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2 Safety and Dangers
2.1 Safety Instructions
Follow the instructions carefully.
Ensure any user has read and understood this manual completely before operating the product.
Use the mattress system only as specied in this manual and in perfect working order.
Use the mattress system only with the correct mains supply (see Electrical Specications).
Use the mattress system only in its original state and do not modify it in any way.
Have the mattress system used only by or under supervision of trained and qualied nursing personnel.
Replace any damaged parts immediately with original spare parts only.
Have the mattress system serviced and installed only by qualied personnel trained and authorized by the
manufacturer.
Do not exceed the maximum patient weight limit (see Mechanical Specications).
Do not use the SCU near ammable gases. This does not apply to oxygen cylinders.
Never use the mattress replacement system near radiators or other heat sources.
Never cover the SCU while in use.
Never handle the mains plug with wet hands.
Disconnect the product from the mains only by pulling the mains plug. When pulling the mains plug, always
hold the plug, not the cable.
Position the mains cable so that there are no loops or kinks in the cable; protect the cable from mechanical
wear and tear.
Improper handling of mains cable can cause an electric shock hazard, other serious injuries or damage to
the mattress replacement system.
2.2 Use and Storage Conditions
Virtuoso is suitable for use or storage in indoor environments meeting the following requirements:
Virtuoso is not suitable for indoor environments:
containing ammable gases (except oxygen cylinders).
3 Standards and Regulations
The mattress replacement system complies with the following standards:
EC directive 93/42/EEC for medical devices
EC directive 89/336/EEC for electromagnetic compatibility
RoHS directive 2011/65/EU
Themanufactureradherestoacertiedqualitymanagementsystemincompliancewiththefollowingstandards:
EN 60601-1
EN 60601-1-2
EN 60601-1-6
EN ISO 10993
EN ISO 9001:2008
EN ISO 13485:2003
EN ISO 14004:2004
Ambient temperature 0 °C (32 °F) to + 40 °C (104 °F)
Relative humidity 30% to 70%
Atmospheric pressure 700 to 1060 hPa
Dust and water protection (SCU) IP 3X
Flammability rating (mattress and seat cushion covers) BS 7175 ignition sources 0, 1 and 5
Environment ISO 14001
2002/95/EC (RoHS)
2002/96/EC (WEEE)
Electromagnetic compatibility BS EN 60601-1-2
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