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SURGICAL ASPIRATOR (AS64R), 60l/min, 230V

https://unicat.msf.org/cat/product/12934
STD EEMDVACE4--

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Former Code(s): EHOEVACE4--
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.
Z120105 - Surgical medical aspirators
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
P
The order of this product needs to be justified and is only acceptable under certain conditions.
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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ASPIRATOR, SURGICAL (AS64R)

Definition

An assembly of devices designed to evacuate large volumes of gas, liquid, tissue and/or other debris from a surgical site by means of suction during surgical procedures. It generally consists of a mains electricity (AC-powered) suction pump, a regulator and gauge, one or more collection canisters, plastic tubes connecting the components to each other, and an overflow protection and/or bacteria filter. The vacuum capability should be at least 400 mm Hg; free flow rates may be as high as 35 liter/min.

Specifications

Electrical surgical aspirator for the operating theatre.

  • powerful aspiration
  • jars of 4 liters
  • accurate settings by regulator
  • quadruple block pump soundproof
  • functioning without greasing
  • electronic start-up circuit: ensures start-up in all conditions
  • compact rolling model
  • safety too full flostop
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Quality standards

ISO 10079-1, 2022, edition 4, Medical suction equipment -- Part 1: Electrically powered suction equipment

Quality Standards Comment

  • ISO 10079-4:2021: Medical suction equipment — Part 4: General requirements

Components

  • 1 x suction pump ref. V20A64R
  • 1 x pneumatic pedal ref. 21SA01
  • 10 x tube diam. 7/13 mm ref. V21TD73
  • 4 x plastic jar (polycarbonate) 4 l ref. V21RPC4
  • 2 x security bottle with antibacterial filter

Technical specifications

  • Vacuum capacity: 60 l/mn ± 10%
  • Adjustable depression, maximum 800 mbar
  • Vacuometer control 0-1000 mbar
  • Rubber pneumatic pedal control
  • 4 plastic jars, 4 l each, graduated, with plug, autoclavable
  • Automatic overflow switch device at the level of the jar's plug
  • 2 security bottles, 300 ml, with overflow switch
  • Support on castors
  • Aspirating tube: 5 m, inner Ø 7 mm, silicone, autoclavable
  • Power supply
    • Voltage: 230 V ± 10%, 50 Hz
    • Power 135 VA
    • External fuses 5TSF 5x20 1A
    • Power lighting switch

Dimensions

  • Dimensions: 35 x 36 x 43 cm
  • Weight: 16 kg

Instructions for use

Refer to instructions for use and maintenance guides.

Precautions for Use

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

Maintenance

  • The apparatus and the pedal ​must be cleaned and disinfected with a detergent/disinfectant for surfaces/non-invasive medical equipment.
  • ​The 4L collection jars (in polycarbonate) must be cleaned and sterilized by steam autoclave after each use at 121°C. Follow the instructions of the manufacturer (autoclave at 121°C during 15 minutes, do not use chlorine).
  • The safety bottle with cap should only be cleaned if it contained liquid (and not routinely after each use). If the bottle has overflowed, the antibacterial filter must be replaced. It should not be sterilised in the autoclave

MSF requirements

Can be used in surgery and anaesthesia.

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