NUROTRON CS-10A User manual

Zhejiang Nurotron Biotechnology Co.,Ltd.
Address: No.17 Longtan Road, Yuhang District, Hangzhou,
Zhejiang 311121, China
National Service Hotline: [phone]
Website: http://www.nurotron.com
CS-10A
BC040122
V 2.4
Operation Manual of
Cochlear Implant

Part I Surgeons’ Manual
1. Working Principle
2. Product Structure
3. Model
4. Serial Number
5. Performance Index of the Product
5.1 Basic parameters
5.2 Performance index
6. Scope of Application
7. Contraindication
8. Measuring Cochlea size and selecting electrode length
9. Surgical Process
10. Operative Complications
11. Operation-related Risk Prevention and Warning
12.1 Risk prevention
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 without physical contact (such as tennis, golf, badminton, jogging and cricket)
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Part I
Surgeons’ Manual
2.2 Strenuous activities and those with physical contacts
(such as soccer, basketball, squash and boxing)
2.3 Water sports (such as swimming, playing at waterside and diving)
3. Electromagnetic Interference
4. Electrostatic Protection
4.1 Children's playground with plastic toys
(such as slide, crawling tunnel, colored ball pool, small air inflated castle)
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. Manufacturer's Information
Part IV Nurotron Cochlear Implant System Components List
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01 02
Operation Manual of Cochlear Implant
5.2 Performance index
5.1 Basic parameters
01 Working Principle
03 Model
05 Performance Index of the Product
The cochlear system comprises of cochlear implant (hereinafter shortened as implant) and
cochlear implant speech processor (hereinafter shortened as speech processor). Implant is the
implantable part of the cochlear system, whose working principle is to receive the sound signal
processed by speech processor in the radiofrequency way, decode the signal and convert it into
electric currents, and then stimulate the residual acoustic nerve through electrode array on the
cochlea, so as to enable the brain of a severe-to-profound sensorineural deafness sufferer to
sense the sound.
Product model: CS-10A. Product model of the implant is printed on the shell of stimulator at
the place shown as in Figure 2.
04 Serial Number
Serial number of the implant is SN: XXXXXX (e.g. SN: 000001), printed on the shell of
02 Product Structure
Implant is the implantable part of the cochlear system, used with the NSP-60 speech processor
produced by Nurotron 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 frequency of every current source: 20 kHz
Width of stimulus pulse: 4µs~425µs
Intensity of stimulus current: 0µA~1900µA
3) Storage condition:
Storage temperature: -10±3 ºC ~55±2ºC
Air pressure: 70kPa±5%~150kPa±5%
No. Name Item Remark
Nominal
parameters
1Stimulator
Diameter
Thickness
Diameter
Length
Length of internal
electrode array
20mm
6.2mm
33mm
102.4mm
20.5mm
16.0 mm
20.5 mm
24.0 mm
≤9g
3.75mm above bone
Customized based on requirement
Standard Electrode (SD)
Thin Short-length Electrode (TS)
Thin Medium-length Electrode (TM)
Thin Long-length Electrode (TL)
Receiving coil
Electrode
Weight
2
3
4
This part (for surgeons) mainly describes the working principle, product structure, performance
index and operation process of cochlear implant.
External ring electrode
External planar electrode
Internal electrode array
Stimulator
Receiving coil
Internal magnet
Model
Serial Number
stimulator at the place shown as in Figure 2.

