Unitron Charger Combi BTE 2 - Page 26

28-Sep-2023
3
Document Detail
Sub Document
PDL-18263 [1]
DOCUMENT
029-1301-27 User Guide Unitron
Charger-Combi-BTE-2 - HE
Sub Document
PDL-18264 [1]
DOCUMENT
029-1301-28 User Guide Unitron
Charger-Combi-BTE-2 - RO
Sub Document
PDL-18265 [1]
DOCUMENT
029-1301-29 User Guide Unitron
Charger-Combi-BTE-2 - FA
Sub Document
PDL-18266 [1]
DOCUMENT
029-1301-42 User Guide Unitron
Charger-Combi-BTE-2 - ES-SA
Sub Document
PDL-18267 [1]
DOCUMENT
029-1301-43 User Guide Unitron
Charger-Combi-BTE-2 - PT-BR
Related
PDL-18365 [1]
DOCUMENT
029-6812-02 User guide Hansaton
B Charger
Approvals
Sign-off BySign-off DateJob TitleLevel Actor
53BHYNESBryan Hynes 1 02-Feb-2023
Coordinator, Information Control
53JBROOKESJanette Brookes 2 02-Feb-2023
Technical Administrator,
Information Control
53HPARMARZeljko Nadjmico 2 07-Feb-2023
Manager, Quality Assurance and
Regulatory Systems
53SBERHANESamson Berhane 2 06-Feb-2023
Product Manager
Access Activity
Accessed By Accessed Date
Revision Notes
Note
Remark
07-Feb-202353TMARINIC
CHANGE-PLN-1100-01063
Humidity 70%
Added to chapter 1.: For charger,
use only IEC 60950-1*,
IEC 62368-1 and/or IEC 60601-1
certified
equipment with an output rating of
5 VDC. Min. 500 mA.
added: add "IEC 60601-1-11"
Changed "Power pack" to "charging
accessory" in warning:
Only authorized personnel are
allowed to open the charging
accessory due to possible electrical
hazard.
Remark
28-Apr-202353MWHITEMAN
The User Guide was approved with
discrepancies compared to the
warning texts of RISK-145 and
RISK-1085. Impact was assessed
and recorded in NC-2023-000681,
NC Deviation record.
The User Guide can be released to
the market in its current version.