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Summary of Contents for Arjo Alpha Active 5
- Page 1 INSTRUCTIONS FOR USE Alpha Active 5 648931EN_02 • 06/2022...
- Page 2 © Arjo 2022. As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice. The content of this publication may not be copied either whole or in part without the consent of Arjo.
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Page 3: Table Of Contents
Product description - Alpha Active 5 mattress ........ -
Page 4: Foreword
IFU is important for your safety and must be read and understood to help prevent possible injury. products. Routine maintenance must be performed on the Alpha Active 5 system before every use or every week (if for long term use) to maintain safety and reliability of the equipment, see “Routine Maintenance” on page 24. - Page 5 WARNING Warning means: Safety warning. Failure to understand and obey this warning may result in injury to you or to others. CAUTION Caution means: Failure to follow these instructions may cause damage to all or parts of the system or equipment.
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Page 6: Intended Use For Alpha Active 5
• The Alpha Active 5 system has been designed for use with patients ranging from 40 kg (88 lb) to 200 kg (441 lb) for the Alpha Active 5 mattresses. If the patient does not meet these criteria an alternative equipment/system shall be used. -
Page 7: Safety Instructions
Safety instructions Before you connect the system pump to a mains socket, read carefully all the installation instructions contained within this manual. The system has been designed to comply with regulatory safety standards including: • EN60601-1:2006/A1:2013 and IEC 60601-1:2005/A1:2012 • EN60601-1-11:2015;... - Page 8 WARNING Only the pump and mattress combination CAUTION as indicated by Arjo should be used. The Pets and children must be supervised in correct function of the product cannot be the vicinity of the system. guaranteed if incorrect pump and mattress combinations are used.
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Page 9: Home Care
IFU. When the Alpha Active 5 system is in use, make sure: • The Alpha Active 5 system is kept away from sources of heat and moisture, and protected from dust, lint and dirt. •... -
Page 10: Preparations
1. Check the package for damage. If the product looks damaged during transport, contact the transport agency. Do NOT use the product. 2. Check that the items are complete: • Alpha Active 5 pump with power cable and hanging brackets. • Alpha Active 5 mattress replacement integrated tube-sets. • Cover. -
Page 11: Parts Designation - Alpha Active 5 Pump
Parts designation – Alpha Active 5 pump 1. Control panel (with indicators) 4. Power cable 2. Alarm indicators 5. Hanging brackets 3. Mattress hoseset socket 6. ON/OFF button Control panel - buttons and indicators Alpha Active 5 1. Lock / Unlock mode 7. -
Page 12: Parts Designation - Alpha Active 5 Mattress
3. Zipped cover 4. Eleven Active (Alternating) mode body cells 5. Base cover 6. Six straps for securing the mattress 7. Five Active (Alternating) mode heel cells with internal vent valves 8. Tube set PARTS DESIGNATION – ALPHA ACTIVE 5 MAT TRESS... -
Page 13: Product Description - Alpha Active 5 Pump
Product description - Alpha Active 5 pump Summary pump The Alpha Active 5 pump comprises of a moulded case with non slip feet on the base and integral hanging brackets. ON/OFF button Pressing the ON/OFF button will activate the pump. - Page 14 An audible alarm will sound until power is resumed or the pump is revert to the last setting once power is restored after a Figure 8 power outage or generator test. See Fig. 8. PRODUCT DESCRIPTION - ALPHA ACTIVE 5 PUMP...
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Page 15: Product Description - Alpha Active 5 Mattress
Active (Alternating) cells that can be selectively and internal valves. The mattress can accommodate 3 4 5 requirements. For the relationship of Heel cell location and patient height see Fig. 11. Heel Cell Location Figure 11 PRODUCT DESCRIPTION - ALPHA ACTIVE 5 MAT TRESS... - Page 16 The lower part of the heel cell will still remain NOTE To avoid the risk of loose valve connector, please do not pull the tube tie. When this function is no longer required then Figure 13 cell. PRODUCT DESCRIPTION - ALPHA ACTIVE 5 MAT TRESS...
- Page 17 activated: (4 steps) 1. Locate the head end of the mattress replacement. 2. Locate the red strap labelled CPR (On the same side as the tubeset). See Fig. 14. 3. Pull the red strap labelled CPR. 4. The air escapes the mattress replacement rapidly. Figure 14 See Fig.
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Page 18: Installing Alpha Active 5 System
Installing Alpha Active 5 system Installing Alpha Active 5 mattress (6 steps) 1. Remove the existing mattress from the bed frame and check that there are no protruding bed springs or sharp objects on the bed frame surface. 2. Unroll the mattress onto the bed frame. Ensure that the tubeset is located near the foot end of the bed and the CPR at the head end. -
Page 19: Mattress And Pump Operation
WARNING Before using the Alpha Active 5 mattress replacement make sure it has been installed correctly in accordance with “Installing Alpha Active 5 system” on page 18, and ensure that the CPR unit on the mattress is clicked ” into the closed position. - Page 20 1. Lie or sit the patient on the mattress. 2. If initial setup (see above) is done skip this step and go to step 3. Press and hold both the plus (+) and minus (–) buttons for at least 3 seconds to reset the mattress pressure to the default comfort (Equivalent to patient weight 100 kg) control level (4 LEDs light up).
