U S E R G U I D E Key Definition of symbols used User guide - medium - high i Important information Caution symbol Electrical hazard Iron - low Type B Applied Part Manufacturer details Visual alarm Alternating mode Static mode Do not iron CL Bleach - chlorine Do not bleach BLEACH Aeda – a brand actively supporting your health A fresh approach to proven pressure care solutions Tumble dry - low - medium - high Do not tumble dry Switch ON/OFF The Aeda mattress and seat category If dry cleaning - do not use a solution stronger than perchloroethane System ready/functioning normally Serial number Seating overlay 70 Operating instructions Disposal: Do not dispose of this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary. Wash instruction here Zip located here Do not immerse control unit Infection control Do not ... OROETH HL P E AN PER C Power Maximum water temperature (in this example - 160°F 70ºC) Control unit Medical equipment mattress system with respect to electrical shock, fire and mechanical hazards only; in accordance with UL60601-1 and CANCSA N22.2 NO. 601.1 CE Marking (European UnionNew Approach Directives) Class II Equipment key Symbol for ”Authoristed Representative in the European Community” Aeria Sit 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 Warranty13 Aeda - Actively supporting your health contentspage 1 System overview Introducing the Aeria Sit Seating Overlay System – this chapter provides a basic system overview, intended use guidelines and a summary of system features and box contents. Box contents • dynamic seating overlay with dual air hoses • • • • compact analogue control unit power cord Aeria Sit User Guide Aeria Sit Quick Set Up Guide Applied part. The cushion is treated as an applied part. page 2 system overview Aeria Sit User Guide Introducing the Aeria Sit Seating Overlay System, this chapter provides a basic system overview, intended use guidelines and a summary of system features and box contents. • in conjunction with the appropriate Aeria dynamic mattress surface and under constant supervision from a healthcare professional, the Aeria Sit is indicated for the prevention and treatment of skin breakdown and pressure ulcers in patients at all grades of risk • 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 products • suitable for transitory periods of day chair use, the seating overlay is constructed from two layers of 7 cells. The bottom layer and 1 top layer cell are static, and the other 6 cells cyclically inflate and deflate in an alternating pattern, providing gentle and dynamic support • suitable for use at home or in long term or extended care environments • designed for use on standard hospital and normal domestic chairs • a static front edge and the bottom layer aids user stability and supports strong posture • connected to the control unit via dual air hoses, seating overlay cells are inflated by an electronic control unit, which includes a pressure sensor for monitoring seating pressure and adjustable pressure settings to match patient weight and comfort needs • operator controls are kept to a minimum for simplicity and ease of use System features Support • two layers of 7 cells - the bottom cells and the front cell in the top layer are static to provide static support for optimum user comfort • vapor permeable, waterproof cushion top cover prevents moisture transfer, while multi-stretch fabric minimizes friction and reduces shear • adjustable pressure level to match users weight and comfort needs • supporting users to a maximum weight of 220 pounds 100 kilograms Aeda - Actively supporting your health Safety Simplicity • non slip mat maintains stability on all surfaces • easily removable, machine washable cover with 360 degree zipper • visible alarm light to warn of pressure failure • • quick connector air hose attachments 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 Sit Seating Overlay System is indicated for: There are other devices necessary for normal operation. • The Aeria Sit seating overlay can be fitted to most standard hospital or normal domestic chairs. the prevention of skin breakdown and pressure ulcers in patients at low to medium risk (when used in conjunction with an appropriate Aeria dynamic mattress surface and under the consent, supervision and management of a suitable qualified health professional) The Aeria Sit compact analogue control unit can be fitted to the back of the chair. Alternatively the control unit can be placed on the floor, underneath the chair or on any other stable surface. Contraindications Patient conditions for which the application of pressure relief therapy on the Aeria Sit Seating Overlay System is contraindicated include: • • • The Aeria Sit Seating 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. instable spinal cord injury cervical traction patients with poor sitting balance Intended care setting Intended care settings for the Aeria Sit Seating Overlay System are: • • long term or extended care home care Working conditions • • Temp: 50°F - 105°F 10°C – 40°C Humidity: 30% ~ 75% Shipping/Storage conditions • • Temperature: 15°F - 140°F -10°C –60°C Humidity: 10% ~ 80% page 4 intended use Aeria Sit 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. Placing layers between patient and seating overlay 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 / seating cushion combination as indicated by Aeda Healthcare should be used, otherwise the correct function of the product cannot be guaranteed. 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. Explosion hazard Aeda - Actively supporting your health 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. Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide. Maximum patient weight The maximum recommended patient weight for this system is 220 pounds 100 kilograms. luid or liquid remaining on the F 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. • • Do not use in the presence of smoking materials or open flame – air flowing through the seat cushion 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. seat cushion 1.Check the chair for any sharp objects that may puncture the cushion. 2.Unzip the top cover and place the seating cushion on top of the chair surface, with the static cell edge to the front. Standing to face the chair, check the following: a. the air cells are in a horizontal position across the chair b.the air hoses appear from the back right corner of the cushion c. with the static cell edge to the front Always use the Aeria Sit in the correct orientation and with the protective top cover. Failure to do so could cause equipment or patient injury. 4.Hang the control unit over the back of your chair, using the inbuilt rear hanging hooks, or place on a flat surface (ie on the floor, underneath the chair or a solid table). control unit power cord Avoid trailing power cords – ensure that any cords or hoses are positioned beneath the chair to avoid causing a hazard. 3.Place the top cover over the seating cushion, ensuring the printed logo is uppermost and faces forwards. Re-zip the cover on to the seating cushion, taking care not to trap any material in the zip. Before attaching the control unit to the floor or the back of the chair, ensure they are sufficiently robust and free of damage. The non-slip mat located on the base of the seating cushion provides added security and stability. page 6 system set up Aeria Sit User Guide This chapter describes the steps necessary to prepare the Aeria Sit system for use. 5.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. 6.Insert the power cord into the base of the control unit, then plug into an appropriate electrical outlet and switch on mains power. Dismantling the system 1. Switch off the control unit. 2.Switch off mains power and unplug the power cord from the mains outlet. 3.Disconnect both the air hoses from the control unit to deflate all cells. 2 Straighten any twists in the air hoses to ensure uninterrupted air flow between the control unit and seating cushion. Also ensure the hoses are not trapped between the seating cushion and chair. Failure to do so could result in an under inflated seat cushion leading to patient injury. Aeda - Actively supporting your health 3 1 4.Remove the seating cushion from the chair and store all items safely. Do not store the system in direct sunlight. 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). Allow up to 10 minutes for complete inflation.The green Ready LED illuminates when the system is ready for use. system set uppage 7 Operation Control unit layout Power switch Establishing pressure Turns system power on and off. The switch illuminates to indicate power is on. 1.Prepare the system for use as described in System Set Up. Ready indicator This green light displays to indicate the system has reached (and maintains) operational pressure. Alarm indicator This red light displays to alert when seating cushion or control unit pressure fails. The alarm indicator remains illuminated until pressure is restored. Pressure dial Adjusts seating cushion pressure from low to high, in line with patient weight and comfort requirements. The patient may sit on the Aeria Sit system during inflation however the seating cushion will fill faster if allowed to inflate first. 2.When the patient is sitting comfortably, turn the Pressure dial to reach the desired setting for effective patient comfort and support. After lowering the pressure setting, always check the Aeria Sit system is working effectively. Failure to do so could cause patient injury. Wait at least 10 minutes between any pressure adjustment or patient assessment as the Aeria Sit system may take a full cycle to adjust to the new pressure setting. Static / Alternating switch No special skills, training or knowledge are required to operate the control unit. page 8 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). operation Aeria Sit User Guide This chapter describes how to safely operate the Aeria Sit system including patient set up and control unit function. i 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. Transport function Alarm function When transporting a patient on the Aeria Sit 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 seating overlay. The Alarm indicator illuminates to indicate that control unit or seating cushion 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: System Removal • turn off the control unit by unplugging the mains cable • to deflate the cushion, pull the connectors and open the quick connector on the umblical cord • place the control unit and mains cable on top of the seat cushion and remove it from the chair 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. • check the air hoses are securely connected to the control unit • check all cells, pipes and hoses are securely connected, and look for air leaks • 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. Opening the unit could cause personal injury or equipment damage. uring transport, regularly check to D ensure the patient is adequately suspended on the seating overlay. Failure to do so could cause patient injury. Note: deflate the cushion by opening quick connectors as shown above. Aeda - Actively supporting your health operationpage 9 Care & cleaning To prevent cross contamination, it is recommended the seating overlay is examined and disinfected between patient use. Clean the seating overlay in accordance with local infection control policy and government regulations for blood borne pathogens. Failure to do so could cause patient or personal injury. 