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ANAESTHESIA VENTILATOR (Glostavent Helix), 160-300V 46-54Hz

https://unicat.msf.org/cat/product/53890
STD EANEANAE5--

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Former Code(s): EANEMISC090 EANEZNL0090
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.
Z12030105 - Pulmonary ventilators for hospital use
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
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PM
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)
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ANAESTHESIA VENTILATOR (Glostavent Helix)

Definition

A mains electricity (AC-powered) stand-alone, automatic cycling device used to assist and control alveolar ventilation during general anaesthesia, and is compatible with inhaled anaesthetic agents. It has fewer functions and is less complex to operate than an intensive care ventilator, but adequately meets the patient's ventilation needs for oxygen (O2) and carbon dioxide (CO2) exchange to maintain normal blood gas concentrations. The device provides a mechanical means to deliver the breathing gas to the patient > 10 kg in a controlled pattern, and is equipped with alarms to warn of changes in respiration or the onset of unsafe operating conditions.

Specifications

The ventilator is a time-cycled, volume limited, pressure generator. It consists of a set of gas driven bellows. The drive gas is oxygen supplied either by the concentrator or, in the event of an electricity failure, from the reserve oxygen cylinder or external oxygen source.

After it has driven the ventilator it is collected and returned to the breathing circuit to supplement the inspired oxygen concentration, always providing the patient with a minimum of 35% oxygen.

The UPS provides a reserve supply of electricity for approximately 30 minutes. It also functions as a voltage and frequency regulator.

The vaporiser can be used with isoflurane (replaces halothane).

Composed by four principal components:

  • a versatile breathing system
  • a pneumatically driven ventilator
  • an oxygen concentrator
  • an uninterruptible power supply for voltage stabilisation and battery backup

Packed in wooden case

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Quality standards

ISO 80601-2-13, 2022, edition 2, Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

Technical specifications

Ventilator

  • Mode of operation Time cycled, volume limited, pressure generator
  • Ventilator type Pneumatic piston driven
  • Source driven by oxygen from the concentrator with cylinder back up
  • Ventilation modes: SV, MV, CV, ACV
  • Tidal Volume 35-1200 ml
  • Inspiratory/expiratory ratio 1:2
  • Alarms High and low pressure with LED indicators
  • Operating temperature range 0 - 40°C
  • Power supply 160 to 300V, 50+/-4 Hz, battery backup
  • Battery backup life >100 hours
  • Respiratory rate Up to 40 breaths/min
  • Battery recharge 90% within 3 hours
  • Inspiratory pressure range 5 - 50 cm water
  • Weaning triggered 1 to 5 cm
  • Drive pressure/volume >20psi : 1/6 minute volume
  • Ventilation backup facility which will run the ventilator on room air for 12 hours in the event of a power cut

Oxygen concentrator

  • 10l/min at 95%

UPS

  • 1000VA Double on-line UPS.

Input voltage range 160-300 Volts, frequency range 50Hz +/- 4%

Circuit breaker protected

Dimensions

  • Size and weight : 54x66x145cm, 98kg
  • Packed weights and dimensions: 158x76x62cm, 165kg

Packaging & Labelling

Unit packaging, wooden box

Supplied with the Article

Glostavent® Helix complete anaesthesia system, supplied with:

  • 1 x oxygen concentrator of 10 litres per min
  • 1 x Ambu PEEP Valve

Specifications include:

  • 1 x reusable silicone patient circuit adult
  • 1 x reusable silicone patient circuit paediatric
  • 1 x trolley/workstation on castors
  • 1 x shelf monitor
  • 1 x set of tubes to connect the ventilator, O2 concentrator and vaporiser
  • 1 x patient circuit support
  • 1 x vaporiser support block
  • 1 x isoflurane vaporiser
  • 1 x bacteriological HEPA filter
  • 1 x funnel for vaporiser
  • 1 x adult self inflating bag for manual ventilation
  • 1 x paediatric self inflating bag for manual ventilation
  • 1 x scavenger tube for expiratory valve
  • 1 x pressure regulator (combined bull nose/pin index)and hose
  • 1 x kit of filters
    • 1 x external foam filter for oxygen concentrator
    • 2 x Hepa filters
  • 1 x 1000VA double on-line UPS
  • 1 x user manual
  • 1 x technical maintenance manual with spare parts diagrams

Instructions for use

Maintenance

Between patients and after every operating day clean and disinfect the equipment and sterilize patient circuits (see Protocol I: User Maintenance).

The manufacturer (Diamedica) issued early 2019 a field safety notice after an incident involving the failure of a battery in a Glostavent Helix anaesthesia machine. They advise a precautionary inspection of the equipment in line with a supplied checklist.

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