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Page 21: Active (Alternating) Mode
Active (Alternating) mode Active (Alternating) mode is the default mode, it provides a moving support surface for instances where reactive direct an individualised repositioning programme. Reactive Constant Low Pressure (Static) mode Provides a stable, non-moving support surface for instances where active therapy is not indicated e.g. to carry out nursing procedures or for patients unable to tolerate a moving surface. -
Page 22: Change In Patient Position
25. Transport mode To transport a patient using the Alpha Active 5 mattress replacement, disconnect the tubeset from the pump and place the attached cap over the end of the tubeset to put the mattress into transport mode. This will automatically switch the mattress into transport mode. -
Page 23: Decontamination
If you are uncertain, you should seek advice from your local Infection Control Specialist. The Alpha Active 5 system should be routinely decontaminated between patients and at regular intervals while in use; as is good practice for all reusable medical devices. -
Page 24: Routine Maintenance
Arjo trained personnel to repair the system. Service period Arjo recommend that the Alpha Active 5 system should be serviced by an Arjo authorised service agent, after 12 months of use has elapsed. The Service symbol illuminates to indicate that the pump is ready for a service (refer to ”Service indicator / pump fault”... -
Page 25: Alpha Active 5 Mattress
2. Bring the tubeset over the mattress to lay parallel to the foot end of the mattress. 3. Roll the mattress from the foot end toward the head end of the mattress. DEFL ATE AND STORE ALPHA ACTIVE 5 MAT TRESS... -
Page 26: Troubleshooting And Alarm Conditions
Troubleshooting and alarm conditions The following table provides a troubleshooting and alarm condition guide for the Alpha Active 5 system in the event of malfunction. These alarms do not cause any delay or interruption in therapy. INDICATOR POSSIBLE CAUSE REMEDY... -
Page 27: Technical Description
Crossover - 30 seconds Crossover - 30 seconds 1: Electrical energy consumption testing based on Arjo’s laboratory data. A typical working sequence is 0.5 automatic mode for 23.5 hours. System power supply is 230V/50 Hz. Operating environment is 25° C and 50% RH. - Page 28 MATTRESS Description Cell Material Base Pad Material Alpha Active 5 MR 90 PU Polyurethane Nylon PU Coated Alpha Active 5 MR 85 PU Polyurethane Nylon PU Coated MATTRESS SIZE INFORMATION Part No Description Welded Length Width Height Spare Cover 648202...
- Page 29 MATTRESS COVER SPECIFICATION **Chlorine concentrations may vary from 250ppm to 10,000ppm depending on local policy and contamination status. If an alternative disinfectant is selected from the wide variety available, Arjo recommend that suitability END OF LIFE DISPOSAL Fabric material used on the mattresses or any other textiles, polymers or plastic materials etc. should be sorted as combustible waste.
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Page 30: Labels
Labels Pump The serial number for the pump is on the label located on the back of the pump case. Mattress The mattress serial label can be found just inside the base cover above the tubeset. SYMBOLS The operator must read this Indicates the product is a Medical document (Instructions for Use) Device according to EU Medical... - Page 31 Use) for a description of the Hospital name. UK SYMBOL EXPLANATION This section is only applicable to United Kingdom (UK) market when UK marking is applied to the Arjo medical device labelling. UK marking indicating conformity with UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) Figures indicate UK Approved Body supervision.
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Page 32: Electromagnetic Compatibility (Emc) Data Sheet
EMC and needs to be installed in accordance with the following: Some procedures can help reduce electromagnetic interferences: • Use only Arjo cables and spare parts to avoid increased emissions or decreased immunity which can compromise the correct functioning of the equipment. •... - Page 33 GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY Immunity Test IEC 60601-1-2 Compliance Electromagnetic test level Level environment - guidance Electrostatic ±2kV k , ±4kV k , ±8kV ±2kV k , ±4kV k , ±8kV Floors should be wood, discharge (ESD) concrete or ceramic tile.
- Page 34 GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY Immunity Test IEC 60601-1-2 Compliance Electromagnetic test level Level environment - guidance Surge ±0,5kV k ±1k ±0,5kV k ±1k Mains power quality ±2kV k , AC Mains, ±2kV k , AC Mains, should be that of a IEC 61000-4-5 Line to Ground Line to Ground...
- Page 35 AUSTRALIA FRANCE Arjo Australia Arjo SAS Arjo Polska Sp. z o.o. Building B, Level 3 2 Avenue Alcide de Gasperi 11 Talavera Road CS 70133 Macquarie Park, NSW, 2113, FR-59436 RONCQ CEDEX Tel: +48 61 662 15 50 Australia Tél: +33 (0) 3 20 28 13 13...
- Page 36 Hans Michelsensgatan 10 211 20 Malmö, Sweden www.arjo.com...
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