Protac SensCircle Instrucciones De Uso página 13

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Technical specifications
Dimensions and weight:
Length/height:
Total weight – Oxford 3820 model with plastic balls and granules:
Total weight – Medley 2600 model with granules:
Weight of outer cover:
Weight per module with plastic balls:
Weight per module with granules:
Standards: Comply with general requirements for aids acc. to the following harmonized standards.
EN ISO 13485:2016/A11:2021: Medical Devices – Quality management systems
EN ISO 14971:2019/A11:2021: Medical devices - Application of risk management to medical devices
DS/EN ISO 21856:2022 : Medical devices - Assistive products - General requirements and test methods.
Ignitability test: Tested in accordance with the standards stipulated in the table
Ignitability test
Fabric Oxford-3820
& EVA plastic balls
Fabric Medley-2600
& granulate
Granulat
The Protac SensCircle
®
granulate
Service information
Do not use balls in your Protac SensCircle
Guide
- to daily inspection of the your Protac SensCircle
No. Check
1
• All parts are in place, no loose parts
(modules)
2
• Stitching ok
Protac A/S
Kystvejen 17, 1.
DK- 8000 Aarhus C
Tel.: 86 19 41 03
Distributor list: Please refer to: www.protac.dk/kontakt
EN 1021-1:2014
X (cigarette test)
contains 3 modules, filled with either EVA plastic balls or polypropylene
other than those used by the manufacturer.
®
EN 1021-2:2014
BS5852-1:1979
X (match
flame test)
X (cigarette test)
before use
®
Remarks
2.50/0.35 m
approx. 4.5 kg.
approx. 3.5 kg.
approx. 1.0 kg.
approx. 2.0 kg.
approx. 0.8 kg.
DK
GB
DE
BS5852-2:1982
FI
X (flame test)
FR
NL
SE
ES
IT
13
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