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Summary of Contents for Medstrom aria flex
- Page 1 Semi-Dynamic Mattress System USER MANUAL PRO00035 Revision 1.3...
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Page 2: About This Document
Information in this User Manual is subject to change without notice and does not represent commitment on the part of Medstrom Ltd. No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording for any purpose without the written permission of Medstrom Ltd. -
Page 3: Table Of Contents
Operational and Storage Conditions 14.3. Disposal Troubleshooting Electromagnetic Compatibility (EMC) Technical Specification 17. 1 . Mattress Specifications 17.2. Control Unit Specifications Consumables and Accessories Product Conformance Standards Warranty Manufacturer’s Details Medstrom Aria Flex – User Manual – PRO00035, Revision 1.3... - Page 4 This page is intentionally blank. Medstrom Aria Flex – User Manual – PRO00035, Revision 1.3...
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Page 5: Conventions Used In The Manual
Protect from Heat and Radioactive Sources Operating Temperature Humidity Limitation Atmospheric Pressure Limitation Limitation Storage Temperature Medical Device under EU Authorised Limitation -10°C to +40°C MDR 2017/745 Representative in Europe Medstrom Aria Flex – User Manual – PRO00035, Revision 1.3... -
Page 6: Introduction
01 97 3. Introduction Thank you for choosing to use the Medstrom Aria Flex Semi-Dynamic Mattress System. The product is a pressure redistributing mattress with an optional control unit intended to reduce the risk of pressure related tissue injuries. The Aria Flex Mattress System features include: •... -
Page 7: Intended Use And Contraindications
The Aria Flex Mattress System, in alternating low-pressure mode, is not suitable for unstable spines. The Aria Flex Mattress System would be indicated for use for patients with unstable spinal injuries when used in the non-powered mode without control unit attached and with standard of care practices for such patients. -
Page 8: Warnings, Cautions And General Information
The Aria Flex Mattress System is NOT to be used when such gaps are present. -
Page 9: Installing The Mattress And Control Unit
To reduce the risk of electric shock, adhere to the following. Failure to do so could result in injury or equipment damage. • Immediately after using the Aria Flex control unit, unplug it from its power source. • Do not place or store the control unit where it can fall or be pulled into a sink or bath. -
Page 10: Recommended Linen
The Aria Flex Mattress System should be transported in the non-powered mode of operation (i.e. no control unit). 8. Cardiopulmonary Resuscitation (CPR) If the Aria Flex Mattress System is in non-powered mode, no action is necessary as the surface is stable enough to perform cardiopulmonary resuscitation (CPR). -
Page 11: Control Unit Functions
9.1. Powered Mode (Control Unit) The Aria Flex Mattress System can be converted to powered therapy with the addition of a control unit. This converts the system into constant immersion (continuous low pressure therapy) or alternating low pressure therapy. 9.1.1. -
Page 12: Comfort Adjust
If the fault cannot be resolved, contact Medstrom Ltd or your medical Engineering Team. 10. Cleaning In order to prevent cross-contamination, the cleaning and disinfection of the entire Aria Flex Mattress System must be carried out between uses with different patients. -
Page 13: Cleaning The Control Unit
Allow time for the mattress top cover to dry (normally less than 10 min) or dry with a clean cloth. Note: Medstrom Ltd provides laundry disinfection services. For further information, please call on +44 345 3711717. If the mattress top cover is soiled or loses its water-resistant properties, it must be replaced. Any resulting damage of the mattress caused by a soiled top cover will be not covered by the warranty. -
Page 14: Disinfection
Please follow the hygiene control regulations of your local authority. 12. Inspection The safe operating condition of the Aria Flex Mattress System has to be checked at each use by the operator or during use at least once in a year in particular with regards to the following: •... -
Page 15: Mattress - Interior Components
Care should be taken to avoid puncturing air cells with objects such as needles, scalpels, pat slides, acrylic nails, etc. • All cells are replaceable and can be obtained easily from Medstrom Ltd. Medstrom Aria Flex – User Manual – PRO00035, Revision 1.3... -
Page 16: Control Unit
To prevent an unacceptable risk, all information necessary for correct replacement of detachable or interchangeable parts should be available and replaced by qualified personnel only. For full list of parts please refer to the Aria Flex Semi-Dynamic Mattress System Technical Manual. -
Page 17: Troubleshooting
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Aria Flex control unit, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. - Page 18 Guidance and manufacture’s declaration – electromagnetic emission The Aria Flex control unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Aria Flex Mattress System should assure that it is used in such an environment.
- Page 19 Guidance and manufacture’s declaration – electromagnetic immunity The Aria Flex control unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Aria Flex Mattress System should assure that it is used in such an environment.
- Page 20 The Aria Flex control unit is intended for use in the electromagnetic environment (for home and professional healthcare) in which radiated RF disturbances are controlled. The customer or the user of the Aria Flex control unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Aria Flex control unit as recommended below, according to the maximum output power of the communications equipment.
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Page 21: Technical Specification
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment The Aria Flex control unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Aria Flex control unit should assure that it is used in such an environment. -
Page 22: Control Unit Specifications
Use only Medstrom Ltd consumables and accessories. 19. Product Conformance Standards The Aria Flex Semi-Dynamic Mattress System is developed in conformance with ISO 13485 Quality management system, ISO 14971 Risk Management, ISO 10993 Biocompatibility, Electrical Safety IEC 60601-1, Electro Magnetic Compatibility (EMC) 60601-1-2, UK Medical Device Regulation (2002) and Medical Device Regulations (MDR 2017/745). -
Page 23: Warranty
For further information relating to technical characteristics, maintenance or After Sales Service, please consult the Aria Flex Semi Dynamic Mattress System Technical Manual available on request. 01 97 GTIN Number: 5060467210195 Medstrom Aria Flex – User Manual – PRO00035, Revision 1.3... - Page 24 Medstrom Ltd, 2 Cygnus Court, Beverley Road, Pegasus Business Park, Castle Donington, Derby, DE74 2SA CRN-0000259 OISL J7353 11/02/2025...
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