U S E R G U I D E Key Definition of symbols used User guide - medium - high i Important information Iron - low Do not iron Caution symbol CL Bleach - chlorine Electrical hazard Do not bleach Type BF Applied Part Manufacturer details Visual alarm Alternating mode Static mode BLEACH Aeda – a brand actively supporting your health - medium - high Switch ON/OFF If dry cleaning - do not use a solution stronger than perchloroethane System ready/functioning normally Serial number Operating instructions Keep dry OROETH HL P 70 Maximum water temperature (in this example - 160°F 70ºC) Mattress overlay Power Do not tumble dry E AN The Aeda mattress and seating category Tumble dry - low PER C A fresh approach to proven pressure care solutions Wash instruction here Control unit Zip located here Do not immerse control unit Infection control Do not ... ANSI/AAMI ES 60601-1 CAN/CSA-C22.2 NO.60601-1 CE Marking (European UnionNew Approach Directives) Disposal: Do not dispose of this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary. Class II Equipment key Symbol for ”Authoristed Representative in the European Community” Aeria 5 User Guide Contents System overview 2 System features 3 Intended use 4 Safety5 Protection against hazards 5 System set up 6 Dismantling the system 7 Operation8 Control unit layout 8 Establishing pressure 8 Alarm function 9 Care and cleaning 10 Troubleshooting 11 Specifications12 Warranty14 Aeda - Actively supporting your health contentspage 1 System overview Introducing the Aeria 5 Mattress Overlay System – this chapter provides a basic system overview, intended use guidelines and a summary of system features and box contents. • dynamic mattress overlay with dual air hoses • • • • • analogue control unit power cord Aeria 5 User Guide Aeria 5 Quick Set Up Guide carry bag overlay top cover overlay base overlay straps elastic dual hoses Applied part. The mattress is treated as an applied part. page 2 system overview Aeria 5 User Guide Introducing the Aeria 5 Mattress Overlay System, this chapter provides a basic system overview, intended use guidelines and a summary of system features and box contents. • the Aeria 5 is indicated for the prevention and treatment of skin breakdown and pressure ulcers in patients at low to medium risk • constructed from 18 transverse cells – 5 inch 115 mm high – that cyclically inflate and deflate in an alternating pattern, providing gentle and dynamic support • cyclic alternation of pressure prevents arterial and venous capillary occlusion in the patient’s surface tissue – maintaining and stimulating the flow of blood and lymphatic fluids through these tissues to provide essential oxygen and remove metabolic waste • connected to the control unit via dual air hoses, mattress cells are inflated by an electronic control unit, which includes a pressure sensor for monitoring mattress pressure and adjustable pressure settings to match patient weight and comfort needs • suitable for use at home or in long term or extended care environments • • designed for use on top of your existing standard single bed mattress air pressure in the mattress overlay is continually monitored and a visual alarm displays in the event mattress pressure becomes too low • operator controls are kept to a minimum for simplicity and ease of use System features Support Safety Simplicity • 18 x 5” 115 mm high density alternating cells • rapid release CPR tag for emergency deflation • machine washable top cover is fully elasticized for firm fit • vapor permeable, waterproof top cover prevents moisture transfer, while multi-stretch fabric minimizes friction and reduces shear • strong elastic straps simply and securely lock the overlay to any standard single bed mattress • • quick connector air hose attachments • static transport function for stable patient handling and transfer • • visible alarm light to warn of a pressure failure overlay can be rotated 180 degrees for preferred control unit position at either end of the bed • adjustable pressure level to match users weight and comfort needs • supporting users to a maximum weight of 330 pounds 150 kilograms Aeda - Actively supporting your health inbuilt rear hanging hooks for easy mounting and control unit portability system overviewpage 3 Intended use Indications Connecting the system to other devices The Aeria 5 Mattress Overlay System is indicated for: There are other devices necessary for normal operation. • The Aeria 5 mattress overlay can be fitted to most standard hospital or single bed mattresses. the prevention and treatment of skin breakdown and pressure ulcers in patients of low to medium risk