SYRINGE PUMP (AGILIA SP MC Z018612), single syr.,drug lib.FR

STD EEMDSYPE41F

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Former Code(s): EEMDSYPE41-
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.
Z12030302 - Syringe pumps
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SYRINGE PUMP (Agilia SP MC)

Definition

A mains electricity (AC-powered) device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It has internal batteries that allow the device to operate for a short period of time when no line power is available.

Synonym

electrical syringe, syringe driver

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

  • Manual pusher: protection for the ongoing infusion (Push Guard)
  • Display: blue graphic LCD monochrome, 66 x 33 mm (256x128 pixels)
  • Swinglock clamp: allows fxation on a rail or on a pole (pole :20-40mm max./Rail: 25-35 x 10 mm)
  • Stackability up ot 3 devices on a pole
  • Flow rate range: 0.1 - 1200 ml, depending on the syringe capacity (0.1 ml/h increment)
    • 0.01 minimum increments is activated when the max patient weight is set to 20 kg in the drug library
    • Flow rate can be limited according to the drug name (soft and hard limits) with Agilia Vigilant Drug'Lib, IV medication safety system
  • Flow rate accuracy: +- 1% on mechanism; +-2% on syringes
  • Syringe capacities: 5, 10, 20, 50/60 ml
  • Infusion modes
    • ml/h mode
    • dose rate mode: ng/h, ng/kg/min, ng/kg/h, ...
    • dilution setting: --units / ml or -- units / -- ml
    • Volume or dose / time: 0.1-99.9 ml; 00h01 - 96h00
    • volume limit: 0.1-999 ml
  • Volume/Dose infused: Vol 0.1 - 999.9 ml; dose 0.1 - 999.999 units
  • Priming: 3 modes (mandatory, not mandatory, or advised / Rate: 1200ml/h)
  • Bolus:
    • direct bolus: rate 50 - 1200ml/h (50mL/h increment)
    • programmed bolus: (dose or volume/time):0.1 - 99.9ml; 0.1 - 9999 units / 1 min - 24
  • Loading dose: Dose or volume / time: 0.1 - 99.9 units / 00 min 01 - 59 min 59 rate auto-calculation
  • End infusion: KVO: adjustable from 0.1 to 5 mL/h, continuous infusion or stop
  • Pause: programmation from 1 minute to 24 hours, increments from minute to minute
  • Graphical history: volume/ dose infused, pressure, flow rate
  • The night mode decreases the brightness of the screen and the green lights. The key beep can eventually be turned off. The night mode can be programmed manually or automatically in a variable time range
  • Profiles
    • Basic profile: infusion without any display of the drug names.
    • 19 Custom profiles configurable with Agilia Vigilant Drug'Lib:
    • Drug library to be created with Agilia Vigilant Drug'Lib.
    • Configuration only: Custom pump configuration without Drug Name
  • Pressure modes
    • variable or 3 pre-set levels
    • Range from 50 to 900 mmHg. (25 mmHg increment from 50 to 250 mmHg / 50 mmHg increment from 250 to 900 mmHg). Can be enabled / disabled and adjusted
  • Pump status
    • GREEN for infusion in progress,
    • ORANGE for Low and Medium priority,
    • RED for High priority - Visibility at 4 meters minimum.
    • All alarms are expressed by means of light indicators, written words, pictograms and sound beeps
  • Protection against solid/ liquid ingress: IP22
  • Power Supply: 100V - 240V, 50/60Hz with functional earth
  • Battery :
    • 7.2V 2.2Ah (< 100 Wh), Li-ion Smart battery
    • remaining battery life and charge level on display
    • battery life when fully charged >13h at 5mL/h
    • attery recharge:
      • pump off: <6H
      • pump on: <20H

Dimensions

135 x 345 x 170 mm

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

Injectomat 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.

Caution, not all brands of syringes are compatible with the syringe pump. When in doubt, please contact your supply centre.

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

Maintenance

Read carefully the manufacturer's leaflet and follow the instructions for 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.

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