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FLUID WARMER, wall mounted,230V 50/60Hz (Enthermics ivNow-3)

https://unicat.msf.org/cat/product/72827
STD EEMDFLWE2--

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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.
Z12030305 - Infusion 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.
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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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FLUID WARMER ivNOW

Definition

A device designed for heating of intravenous (IV) solutions, and irrigation fluids to body temperature before use. The warmer is used to minimize adverse thermal reactions in the patient.

It is mounted on a wall. It can accept up to 3 different flexible bags of a maximum of 3 litres. Warming up to 40°C takes place in 30 minutes.

Specifications

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Components

  • IvNow-3 (three bag capacity), 230V, 50-60HZ, 600W, bottom cord (ref. 504901)
  • Horizontal wall mount kit: 2 brackets, 2 rails (ref.: 50122442)

Technical specifications

  • Anodized aluminium heat plate with
    • Temperature sensor for the flexible bag
    • 3 cavities for flexibale bags from 0.5 l to 3 l
  • Every single cavity has a power switch and control panel with LED display and status button / key:
    • temperature in Celsius or Fahrenheit or
    • time the fluid has been held at temperature
    • green light: when fluid is within +0/-2°C of the set point
    • the factory default temperature is 40°C (104°F)
  • Power supply:
    • Voltage: 230 V.A.C. - 50/60 Hz, 3.8 Amps
    • average consumption: 0.45 kW,
  • Power cable: +/- 1.4 m
  • Protection against electric shock
    • Class I equipment
    • no applied parts

Dimensions

Height x width x depth: 48cm x 36.8cm x 17.1cm

Net weight: 9 kg

Instructions for use

Read carefully the user manual.

The ivNow-3 (three (3) bag capacity) must be mounted on a wall using mounting brackets.

Precautions for Use

Operational environmental conditions:

  • Unit must acclimate to room temperature in the environment it will be placed (24 hours is recommended).
  • Recommended environmental temperature range is 15°C to 32°C (60°F to 90°F)
  • Recommended relative humidity is above 20%, non-condensation

Do not use this warming appliance in the presence of flammable anesthetic mixtures (with air or with oxygen or nitrous oxide).

Maintenance

Clean the unit regularly:

  • Turn the unit off.
  • Disconnect the module from the power source.
  • Wipe the metal, plastic, control surfaces, and sensor switch of the module 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. Avoid contact with the electrical connections and electrical components.

NOTE: In the event that fluid should spill inside the module, unplug the unit to prevent an electrical shock hazard. Wipe excess fluid from module immediately. Refer to qualified service personnel. Qualified service personnel should remove the module control and remove any remaining liquid. Perform necessary hospital electrical safety check before returning the unit to operation.

Annual preventive maintenance:

  • Inspect condition of plug and cord. Replace if damaged.
  • Check condition of wall mounting hardware. Ensure mounting screws and assembly are secure.
  • Check control panel overlay condition. Are there any tears or excessive wear on the graphic? Does the control work properly when buttons are pushed?
  • Check that all control LEDs light up. Test by turning the unit off and then on. All LEDs illuminate for one second at start-up. Contact Service for immediate repair if any problems exist.

MSF requirements

The Fluid Warmer quickly warms and maintains the temperature of injection/intravenous and irrigation solutions at body temperature prior to their use.

The article has been introduced in order to facilitate warming the fluids for peritoneal washouts, mainly in trauma centres, to avoid hypothermia that is one of the three leading causes of mortality in trauma.

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