Contraindications Patient conditions for which the application of pressure relief therapy on the Aeria 5 Mattress Overlay System is contraindicated include: • • instable spinal cord injury The Aeria 5 compact analogue control unit can be fitted to the foot or head board of most hospital or home care beds. Alternatively, the control unit can be placed on the floor, underneath the bed, or on any other stable surface. cervical traction The Aeria 5 Mattress Overlay System is an aid to the prevention and management of pressure ulcers. If there is no improvement in the patient’s condition, clinical advice should be sought. Therapeutic devices should only be used in accordance with manufacturer’s instructions and under the consent, supervision and management of a suitably qualified health professional. Aeda Healthcare accepts no liability for any use, change or assembly of the product other than that stated in this User Guide. Intended care setting Intended care settings for the Aeria 5 Mattress Overlay System are: • • long term or extended care home care Operating environment • • • Temp: 5°C to 40°C Humidity: 15% to 93% RH Pressure altitude: 700 hPa to 1060 hPa Storage and shipping conditions • • • Temperature: 10°C to 40°C Humidity: 10% to 95% RH Pressure altitude: 700 hPa to 1060 hPa page 4 intended use Aeria 5 User Guide Safety This chapter provides general safety precautions and recommended patient specifications. General safety precautions Protection against hazards For your own safety and the safety of equipment, always take the following precautions: Fluids • Before commencing set up or installation, ensure the power is switched off and disconnect the power cord from the control unit. • Unplug the system from the supply mains to disconnect its circuits. • Placing layers between patient and seat cushion should be avoided or kept to a minimum. As part of sensible pressure care, avoid wearing clothing that may cause areas of localized damage due to creases, seams, objects in pockets, etc. • Never use sharp objects or electrically heated blankets on or under the system. • Product top cover is not completely air permeable and may present a suffocation risk. It is the responsibility of the caregiver to ensure that the patient can use this product safely. • Avoid blocking the air intakes of the control unit, located at the rear of the unit. • Only the control unit and mattress combination as indicated by Aeda Healthcare should be used, otherwise the correct function of the product cannot be guaranteed. Maximum patient weight The maximum recommended patient weight for this system is 330 pounds 150 kilograms. Aeda - Actively supporting your health Avoid spilling fluids on any part of the control unit. If spills do occur: • Turn off control unit power and disconnect the unit from the main electricity supply. • Immediately clean fluids from the casing by wiping with a soft cloth. Ensure there is no moisture in or near the power inlet, power switch and power cord before reconnecting the power supply. Do not position the system so that it is difficult to operate the disconnection device. Check the operation of controls and other components around the spill area. Fluid or liquid remaining on the electronic controls can cause corrosion that may cause the electronic components to fail. Component failures may cause the unit to operate erratically, possibly producing potential hazards to patient and carers. Explosion hazard Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide. • • Do not open the control unit – risk of electrical shock. Refer servicing to qualified service personnel. • Do not modify this system without the authorization of the manufacturer. Disposal At the end of useful life, dispose of all components (air filter, air cells, mattress cover and base) according to local procedures and regulations or contact your local Aeda Healthcare authorized dealer for advice. Power cord The system should never be operated with a worn or damaged power cord. Should the power cord be found to be worn or damaged, contact your local Aeda Healthcare authorized dealer for a replacement. Interference Significant risks of reciprocal interference may be posed by the presence of the system during specific investigations or treatments. Potential electromagnetic or other interference between the system and other devices may occur. If interference is suspected, move equipment from sensitive devices of contact the manufacturer. Do not use in the presence of smoking materials or open flame – air flowing through the mattress will support combustion. safetypage 5 System set up Preparing the system for use Carefully unpack the system and locate all items shown in the picture below. Inspect each item for any damage that may have occurred during shipping. Any damage or missing components should be reported to your local Aeda Healthcare authorized dealer as soon as possible. 