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WARMING UNIT, forced air generator (Bair Hugger 775)

https://unicat.msf.org/cat/product/12943
STD EEMDWAUE2--

Valid Article

Former Code(s): EHOEWARU2-- EHOEZFR0724
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
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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WARMING UNIT (Bair Hugger 775)

the 775 model replaces the 505, nevertheless the spare-parts are not necessarily the same.

Definition

Generator blowing warm air at controlled temperature and flow. It is connected to a warming blanket intended to help prevent a patient from cooling prior to, during, and after a surgical intervention or in the emergency room.

Synonym

Heating cover generator

Specifications

Compact unit for forced-air warming

  • Two airflow settings and hose-end temperature sensing for precise temperature delivery
  • Three temperature sensors
  • Tracks and reports therapy duration, over temperature information, calibration, hours used (via built-in meter), fault codes
  • Usage information available via the front panel -no need to open the unit
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Quality Standards Comment

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

  • Generator
  • Connecting pipe
  • Air filter

Caution : the blankets are not included!

Technical specifications

  • Power supply: 110-120VAC, 50/60Hz 11,7A or 220-240 VAC, 50/60 Hz, 7,2A
  • Hose with connector for warming blanket: length +/- 1.8 m
  • Power cord
  • Controlled temperatures:
    • high: 43°C +/- 1.5°C
    • medium: 38°C +/- 1.5°C
    • low: 32°C +/-1.5°C
  • Air flow:
    • 15.1 l routinely
    • 17.5 l for surgery
  • Filter: HEPA 0.2 µm
  • Support on castors
  • Electrical protection : the generator has two fuses. They are located inside the generator.
  • The equipment works only on mains power supply, there is no battery inside.
  • Alarm for overheating detection

Dimensions

  • Size: approx. 35 x 25 x 30 cm
  • Weight: approx. +/- 7 kg

To be Ordered Separately

The warming blankets have to be ordered separately (see related article). None is supplied with the warming unit.

Instructions for use

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Precautions for Use

This equipment must be used by trained people who read the user manual.

For the good functioning and to avoid burns of the patient, this equipment must always be used in connection with a reusable blanket (see related articles below).

To avoid electrical hazard, because the generator and the blanket are in direct contact with the patient, ensure that the equipment is well grounded.

Maintenance

  • Check the outflow temperature of the generator every 6 months or after 500 h of use.
  • Check the working status of the overheating alarm every 6 months or after 500 h of use.
  • Replace the air filter every 12 months, or after 500 h of use.
  • Clean regularly the generator 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.

MSF requirements

Small and lightweight warming unit for hot air. Easy to use, designed to provide effective patient warming at safe and controlled air delivery temperatures and flow. It notoriously reduces clotting disorders, infection and cardiac bad outcomes due to the neutralisation of hypothermia.

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