10
Technical specifications
Standards:
Comply with general requirements for aids acc. to the following harmonized standards:
Clinical evaluation:
EN 12182:2012
Risk analysis:
DS/EN ISO 14971:2019
Quality management systems:
EN ISO 13485:2016
Service information
No other balls can be used in a Protac SensOn
®
than those used by the manufacturer.
Guide
- to daily inspection of Protac SensOn
®
before use
No. Check
Remarks
1
• All parts are in place, no loose parts
2
• No sign of holes, damage to the
textile or seams
Protac A/S
Niels Bohrs Vej 31 D, Stilling
DK-8660 Skanderborg
Tel.: 86 19 41 03
e-mail: [email protected]
Distributor list: Please refer to: www.protac.dk/kontakt
GB
