14
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 9001
Managing systems for quality: requirements
UNI EN ISO 13485
Medical Devices - Managing systems for quality – Requirements for
regulamentation requirements
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
MEDDEV 2.12/1
Medical Devices vigilance system
UNI EN 14155
Clinical evaluation of the medical devices for human beings - Part 2:
Clinical evaluation plans
BS OHSAS 18001
Managing systems for safety and health at workplace
3.6
Environmental conditions
Functioning temperature: from -10 to +50 °C
Storage temperature: from -20 to +60 °C
Relative humidity: from 5 to 95%
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.
4.2
Preparation
On receipt of the product:
Remove the packaging and display the material so that all components are visible.
Check that all the components/pieces on the accompanying list are present.
The appliance must be checked before every use so as to reveal any working abnormalities and/or damage caused by
transport and/or storage. In particular, check:
General functionality of the device
Cleanliness of the device (remember that the failure of cleaning may cause the
risk of cross infections)
Absence of cuts, holes, tears on the structure, including the straps
Correct fixation of all nuts, bolts and screws
Correct fixation of straps
Correct fastening of straps
State of use (moving parts, wheels, belts)
Integrity of components
State of use of wheels and breaking system
There are seat belts for the immobilization of the patient and they are intact and
functioning
No piping or metal sheet present bends or cracks
The backrest has no structural damages or fissures
If the above conditions are met, the device may be considered ready for use; otherwise you must immediately remove the
device from service and contact the Manufacturer.
4.3
Functioning
4.3.1
Opening and closing the longitudinal stretcher
For Spencer 250, act on the two central hubs as shown in figure C and D.
After that, proceed with the approach of the two halves of the stretcher as shown in figure E.
To open, follo the same procedure in reverse order.
Fig. C
Fig. D
Fig. E