5
3.4
Technical data
Lifting bridles system
STX 519
STX 540
STX 542
Webbing length (mm)
maximum 1680
minimum 1250
1600 and 1550
1660
Webbing width (mm)
50 / 20
30
30
Weight (kg)
1,8
0,8
0,6
Material
nylon, aluminium, steel
nylon, aluminium, steel
nylon, aluminium, steel
Type of fixation
carabineer
noose
carabineer
Number of fixing straps
4
4
2
Compatibility
all basket stretchers
made by Spencer
all basket stretchers made by
Spencer
all basket stretchers made by
Spencer
Maximum static safety load
450 kg (1000 lbs)
450 kg (1000 lbs)
450 kg (1000 lbs)
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 ISO 15223-1
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
3.6
Environmental conditions
Functioning temperature: from -20 to +60 °C
Storage temperature: from -20 to +60 °C
Relative humidity: from 5 to 85%
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 damages
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.
Do the straps fold in the correct way?
Correct grasp of the straps
Status of wear of the components (straps, buckles)
Proper working of buckles
