European Directive about Medical Devices
Modifications to 90/385/CEE Directive about active
implants, Directive 93/42/CEE about medical devices
and Directive 98/8/CE about the introduction of biocides
onto the market
Legislative Decree 24/02/1997, n. 46
Application of the 93/42/CEE Directive about Medical
Devices
Legislative Decree 25/01/2010, n. 35
Modifications and additions to the 20/02/97 Decree n.
46
Application of risks managing to medical devices
Graphic symbols used for medical devices labelling
Information supplied by the medical devices
manufacturer
Medical Devices - Application of the utilisation
characteristics of engineering to medical devices
Guideline for the classification of medical devices
Clinical evaluation of the medical devices for human
beings - Part 2: Clinical evaluation plans
Directives for stretchers and other patient transport
equipment on ambulances
3.6 Environmental conditions
Functioning temperature Spencer Rock: from -35 to +55 °C
Functioning temperature Rock Pin/Pin Max: from -20 to +50 °C
Storage temperature: from -20 to +60 °C
Relative humidity: from 0 to 100 %
4. OPERATING INSTRUCTIONS
4.1 Transport and storage
Before transporting the appliance, make sure that it is correctly packaged ensuring also that there
are no risks of shocks, bumps or falls during the transport itself.
Keep the original packaging for use in case of any further transport and for storage. Damage to the
appliance caused during transport and handling is not covered by the guarantee. Repairs or
replacement of the damaged parts are the responsibility of the client. The device must be stored in a
dry, cool area away from direct sunlight. It must not be placed in contact with any substances or
chemical agents which could cause damage and reduce safety characteristics.
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