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INFANT WARMER (Ceratherm 600-3), mobile

https://unicat.msf.org/cat/product/12941
STD EEMDWAIE3--

Valid Article

Former Code(s): EHOEWARI3--
Article is intended to be used with children (<12 years) ONLY.
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
Z12080407 - Neonatal radiant warmers
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIb
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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INFANT WARMER, mobile Ceratherm 600-3

Definition

A mains electricity (AC-powered) mobile device that contains heating element(s) designed to emit controlled, evenly distributed overhead heat to the body of a newborn/infant patient requiring supplemental heat. This device is equipped with wheels so that it can easily be moved to different areas of a room, ward, or department.

Synonym

Specifications

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Quality standards

EN IEC 60601-2-21, 2021, Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

Technical specifications

  • Simple model without bed or skin temperature sensors
  • Mobile stand with 3 castors, adjustable height
  • 4 heating levels: 20% , 50%, 75% and 98% of maximal capacity
  • A reminder alarm (acoustic and visual) is triggered every 15 minutes. If this is not cancelled within 8 seconds, the control system automatically returns to the safety level of 20%.
  • The integrated ceramic heating element of 600W produces invisible infrared heating in the range of 3 µm wavelength.
  • Built-in 20W halogen examination lamp
  • Power supply: 230V ± 10%
  • Consumption: max - standby = 630W - 0.03W

Dimensions

  • Heater:
    • (h x l x w): 9 x 55 x 21 cm
    • weight: 4.3 kg
  • Mobile stand:
    • (h x l x w): 170-190 x 64 x 58 cm
    • weight: 34 kg

Instructions for use

Use restricted to the delivery room.

Equipment intended to provide the necessary care to newborn for maximum 20 to 30 minutes after birth.

Be aware of the danger of burns if the newborn child remains a long time under the warmer.

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Precautions for Use

Contact your biomedical officer in order to see the need to protect the apparatus with a double conversion UPS (see related articles below).

Maintenance

After each use, the warmer must be cleaned and disinfected with a detergent/disinfectant for surfaces/non-invasive medical equipment. Prepare use-solution in concentration required. Always read the label and product information before use. Do not mix with other products. Make sure to wet surfaces completely, use a wipe or towel, keep them wet for the whole exposure time.

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