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www.humancaregroup.com
seBastian II
Product label
Product symbols
The product label contains information about
the product and is located on the right-hand
side, close to the mast.
Human Care is an ISO 13485:2016 Swedish
certified medical device company . The Quality
Management System is in compliance with US
21 CFR part 820.
The product has been tested in accordance with
ISO 10535.
The product has a CE marking in accordance
with the Medical Device Directive 93/42/
EEC and/or Medical Device Regulation (EU)
2017/745). The CE mark label is at the product.
This product has been tested by an accred-
ited test institution and meets the following
necessary medical requirements: EN 10535, EN
60601-1 (electrical safety) and EN 60601-1-2
(EMC). This product carries the CE marking.
Symbols on the product and the product label:
Product operating cycle
CE marking
MD Medical Device
Product manufacturer
Maximum user weight
For indoor use
User manual: Please read the manual
to familiarize yourself with its contents
before using the product
This product contains electrical and elec-
tronic components and must be recycled
according to local guidelines.
Electric shock protection class II
Product type B: approved for physical
contact with clients (IEC 60601-1)
Содержание 90554
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