Spencer Rock, User Manual, Page: 6 / 14

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3.4
Technical data
Characteristics Spencer Rock Rock Pin Rock Pin Max
Length (mm) 1825 1840 1840
Width (mm) 445 445 445
Thickness (mm) 66 50 50
Handles 12 16 16
Fixing pins / 14 14
Load capacity (kg) 192 200 350
Radiolucent SI SI SI
Weight 7,8 ± 0,2 kg
Material Polyethylene
3.5 Reference standards
Reference Title of document
MDD 93/42/CEE European Directive about Medical Devices
MDD 2007/47/CEE
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
UNI EN ISO 14971 Application of risks managing to medical devices
UNI CEI EN 980 Graphic symbols used for medical devices labelling
UNI CEI EN 1041
Information supplied by the medical devices
manufacturer
CEI EN 62366
Medical Devices - Application of the utilisation
characteristics of engineering to medical devices
MEDDEV 2.4/1a-b Guideline for the classification of medical devices
NB-MED 2.5.1/Rec 5 Technical Documentation
MEDDEV 2.7.1 Clinical Data
UNI EN 14155
Clinical evaluation of the medical devices for human
beings - Part 2: Clinical evaluation plans
UNI EN 1865-1:2010
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.