to the temporal artery and its direct contact with the brain, and its responsiveness to fever. The thermometer takes a series of readings in a tenth of a second, which are then processed by a microprocessor, taking into account room temperature, to display the correct body temperature.
The device features two main measurement modes:
- Forehead Temperature Reading (FACE button): This is the primary mode for body temperature. When the "FACE" button is pressed, two aiming lights and the button's light turn on, projecting the temperature reading onto the forehead. The user adjusts the distance until the temperature is squarely between two projected dots. The software automatically applies a correction factor to make the reading comparable to axillary, oral, or rectal measurements.
- Other Readings (HOME button): This mode is for non-medical use, such as measuring skin surface temperature, or the temperature of objects, food, and liquids. When the "HOME" button is pressed, the projection appears on the surface, and the "HOME" button light turns on. Skin surface temperature is not body temperature.
The VisioFocus MINI also includes a Memory Function (MEM button) that allows users to recall the last 9 temperature readings. The "MEM" button can also be used to display the Ambient Temperature, showing the letter "A" alternating with the room temperature value.
Important Technical Specifications:
- Body Temperature Measurement Range: 34.0°C to 43.0°C (93.2°F to 109.4°F).
- Other Readings Measurement Range: 1.0°C to 80.0°C (33.8°F to 176.0°F).
- Ambient Temperature Measurement Range (stand-by): 5.0°C to 45.0°C (41.0°F to 113.0°F).
- Resolution: 0.1.
- Accuracy (Body Temperature):
- 34.0 to 35.9°C: ±0.3°C (93.2 to 96.7°F: ±0.5°F)
- 36.0 to 39.0°C: ±0.2°C (96.8 to 102.2°F: ±0.4°F)
- 39.1 to 43.0°C: ±0.3°C (102.3 to 109.4°F: ±0.5°F)
- Accuracy (Other Readings):
- 1.0 to 33.9°C: ±0.3°C (33.8 to 93.1°F: ±1.8°F)
- 34.0 to 35.9°C: ±0.3°C (93.2 to 96.7°F: ±0.5°F)
- 36.0 to 39.0°C: ±0.2°C (96.8 to 102.2°F: ±0.4°F)
- 39.1 to 43.0°C: ±0.3°C (102.3 to 109.4°F: ±0.5°F)
- 43.1 to 80.0°C: ±1.0°C (109.5 to 176.0°F: ±1.8°F)
- Accuracy (Ambient Temperature): ±1.0°C (±1.8°F).
- Room Temperature Working Range:
- Standard: 16.0°C to 40.0°C (69.8°F to 104.0°F).
- Extended: 10.0°C to 45.0°C (50.0°F to 113.0°F) for body temperature, and 5.0°C to 45.0°C (41.0°F to 113.0°F) for other readings. Accuracy is not guaranteed outside the standard range.
- Power Supply: 2 AAA (LR03) alkaline batteries - 1.5 V (included).
- Battery Life: More than 10,000 readings or up to 3 years.
- Dimensions: 94.5 x 43.5 x 21.5 mm (3.72 x 1.71 x 0.85 inches).
- Weight: 60 gr. (2.12 oz.) - batteries included.
- Distance from Subject: Approximately 6 cm (2.36 inches), calculated using an optical aiming system.
- Expected Life: 10 years.
- Operating Conditions: Atmospheric pressure 700 to 1,060 hPa, relative humidity 15% to 93% (non-condensing).
- Storage Temperature: -25°C to +70°C (-13°F to 158°F).
- LEDs: Emit low light radiation in compliance with EN 62471.
Usage Features:
- Non-Contact Measurement: Allows temperature readings without touching the skin, which is ideal for sleeping children or individuals sensitive to contact.
- Aiming Lights: Two aiming lights guide the user to position the thermometer correctly, ensuring the temperature reading is projected accurately between two dots on the forehead.
- Automatic Quick Calibration System (AQCS): The device automatically stabilizes its readings. If moved before stabilization or in strong electromagnetic fields, it displays "E.8".
- Manual Quick Calibration System (MQCS): Allows for manual calibration if the device needs to be stabilized quickly, especially when moving between rooms with different temperatures. This involves focusing on a uniform internal wall and pressing both "FACE" and "HOME" buttons simultaneously.
- Temperature Settings: The thermometer can be preset to Celsius (°C) or Fahrenheit (°F) and can display readings referred to oral, rectal, axillary, or internal temperature, which can be modified by the user.
- Eyelid Reading: In cases of profuse sweating, oils, make-up, or for elderly individuals, temperature can be taken on the closed eyelid as an alternative to the forehead.
- Memory Recall: Stores the last 9 temperature readings for easy reference.
- Room Temperature Display: Can show the ambient temperature when in stand-by mode.
- Warnings and Troubleshooting: The device displays various messages (e.g., "bAt" for low battery, "E.1" for dead battery, "CAL" for stabilization, "Hi.4" or "Lo.5" for room temperature outside working range, "Hi.2" or "Lo.3" for detected temperature outside limits) to guide the user in case of issues.
Maintenance Features:
- Battery Replacement: Uses 2 AAA (LR03) alkaline batteries. Instructions are provided for safe replacement, including a recommendation to stabilize the thermometer for 20 minutes or perform an MQCS after changing batteries. Batteries should be removed if the thermometer will not be used for a long time.
- Cleaning:
- Waveguide: The sensor window at the bottom of the waveguide is delicate and must be kept clean. Dust or dirt can be removed with a cotton swab slightly dampened with alcohol. No other objects or liquids should be used to avoid scratching or damaging the sensor.
- Thermometer Body: Can be cleaned with a soft cloth dampened with soap and water, and possibly re-wiped with a sodium hypochlorite disinfectant.
- Storage: Should be stored in a clean, dry place, away from dust, and within the specified temperature range (+16°C to +40°C for operating, -25°C to +70°C for storage).
- Durability: Designed to be robust, but users are advised to avoid knocking or dropping it, and not to use it if damaged or not functioning properly.
- Technical Service: In case of damage or water seepage, users are instructed to contact their Dealer or the Manufacturer for technical service.
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