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ELECTRIC HEATING MATTRESS 620x350x13mm (Calibed)

https://msf.oodin.sh/cat/product/75116
STD EEMDHEPE2--

Valid Article

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.
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
PM
The order of this product needs to be justified and is only acceptable under certain conditions.
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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ELECTRIC HEATING MATTRESS (Calibed)

Definition

An assembly of mains electricity (AC-powered) devices designed to heat a patient's whole body, to compensate for the loss of normal body heat, with heat generated from an externally applied pad typically containing electrical heating elements or cables.

The system includes the pad designed to heat under the baby, and a control unit to regulate and monitor the heat. The system is used in the operating room (OR), the intensive care unit (ICU), or in neonatal and recovery units.

Synonym

warming mattress, heating mattress

Specifications

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Quality standards

EN IEC 80601-2-35, 2020, Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

Components

  • Control unit with
    • LCD screen for good visibility of data and alarms
    • a functional handle allowing its fixation on cradles.
  • Heating element
  • Polyurethane gel mattress, prevents pressure sores, autoclavable, without latex or silicone​

Technical specifications

  • Mattress temperature regulation from 28 to 38.5°C
    • with secure access below 35°C and above 37°C
  • Audible and visual alarms: 3 groups alarms according to the degree of urgency of intervention
  • Heating power: 75 W (absorbed power: 100VA)
  • Power supply:
    • control unit: 220-240V / 50-60Hz
    • mattress: low voltage security 24VAC
  • Protection against electric shock
    • Class I
    • Type BF

Dimensions

  • control unit (excluding handle): WxLxH 300x190x75 mm
  • sleeping area: LxW 600x325 mm

Instructions for use

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Precautions for Use

Secure the electrical protection of the apparatus with a double conversion UPS (see related articles below).

Maintenance

Clean and disinfect the mattress between each use 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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