IRT3515EE

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Critical warnings

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

CW999
This thermometer is not intended for pre-term babies or small-for-gestational age newborn babies (birth to 4 weeks of age). Pre-term is defined as babies born before 37 weeks of gestation. Small-for-gestational-age is defined as a newborn baby, born at 37 weeks or later, with a weight below the 10th percentile for newborn babies of the same gestational age.
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. Do not allow children under 12 to take their temperatures unattended. This thermometer is intended for household use only. This product is not intended to diagnose any disease, but is a useful screening tool for temperature. Use of this thermometer is not intended as a substitute for consultation with your physician.
CW999
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. in spite of absence of fever. The operating ambient temperature range for this thermometer is 10 – 40 °C (50 – 104 °F). Do not expose the thermometer to temperature extremes (below –25 °C / –13 °F or over 55 °C / 131 °F) or excessive humidity (> 95 % RH). This thermometer must only be used with genuine Braun ThermoScan® Hygiene Caps. Other probe covers can lead to inaccuracy. To avoid inaccurate measurements always use this thermometer with a new, clean, Hygiene Cap. If the thermometer is accidentally used without a Hygiene Cap, clean the lens after use (see «Care and cleaning»). Keep Hygiene Caps out of reach of children.
CW018
EUDAMED did not publish a description for this code.
CW999
The ThermoScan® Ear thermometer is not intended to interpret hypothermic temperatures. This thermometer must stay in stable ambient (room) temperature for 30 minutes before operating. Temperature elevation may signal a serious illness, especially in adults who are old, frail, have a weakened immune system, or neonates and infants. Please seek professional advice immediately when there is a temperature elevation and if you are taking temperature on: • neonates and infants under 3 months (consult your doctor immediately if the temperature exceeds 37.4 °C or 99.4 °F) • Individuals over 60 years of age • Individuals having diabetes mellitus or a weakened immune system (e.g., HIV positive, cancer chemotherapy, chronic steroid treatment, splenectomy) • Individuals who are bedridden (e.g., nursing home patient, stroke, chronic illness, recovering from surgery) • a transplant recipient (e.g., liver, heart, lung, kidney) Do not allow children to take their temperatures unattended. People 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. This thermometer contains small parts that can be swallowed or produce a choking hazard to children. Always keep the thermometer out of children’s reach.

Country	On market since	Until
BelgiumPrimary placement		Still on market
Bulgaria		Still on market
Cyprus		Still on market
Croatia		Still on market
Ireland		Still on market
Poland		Still on market
Sweden		Still on market
Slovenia		Still on market
Türkiye		Still on market

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