Cochlear CP1110S Surgical Processor Instruction Manual

Warnings
Warnings
Surgical processor and parts
Your device contains magnets that should be kept away from life supporting devices (for example, cardiac pacemakers and ICDs (implantable cardioverter defibrillators) and magnetic ventricular shunts), as the magnets may affect the function of these devices. Keep your surgical processor at least 15 cm (6 in) from such devices. Contact the manufacturer of the specific device to find out more.
Your surgical processor and tablet radiate electromagnetic energy that may interfere with life supporting devices (for example, cardiac pacemakers and ICDs). Keep your surgical processor and tablet at least 15 cm (6 in) from such devices. Contact the manufacturer of the specific device to find out more.
Do not attempt stimulation of unsupported implants with Nucleus SmartNav or the surgical processor.
Your surgical processor may be affected by other sound processors or coils. Always keep your surgical processor more than 1 cm away from other sound processors or coils.
The surgical processor and other parts of the system contain complex electronic parts. These parts are durable but must be treated with care.
Do not use excessive force on the surgical processor when in contact with the implant. Use of excessive force interferes with the surgical placement of the implant.
Check the surgical processor for signs of overheating when in use. Remove the device immediately if it becomes hot.
Do not expose the surgical processor or parts to heat. Do not use the surgical processor in a room where an MRI scanner is located. No modification of this equipment is allowed. Warranty will be void if modified. Consider security when connecting your surgical processor to devices. Only connect to
devices that are protected, for example, password or PIN access control. Do not connect to devices that have had their operating system altered.

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Warnings
Batteries
Do not use damaged or deformed batteries. If skin or eyes come into contact with battery fluid or liquid, wash out with water and seek medical attention immediately.
Dispose of used batteries promptly and carefully, in accordance with local regulations. Keep away from children.
Do not short-circuit batteries (for example, do not let terminals of batteries contact each other, do not place batteries loose in pockets).
Do not disassemble, deform, immerse in water or dispose of batteries in fire. When surgical processor is not in use, remove the batteries and store separately in a
clean and dry place. Wipe batteries with a clean dry cloth if they become dirty. Store unused batteries in original packaging, in a clean and dry place. Do not expose batteries to heat. Never put batteries in your mouth. If swallowed, immediately contact your physician or
local poison information service. Only use rechargeable batteries and battery chargers supplied by Cochlear. Use of other
batteries or battery chargers may result in harm or injury. Charge rechargeable batteries before use. Do not touch the battery charger contacts.
Intraoperative considerations
When using the Cochlear Objective Measures software, the computer running the software must be positioned away from the operative field in a location that keeps cords from crossing the sterile field and out of the way of all operating room staff.

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Medical treatments

Medical treatments
Magnetic resonance imaging (MRI)

The Cochlear Surgical Processor is MR Unsafe. Do not use the surgical processor in the same room where an MRI scanner is located.
Full MRI safety information is available at:
www.cochlear.com/mri
or by calling your regional Cochlear office (contact numbers available at the end of this document).

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Other information
Other information
Physical configuration The processing unit comprises:
custom analogue and digital integrated circuits with digital signal processing (DSP) and bidirectional wireless communication capabilities
a tri-colour visual indication of surgical processor function or problem control button allowing user control of key features custom 4-pin connector for coil cable. The batteries provide power to the processing unit. The coil acts as a transformer coupling that transfers energy and data to the implant.

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Other information

Materials
The table below lists the materials of the main components of the CP1110S Surgical Processing Unit and Surgical Coils that come into contact with the skin.

Component Processing unit Earhook Magnet Magnet casing Battery modules
Microphone cover
Top housing
Bottom housing
Coil

Material Copolyester PA12 + liquid silicon rubber Neodymium ABS Copolyester Copolyester GORE® cartridge: Oleophobic Polyester Blend Colour: White Copolyester Colour: Yellow Copolyester Colour: White Polypropylene (PP) Thermoplastic elastomer (TPE)

Coil cable sheath Coil spacer
Coil cable plugs

Polyvinyl chloride (PVC) Bormed RF830MO Polypropylene (PP) and Thermoplastic elastomer (TPE)

Battery life, charge cycles and lifespan
Battery life means the time a device will run before the rechargeable battery module must be recharged.
Battery charge cycle is a full charge and discharge of the rechargeable battery.
Battery lifespan means the total number of charge cycles a rechargeable battery will last before the battery life degrades to 80% of its original fully-charged capacity.

