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Operation Manual of Cochlear Implant

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
Registration address: No.17 Longtan Road, Yuhang District, Hangzhou, Zhejiang 311121, China
6) National Service Hotline: +86-4006-333-571
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

5.1 Stores

The safety system of stores will not influence the cochlear system. But when wearers pass safety 
system with speech processor on, a warning alarm will be given. To avoid misunderstandings, 
please turn off speech processor when passing safety systems, or carry with an identification 
card for check.

5.2 Airport security check

Security gates of some airports are provided with magnetic induction facilities, which may 
cause damage to your speech processor. Please turn off speech processor when passing such 
systems. The off condition will also protect your speech processor from damage by X-ray 
inspection instruments. 
Implant may incur alarm of metallic instruments. You may apply for inspection by portable 
instruments, or pass through the passage for the handicapped.

05

Safety System

Some airlines may require passengers to turn off electronic devices when air plane takes off or lands 
on. So please turn off your speech processor temporarily. You can tell stewardess that you are hearing 
impaired, so that they may inform you of necessary safety measures.

06

Taking Air Plane

If body temperature of wearer of cochlear implant exceeds 39ºC, please turn off speech processor and 

cochlear implant. Before implantation surgery, patients are suggested taking fitting test of hearing aid. 
If patients suffer from deafness caused by infectious diseases (such as meningitis), they are advised to 
take cochlear implantation immediately. To achieve the best, patients who are ready to take cochlear 
implantation and their families shall be highly enthusiastic about cochlear implantation and hold a 
suitable expectation. Meanwhile, they shall understand the importance of periodic fitting of speech 
processor programs, evaluation and speech therapy.

07

Other information

Service and warranty: the quality warranty period of implant is 12 years starting from the date of 
implantation. If your cochlear implant is used under normal conditions guided by the precautions and 
direction specified in the Operation Manual and comes up with any quality problem, our company will 
replace the product (same model) free of charge after identifying the necessity. Any improper use or 
artificial damage is beyond the warranty scope, and a certain fee will be charged at the discretion of 
Nurotron Company.

08

Warranty

09

Manufacturer's Information

conducted to the speech processor. To prevent such things, please proceed as follows:
a) When touching other people's speech processor:
Step 1 - Touch his/her body to reduce accumulation of static electricity;
Step 2 - Touch speech processor; 
b) When taking up speech processor from a table: 
Step 1 - Touch the table;
Step 2 - Take up speech processor

4.6 TV screen and computer screen

Please don't let speech processor contact these screens. Please periodically clean screens to 
prevent accumulation of static electricity. Better use anti-static screens. If touch-sensitive display 
is used, it is preferred to use a pencil with rubber on one end and touch the rubber on the screen, 
instead of using your finger.

4.7 Thunder storm zone

1) If wearer of cochlear implant stands in thunder storm, please stay away from metallic 
appliances and take down the speech processor. 
2) If children with the implantation act restlessly in thunder storm, please help them take down the 
speech processor.  

Содержание CS-10A

Страница 1: ...technology Co Ltd Address No 17 Longtan Road Yuhang District Hangzhou Zhejiang 311121 China National Service Hotline 086 4006 333 571 Website http www nurotron com CS 10A BC040122 V 2 4 Operation Manual of Cochlear Implant ...

Страница 2: ...12 2 Warning information 12 Sterilization 13 Notes on Opening Package 14 Storage Transportation and Disposal 15 Other Precautions 16 Interference to and Removal of Cochlear Implant 16 1 Interfering devices 16 2 Removal of cochlear implant 17 Manufacturer s Information 18 Marcs 19 Appendix Part II Patients Manual 1 Influence of Other Medical Surgical Methods 2 Sports and Games 2 1 Activities withou...

Страница 3: ... 4 2 Electrostatic experiments 4 3 Clothes 4 4 Getting off a car 4 5 Touching speech processor 4 6 TV screen and computer screen 4 7 Thunder storm zone 5 Safety System 5 1 Stores 5 2 Airport security check 6 Taking Air Plane 7 Other information 8 Warranty 9 Manufacturer s Information Part III Audiologist Manual 1 Mapping Time 2 Preparatory Works before fitting 3 Basic Fitting Procedures 4 Manufact...

Страница 4: ...Company Its commissioning shall be conducted with the aid of NuroSound fitting software Components of the implant include stimulator receiving coil internal electrode array external ring electrode and internal magnet Figure 1 Product Structure Diagram Figure 2 Model and Serial Number Diagram 1 Range of electrode impedance 1KΩ 20KΩ 2 Performance of stimulus signal of electric pulse Max stimulus fre...

