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INFUSION PUMP (Agilia VP Z019589) 100-240V 50/60Hz EN

https://unicat.msf.org/cat/product/90780
STD EEMDINPE4E-

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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.
Z12030301 - Infusion 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.
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
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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INFUSION PUMP (Agilia VP)

There are 2 different codes according to the language presettings: English or French.

Definition

A mains electricity (AC-powered) device designed to facilitate the accurate and consistent administration of drugs and solutions which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set. It is used to supply higher pressures than those provided by manually clamped gravity infusion sets or infusion controllers. The device has a typical flow range of 1 to 999 ml/hour and delivers solutions from a standard infusion bag or bottle of fluid. It typically has internal batteries that enable operation for a short period when no mains electricity is available (e.g., during transportation or a power outage).

Specifications

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Quality standards

  • EN 60601-2-24, 2015, Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
  • ISO 8536-8, 2015, edition 2, (confirmed 2021) Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus

Technical specifications

  • Infusion Modes : ml/h modes:
    • Volume + Flow rate
    • Volume + Time
    • Flow rate + Time
    • Volume + Time + Rate
    • Drop/min
  • Flow rate range:
    • primary infusion: 0.1 - 1200 ml/h with minimum increments
      • 0.01 (0.10 => 9.99 ml/h)
      • 0.1 (10.0 => 99.9 ml/h)
      • 1 (100 => 1200 ml/h)
    • direct bolus 50 - 1200 ml/h
    • KVO (keep the vein open): 0 -20 ml/h
    • Priming: 1200 ml/h
  • Volume to be infused
    • infusion: 0.1 - 9999 ml
    • direct bolus: 0.1 - 50 ml
  • Infusion time with minimum increment 1 min
    • primary: 00h01 - 168h00
    • KVO: 00h01 - 12h00
    • pause: 00h01 - 24h00
  • Air detection:
    • total air volume over 15 minutes
      • range of settings 10 - 2000 µl
      • default value 250 µl
      • increment 10 µl
    • air bubble filter
      • range of settings 10 - 2000 µl
      • default value 250 µl
      • increment 10 µl
  • Infusion pressure mode: 3 levels
    • low 30-300 mm Hg
    • medium 150-600 mm Hg
    • high 250-750 mm Hg
  • Infusion indicators
    • flashing green: infusion in progress
    • constant yellow: low-priority alarm
    • flashing yellow: medium-priority alarm
    • flashing red: high-priority alarm
  • Auditive alarm
  • Power supply
    • Voltage: 100 – 240V, 50-60Hz with functional earth
    • Maximum consumption 10-15 VA
    • Protective fuse: 1 X T1.6AH 250V accessible in the battery compartment
    • Battery < 100 Wh
  • Protection against solid/ liquid ingress: IP22

Dimensions

  • 135 x 190 x 170 mm (H x W x D)
  • Weight : 2 kg

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
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Supplied with the Article

Volumat Agilia comes with an initial drug library. A maximum of four libraries can be stored in the device. These libraries can be configured with the Vigilant Drug'Lib software.

Instructions for use

Precautions for Use

To be used by duly trained staff only.

Always check that the calculation of the dilution and the registered rate correspond to the medical prescription.

Read the manufacturer's manual carefully and follow the maintenance instructions.

Be careful the infusion tubing is specific with the infusion pump. If in doubt, contact your supply office.

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

Maintenance

Must 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 surfaces completely, use a wipe or towel, keep them wet for the whole exposure time.

MSF requirements

Following a high demand in IV fluids infusion and blood transfusion, it is justified to have a pump-controlled device for more accuracy and to ensure a correct and accurate amount (of IV fluids/blood components transfusion) is being infused to patients.

  • A simple-to-use device with minimal power requirements and capable to operate with batteries.
  • A device that can be of use for all types of patients: from adults to infants.
  • Robust device that is able to withstand a high demand.
  • Minimal maintenance or (maintenance-free) device.
  • Easy to clean: device is used for blood transfusion, infection control to take into consideration.
  • Easy to use and equipped with audible/visual alarms to prevent incidents originating from an inadequate infusing/transfusing.
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