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Operating characteristics

Other information

Surgical processor and associated accessories

Factor Supplied sterile or non-sterile

Conditions of use Non-sterile

Special installation requirements

Not Applicable device is not permanently installed

Equipment required for intended use

Nucleus SmartNav or
Cochlear Research Platform Software and Cochlear Wired Programming Pod
Sterile covering

Mode of operation

Continuous operation

Environmental conditions
Condition Storage and transport temperature Storage and transport humidity
Operating temperature (surgical processor)
Operating temperature (battery charger) Operating relative humidity Operating pressure

Minimum -10° C (+14° F) 0% RH +5° C (+41° F)
0° C (+32° F) 0% RH 700 hPa

Maximum +55° C (+131° F) 90% RH +30° C (+86° F)
+40° C (+104° F) 90% RH 1060 hPa

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Other information

Surgical processing unit

Characteristic Form factor
Wireless data or power interfaces
Wired data or power interfaces Magnets Battery options RF frequency Max. RF output power
Input voltage
User interface Button functions Colours

Value / range
Behind the Ear (BTE)
Proprietary radiofrequency (RF) link to implant 2.4 GHz connectivity data link to compatible devices Published commercial wireless protocol (Bluetooth
Low Energy) Proprietary 6-pin (NEUF)
Type: Imaging Strength: 5(I)
Power Extend battery module
2.4 GHz
< 4 dBm
3.00 – 4.2 V (when using SmartNav only) 3.00 V (when using the Cochlear Wired Programming Pod only)
Button, Tri-colour LED indicator Turn surgical processor on and off, device verification White, yellow (top housing), grey (button)

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Battery module Type Power extend battery module Type and chemistry Capacity / Nominal voltage Usable voltage range Typical battery life (Battery autonomy) Battery recharge time
Battery lifespan
Colour options

Other information
Capacity / voltage range
Rechargeable lithium ion 183 mAh / 3.7 V 3 4.2 V At least 4 hours1 Less than 4 hours >= 80 % capacity after 400 charge/discharge cycles at room temperature Values may vary depending on use White (same as processing unit and coil)

Coil
Characteristic Coil
Variants
Input voltage Output voltage Operating frequency Transmission range Data rate Colour options (coil and cable where applicable)

Value / range Separate from processing unit (BTE), integrated cable Surgical includes in-line choke and in-line voltage booster 17 cm, 2 m lengths 2.6 V 3.3 V 5 MHz 1 – 16 mm Variable dependent on link mode
White (same as processing unit and battery module)

1 Battery life (or Battery Autonomy) is based on two typical SmartNav sessions of one hour each and two hours of `coil off time’, with processor not paired with an implant, but still paired with the iPad running SmartNav

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Other information

Product component dimensions (Typical values)

Length

Width

Depth

Diameter

Surgical processing unit with medium earhook and power extended battery module

43.4 mm

8.9 mm

41.3 mm

N/A

Surgical Coil

N/A

6.4 mm

30.7 mm

Power extend battery module

24.8 mm

8.9 mm

17.6 mm

N/A

Product weight (Typical values)

Component

Surgical processing unit (no battery module)

Surgical processing unit with power extend battery module

Surgical coil and cable (without coil magnet)

Surgical coil (2 m) (without coil magnet)

Type

Strength

Magnets

Imaging

5(I)

Weight 3.3 g 9.4 g 8.5 g 19.2 g Weight 6.4 g

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Other information
Wireless communication link Bluetooth Low Energy operates in the 2.4 GHz ISM band, using frequency hopping over 37 channels to combat interference. Operating range is up to 10 metres, and Nucleus SmartNav indicates when the surgical processor is out of operating distance (or switched off) or when the link is interrupted due to broad spectrum interference.
Equipment classification
Your sound processor is internally powered equipment Type B applied part as described in the international standard IEC 60601-1:2005/A1:2012+A2:2020, Medical Electrical EquipmentPart 1: General Requirements for Basic Safety and Essential Performance.

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Other information
Electromagnetic compatibility (EMC)
Guidance and manufacturer’s declaration – electromagnetic emissions The CP1110S Surgical Processor is intended for use in the electromagnetic environment specified below. The customer or the user of the CP1110S Surgical Processor should assure that it is used in such an environment.

Emissions Test

Compliance

RF emissions CISPR 11 Group 1

Class A

Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker emissions IEC 61000-3-3

Not applicable Not applicable

Electromagnetic Environment-Guidance
The CP1110S Surgical Processor uses RF energy only for its internal function. RF emissions adhere to the requirements of the standards for use in the professional healthcare environment.
The device is suitable for use in clinics and hospitals.

Note: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential ENVIRONMENT (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radiofrequency communication services. The user might need to take mitigation measures, such as relocating or reorienting the equipment.

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Immunity Test

Compliance Level

Electrostatic discharge (ESD) IEC 61000-4-2

Contact discharge: ± 8 kV
Air discharge: ± 2, ± 4, ± 8, ± 15 kV

Electrical fast transient/burst IEC 61000-4-4

Not applicable

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Not applicable

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

30 A/m

Proximity magnetic
fields 9 kHz to 13.56 MHz

8 A/m 30 kHz 65 A/m 134.2 kHz 7.5 A/m 13.56 MHz

Electromagnetic Environment-Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Not applicable
Not applicable
Power frequency magnetic fields should be at levels charcteristic of a typical location in a typical commercial or hospital environment. Refer to Guidance on page 49.

