human care 90700 - Compliances and Standards; Product lifetime

4 www.humancaregroup.com
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Human Care is an ISO 13485:2016 cered
Swedish medical device company. The Quality
Management System is in compliance with US
21 CFR part 820.
The product is CE marked in accordance with
EU Direcve 93/42/EEC (MDD) and/or EU
Regulaon 2017/745 (MDR), as class I medical
device.
The CE mark is on the product.
This bed complies with all requirements
of the IEC/ISO Internaonal Standards: IEC
60601‐2‐52:2009
Compliances and Standards
This User Manual informs you, as the operator,
and your users, about the product features,
assembly and operang funcons necessary
to ensure ease of operaon, and safe handling
of this product in its normal and expected
environment.
You should therefore also regard this User
Manual, as a praccal reference book, to be
kept near the product and readily available
at all mes, for anyone involved in its use or
operaon.
Is a warning triangle used for situaons which
require extra care and aenon.
CAUTION!
Do not assemble or operate the bed accessory,
before reading this manual, as personal injury
or damage to product may occur!
Please contact Human Care in the event of any
uncertaines or quesons.
Product lifeme
The product´s expected lifeme is ten (10)
years, if the product is used as intended and
maintained according to the manufacturer´s
instrucons, depending on the intensity of use
and maximum load applied during use. If the
product label is no longer legible, the product
should be discarded.