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09 10
Operation Manual of Cochlear Implant
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Manufacturer’s Information
1) Medical Device Registration Certificate No.: GXZZ 20173464498
2) Registered Product Standard No.: GXZZ 20173464498
3) Production License No.: ZSYJSCX No.20130030
4) Manufacturer: Zhejiang Nurotron Biotechnology Co., Ltd.
5) Address: No.17 Longtan Road, Yuhang District, Hangzhou, Zhejiang 311121, China
6) National Service Hotline: +086-4006-333-571
7) Website: http://www.nurotron.com
Information of CE Authorized Representative
1) CE Authorized Representative: BIOTECH INNOVATION & SOLUTIONS, S.L.
2) Address: Escoles Pies 103, 08017 Barcelona, Spain
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Marks
Following marks are printed on CS-10A implant component or package:
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Appendix
Appendix 1 - Surgical Operation Information of Cochlear Implant
Appendix 2 - Patient Identification Card
be cleared away. For implant, damage at this level is harmless. After being removed, the implant
shall be treated as polluted biologically hazardous substance that shall abide by universal
precautionary measures, placed inside a leakproof brine vessel which has been sterilized (or
disinfected), and sent back to Nurotron Company.
Warning:
After removal, the cochlear ossification may be caused by no implant in the cochlea. This side
of cochlea can’t be implanted if it has cochlear ossification.
Symbol
Explanation
Consult instruction for use
Fragile, handle with care
Humidity limitation for storage
and transport
Temperature limitation for storage
and transport
Do not re-use
Sterilized using ethylene oxide
43℃
( 109°F )
0℃
( 32°F )
Symbol
Explanation
Should not be littered with
household waste, must be deliver
to recycle bin for recycling
Do not use if package is damage
Use-by date
MR Conditional.
See MRI Safety Information
Comply with the Directive 90/385/EEC
First EC Certificate issued by BSI
Group The Netherlands B.V. in 2021