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Other information
Guidance and manufacturer’s declaration – electromagnetic immunity The CP1110S Surgical Processor is intended for use in the electromagnetic environment specified below. The customer or the user of the CP1110S Surgical Processor should assure that it is used in such an environment.
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used no closer to any part of the CP1110S Surgical Processor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Immunity Test: Conducted RF IEC 61000-4-6 Compliance Level: 3 V 0.15 to 80 MHz; 6 V in ISM 0.15 to 80 MHz Recommended separation distance d = 1.16P
Immunity Test: Radiated RF IEC 61000-4-3 Compliance Level: 3 V/m 80 MHz to 2.7 GHz d = 0.35 P 80MHz to 800MHz d = 0.70 P 800 MHz to 2.7 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
Immunity Test: Proximity fields from RF wireless communications equipment IEC 61000-4-3. Refer to Guidance on page 49. Compliance Level: 385 MHz (27 V/m); 450, 810, 870, 930, 1720, 1845, 1970, 2450 MHz (28 V/m); 710, 745, 780, 5240, 5500, 5785 MHz (9 V/m)
Note: · At 80 MHz and 800 MHz, the higher frequency range applies. · These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. · If abnormal performance is observed, additional measures may be necessary, such as relocating your position, or reorienting the CP1110S Surgical Processor or accessories, before attempting the action again.

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Other information
Guidance Interference may occur in the vicinity of equipment marked with the following symbol:
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in.) to any part of the Surgical Processor, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Radio Frequency Identification
RFID uses electromagnetic fields to automatically identify and track tags attached to objects. Interference may occur in the vicinity of equipment that uses RFID readers, such as shop security, card scanners, contactless payments.
Note: The existence of fixed or mobile RFID readers may not be visible as you pass through a RF zone.

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Other information
Environmental protection
Your surgical processor contains electronic components subject to the Directive 2012/19/EU on waste electrical and electronic equipment.
Help protect the environment by not disposing of your surgical processor or batteries with your unsorted household waste. Please recycle or dispose of your surgical processor according to your local regulations for electronics.

Compatible accessories

Category Power Retention Clinical

Accessories
Cochlear Power Extend Rechargeable Battery Module, Cochlear Y Battery Charger, Cochlear USB Power Adaptor.
Cochlear Magnet (5(I) only), Cochlear 5(I) Magnet Cover, Cochlear Earhook (M only).
Cochlear Wired Programming Pod, Cochlear Programming Cable.

Compatible software applications

Application
Nucleus SmartNav
Cochlear Research Platform

Module Not applicable. Cochlear Objective Measures software.

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Other information
FCC (Federal Communications Commission) compliance
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
This device complies with part 15 of the FCC Rules, including part 15B for equipment classes with Unintentional Radiators. Operation is subject to the following two conditions:
1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause
undesired operation. RF exposure safety This device complies with the FCC RF exposure limits and has been evaluated in compliance with portable exposure condition.
There is no limitation as to which distance can be used from the human body.
Not e:
This equipment has been t est ed and found t o comply wit h t he limit s for a Class A digit al device, pursuant t o part 15 of t he FCC Rules.
These limit s are designed t o provide reasonable prot ect ion against harmful int erference when t he equipment is operat ed in a commercial environment . This equipment generat es, uses, and can radiat e radio frequency energy and, if not inst alled and used in accordance wit h t he inst ruct ion manual, may cause harmful int erference t o radio communicat ions. Operat ion of t his equipment in a resident ial area is likely t o cause harmful int erference in which case t he user will be required t o correct t he int erference at his own expense.

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Other information
FCC ID: WTO-CP1110S Supplier’s declaration of conformity 47 CFR § 21077 Compliance Information Unique identifier: CP1110S Responsible party: Cochlear Americas
10350 Park Meadows Drive Lone Tree, CO 80124, USA Toll free: +1 800 483 3123 Telephone: +1 303 790 9010 https://www.cochlear.com/us
Cochlear Ltd warrants that each unit marketed under this Supplier’s Declaration of Conformity will be identical to the unit tested and found acceptable with the standards. The devices will continue to comply within the variation that can be expected due to quantity production and testing on statistical basis.
The records maintained by the responsible party will continue to reflect the devices being produced under the Supplier’s Declaration of Conformity.

