10
11
If items are to be returned for any reason, please contact your local distributor quoting the part
number and serial number (where applicable).
You will be issued with a returns number and returns form that will need to be completed in full to
ensure that your request is dealt with promptly
.
Returns
Quality assurance
Steeper is registered with both the
Medicines and Healthcare Regulatory Authority
in the UK and the
Food and Drugs Administration
of the United States Government for the manufacture and supply of
prosthetics and orthotics products.
MHRA Registration N°: 6617
FDA Registration N° : 9612243
Model N°: RSL-RP616
Continued compliance with the standard is monitored by a programme of internal and external
audits. All individual products are marked indicating that they comply with the requirements of
the Medical Devices Directive 93/42/EEC (MDD). The CE mark may be applied on packaging,
accompanying literature or an enclosure, rather than the product itself.
Test certification & environmental conditions
The S-Charge Hub Kit and its associated components listed in this document have been tested and
certified to the following standards and requirements:
•
Medical Safety Testing:
• IEC 60601-1: 2005/A1:2012.
• IEC 60601-1-11: 2015; Includes meeting requirements: ISO 14971:2012.
• IEC 60601-2: 2014.
•
IP22 to BS EN 60529: 1992+ A2: 2013, when the S-Charge display is sealed using the silicone
sealant as outlined in the fitting instructions in the main S-Charge System Technical Manual
(STPPR042).
Environmental operational conditions
Storage, transport and operation
-20°C (-4°F) to +50°C (+122°F)
Operational
-5°C (-23°F) to +40°C (+104°F)
Pressure range
700-1060 hPA
Maximum 80% relative humidity, above non-condensing
Do not expose to EM emissions above 8kV contact, 15kV air
