Diamedica GLOSTAVENT Instructions For Use Manual

Helix anaesthesia system

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For anaesthesia and ventilation in difficult circumstances

Diamedica (UK) Ltd

Grange Hill Industrial Estate

Bratton Fleming, Barnstaple, Devon,

EX31 4UH, United Kingdom

Alphamed Consulting Ltd, Knock, Barnaderg, Tuam,

Co. Galway, H54 W220

1639

GV HELIX MANUAL ENG

GLOSTAVENT

HELIX ANAESTHESIA SYSTEM

INSTRUCTIONS FOR USE MANUAL

Revision F

Tel: +44 (0)1598 710066

WhatsApp: +44 (0) 7716 503156

Email:

Web:

06/01/2023

DCN-0204

support@diamedica.co.uk

www.diamedica.co.uk

ENG

0120

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Page 1 Bratton Fleming, Barnstaple, Devon, Email: support@diamedica.co.uk EX31 4UH, United Kingdom Web: www.diamedica.co.uk Alphamed Consulting Ltd, Knock, Barnaderg, Tuam, Co. Galway, H54 W220 0120 1639 Revision F 06/01/2023 DCN-0204 GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 1 of 57...
Page 2: Read This Section First
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 Daily set up and test instructions should be successfully carried out to ensure that the Glostavent® Series of anaesthetic machines are in operating condition. If any parameter or test is found to deviate from the instructions the machine should not be used, until the issue is resolved.
Page 4 Battery recharger – IP67 UPS – IP20 Method(s) of sterilization The Glostavent Helix Anaesthesia machine is a non-sterile device and is not intended to be sterilized by the user. Suitability for use in an OXYGEN RICH ENVIRONMENT Intended for use in an Oxygen rich environment.
Page 5 Reorient or relocate either device to Increase the separation between the equipment. If the unit is charged disconnect from the power supply and remove power lead. Consult the manufacturer for help when required. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 5 of 57...
Page 6 ® 1. INTRODUCTION 2. SPECIFICATIONS 3. CLEANING, GENERAL MAINTENANCE AND DISPOSAL HELIX 4. THE PRINCIPLE OF THE GLOSTAVENT ® 5. THE COMPONENT PARTS OF THE GLOSTAVENT HELIX ® 6. THE GLOSTAVENT HELIX – CONTROL AND OPERATION ® 7. GLOSTAVENT HELIX ALTERNATIVE POWER SOURCES ®...
Page 7 Helix anaesthetic machine has been developed to meet these requirements ® and the needs of anaesthetists working in difficult environments. 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 competent in its operation.
Page 8: Specifications
2. SPECIFICATIONS The Glostavent Helix Anaesthesia machine is suitable for adult and paediatric use. The specifications for Glostavent Helix are provided in the table below. Component / Feature Specification Dimensions Height 145cm Width 66cm Depth 54cm Weight 102kg Ingress protection (IP) IPXX Individual components are assessed as follows;...
Page 9 *** Delivered concentration accurate within ±20 % of set value for concentrations (volume fraction) greater than 1 % and ±50 % of set value for concentrations of 1 % or below. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 9 of 57...
Page 10 (i) Breathing circuit Each Glostavent Helix Ventilator 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, the reusable breathing tubing and patient valve provided with the anaesthesia machine should be cleaned and disinfected according to your hospital’s infection...
Page 11 (ii) Filters It is very important to check the condition of the particulate filters on the rear of the Glostavent panel and on the rear of the concentrator, at least once every week, and more often if the environment is very humid and dusty.
Page 12 The patient circuit tubing is Non-conducting (Applied Part). DO NOT replace with conducting/anti- static tubing. A full list of spares is available by contacting Diamedica - support@diamedica.co.uk If the anaesthetist has any concerns relating to cleaning or maintenance or the function of the Glostavent they should contact the manufacturer.
Page 13 Replacement of Control panel battery. In the event that a new battery is required, this must be done by a suitably competent service technician. The battery is a 12V 10ah VRLA Battery. This is available by contacting Diamedica support@diamedica.co.uk To remove the Control Panel battery.
Page 14 Once removed replace with a 2 Amp fuse. Once the battery has been replaced reconnect the battery connecting the live terminal (Red) first. Reconnect red terminal first. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 14 of 57...
Page 15 Non serviceable components. The PC Control board and loom contained within the unit are non-serviceable please contact Diamedica for any enquiries relating to these components. Email: support@diamedica.co.uk WhatsApp: +44 (0) 7716 503156 Accessories and spares All patient circuit accessories used with the Glostavent anaesthesia machine must: •...
