IRT3515WE

Organization name

KAZ Europe Sàrl

SRN

CH-MF-000029980

Manufacturer status

Active

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

• CW018

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

Primary placement in Belgium; available across 13 countries total.

Trade name

not provided

UDI-DI code

07630759301511

Basic UDI-DI

76307593IR3030G5

Reference / catalog number

IRT3515WE

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

Infrared Ear 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

• V0301010201CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES)

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• Expiration date
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