1.Remove all bedding from your mattress and place the mattress overlay on the bed – printed top cover facing upwards and air hoses towards the base of the bed. 2.Hang the control over the foot end of your bed, using the inbuilt rear hanging hooks. The control unit can also be placed on a flat surface (ie on the floor or underneath the bed). mattress overlay (top cover & base) Ensure the control unit is firmly secured to the bed. Failure to do so could result in equipment damage. control unit Secure to the bed by sliding the elastic straps, located on the underside of the mattress overlay, around each end of your existing mattress. Ensure the straps fit firmly, and are not twisted or pulled towards the corners. Before attaching the control unit to the floor or the foot board of the bed, ensure they are sufficiently robust and free of damage. power cord Do not secure mattress straps to bed side rails – straps will tear. Ensure that straps do not interfere with the operation of the bed, and that the mattress overlay is properly secured. Failure to do so could result in patient injury or equipment damage. page 6 system set up i The Aeria 5 mattress overlay can be rotated 180 degrees to position the control unit at the head of the bed if preferred. Aeria 5 User Guide This chapter describes the steps necessary to prepare the Aeria 5 system for use. 3.Attach the two air hoses to the control unit – the quick connectors simply press into place. The connectors include a press button release system for ease of use. 5.Before inflating, pull back the top cover to ensure the cells are straight and the cell straps are not twisted. Refit the top cover, ensuring both air hoses are fitted through the custom opening in the base of the cover. illuminates when the system is ready for use. 8.Once the overlay is fully inflated, bedding can be replaced. Secure sheets loosely enough to ensure they do not interfere with cell alternation. Dismantling the system 1. Switch off the control unit. Straighten any twists in the air hoses to ensure uninterrupted air flow between the control unit and overlay. Also ensure the hoses are not trapped between the overlay and bed. Failure to do so could result in an under inflated mattress leading to patient injury. 2.Switch off mains power and unplug the power cord from the mains outlet. 6.Insert the power cord into the base of the control unit, then plug into an appropriate electrical outlet and switch on mains power. 2 3 1 4.Locate the CPR tag at the head of the mattress overlay and ensure the CPR sealing connectors are fully inserted into the air hoses, as shown below. 7.On the control unit, turn the Pressure dial to maximum and then switch on (the power switch illuminates to indicate the system is operational). 3.Disconnect both the air hoses from the control unit. This will allow deflation of all cells except static head cells. 4.To deflate the head cells, firmly pull the CPR tag. 5.Once air has been released from the system, detach the overlay from your mattress by removing both elastic straps, then fold and roll the overlay for storage. 6.Return all items to the custom carry bag for safe keeping. Do not store the system in direct sunlight. Allow up to 50 minutes for complete inflation. The green Ready LED Aeda - Actively supporting your health system set uppage 7 Operation Control unit layout No special skills, training or knowledge are required to operate the control unit. Establishing pressure 1.Prepare the system for use as described in System Set Up. The green Ready LED will illuminate once the replacement has reached the required pressure and is ready for use. 2.Cover loosely with a sheet before placing patient on the replacement. The patient may lie on the Aeria 5 system during inflation however the replacement will fill faster if allowed to inflate first. 