(iii)
GENERAL SAFETY
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
EN60601-1-11:2010; IEC 60601-1-11:2010 and IEC60601-1-8:2012
ANSI/AAMI ES 60601-1(2005)+AMD(2012) and CAN/CSA C22.2 No.60601-1(2008)+(2014).
Safety Warnings
• It is the responsibility of the care giver to ensure that the user can use this product
safely.
• Whilst the patient is unattended, the decision to use safety sides should be based on
clinical assessment and in line with local policy.
• Alignment of the bed frame, safety sides and the mattress should leave no gap wide
enough to entrap a patient's head or body, or to allow egress to occur in a hazardous
manner where entanglement with the mains power cable and tubeset or air hoses may
result. Care should be exercised to prevent occurrence of gaps by compression or
movement of the mattress. Death or serious injury may occur.
• Make sure that the mains power cable and tubeset or air hoses are positioned to avoid
causing a trip or other hazard, and are clear of moving bed mechanisms or other possible
entrapment areas. Where cable management flaps are provided along the sides of the
mattress, these should be used to cover the mains power cable.
• Electrical equipment may be hazardous if misused. There are no user-serviceable parts
inside the pump. The pump's case must only be removed by authorised technical
personnel. No modification of this equipment is allowed.
• The power switch must be accessible at all times. Use the power switch to disconnect the
pump completely from the power supply.
• The Rapid Deflate indicator tag must be visible and accessible at all times.
• Disconnect the pump from the mains power socket before cleaning and inspecting.
• Keep the pump away from sources of liquids and do not immerse in water.
• Do not use the pump in the presence of uncontained flammable liquids or gasses.
• The cover of this product is vapour permeable but not air permeable and may present a
suffocation risk.
• Bags supplied with this equipment may present a suffocation risk; to avoid the risk of
suffocation keep the bags away from babies and small children.
• There is no Transport facility on the Alpha Trancell
®
Deluxe seat cushion.
• Only the pump and mattress combination as indicated by Arjo should be used. The
correct function of the product cannot be guaranteed if incorrect pump and mattress
combinations are used.
• If a serious incident occurs in relation to this medical device, affecting the user, or the
patient then the user or patient should report the serious incident to the medical device
manufacturer or the distributor. In the European Union, the user should also report the
serious incident to the Competent Authority in the member state where they are located.
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