Страница 5: ...depth and wearer s skull is too thin or signal transmission is affected if the skull is thick dizziness tinnitus facial tic or pain during electric stimulus Severe complications Electrode prolapse or implant displacement severe infections of incision breakdown necrosis of skin flap massive haemorrhage due to damage of emissarium mastoideum or sigmoid sinus leakage of cerebrospinal facial nerve par...

Страница 6: ... similar tissues muscular tissue is not recommended to form a sealed condition around the electrode array at the entrance of cochlea so as to protect electrode array and seal the operative opening 2 After the electrode array is inserted the electrode wire outside cochlea may be fixed through stitching so as to avoid displacement of electrode array after operation Spare electrode wires must be woun...

Страница 7: ...rea of an MRI scanner unless the following conditions have been met The external sound processor and headpiece are removed before entering a room where an MRI scanner is located Patient has no fever For 3T MRI implant magnet should be removed by a qualified surgeon For 1 5T MRI with implant magnet in position the bandaging procedure in Nurotron s MRI examination guide should be followed to avoid m...

Страница 8: ...leared 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...

Страница 9: ...s MRI safety information should be followed to avoid magnet movement patient discomfort or trauma and pain to the patient Caution The bandaging procedure in Nurotron s MRI safety information was developed to prevent magnet displacement and counteract magnet torque during a 1 5T MRI procedure but 01 Influence of Other Medical Surgical Methods This part for wearer of Nurotron cochlear implant mainly...

Страница 10: ... may be 04 Electrostatic Protection Wearers shall pay attention to following aspects when taking part in sports or games 2 1 Activities without physical contact such as tennis golf badminton jogging and cricket Before taking these activities please put the connection wire of battery case inside clothes lest it would be hooked and the speech processor be pulled off 2 2 Strenuous activities and thos...

Страница 11: ...re implantation surgery patients are suggested taking fitting test of hearing aid If patients suffer from deafness caused by infectious diseases such as meningitis they are advised to take cochlear implantation immediately To achieve the best patients who are ready to take cochlear implantation and their families shall be highly enthusiastic about cochlear implantation and hold a suitable expectat...

Страница 12: ...owing facilities should be prepared by audiologist before fitting 1 A computer installed with NuroSound fitting software 2 Cochlear implant speech processor 3 Connection wire for fitting 02 Preparatory Works before fitting 1 Wear signal processing unit and transmission coil on patient s ear with the implantation Connect signal processing unit with fitting software Tell patient or his her parents a...

Страница 13: ...esentative BIOTECH INNOVATION SOLUTIONS S L 2 Address Escoles Pies 103 08017 Barcelona Spain Hear more Live better 19 20 Operation Manual of Cochlear Implant 04 Manufacturer s Information 6 Test hearing After setting the T and C values of every electrode an electric audiogram will be formed Save this audiogram in computer Activate it through the computer and play it to patient Adjust the audiogram...

Страница 14: ...Enduro Earhook Enduro Transmission Wire 6cm Enduro Transmission Wire 8cm Enduro Transmission Wire 10cm Enduro Transmission Wire 20cm Enduro Transmission Wire 28cm Enduro Waterproof case Enduro Signal processing unit button assembly COCHLEAR IMPLANT CS 10A SD COCHLEAR IMPLANT CS 10A TS COCHLEAR IMPLANT CS 10A TM COCHLEAR IMPLANT CS 10A TL Sterile non magnetic metal plug Implant magnet Product Refer...

Страница 15: ...cm Transmission Coil VENUS 60C 20cm Transmission Coil VENUS 60C 28cm VENUS 60C External magnet 2 VENUS 60C External magnet 3 VENUS 60C External magnet 4 VENUS 60C External magnet 5 VENUS 60C External magnet 6 VENUS 60C External magnet 8 Product Reference Product Name CP02 1038 CP02 1039 CP02 1041 CP02 1046 CP02 1045 CP00 0026 CP02 1025 CP02 1023 CP00 0082 CP00 0001 CP02 1022 VENUS 60C Rechargeable...

Страница 16: ... SD is also noted as CS 10A in internal documents of Nurotron Picture Picture Product Reference Product Name Picture CP02 1034 CP02 1035 CP02 1036 VENUS 60C BTE Battery Extension Wire 20cm VENUS 60C BTE Battery Extension Wire 30cm VENUS 60C BTE Battery Extension Wire 40cm ...

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