Page 16 4. THE PRINCIPLE OF THE GLOSTAVENT ® HELIX The Glostavent ® Helix is a free-standing anaesthetic machine which has been specifically designed to facilitate the administration of inhalational anaesthesia in difficult environments. It is easy to understand and operate, economical to run and can be maintained and serviced using locally available skills.
Page 17: Pressure Gradient
5. THE COMPONENT PARTS OF THE GLOSTAVENT HELIX 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 18 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 be suitable for both these modes.
Page 19 A reservoir tube with an open end through which air is entrained during inspiration. (2) A side port for supplementary oxygen, if available. 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 20 10kg using a Mapleson F (Ayres ‘T’ piece circuit using the fresh gas flow recommended for that particular system. A one-way valve after the vaporiser on the Glostavent Helix prevents backflow through the system when these circuits are in use.
Page 21 The vaporiser is turned off and the inspiratory limb of the circuit is briefly disconnected from the patient while the oxygen flush button on the Glostavent ® control panel is depressed for 10 seconds to purge the circuit of the anaesthetic mixture.
Page 22 Glostavent Helix. ® Q. What is the most effective way of pre-oxygenation of patients? A. Satisfactory pre-oxygenation can be achieved with the Glostavent Helix Drawover ® circuit using an oxygen flow rate of 10 l/min. GV HELIX MANUAL ENG ©...
Page 24 Q. Can the concentrator function in the presence of high voltage fluctuations? A. The Concentrator is connected to the mains via a UPS system which incorporates a voltage stabiliser enabling the Glostavent to function in the presence of the following ®...
Page 25 The tidal volume range on the Glostavent Helix is 100ml to 1200ml, the displaced volume over this range is accurate to +/- 10% over the full range of possible BPM (6-40) GV HELIX MANUAL ENG ©...
Page 26 ❺ When the bellows have completed the up cycle, occlude the outlet completely ❻ On the down cycle check the bellows do not fall below 500 tidal volume. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 26 of 57...
Page 27 OXYGEN ANALYSER The Glostavent Helix has been fitted with an oxygen analyser. This device measures the oxygen concentration in gas and air mixture prior to entering the vaporizer. The actual measurement takes place at the opening of the sensor which is inside the gas circuit. Due to the design of the sensor, the device should be calibrated at regular intervals (at fresh air =20.95%...
Page 28 Calibration failed (Value to high) Sensor not Connected or replace sensor Please refer to supplied Operating manual for additional configuration and system display codes. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 28 of 57...
Page 29 Once the sensor power connector is removed, unscrew the white sensor cell anti clockwise until fully removed. Once the cell is removed, replace with new cell by screwing clockwise. New cell GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 29 of 57...
Page 30 Ensure the sensor power connector is replaced and pushed on fully. Once installation is complete refer to manual for calibration GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 30 of 57...
Page 31 AVS30 AUTOMATIC VOLTAGE PROTECTION UNIT This Glostavent anaesthesia systems are fitted with an AVS30 Voltage protection unit to automatically protect the on-board mains circuitry path from damage due to unstable voltage. The AVS30 is an Automatic Voltage Switcher rated at 30 Amps. The...
Page 32 6. THE GLOSTAVENT HELIX - CONTROL AND OPERATION INTER-RELATION OF COMPONENT PARTS Below the ventilator is the oxygen concentrator which provides both oxygen to ① supplement the inspired mixture and to drive the ventilator . It also provides air to ②...
Page 33 However, because of the respiratory depressive effects of the anaesthetic agents, controlled ventilation is required to prevent hypoxia. This can be achieved by utilising the self-inflating bag ⑦ supplied as part of the breathing circuit. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 33 of 57...
Page 34 A. It is preferable but not essential for short term ventilation e.g. the duration of surgery. For long term ventilation as in an intensive care unit humidification is advisable using either a filter or humidifier at the patient’s airway. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 34 of 57...
Page 35 Helix screw ❾ for tidal volume adjustment. Ventilator drive gas and return ❿. Oxygen drive gas to the ventilator ⓫. Tidal volume lock ⓬. 0 1 2 3 4 5 ❽ GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 35 of 57...
Page 36 7. One-way air inlet valve 17. Ventilator connections 8. Battery 18. Bull nose and pin index connections 9. Oxygen changeover system 19. Scavenger tube 10. Oxygen reservoir 20. Expiratory Valve GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 36 of 57...
