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Diamedica Glostavent Helix Instructions For Use Manual

Diamedica Glostavent Helix Instructions For Use Manual

Anaesthesia system
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GLOSTAVENT
INSTRUCTIONS FOR USE MANUAL
For anaesthesia and ventilation in difficult circumstances
Diamedica (UK) Ltd
Grange Hill Industrial Estate
Bratton Fleming
Barnstaple, Devon
EX31 4UH, United Kingdom
Tel: +44 (0)1598 710066
0088
Email: support@diamedica.co.uk
®
HELIX ANAESTHESIA SYSTEM
Fax: +44 (0)1598 710055
www.diamedica.co.uk
Revision A
© Copyright Diamedica (UK) Ltd 2017
Ventilation
Back Up
05-05-2017
DCN-0002
ENG
Page 1 of 38

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Summary of Contents for Diamedica Glostavent Helix

  • Page 1 Diamedica (UK) Ltd Grange Hill Industrial Estate Bratton Fleming Barnstaple, Devon EX31 4UH, United Kingdom Tel: +44 (0)1598 710066 Fax: +44 (0)1598 710055 0088 Email: support@diamedica.co.uk www.diamedica.co.uk Revision A 05-05-2017 DCN-0002 Page 1 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 2 Separate IFU Manuals for the UPS and Oxygen Concentrator are also included and must be reviewed for specific Safety and maintenance requirements before use. The policy of Diamedica (UK) Ltd is to continuously improve its products. Changes may be made to this manual without notice being given.
  • Page 3 Drawover anaesthesia is contraindicated for patients below 10kg, for these patients the machine should be used in continuous flow (see section 9). The system is only intended to be used by Qualified Anaesthetists. Page 3 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 4 HELIX – CONTROL AND OPERATION ® GLOSTAVENT HELIX ALTERNATIVE POWER SOURCES TEST PROCEDURE BEFORE USE ® USE OF THE GLOSTAVENT HELIX IN ADULTS USE IN PAEDIATRIC PATIENTS 10. TROUBLE SHOOTING 11. GLOSSARY Page 4 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 5 This manual has been prepared to provide practical guidance for those using the ® Glostavent Helix anaesthetic machine. It should only be operated by experienced anaesthetists who have received specific training in its use and are fully conversant with its operation. Page 5 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 6 Patient safety is the primary concern of the anaesthetist and infection control is critical to ensuring the safety of surgical procedures. Each Glostavent Helix is supplied with a reusable breathing circuit as these items may come in contact with the patient and can therefore potentially pass infectious agents from one patient to another if used improperly.
  • Page 7 Be biocompatible,  Comply with the general requirements of the 93/42/EEC European Directive A full list of available spares is available by contacting Diamedica – support@diamedica.co.uk 2.3 Technical data enquiries For all Technical, performance or component related enquiries please contact Diamedica - support@diamedica.co.uk...
  • Page 8 3. An oxygen concentrator which produces oxygen and air for the patient to breathe and oxygen to drive the ventilator. 4. An integrated method of manual assisted ventilation that can be taken to the patient’s side. Figure 1 Page 8 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 9: The Breathing System

