Diamedica HELIX ADULT Instructions For Use Manual

Paediatric portable ventilator

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ELIX

DULT -

Part Reference - HELIX VENT A/P

INSTRUCTIONS FOR USE MANUAL

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

MANUAL A/P HELIX VENT

AEDIATRIC

Revision I

14/06/2022

ORTABLE

ENTILATOR

Tel: +44 (0)1598 710066

WhatsApp: +44 (0) 7716 503156

Email: support@diamedica.co.uk

Web: www.diamedica.co.uk

DCN-0161

ENG

1639

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Page 1 Bratton Fleming, Barnstaple, Devon, EX31 Email: support@diamedica.co.uk 4UH, United Kingdom Web: www.diamedica.co.uk Alphamed Consulting Ltd, Knock, Barnaderg, Tuam, Co. Galway, H54 W220 1639 Revision I 14/06/2022 DCN-0161 MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 1 of 36...
Page 2: Intended Use
The Helix Adult Paediatric Portable Ventilator is not intended for use in The EU. It is suitable for use in dry non-condensing atmospheres and should be kept free of surface liquid.
Page 3 Mains power supply isolation: Disconnect the mains supply cable from the socket (see Section 4). The Helix Adult Paediatric Portable Ventilator does not include patient monitoring for ETCO2 FIO2, Patient airway pressure, expired volume, or PEEP. It is the responsibility of the clinician in charge to ensure suitable monitoring is in place for the patient and procedure being performed and in the environment in which it is being completed.
Page 4 Electromagnetic conformity The Helix Adult / Paediatric Portable Ventilator is a 12V portable device that complies with the requirements of the 93/42/EEC European directive and has been assessed against the...
Page 5 Do not leave the charger connected to the battery for long periods after the battery is fully charged and the unit is not in use. Consult the manufacturer for help when required. Page 5 of 36 MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022...
Page 6 DIAMEDICA HELIX ADULT - PAEDIATRIC PORTABLE VENTILATOR INDEX INTRODUCTION SPECIFICATIONS CLEANING, GENERAL MAINTENANCE AND DISPOSAL COMPONENT PARTS OF THE HELIX VENTILATOR USE OF THE VENTILATOR DAILY SET UP AND TEST PERIODIC (Monthly) CIRCUIT INTEGRITY CHECK USE OF THE HELIX VENTILATOR IN ADULTS...
Page 7 INTRODUCTION DIAMEDICA HELIX ADULT - PAEDIATRIC PORTABLE VENTILATOR This is a time cycled, volume limited pressure generator. Delivered pressure is limited via a pressure regulator. It is a gas driven ventilator and can therefore function largely independently of the supply of electricity.
Page 8: Specifications
SPECIFICATIONS The Diamedica HAPPV is suitable for adult and paediatric use. The specifications for HAPPV are provided in the table below. Helix Adult-Paediatric Portable Ventilator specifications Feature Specification Height 40 cm (Helix Screw closed) 48 cm (Helix Screw Open) Diameter...
Page 9 ③ Cleaning Time on Time off Comments Suggested usage log for Helix adult-paediatric portable ventilator a) Cleaning The ventilator should be cleaned daily by wiping down with a damp cloth. Ensure unit is dry free from moisture after wiping Patient safety is the primary concern of the Clinician and infection control is critical to ensuring the safety of medical procedures.
Page 10 WARNING 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 MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 10 of 36...
Page 11 In the event that a new battery is required, this must be done by a suitably competent service technician. The battery is a ‘Tracer’ 12V 4ah Lithium Polymer Battery. This is available by contacting Diamedica – support@diamedica.co.uk To remove the ventilator battery.
Page 13 Diamedica Email: support@diamedica.co.uk WhatsApp: +44 (0) 7716 503156 The Fuse must be replaced by a technician under guidance from Diamedica – Replacing the fuse with an incorrect type may lead to malfunction, fire, and or injury. Non serviceable components.
Page 14 -25 °C - +85 °C In the event that the supplied charging lead becomes lost or damaged DO NOT substitute with an alternative, contact Diamedica – support@diamedica.co.uk / WhatsApp +44 (0) 7716 503156 MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022...
Page 15 The circuit may contain pressure up to 66 cmH2O (This will be under alarm conditions at greater than 60cmH2O) After which point the relief valve will crack and vent. MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 15 of 36...
Page 16 Diamedica Helix Portable Ventilator Tidal Volume Control The tidal volume is adjusted by turning the helix screw on top of the bellows, restricting the movement of the drive piston. The set tidal volume limit is read at the bottom of Tidal the helix screw in the position indicated by the arrow.