Page 37 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. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 37 of 57...
Page 39 ❻ Reserve oxygen cylinder holder ❼ Auxiliary oxygen connection and hose (BS 5682) ❽ The Uninterruptible Power Supply ❾ Oxygen regulator (4 bar) ❿ Scavenger unit GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 39 of 57...
Page 40 The valves on the patient circuit ⑤ The expiratory limb ⑥between the valve and the scavenging system The patient circuit Connections for circuit are standard 22mm to fit all common circuits ⑦ GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 40 of 57...
Page 41 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 42: 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. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 42 of 57...
Page 43 Hold down the right-hand button until a signal is heard. Wait until the display shows ‘Line;’ mode. The UPS is now set for the Glostavent® Helix to be used. 6. Turn on oxygen concentrator. Alarm sounds for five seconds then stops automatically.
Page 44 Cleaning and general maintenance. After use clean with a damp cloth, removing all sharps carefully. Refer to ‘Daily set up and test’ document for routine testing. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 44 of 57...
Page 45 USE OF THE GLOSTAVENT ® HELIX ON ADULTS (For use in children under 10 Kg see section 10) 1. SELECTION OF BREATHING SYSTEM The Glostavent ® Helix is normally operated in drawover mode using the drawover breathing system described previously. This is safe, reliable, and economical and enables the anaesthetic to continue without interruption in the event of a failure in the supply of oxygen or electricity or both.
Page 46 Always check the patient – a rise in inflation pressure may also indicate bronchospasm, anaphylaxis, fluid overload, bronchial intubation. Seek and treat the cause first, do not immediately turn the ventilation up. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 46 of 57...
Page 47: After Use
Positive end expiratory pressure (PEEP) is occasionally required in some forms of lung dysfunction and this can be applied by attaching a PEEP valve to the expiratory limb of the breathing system. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 47 of 57...
Page 48 10. USE IN PAEDIATRIC PATIENTS Children weighing 10 Kg and above are able to use the Glostavent Helix as described ® above for adults. Small children breathing spontaneously may have difficulty in generating enough inspiratory flow to produce the necessary pressure gradient across the vaporiser, which therefore fails to deliver enough anaesthetic.
Page 49 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. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 49 of 57...
Page 50 **Audible alarm may be silenced by the mute button for 15 seconds. Visual warning remains on. Unit should be positioned adjacent to the patient such that the operators eyeline is within a 120°sweep angle to the front of the Glostavent Helix to ensure clear vision of the warning lights. 120°...
Page 51: Testing Alarms
Not tested. Low level battery warnings should be recorded on usage log comments (Refer to Section 3) Battery life > 300 hours, if indications of low battery levels occur at lesser intervals than this, a new battery should be considered. This is available by contacting Diamedica – support@diamedica.co.uk Battery failure Not tested.
Page 52: 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 ® Helix by untrained personnel.
Page 53 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. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 53 of 57...
Page 54 Cause: The bellows in the ventilator may need to be closed, turn the helix screw on the ventilator clockwise until the bellows is closed. There may be a disconnection between the bag and the common gas outlet of the Glostavent ®...
Page 55: Symbols Glossary
Indicates a medical device that can be with care broken or damaged if not handled carefully. Keep dry Indicates a medical device that needs to be protected from moisture. GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 55 of 57...
Page 56 No latex Does not contain the presence of natural rubber or dry natural rubber latex Recyclable Indicates that an object is capable of being recycled GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 56 of 57...
Page 57 Medical device Indicates the item is a medical device Unique Device Indicates a carrier that contains Unique Device Identifier information Identifier GV HELIX MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 57 of 57...

Diamedica GLOSTAVENT Instructions For Use Manual

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