arjo Alpha Active 4 Notice D'utilisation page 5

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 caregiver
safely.
• Whilst the patient is unattended, safety sides should be used 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 mains power socket/plug must be accessible at all times. To disconnect the pump
completely from the electricity supply, remove the plug from the mains power socket.
• The CPR control and/or the CPR 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.
• 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.
1. Caregiver may be a healthcare professional or a lay person who operates this medical device.
to ensure that the user can use this product
1
(iii)