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03 04
Operation Manual of Cochlear Implant
06 Scope of Application
07 Contraindication
08 Measuring Cochlea size and selecting electrode length
09 Surgical Process
The cochlea implanting operation shall be performed in accordance with the Operating Guidance
on Implantation of Cochlea published by China Medical Association, which mainly includes
following procedures:
1) Make an incision behind the ear, detach skin flap, cut open musculo-periosteal flap, and expose
the mastoid and back wall of bony external auditory meatus;
2) Open the mastoid cavity;
3) Grind a bone bed of 15mm in diameter and 2.5mm in depth on the surface of skull;
4) Open facial recess and perform fenestration operation of the cochlea;
5) Place implant in the bone bed and implant electrode in the tympanic canal;
6) Stitch in sequence musculo-periosteal flap, subcutaneous tissue and skin;
7) Carry out impedance test of implant during the operation.
Notes:
1) The implanting operation of cochlea shall be performed by professional doctors who are skillful
in otology micro-surgery and have taken specialized trainings on cochlea operations.
2) Maintain the surface facing the cochlea axis and insert the electrode in, until the marking on the
end of electrode contact array reaches the opening of cochlea.
3) If impedance test of implant is to be conducted before stitching skin flat, temporarily restore
skin flap and / or use other means to enhance the contact between implant and tissues, so as to
decrease the impedance of implant. Operating distance of transmission coil of speech processor is
3-10mm. Beyond this distance, the system may not function properly.
10 Operative Complications
Cochlear implantation is a relatively safe operation, with such commonly seen complications as:
Common complications: subcutaneous hematoma; tympanum or external auditory meatus
perforation; facial nerve or tympanic cord nerve paralysis; implant is prolapsed if it is not
implanted to a sufficient 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 paralysis; electrode failure; taste
disturbances.
Other complications: Implanted silicone allergy; Device failure; Wound Swelling; Wound
breakdown
Declining cognitive function; Acute otitis media; Pain; Non-auditory sensation.
The product is applicable to severe-to-profound sensorineural deafened patients aged 12 months
and above. Implant is the implantable part of the cochlear system, used with the NSP-60C speech
processor produced by Nurotron Company. The part has been certified by national or local SFDA
departments. Its commissioning shall be conducted with the aid of NuroSound fitting software.
Absolute contraindications:
1) Serious malformation of inner ear, such as Michel deformation or cochlea absence;
2) Auditory nerve absence;
3) Deafness caused by non-cochlea illness;
4) Serious mental disease;
5) Uncured purulent mastoiditis of middle ear.
Relative contraindications:
1) Bad physical condition;
2) Uncontrollable epilepsy.
CS-10A cochlear implant electrodes have three different lengths: TS 16mm, TM and SD 20.5mm
and TL 24mm. To maintain a relatively constant insertion depth for patients with different
cochlear sizes, a small cochlea shall fit a short electrode and a large cochlea shall fit a long array.
The cochlea size shall be estimated by measuring the basal diameter of the cochlea (defined as A
value as shown in the figure below) on a CT scan image with
an oblique coronal view or the axial plane view. The A value
is measured from the mid-round window through the center
of the cochlea to the lateral wall. Based on the A value,
electrode type can be selected per the Table below.
Other methods to estimate cochlea size can be also used at the
surgeons’ discretion.
< 8 mm 8 – 10 mm > 10 mm
TS electrode SD /TM electrode TL electrode
Cochlea Diameter A value
Electrode Type

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Operation Manual of Cochlear Implant
11 Operation-related Risk Prevention and Warning
11.1 Risk prevention
1) Cochlear implantation operation shall be performed under a general anesthesia. The patient
needs anesthesia evaluation before surgery to determine whether general anesthesia can be
performed, especial the patients with recent colds, pneumonia patients, and hypertensive patients.
2) Meningitis is a rare but possible complication of the operation. By injecting vaccine, antibiotics
or performing operations, the risk of meningitis may be lowered;
3) To reduce the risk of facial nerve injury, a facial nerve monitor is suggested during operation;
4) To minimize the risk of postoperative infection/wound breakdown, it is suggested that bone bed
shall be ground first, then perforate the cochlea. The implantation shall avoid contacting of
implant with sharp edges of bones or entering of bone dust into cochlea.
5) Preventive antibiotics are suggested during the operation unless medically prohibited;
6) Dissection marks shall be made explicitly. Try not to expose cerebral dura mater when drilling
mastoid. Exposure or injury of cerebral dura mater will increase the risk of postoperative
meningitis;
7) Implant shall be fixed on the groove of temporal bone, and electrode shall be placed inside
intraosseous access. In this way, the part implanted will not displace. Constant displacement of
implant will result in electrical connection problems;
8) To achieve the highest magnetic force and optimum coupling, the implantation is performed by
making an incision behind the ear. Thickness of skin flap shall be controlled within 2~9mm.
Groove of temporal bone must be flat to secure the implant. The transition from temporal bone
groove to electrode access must be smooth and inclined and without any sharp edges, so as to
avoid damage of electrode contacts;
9) To avoid other postoperative risks, please refer to Operation Manual of Cochlear Implant
Speech Processor.
11.2 Warning information
1) All electrodes shall be inserted into cochlea with no pressure exerted. Use aponeurosis or
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 wound under the overhung inner bone of mastoid cavity, so as to avoid moving of
electrode array out of cochlea, or electric fault due to moving of electrode array under external
12 Sterilization
Implant has been sterilized by epoxy ethane and aseptically packaged. Before use, make sure that
the product is within its validity period. Before operation, please do not open the aseptic package.
Aseptic package shall be opened in the operating room. Once the package is opened, the implant
shall be implanted immediately. Do not use the implant if the package is broken, or sterilize for
the second time. All implants can only be used once.
13 Notes on Opening Package
For notes on the opening package, please refer to the opening instructions on the inner cover of
implant's packing carton.
14 Storage, Transportation and Disposal
Sterilized implant shall be put inside implant's packing carton, stored and transported under the
humidity range of 15-75% and temperature range of 0 ºC (32°F)-43 ºC (109°F). All implants shall
be used within the validity period printed on the package. Disposal of package shall be in
accordance with relevant laws and regulations (Please refer to Note 1).
Note 1: Packing carton and plastic package of implant (PETG and Tyvek) may be produced by
recyclable materials.
15 Other Precautions
1) Implant can not be reconstructed for other use.
2) Expected service performance of cochlea can not be precisely estimated. Patient and his/her
pressure.
3) Do not place the commissure directly over electrode array.
4) Incorrect implanting position of electrode array may impair the auditory sense of human body
system. In such cases, new operations shall be performed, which will increase expenses and pains
of wearers. Incorrect fixation or position of electrode array may also result in premature failure of
implant.
5) Surgical instruments coming up to requirements shall be used in the implantation operation.