Page 18 The battery recharge socket is marked above. The charger should be connected whenever power is available. When fully charged the battery should operate for more than 100 hours. MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 18 of 36...
Page 19 FIO2 to 40% approx.) 6. Pressure regulator. 16. Patient circuit connection block. 7. Flow regulator. 17. Drive gas input. 8. Inspiratory valve. 9. Piston. 10.Supplemental Oxygen inlet. MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 19 of 36...
Page 20: Set Up And Test
Patient Pressur Top view Expired Tube connection for recycled O2 (If used) Or supplementary supply Side view Reservoir bag Self-inflating bag (Patient circuit connected) MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 20 of 36...
Page 21 Circuit Valve (PCV) Refer to section 6 for Alarms testing. The ventilator is now ready to use. Reset the parameters to the appropriate settings for the next patient. MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 21 of 36...
Page 22 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. MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 22 of 36...
Page 24: After Use
To adjust the level of PEEP, turn the cap clockwise to increase and turn anti clockwise to reduce. PEEP valve positioned on expiratory end of Patient valve MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 24 of 36...
Page 25 Unit should be positioned adjacent to the patient such that the operators eyeline is within a 120°sweep angle to the front of the ventilator control panel to ensure clear vision of the warning lights. 120° MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 25 of 36...
Page 26 Not tested. Low level battery warnings should be recorded on usage log comments (Refer to Section 3) Battery life > 100 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 27 It is the user’s responsibility to ensure continuous suitable supply is in place and effective warning in case of failure. It is the user’s responsibility to ensure that the delivered concentration and resultant patients SATs are monitored at all times. MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 27 of 36...
Page 28 Any adjustment of the TV or BPM settings on the ventilator will alter the delivered O2 as such the supplementary flow rate setting should be reviewed and adjusted accordingly. MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 28 of 36...
Page 29: Troubleshooting
N.B. in the event of any other malfunction the ventilator must be taken out of service immediately and advice sought from Diamedica. Under no circumstances should there be any unauthorized tampering with the inside of the ventilator by untrained personnel.
Page 30: Frequently Asked Questions
A. For long term ventilation as in an intensive care unit humidification is advisable using a filter/ humidifier at the patient’s airway or by passing the inspired gases over a container of water. MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 30 of 36...
Page 31 10. USE OF THE HAPPV VENTILATOR WITH THE DPA 02 and DPA 03 PORTABLE ANAESTHESIA SYSTEMS This section deals with the use of the ventilator with the Diamedica portable anaesthesia system. For all other instructions follow the previous sections. The Helix Portable Ventilator (HAPPV) is designed to work alongside the Diamedica Portable Anaesthetic System (DPA 02 and DPA 03).
Page 32 The regulator supplied is a ‘Bull Nose’ type but an adaptor for ‘Pin Index’ can also be supplied. The drive gas (if oxygen) should then be recycled into the connection on the DPA reservoir block. MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 32 of 36...
Page 33 Grange Hill Industrial Estate, Bratton Fleming Barnstaple, Devon, EX31 4UH, UK Tel : +44(0)1598 710066 Email : support@diamedica.co.uk www.diamedica.co.uk 1639 Alphamed Consulting Ltd, Knock, Barnaderg, Tuam, Co. Galway, H54 W220 MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 33 of 36...
Page 34: Symbols Glossary
Indicates a medical device that can be broken with care or damaged if not handled carefully. Indicates a medical device that needs to be Keep dry protected from moisture. MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 34 of 36...
Page 35 Chemical symbol for battery type included recycling symbol beneath Does not contain or presence of natural rubber latex Indicates that an object is capable of being recycled MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 35 of 36...
Page 36 Indicates the range of humidity to which the medical device can be safely exposed. Temperature limit Indicates the temperature limits to which the medical device can be safely exposed MANUAL A/P HELIX VENT © Copyright Diamedica (UK) Ltd 2022 Page 36 of 36...

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Diamedica HELIX ADULT Instructions For Use Manual

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