Braun Sensian 3, BNT050EE

Organization name

KAZ Europe Sàrl

SRN

CH-MF-000029980

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• CW018

  EUDAMED did not publish a description for this code.
• CW014

  EUDAMED did not publish a description for this code.
• CW999

  This thermometer is not intended for clinical use in a professional environment and is for home usage only. This thermometer is not intended to interpret hypothermic temperatures . If the device displays a temperature of 35.7 °C (96.3 °F) or less, and the individual is exhibiting atypical symptoms or behaviors, contact your physician or health care professional. This thermometer is not intended for pre-term babies or small-for-gestationalage babies. Pre-term is defined as a baby, born before 37 weeks of pregnancy are completed. Small-for-gestational-age is defined as a newborn baby (birth to 4 weeks of age), born at 37 weeks or later, with a weight below the 10th percentile for newborn babies of the same gestational age. Use of this thermometer is not a substitute for consultation with your doctor.
• CW999

  Keep out of reach of children under 12 years. NEVER use the thermometer for purposes other than those for which it has been intended. Please follow the general safety precautions when using on Children. NEVER immerse the thermometer into water or other liquids (not waterproof). For cleaning and disinfecting please follow the instructions in the “Care and cleaning” section. DO NOT store this thermometer in temperature extremes below -25 ºC/–13 °F or over 55 ºC/131 °F or in excessive humidity (above 95% non-condensing relative humidity). If thermometer is stored in a location that is cooler or warmer than where it will be used, allow it to acclimate to the room temperature for 30 minutes before taking a measurement. An individual must be inside and in the same room as the thermometer for 30 minutes before taking a measurement. If the individual is inside but in a room that is more than a few degrees warmer or cooler than the room the thermometer is in, it will impact the accuracy of the reading. DO NOT use the thermometer if there are signs of damage on the scanner or on the thermometer itself. If damaged, DO NOT attempt to repair the product. NEVER insert a sharp object into the scanner area or any other open surface on the thermometer. This thermometer consists of high-quality precision parts.DO NOT drop the instrument. Protect it from severe impact and shock. DO NOT use the device if it is damaged/degraded/loosened in any way. The effects of degraded sensors and electrodes, or loosened electrodes, that can degrade performance or cause other problems.
• CW999

  Temperature elevation may signal a serious illness, especially in neonates and infants, or in adults who are old, frail, or have a weakened immune system. Please seek professional advice immediately when a temperature elevation occurs on persons that are: • Neonates and infants under 3 months (consult your doctor immediately if the temperature exceeds 37.4 ºC (99.4 ºF) • Individuals over 60 years of age (Fever may be blunted or absent in older individuals) • Individuals having diabetes mellitus or a weakened immune system (e.g., HIV positive, cancer chemotherapy, chronic immunosuppressant treatment, splenectomy) • Individuals who are bedridden (e.g., nursing home patient, stroke, chronic illness, paraplegia, quadriplegia, surgical recovery)A transplant patient (e.g., liver, heart, lung, kidney) DO NOT allow children to take their temperatures unattended. Please consult your physician if you see symptoms such as unexplained irritability, vomiting, diarrhea, dehydration, changes in appetite or activity, seizure, muscle pain, shivering, stiff neck, pain when urinating, etc., even in the absence of fever. Even in the absence of fever, those who exhibit a normal temperature may still need to receive medical attention. Individuals who are on antibiotics, analgesics, or antipyretics should not be assessed solely on temperature readings to determine the severity of their illness. DO NOT modify this equipment without the authorization of the manufacturer.

Primary placement in Belgium; available across 7 countries total.

Trade name

Braun Sensian 3, BNT050EE

UDI-DI code

07630759300330

Basic UDI-DI

76307593BNT050K4

Reference / catalog number

BNT050EE

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

No Touch + Touch Forehead Thermometer

Additional information URL

https://www.helenoftroy.com/emea/

Clinical sizes

• Patients having ages ranging from normal weight (full term) new-born to geriatric adult,

• V0301010202NON-CONTACT DIGITAL THERMOMETERS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification