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
• 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 to ensure that the user can use this product
safely.
• 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.
• 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.
• 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.
• Only the pump and garment combination as indicated by Arjo should be used. The
correct function of the product cannot be guaranteed if incorrect pump and
garment combinations are used.
• The Flowtron
®
ACS900 system is NOT intended for use in the home healthcare
environment (for example private dwellings).
Caution (applicable to the USA market only)
• US Federal law restricts this device to sale by or on the order of a physician.
Precautions
For your own safety and the safety of the equipment, always take the following precautions:
• Do not expose the system to open flames, such as cigarettes, etc.
• Do not store the system in direct sunlight.
• Do not use phenol-based solutions to clean the system.
• Make sure the system is clean and dry prior to use or storage.
• 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.
GENERAL SAFETY
(iii)