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www.humancaregroup.com
Care Assist Rail
Human Care is an ISO 13485:2016 certified
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 Directive 93/42/EEC (MDD) and/or EU
Regulation 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 International 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 operating functions necessary
to ensure ease of operation, and safe handling
of this product in its normal and expected
environment.
You should therefore also regard this User
Manual, as a practical reference book, to be
kept near the product and readily available
at all times, for anyone involved in its use or
operation.
Is a warning triangle used for situations which
require extra care and attention.
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
uncertainties or questions.
Product lifetime
The product´s expected lifetime is ten (10)
years, if the product is used as intended and
maintained according to the manufacturer´s
instructions, 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.
