User’s Manual for Xplore
Version 2.53 - Version date: 15.02.2022
Page
38
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46
13.
Tests and approvals for
The Xplore and its accessories are CE marked in accordance with the following regulation and standards:
EU 2017/745 Medical Device Regulation (MDR)
FOR-2021-05-09-1476 Forskrift om medisinsk utstyr
NS-EN 12182 :2012
SS-EN 12182 :2012
DIN EN ISO 11199-3 :2005 §4.3
NS-EN ISO 14971 :2019
NS-EN ISO 13485 :2016
Declaration of conformity is available upon request.
This user’s manual is delivered together with the product. The user’s manual can also be downloaded
from our web-site: www.madeformovement.com
14.
Waste handling
All the parts of the Xplore can be recycled. The product should be delivered to an approved waste
management facility. Straps, elastic bands, padding and clips can be treated as normal household waste.
15.
Cleaning and maintenance
a.
Cleaning
The Xplore should be cleaned with a damp cloth and mild soapy water. Do not use solvents, high
pressure washers or other strong cleaning methods. The same applies to the straps and padding. If
the Xplore is used outdoors, sand and dirt must be brushed off properly after use.
The Xplore is resistant to disinfectants and can be disinfected if necessary with commercially
available disinfectants or those listed on the Norwegian Medicines Agency’s VAH/RKI list.
The cuffs can be machine-washed, max. 40°C. Avoid using a tumble dryer.
Use mild soap!
