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S-Charge User Guide
ISO 13485:2016
ISO 14971:2019
MDSAP
Directive RoHS 2015/863/EU.
This S-Charge is an accessory for Class I Medical
Devices which meets the general safety and
performance requirements in MDR 2017/745 Annex I.
This device is CE marked which indicates that the
device meets EU safety, health and environmental
requirements. It also indicates the device’s
compliance with EU legislation and free movement
within the European market.
This device is UKCA marked which indicates that
the device meets safety, health and environmental
requirements. It also indicates the device’s
compliance with the legislation of Great Britain
(England, Wales, Scotland) and free movement
within the market of Great Britain.
The design and manufacture of Steeper equipment
and components are subject to a policy of
continuous reappraisal. The company, therefore,
reserves the right to introduce changes and
withdraw products without notice. For the most
recent issue of this user guide, please visit:
www.steepergroup.com
.
Quality Assurance cont.