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07 08
Operation Manual of Cochlear Implant
CS-10A series cochlear implant is MRI Conditional for 1.5T or 3.0T closed bore MRI scanning.
There is a small chance that during MRI, the implant magnet could dislocate from the retainer
implant if not properly bonded; the magnet strength may change; Patients may feel discomfort or
pain at the implant site. The magnet and the titanium case shell of implant cause artifact (please
see pictures below). 1.5T MRI can be performed with the implant magnet in place if the bandaging
procedure of implant magnet is followed. For 3T MRI, the implant magnet must be removed by a
qualified surgeon.
16 Interference to and Removal of Cochlear Implant
16.1 Interfering devices
1) Monopole electro surgical apparatus is strictly prohibited.
2) Nurotron cochlear implant CS-10A is MR Conditional. Before MRI examination, the patient
should clearly inform Nurotron of which MRI examination is to be performed. The patient can
contact local Nurotron staff or Nurotron clinical personnel through customer service hotline (+86)
400-6333571 (China Headquarter), or ([phone] (European Representative). Before MRI,
the patients should see their implantation surgeon to make sure they are safe to take MRI
examination.
family shall have a practical expectation upon the effect of cochlea.
3) Always ensure asepsis of implant.
4) Make sure no falling of implant on hard objects.
5) Mechanical damages may result in implant failure, such as due to bump on head or other
technical failure of electronic device or implant. In case of any technical failure, re-implantation
is necessary.
6) Before implantation surgery, patients are suggested taking fitting test of hearing aid. Patients
suffering deafness caused by infectious diseases (such as meningitis) 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.
MRI Warnings
Do not allow patients with a CS-10A cochlear implant to be in the area 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 magnet movement, patient discomfort, or trauma
and pain to the patient.
● Caution: The bandaging procedure in Nurotron’s MRI examination guide was developed to
prevent magnet displacement and counteract magnet torque during a 1.5T MRI procedure, but
some discomfort and pain at the implant site may still be experienced. Please consult with your
physician if this is an issue.
3) The influence of thermal healing process, nerve stimulation, electric shock, ionizing radiation,
cobalt therapy, positive electron section scan, transcranial ultrasound, linear acceleration,
high-energy electric field and defibrillator upon implant are unknown, and these treatment
methods are not suggested temporarily.
16.2 Removal of cochlear implant
If implant is not in normal working condition due to accidents, medical or technical reasons, it is
better to be taken out of body. If not, periodic functional check of the implant is suggested.
Ex-plantation may result from different reasons:
If it is caused by the implant failure or upgradation, please incise the skin to expose the implant
and electrode wire to the point of round window or the original fenestration. Gently remove the
sclerotin around implant and electrode wire, and then remove the previous implant. After that,
please insert in the new implant and make sure it is properly fixed. And please send the ex-planted
implant back to NUROTRON.
If it is caused by skin infection, please incise the skin to expose the implant, and cut the electrode
wire in a proper position to preserve the intra-cochlear electrode, which benefits the
re-implantation. Then remove the stimulator and receiving coil and send back to NUROTRON.
Anti-infection treatment shall be provided and infected wound drainage shall be provided if
necessary.
If it is caused by labyrinthitis, please remove the whole implant including coil, stimulator and
intra-cochlear electrode at once. And take care of the wound accordingly.
After the implant is taken out, it shall be suitably cleaned and sterilized, and body tissue shall

