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BLOOD/FLUID WARMER (3M RANGER 245), 230V 50/60Hz

https://unicat.msf.org/cat/product/74223
STD EEMDBFWE4--

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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.
Z12019008 - Blood heaters
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
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
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BLOOD/FLUID WARMER (3M RANGER 245)

Definition

A mains electricity (AC-powered) device designed for heating of blood products or intravenous (IV) solutions, typically from about 4ºC to near body temperature (i.e. 35 to 40ºC) before infusion, through the conduction of heat.

The device includes a surface heat exchanger for the conduction of heat to the infusion blood/fluid via a disposable tubing set.

The warmer is used to minimize adverse thermal reactions in the patient.

It is mounted with a clamp on an infusion stand under the infusion bag or on a normed rail. It does not infuse blood/fluid.

Specifications

Device that heats blood products or solutions by passing through the warming sets before IV administration to the patients.

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Technical specifications

  • Concurrent warming of multiple transfusions / infusions
  • Temperature adjustment: 37° to 41°C with 0.5°C interval
  • Set point temperature: 41°C
  • Heating time: approx. 45 sec
  • External service interface for PC
  • Compact design with integrated handle for easy transport and built-in IV pole clamp for secure mounting on a standard rail and IV pole
  • Large, easy-to-read temperature display
  • Highly conductive aluminium plates
  • Convenient over-temperature test function
  • Flow Rates
    • Pediatric KVO – 100 mL/min
    • Standard Flow KVO – 150 mL/min
    • High Flow KVO – 500 mL/min
  • Audible/visible over-and under-temperature alerts
    • Over-temperature primary setpoint: 43°C
    • Over-temperature secondary setpoint: 44°C
    • Hearing alarm frequency: 3400 Hz, level of acoustic aggression: 70dB(A)
  • Security features: multiple independent cuts at 42°C
  • Power supply
    • Voltage: 220V-240V AC or 115 V AC, 50/60 Hz
    • Consumption: 280 W
    • Current: 1.5 A
    • Fuses: primary 2 x 1.6 AT secondary 500 mAT
  • Protection against solid/ liquid ingress: IPX4
  • Protection against electric shock
    • Class I
    • Type B

Dimensions

Weight: 3.3 kg

w x h x d: 19 x 11 x 25 cm

To be Ordered Separately

3M™ Ranger™ Blood/Fluid warming sets accommodate up to 300 mmHg of pressure and are made without natural rubber latex and without DEHP. They are sterile, for single use.

  • EEMDBFWC401 (warmer 3M RANGER) SET, pediatric, s.u. sterile 24450
    • cassette
    • for pediatric & neonatal use
    • flow rate: KVO - 150 ml/min or 9 L/hr
    • priming volume 20 ml
    • needleless injection port
    • bubble trap with air aspiration port
    • patient line: 46 cm
  • EEMDBFWC402 (warmer 3M RANGER) SET high flow, s.u. sterile 24355
    • cassette
    • for rapid and massive transfusions in adults
    • priming volume 150 ml
    • flow rate: KVO - 500 ml/min or 30 L/hr
    • two bag spikes
    • drip chamber with 150 micron blood filter
    • roller clamps
    • auto-venting bubble trap
    • needleless injection port
    • patient line: 152 cm
  • EEMDBFWC403 (warmer 3M RANGER) SET, standard, s.u. sterile 24250
    • cassette
    • for normal transfusions in adults
    • priming volume 39-44 ml
    • flow rate: KVO - 150 ml/min or 9 L/hr
    • two bag spikes
    • drip chamber with 150 micron blood filter
    • roller clamps
    • auto-venting bubble trap
    • needleless injection port
    • patient line: 152 cm

Instructions for use

Read carefully the user manual

Associated protocol

  • Continuous Intraoperative Temperature Monitoring MSF-OCP Feb 2018

Associated equipment

  • Temperature probes: see related articles
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Precautions for Use

The length of the tube between the device and the patient must be at least 40 cm, and the tube must not be stretched.

The ambient operating temperature must be in the range of 10° to 30°C.

Maintenance

Cleaning and disinfection:

  • Can 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 the surfaces completely, use a wipe or towel, keep them wet for the whole exposure time.
  • Do not disinfect the device with steam (i.e. in autoclaves), hot air or thermochemical cleaning solutions

Periodic inspections:

Must be carried out at least every 12 months

  • checking the warm-up period
  • checking the control temperature
  • checking the low temperature information signal
  • checking the high temperature alarm
  • visual check of general condition
  • electrical safety
  • visual check of general condition (TubeFlow)
  • checking the control temperature (TubeFlow)
  • over temperature control (TubeFlow)

Refer to the user manual for more details on how to carry out the checks mentioned above.

MSF requirements

Warming of high flow IV fluid and blood during trauma resuscitation or massive maternal haemorrhage.

Replaces the previous fluid warmer (EEMDBFWE1-- Biegler BW-685S) as it is inadequate for rapid and massive transfusions in trauma and maternal haemorrhage.

Hypothermia constitutes one of lethal triad in trauma management and massive transfusion. The Ranger Fluid Warming unit is capable of administering warmed IV fluid and blood at a very rapid rate (30 l/h).

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