3.When the patient is lying comfortably, turn the Pressure dial to reach the desired setting for effective patient comfort and support. When adjusting or lowering the pressure, ensure the Aeria 5 system is working effectively by performing a ‘bottoming out’ test (a test to ensure the patient is adequately suspended away from the base). ‘Bottoming out’ test Power on / off switch Pressure dial Turns system power on and off. The switch illuminates to indicate power is on. Adjusts mattress pressure from low to high, in line with patient weight and comfort requirements. Ready indicator Static / Alternating switch This green light displays when the system reaches (and maintains) operational pressure. Switches between Static and Alternating operational modes. The orange Static Mode indicator illuminates when the mattress is operating in static mode (all cells fully inflated with no dynamic alternation). When the static mode indicator is not illuminated, the mattress is operating in dynamic Alternating Mode (alternate cells cyclically inflating and deflating). Alarm indicator This red light displays to alert when the control unit or mattress pressure fails. The alarm indicator remains illuminated until pressure is restored. page 8 operation a. With the patient lying in the supine position (lying on back, face upwards), pull back one side of the top cover, just past the sacral region (lower spine). b. Slide your hand underneath the patient and feel for a deflated cell under the patient’s lower spine – your hand should easily slide between patient and base. c. If the patient is adequately suspended, the pressure setting can be lowered. Aeria 5 User Guide This chapter describes how to safely operate the Aeria 5 system including patient set up and control unit function. After approximately 12 minutes, reassess system function and patient comfort. If pressure fails for whatever reason the red Alarm indicator will display – immediately increase pressure to the maximum pressure setting. After lowering the pressure setting, always check the Aeria 5 system is working effectively. Failure to do so could cause patient injury. Wait at least 12 minutes between any pressure adjustment or patient assessment as the Aeria 5 system may take a full cycle to adjust to the new pressure setting. 4.Having established a base line, pressure should be increased to provide added support when the patient is semirecumbent (sitting up). Transport function When transporting a patient on the Aeria 5 system, disconnect both air hoses from the control unit and snap ends together (connect the air hoses to each other) to retain air in the mattress replacement. The length of time the system remains inflated during transport will depend on the weight and height of the patient, and will vary on a case by case basis. During transport, regularly perform a ‘bottoming out’ test (see page 8) to ensure the patient is adequately suspended on the replacement. Failure to do so could cause patient injury. CPR / Re-inflation Rapid deflation of the mattress replacement may be necessary for emergency treatment (or to decommission the unit). Pulling the CPR tag, located at mattress head, will rapidly deflate the entire system. If CPR or emergency treatment is required, firmly pull the CPR tag ensuring both sealing connectors are fully disconnected from the air hoses. For maximum deflation rate, also disconnect both air hoses from the control unit. To re-inflate the system after the CPR tag has been pulled, restore all disconnected air hoses to the mattress replacement and wait for the mattress to gain optimal pressure for patient use. If parts need to be repaired, circuit diagrams and a list of component parts can be provided by the manufacturer. Aeda - Actively supporting your health A “control setting guide” is included on the side of the control unit, to provide a quick reference for recommended weight setting. These settings are a guide only. Always verify pressure settings with a ‘bottoming out’ test. Alarm function The Alarm indicator illuminates to indicate that control unit or replacement pressure has failed (when pressure drops below the accepted minimum level). The indicator will remain illuminated until appropriate pressure is restored. If the Alarm indicator is illuminated, and the system fails to inflate or loses pressure: • check the replacement air hoses are securely connected to the control unit • check all replacement air cells and hoses for any air leakage • check that the air filter cover is correctly secured • check the air filter is clean If the problem persists, contact your local Aeda Healthcare authorized dealer for further advice about repair. Do not try to open the control unit. operationpage 9 Care & cleaning To prevent cross contamination, it is recommended the overlay is examined and disinfected between patient use. This chapter describes general care and cleaning for the Aeria 5 system, including basic maintenance procedures. Dry thoroughly before refastening. Do not machine wash the overlay base. Top cover cleaning Air filter replacement 1.Switch off power supply to the control unit and disconnect the air