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09 10
Operation Manual of Cochlear Implant
17 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: [phone]
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
18 Marks
Following marks are printed on CS-10A implant component or package:
19 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

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Operation Manual of Cochlear Implant
MRI
Nurotron cochlear implant CS-10A is MR Conditional. Before MRI examination, the patient
should clearly inform Nurotron of which MRI examination is to be performed. The patient can
contact local Nurotron staff or Nurotron clinical personnel through customer service hotline (+86)
400-6333571 (China Headquarter), or ([phone] (European Representative). Before MRI,
the patients should see their implantation surgeon to make sure they are safe to take MRI
examination.
MRI Warnings
Do not allow patients with a CS-10A cochlear implant to be in the area 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
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 describes the daily precautions and
directions for the use of Nurotron cochlear system.
Wearers shall pay attention to following aspects in daily life:
CS-10A series cochlear implant is MRI Conditional for 1.5T or 3.0T closed
bore MRI scanning. There is a small chance that during MRI, the implant
magnet could dislocate from the retainer implant if not properly bonded; the
magnet strength may change; Patients may feel discomfort or pain at the
implant site. The magnet and the titanium case shell of implant cause artifact
(please see pictures below). 1.5T MRI can be performed with the implant
magnet in place if the bandaging procedure of implant magnet is followed. For
3T MRI, the implant magnet must be removed by a qualified surgeon.
Part II
Patients’ Manual

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13 14
Operation Manual of Cochlear Implant
Wearers of cochlear implant are open to electromagnetic interference of some equipments. But
this is a temporary phenomenon, and will not damage the cochlear implant or wearers' ear.
Interfering equipments generally include:
1) Around high-voltage line system;
2) Radio signal or TV signal transmitting tower;
3) Mobile-phone signal transmitting tower;
4) Safety system of shopping center or airport.
If you continuously hear humming sound or changing tones, please take down the speech
processor and contact our after-sale service personnel.
03 Electromagnetic Interference
Electrostatic discharge could damage implant's electronic components or speech processor's
programs. Static electricity is very common in our daily life. Following precautionary measures
may reduce electrostatic interference.
4.1 Children's playground with plastic toys
(such as slide, crawling tunnel, colored ball pool, small air inflated castle)
Before children enter a playground, please turn off and remove their speech processor, because the
off condition will still result in static electricity and program loss.
4.2 Electrostatic experiments
Before running electrostatic experiments, please take down speech processor.
4.3 Clothes
Friction of clothes will incur static electricity. All-cotton clothes are recommended. Generally,
wearers shall wear clothes first and turn on speech processor. Before taking off clothes, please turn
off speech processor and take it down, so as to prevent accumulation of static electricity.
4.4 Getting off a car
To get off a car, wearers shall grab car door, step on ground and then lose hold of hands. Children
shall get off in the same way with the help of parents or guardians.
4.5 Touching speech processor
When touching or taking up a speech processor, electric charge built-up in human body 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 those with physical contacts (such as soccer,
basketball, squash and boxing)
Wearers of cochlear implant shall try not to take part in such activities. If they have to take such
activities, please remove speech processor beforehand for safety considerations. These activities
may bump or squeeze your head. Therefore, please put on a helmet or take other protective
measures to avoid direct impingement on head part with the implant.
2.3 Water sports (such as swimming, playing at waterside and diving)
Please remove speech processor first before taking water sports. Protective devices such as
goggles shall not pressurize on the head part with implant, lest damage of the implant occurs. If
possible, please wear a safety helmet to prevent any damage to implant.
Some wearers of the cochlear implant will suffer from loss of equilibrium sense. When they are
diving under water, they may lose the direction-sense and space-sense. Therefore, wearers of the
implant are suggested diving under the direction of professionals to distinguish directions. It is
risky to dive. Please be aware that water pressure and diving equipments may damage your
implant.
02 Sports and Games
some discomfort and pain at the implant site may still be experienced. Please consult with your
physician if this is an issue.
Monopole electro surgical apparatus is strictly prohibited.
The influence of thermal healing process, nerve stimulation, electric shock, ionizing radiation,
cobalt therapy, positive electron section scan, transcranial ultrasound, linear acceleration,
high-energy electric field and defibrillator upon implant are unknown, and these treatment
methods are not suggested temporarily.