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ENTERAL NUTRITION PUMP (Flocare Infinity) 230V with battery

https://unicat.msf.org/cat/product/12757
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Valid Article

Former Code(s): -X EHOEZFR0532 EEMDEFPE1-- EHOEZBE1021 EEMDEFPE001
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.
Z12030303 - Enteral feeding pumps
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.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
UN3481
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
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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ENTERAL FEEDING PUMP (Flocare Infinity)

The manufacrturer has ended the commercialisation of this device in March 2024. Corrective maintenance will remain available until 2029. the updated model Flocare Infinity III is proposed as replacement by the manufacturer, all consumables and accessories are compatible.

Definition

Enteral feeding enables nutrients to be fed through a tube, in order to meet daily nutritional requirements and to fight malnutrition in patients unable or unwilling to eat normally. The enteral nutrition pump enables the nutrient mixture to enter the patient's stomach, by a pipe and a probe. The pump delivers nutrients through pulsation; by using a roller around which is wound a tube.

Enteral nutrition can be done:

  • discontinuously: by administering the nutrient liquid over a period of 4 to 6 hours several times a day.
  • continuously: over a period of 24 hours, changing the feeding bags continuously, at the same rate.

Synonym

Enteral feeding pump

Specifications

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Technical specifications

  • Charger: 100-240 V 50-60Hz current capacity of at least 0.75 for Amp (100 VAC) or 0.35 Amp (for 240 V AC) output 5 V DC 2.4 A
  • Battery: Internal rechargeable Lithium Ion, 2000 mAh 3.6 VDC
  • Autonomy of battery: 24 h at 125ml / h
  • Protection against solid/ liquid ingress: IPX5
  • Microprocessor control
    • flow accuracy: ± 5.0% with Flocare ® Infinity ™ tubes.
    • occlusion pressure: upstream: -34 kPa (21 kPa tolerance)
    • downstream: 83 kPa (21 kPa tolerance)
    • detection of air bubbles: the amount of air that must pass in front the air detector before the container is empty varies between 0.5-1 ml, which corresponds to an air bubble of a length 6-13 cm at the level of the silicone insert.
  • The functioning of the pump is not affected by proximity to other electronic devices. The pump does not affect these other devices.
  • Environmental Conditions
    • Humidity: 30% to 75% noncondensing
    • Temperature: 13°C to +40°C
    • Atmospheric pressure: 70 to 106 kPa​

Dimensions

  • h x l x L: 140 x 95 x 35 mm
  • Weight: 392 g

Transport Dangerous Goods

  • UN3481 Lithium ion batteries contained in equipment
  • Class: 9
  • Packing Instructions: 967 Section II
  • The label must include the UN code of the battery + an emergency number to contact in case of an incident
  • Limit per package:
    • Pax A/C (Passengers & Cargo Aircraft) = 5 kg
    • CAO (Cargo Aircraft Only) = 5 kg
Image

To be Ordered Separately

  • Administration set is pump specific!
  • Nasoenteral tubes
  • Enteral nutrition

(See related articles below)

Instructions for use

Device reserved for specially trained personnel

Precautions for Use

  • To ensure the accuracy of the pump and prevent any risk of infection, change tubing every 24 hours.
  • Preventive maintenance of the pump by an authorised service every 2 years

Maintenance

Cleaning

  • Always disconnect the pump before cleaning to prevent a short circuit.
  • Regularly clean all surfaces of the pump (including sensors and rotor) with warm soapy water or 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.
  • The pump can be washed with clean water under the tap. It must never be immersed.
  • The rollers of the rotor must be kept in a clean state so that they can rotate freely.
  • The adapter normally does not need to be cleaned. If necessary, you can clean the outer part with a dry or slightly damp cloth. Make sure the adapter is unplugged.

Storage

  • Humidity: 10% to 95% noncondensing
  • Temperature: -20°C to +65°C
  • Atmospheric pressure: 50-106 kP
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