hoses and power cord. lean the mattress overlay system in C accordance with local infection control policy and government regulations for blood borne pathogens. Failure to do so could cause patient or personal injury. Remove the top cover from the base before washing. For basic care and cleaning, wipe down with warm water containing detergent. The top cover can also be machine washed at 160°F 70ºC. The system is not protected against excessive amounts of water. Disconnect power supply before cleaning. Failure to do so could result in equipment damage or electric shock. For infection control, swab with a solution of sodium hypoclorite or similar (up to 10,000 ppm available chlorine). Dry thoroughly before use. 3.Use a small screwdriver to carefully remove the air filter cover. Clean the dust from the filter or discard and replace with a new filter. Refer to the top cover wash tag for cleaning instructions. 4.Refit the air filter cover to the control unit before use. Do not use high temperature autoclave steam cleaning devices or phenolicbased products for cleaning. This could result in damage to the equipment and loss of waterproof qualities of the top cover. Switch off and disconnect the control unit from mains power supply before cleaning. Do not immerse in water. Cleaning & infection control I t is recommended that the system be cleaned regularly if in constant use. Base cleaning Should the base require cleaning deflate the mattress, disconnect air cells from the base by unfastening the press studs at each end. Remove double tubing from main base air tubes and slide the cell out from the cell straps. Swab the cell with a solution of sodium hypoclorite or similar (up to 10,000 ppm available chlorine). page 10 Do not use system without top cover. Control unit external cleaning Disconnect control unit from mains power before cleaning. Gently wipe down the external case with a soft cloth. Soak the cloth in warm water containing detergent, and twist dry any excess water before use. Repeat the process with a dry cloth to remove excess moisture. Ensure the control unit is disconnected from mains electricity before cleaning. Disinfection The mattress overlay, top cover and control unit may be decontaminated by using ETO (Ethylene Oxide). Periodic maintenance Care should be taken to avoid the risk of electric shock when changing the air filter and fuse. care & cleaning 2.Place the control unit face down on a soft, flat surface with back panel uppermost (use a soft cloth to prevent scratches). It is recommended that the air filter be replaced each year. Replacement air filters are available from your local Aeda Healthcare authorized dealer. Fuse replacement 1.Switch off power supply to the control unit and remove the power cord from the socket in the base of the unit. 2.Insert a small screwdriver into the groove and turn anti-clockwise (quarter turn). 3.Remove the ‘blown’ fuse from the fuse holder clip and discard. 4.Insert a new fuse into the plug. Push against the force of the spring and turn clockwise with the screwdriver (quarter turn). When changing the replaceable fuse, use same rating fuse only (T1AL/250V). Preventive inspections and calibration are not required. Aeria 5 User Guide Troubleshooting This chapter provides basic troubleshooting support for the Aeria 5 system. Problem Cause Solution Control unit does not operate The control unit may not be attached to a power source or a fuse may need replacing. Check the control unit is connected to an electrical power outlet. Check the control unit is switched on. Check the mains plug fuse (3 AMP) and both control unit fuses (1 AMP). Control unit operational but red Alarm LED illuminates Mattress overlay fails to inflate The alarm illuminates when mattress overlay pressure fails to reach or drops below the accepted minimum level, this can be an indication of an air leak in the system. Check both air hoses are properly attached to the control unit. Check all hoses along the inside of the overlay – each should be firmly connected. Check each air cell is securely attached to the connecting air pipe. Check all cells, pipes and hoses for any air leakage. Check that the air filter cover is correctly secured and the air filter is clean. Do not try to open the control unit. Opening the unit could cause personal injury or equipment damage. Patient is sinking or “bottoming out” while lying flat on the mattress overlay The pressure may be set too low for the patient’s weight Increase pressure setting – usually an incremental increase is sufficient however wait 10-12 minutes (one full cycle) before checking the increase was