www.humancaregroup.com 17
ENGLISH
Compliances and Standards
Human Care is an ISO 13485:2016 cered
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
Direcve 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 product has been tested in accordance
with ISO 11199-2:2005.
Compliances and Standards
About our products
On delivery
Check the following before using your new
product:
1. Check that no damage has occurred during
transport (if this is the case, please immedia-
tely inform the delivery agent).
2. Check that the number and type (s) of
products detailed on the delivery cercate
agree with the goods delivered.
3. Check that the delivery is of the desired
model and type of product.
Please contact us immediately in case of any
delivery problem.
Return or refund
If any product has to be returned for any rea-
son, please contact us to obtain a claim number
and advice on how to proceed.
The goods should be returned in complete and
undamaged condion in their original packa-
ging.
The following informaon should accompany
any product on its return. The product’s iden-
caon number, delivery date, the date the user
took possession of the aid, the date of the pro-
duct’s last service, the person whom we should
contact about the fault, whether it be the user
or another, and the nature of the fault.
Human Care HC AB reserves the right to inspect
the returned product. If no fault can be found,
the item will be returned to the user. Transport
costs may then be chargeable.
Product lifeme
The product´s expected lifeme is seven (7)
years, if the product is used as intended and
maintained according to the manufacturer´s
instrucons, 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.