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. o not use high temperature autoclave D steam cleaning devices or phenolicbased products for cleaning. This could result in damage to the equipment and loss of waterproof qualities of the seat cover. Switch off and disconnect the control unit from mains power supply before cleaning. Do not immerse the control unit in water. Disinfection The seating cushion, top cover and control unit may be decontaminated by using ETO (Ethylene Oxide). This chapter describes general care and cleaning for the Aeria Sit system, including basic maintenance procedures. Cleaning & infection control I t is recommended that the system be cleaned regularly if in constant use. Base cleaning Once deflated, slide air cells from the cell straps to detach from the base – cells will remain permanently connected to the dual air hoses. Swab the cells and cell strap base with a solution of sodium hypoclorite or similar (up to 10,000ppm available chlorine). Dry thoroughly before reattaching. Do not machine wash the base. Top cover cleaning Unzip the seat 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. For infection control, swab with a solution of sodium hypoclorite or similar (up to 10,000ppm available chlorine). Dry thoroughly before use. Refer to the seating cover wash tag for cleaning instructions. Do not use the system without the 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. Periodic maintenance Air filter replacement 1.Switch off power supply to the control unit and disconnect the air hoses and power cord. 2.Place the control unit face down on a soft, flat surface with back panel uppermost (use a soft cloth to prevent scratches). 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. 4.Refit the air filter cover to the control unit before use. 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. page 10 care & cleaning Aeria Sit User Guide Troubleshooting This chapter provides basic troubleshooting support for the Aeria Sit 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 indicator illuminates Seating overlay fails to inflate The alarm illuminates when seating 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 each air cell is securely attached to the connecting air pipe. Check all cells 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 sitting on the seating 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 to the increase was sufficient. 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 Sit 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 Class II Equipment Ordinary Equipment Maximum recommended patient weight 220 lb 100 kg Risk category Low - medium Seaing overlay Control unit Type Compact analogue Dimensions 5.5” x 4.5” x 10.5” 135 x 115 x 270 mm 4.5 lb 2.1 kg Dimensions (inflated) 18” x 18” x 5” 460 x 460 x 130 mm Weight Weight 2.6 lb 1.18 kg Rated voltage Number of cells 6 alternating 8 static Cell height 2.5” 65 mm Alternation type 1 in 2 Cell material TPU coated nylon Base material TPU coated nylon Top cover materialPU coated multi-stretch polyester Cover attachment Quick release zipper Skirt seams RF welded Foam No US 110-120VAC 50/60Hz 0.2A EU 220 - 240VAC 50/60Hz 0.2A Rated input power 20 va Protection class Class 2 Power cord length 16 ft 5 m Air output (Lpm) 6.5 Cycle time (mins) 10 - 12 System part numbers Aeria Sit Seat Cushion System: US: SC-A3-001 SC-A3-002 EU: Aeria Sit Control Unit: page 12 US: MT-S4-035 EU: MT-S4-030 Aeria Sit Cushion: MT-S4-100 specifications Aeria Sit User Guide This chapter provides the various physical and technical specifications of the Aeria Sit system, including details of replacement parts. Specifications Electromagnetic emissions for all Aeria EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic emission The Aeria Sit is intended for use in the electromagnetic environment specified below. The customer or the user of the Aeria Sit should ensure that it is used in such an environment. Emission test Compliance Electromagnetic environment – guidance Harmonic emissions Class A The Aeria Sit 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 Complies The Aeria Sit is not suitable for interconnection with other equipment. Warranty Aeda Healthcare Ltd warrants each of its products to perform in accordance with established specifications for specified time periods, starting from the date the product is shipped from Aeda Healthcare Ltd. 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. Aeda - Actively supporting your health In the event of a defect, repair work should be completed by returning the faulty system 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. specifications & warranty Neither Aeda Healthcare, its distributors, officers, directors, employees or agents shall be liable for consequential or other damages, 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. page 13 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 developing quality healthcare products that simply look good. Aeda Healthcare Limited 15th Floor 100 Queen’s Road Central Central Hong Kong T +852 6832 5199 F +852 6832 5373 E [email protected] www.aeda.com Actively supporting your health 3VB8 E336602 AU-8204
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