sufficient. heck effective system performance by C conducting a ‘bottoming out’ test as described on page 8. If the problem cannot be resolved, please contact your local Aeda Healthcare authorized dealer for further support. Aeda - Actively supporting your health troubleshooting page 11 Specifications This chapter provides the various physical and technical specifications of the Aeria 5 system, including details of replacement parts. Technical specifications Classification Equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide. Continuous operation Type B Equipment Control unit Class II Equipment Type Analogue Ordinary Equipment Maximum recommended patient weight Dimensions 10.5” x 5.5” x 11.5” 270 x 140 x 290 mm 330 lb 150 kg Weight 6.5 lb 2.9 kg Risk category Low – medium Rated voltage: Operation altitude ≤ 2000 m US 100-120VAC 60Hz 0.3A EU 220 - 240VAC 50/60Hz 0.3A Rated input power 20 va Protection class Class 2 Power cord length 16 ft 5 m Air output (Lpm) 6.5 Cycle time 10 - 12 minutes Mattress overlay Dimensions (inflated): US, EU wide EU narrow 80” x 35” x 5” 2000 x 880 x 130 mm 80” x 32” x 5” 2000 x 830 x 130 mm Weight US, EU wide 12.1 lb 5.5 kg EU narrow 11.0 lb 5.0 kg Number of cells 18 Cell height 5” 115 mm Alternation type 1 in 2 Cell material PVC coated nylon Base material PVC Top cover materialPU coated multi-stretch polyester System part numbers Aeria 5 Mattress Overlay System: US: MT-A3-030 EU wide: MT-A3-130 EU narrow: MT-A3-215 Aeria 5 Control Unit: US: MT-S4-035 EU: MT-S4-030 Aeria 5 Mattress: Cover attachment Elastic US: MT-S4-135 Skirt seams Taped and sewn EU wide: MT-S4-135 EU narrow: MT-S4-145 page 12 specifications Aeria 5 User Guide Specifications This chapter provides the various physical and technical specifications of the Aeria 5 system, including details of replacement parts. Electromagnetic emissions for all Aeria EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic emission The Aeria 5 is intended for use in the electromagnetic environment specified below. The customer or the user of the Aeria 5 should ensure that it is used in such an environment. Emission test Compliance Electromagnetic environment – guidance Harmonic emissions Class A The Aeria 5 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. IEC 61000-3-2 Voltage fluctuations/ flicker emissions Complies IEC 61000-3-3 RF emissions CISPR 14-1 Aeda - Actively supporting your health Complies The Aeria 5 is not suitable for interconnection with other equipment. specifications page 13 Warranty The warranty and lifetime is two years. During this warranty period, in the unlikely event of a defect in materials or workmanship, a local Aeda Healthcare authorized dealer will repair, replace or supply replacement parts under standard warranty terms and conditions in effect at time of purchase, unless the problem and/or failure is due to customer damage, negligence and/or misuse; or unauthorized repairs. to a local Aeda Healthcare authorized dealer. Items not covered under warranty include, but are not limited to; stains, punctures, cuts, damage to power cords, rips or tears, dents, electrical overload, surge, spikes and lost or missing parts. Warranty repairs do not extend the length of the warranty period. Warranty terms and conditions are subject to change at any time without notice. In the event of a defect, repair work should be completed by returning the faulty system page 14 warranty Neither Aeda Healthcare, its distributors, officers, directors, employees or agents shall be liable for consequential or other amages, including but no limited to personal injury, loss, or any other expense, directly or indirectly arising from the use of its products. The sole remedy for breach of the limited warranty granted herein shall be repair or replacement of the Aeda Healthcare products. Visit www.aeda.com to view a copy of the manufacturer’s Warranty Statement. Aeria 5 User Guide Notes Aeda - Actively supporting your health notes page 15 Notes page 16 notes Aeria 5 User Guide Notes Aeda - Actively supporting your health notes page 17 Aeda Healthcare is all about helping people enjoy a freedom of life, throughout every stage of life. About improving mobility, independence, dignity and offering choice. About making products that are practical, reliable, affordable – and stylish. Aeda Healthcare Ltd. 20F-1, No. 79, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City, Taiwan T +852 6832 5199 F +852 6832 5373 E [email protected] www.aeda.com Actively supporting your health E362187 ANSI/AAMI ES 60601-1 CAN/CSA-C22.2 NO.60601-1 AU-K200
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