    THE COMPONENT PARTS OF THE GLOSTAVENT HELIX 4.1. THE BREATHING SYSTEM. Before a volatile anaesthetic agent can be administered to a patient it must first be vaporised. A carrier gas containing oxygen passes through the chamber of a vaporiser where vaporisation occurs and the resulting mixture is delivered to the patient.
  • Page 10 This is described further in later sections of the manual. The Diamedica vaporisers output is consistent in both modes, the output from other drawover vaporisers may not suitable for both these modes.
  • Page 11 (2) A side port for supplementary oxygen, if available. (3) A vaporiser with a low resistance to breathing, such as the Diamedica vaporiser above. (The standard plenum type vaporiser, such as the Selecta-tec, is unsuitable for drawover anaesthesia because the resistance is too high).
  • Page 12 Patient circuit protection Relief valve characteristics Circuit may contain Cracking point pressure up to 50 cmH2O 50cmH2O at which point the relief valve will crack and vent Page 12 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 13 The inspiratory limb is then re-connected, the oxygen flowmeter is set to maximum and the lungs ventilated with oxygen. Q. Does the Diamedica vaporiser have any advantage over a standard plenum type vaporiser? A. (1) It has a low resistance allowing patients to breathe spontaneously through it.
  • Page 14 ® circuit using an oxygen flow rate of 10 l/min. Q. What regular maintenance is required for the Diamedica vaporiser? A. The vaporiser has been designed to require minimal maintenance. If movements of the dial lever become stiff, the shuttle casing should be cleaned. A small quantity of Halothane is poured into the chamber which is inverted and shaken several times before being discarded.
  • Page 15 The electricity consumption is only 590 Watts (equivalent to four electric light bulbs) and is the same regardless of the flow of gases. Page 15 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 16 This should normally be carried out every 3-4 days but more frequently in dusty conditions. Page 16 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 17 The tidal volume range on the Glostavent Helix is 35ml to 1200ml, the displaced volume over this range is accurate to +/- 10% over the full range of possible BPM (4- Page 17 of 38 ©...
  • Page 18 5. THE GLOSTAVENT HELIX - CONTROL AND OPERATION INTER-RELATION OF COMPONENT PARTS (Fig 10) Below the ventilator is the oxygen concentrator (1) which provides both oxygen (2) to supplement the inspired mixture and to drive the ventilator. It also provides air (3) to add gas flow for continuous flow operation if required.
  • Page 19 The individual components of the Glostavent® Helix are interconnected on a mobile workstation with a flow meter control panel above a shelf and has an arm supporting the ventilator, and an oxygen concentrator below. Page 19 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 20 This will flush with oxygen at a rate of 30 l per minute. Self-inflating bag (8) for manual/assisted ventilation. Helix screw (9) for tidal volume adjustment. Ventilator drive gas and return (10). Oxygen and Air connections from the oxygen concentrator (11). Tidal volume lock (12). Page 20 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 21 7. One way air inlet valve 8. Battery 9. Oxygen changeover system 10. Oxygen reservoir 11. Reserve oxygen hose THE HELIX VENTILATOR 12. External oxygen hose Ventilator stored for transport Page 21 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 22 This is illuminated if the airway pressure fails to reach 5cm water during IPPV. After twenty seconds this is accompanied by an audible warning. On the right hand side are the patient outlet and return. Page 22 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 23 Expired gases tube (7) Scavenger (8) Page 23 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 24 Auxiliary oxygen connection and hose (BS 5682) (7) The Uninterruptible Power Supply (8) Oxygen regulator (4 bar) (Bull Nose BS 341-1 no. 3 supplied with adaptor for Pin Index ISO 407) (9) Page 24 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 25 The valves on the patient circuit (5) The expiratory limb (6) between the valve and the scavenging system The patient circuit Connections for circuit are standard 22mm to fit all common circuits (7) Page 25 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 26 THE GLOSTAVENT HELIX ALTERNATIVE POWER SOURCES ® Due to the likely difficult operating environments of the Glostavent Helix a number of alternative methods of driving the anaesthetic machine; both for the oxygen supply and the ventilator have been incorporated into the design. There are essentially 4 back-up systems.
  • Page 27: Manual Ventilation

    The final back up level if all other sources are exhausted is to manually ventilate the patient using the self inflating bag until another source of power is available. Figure 18 Page 27 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 28 (now powered by oxygen cylinder). h. switch off ventilator. After completing test procedure turn on mains and UPS Page 28 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 29 (but is not essential) in order to create the negative pressure normally required in drawover Page 29 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 30: Agent Monitoring

    9. MONITORING RESPIRATION If gas analysis and oximetry are not available monitoring of respiration depends on good clinical observation of the patient and breathing system. Page 30 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 31: After Use

    The tidal volume and respiratory rate are set to the desired levels and the vaporiser is turned off. Room air is supplemented with oxygen from the concentrator to give the required inspired oxygen concentration. Page 31 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 32 However, it should be noted that the maximum pressure that can be applied during controlled ventilation is limited to the pressure set by the control on the ventilator panel. Page 32 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 33 The PEEP valve can be removed by pulling the valve from the clear case. To adjust the valve, turn red cap clockwise to increase pressure and anti-clockwise to reduce pressure. The PEEP valve pressure ranges from 0-20 cmH20. Page 33 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 34: Troubleshooting

    ® N.B. in the event of any other malfunction the Glostavent Helix must be taken out of service immediately and advice sought from Diamedica. Under no circumstances should there be any unauthorised tampering with the inside of the Glostavent ®...
  • Page 35 Cause: There is a mechanical fault inside the ventilator. Response: Turn the ventilator off and continue with manual ventilation via the self- inflating bag. Consult the manufacturers for advice. DO NOT TAMPER WITH THE INSIDE OF THE VENTILATOR. Page 35 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 36 DIAMEDICA (UK) LTD Grange Hill Industrial Estate, Bratton Fleming Barnstaple * Devon EX31 4UH * U K Tel : +44(0)1598 710066 Email : support@diamedica.co.uk www.diamedica.co.uk 0088 Page 36 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 37: Symbols Glossary

    Fragile, handle Indicates a medical device that can with care be broken or damaged if not handled carefully. Keep dry Indicates a medical device that needs to be protected from moisture. Page 37 of 38 © Copyright Diamedica (UK) Ltd 2017...
  • Page 38 The battery Chemical symbol for battery type recycling symbol included beneath Does not contain presence of natural rubber latex Indicates that an object is capable of being recycled Page 38 of 38 © Copyright Diamedica (UK) Ltd 2017...