001-31249-EN rev
. 3
Technical Specifications
47
Approvals and list of Standards
The
Maxi Sky
2 Plus is tested according to standards by:
Canadian Standards Association:
IEC 60601-1 series including applicable collateral standards and national deviations
Technischer Überwachungs-Verein:
Production monitored
Safety tested
ISO 10535 : 2006 standard
CE Marking:
Safe Disposal at End of Life
Package/Product
Corrugated cardboard, recyclable. Components that are primarily be made up of different kinds of
metal (containing more than 90% metal by weight) for example sling bars, rails, upright supports, etc.,
should be recycled as metals.
Battery
All batteries in the product must be recycled separately. Batteries are to be disposed in accordance
with national or local regulations.
Electrical and
electronic
components
Lift systems having electrical and electronic components or an electrical cord should be disassembled
and recycled per Waste of Electrical and Electronic Equipment (WEEE) or in accordance with local or
national regulation.
Slings
Slings including stiffeners/stabilizers, padding material, any other textiles or polymers or plastic
materials etc. should be sorted as combustible waste.
Electromagnetic Compliance
The
Maxi Sky
2 Plus has been tested for compliance with current regulatory standards regarding its
capacity to block EMI (electromagnetic interference) from external sources.
Nonetheless, some procedures can help reduce electromagnetic interferences:
• Ensure that other devices in patient-monitoring and/or life-support areas comply to accepted
emissions standards.
• Maximize the distance between electromedical devices. High-powered devices may produce EMI
that can affect the lift.
For more information on how to manage the unit's RF electromagnetic environment, please consult the
AAMI TIR 18-1997 - Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/
Biomedical Engineers
.
WARNING:
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
WARNING:
The equipment may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take action, such as reorienting, relocating the equipment or
shielding the location.
WARNING:
Use of accessories, cables and spare parts other than those specified or provided by
Arjo could result in increased electromagnetic emissions or decreased electromagnetic immunity of
this equipment and result in improper operation.