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Other information
ISED compliance
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
This device complies with ISED license-exempt RSS(s). Operation is subject to the following two conditions:
1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause
undesired operation. RF exposure safety This device complies with the ISED RF exposure limits and has been evaluated in compliance with portable exposure condition.
There is no limitation as to which distance can be used from the human body.
CAN ICES-003 (B) This Class B digital apparatus complies with Canadian ICES-003.
IC: 8039A-CP1110S

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Other information
Labelling symbols
The following symbols may appear on the surgical processor or accessories and/or product packaging:
Symbol Description
Refer to instruction manual
Consult instructions for use Specific warnings or precautions associated with the device, which are not otherwise found on the label
Manufacturer

Compatible implants

UDI

Compatible sound processors Authorised representative in the European Community /European Union Authorised representative in Switzerland Unique Device Identification Medical Device Catalogue number Serial number Batch code Date of manufacture

Temperature limits CE registration mark with notified body number CE registration mark

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Other information

R
IP21

Radio compliance certification for Australia and New Zealand Radio compliance certification for Japan
Radio compliance certification for Korea By prescription Recyclable material
Dispose of electrical components in accordance with your local regulations
Type B applied part Ingress Protection Rating
First digit of 2: Protected against solid objects over 12mm. For example, fingers.
Second digit of 1: Protected against vertically falling water drops. Model number

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Other information
Trademark legal notice
ACE, Advance Off-Stylet, AOS, Ardium, AutoNRT, Autosensitivity, Baha, Baha SoftWear, BCDrive, Beam, Bring Back the Beat, Button, Carina, Cochlear, , , , Cochlear SoftWear, Contour, , Contour Advance, Custom Sound, DermaLock, Freedom, Hear now. And always, Hugfit, Human Design, Hybrid, Invisible Hearing, Kanso, LowPro, MET, MP3000, myCochlear, mySmartSound, NRT, Nucleus, Osia, Outcome Focused Fitting, Off-Stylet, Piezo Power, Profile, Slimline, SmartSound, Softip, SoundArc, SoundBand, True Wireless, the elliptical logo, Vistafix, Whisper, WindShield and Xidium are either trademarks or registered trademarks of the Cochlear group of companies.
iPad is a trademark of Apple Inc., registered in the U.S. and other countries. Bluetooth is a registered trademark of Bluetooth SIG, Inc. GORE is a trademark of W. L. Gore & Associates

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Notes

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Notes

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Hear now. And always

AU Cochlear Ltd (ABN 96 002 618 073)

TR Cochlear Tibbi Cihazlar ve Salik Hizmetleri Ltd. ti.

1 University Avenue, Macquarie University, NSW 2109, Australia Küçükbakkalköy Mah, Defne Sok, Büyükhanli Plaza No:3 Kat:3

Tel: +61 2 9428 6555 Fax: +61 2 9428 6352

Daire: 9-10-11-12, 34750, Ataehir, stanbul, Türkiye

DE Cochlear Deutschland GmbH & Co. KG

Tel: +90 216 538 5900 Fax: +90 216 538 5919

Mailänder Straße 4 a, 30539 Hannover, Germany

HK Cochlear (HK) Limited

Tel: +49 511 542 770 Fax: +49 511 542 7770

Room 1404-1406, 14/F, Leighton Centre, 77 Leighton Road,

CH Cochlear AG Peter Merian-Weg 4, 4052 Basel, Switzerland

Causeway Bay, Hong Kong Tel: +852 2530 5773 Fax: +852 2530 5183

Tel: +41 61 205 8204 Fax: +41 61 205 8205

KR Cochlear Korea Ltd

US Cochlear Americas 10350 Park Meadows Drive, Lone Tree, CO 80124, USA Tel: +1 303 790 9010

2nd Floor, Yongsan Centreville Asterium, 25, Hangang-daero 30 gil, Yongsan-gu, Seoul, Korea (04386) Tel: +82 2 533 4450 Fax: +82 2 533 8408

CA Cochlear Canada Inc

CN Cochlear Medical Device (Beijing) Co., Ltd

2500-120 Adelaide Street West, Toronto, ON M5H 1T1, Canada Unit 2608-2617, 26th Floor, No.9 Building, No.91 Jianguo Road,

Tel: +1 (800) 483 3123 Fax: +1 416 972 5083

Chaoyang District, Beijing 100022, P.R. China

Tel: +86 10 5909 7800 Fax: +86 10 5909 7900

GB Cochlear Europe Ltd

6 Dashwood Lang Road, Bourne Business Park, Addlestone,

IN Cochlear Medical Device Company India Pvt. Ltd.

Surrey KT15 2HJ, United Kingdom

Ground Floor, Platina Building, Plot No C-59, G-Block,

Tel: +44 1932 26 3400 Fax: +44 1932 26 3426

Bandra Kurla Complex, Bandra (E), Mumbai 400 051, India

Tel: +91 22 6112 1111 Fax: +91 22 6112 1100

BE Cochlear Benelux NV

Schaliënhoevedreef 20 i, B-2800 Mechelen, Belgium

JP (Nihon Cochlear Co Ltd)

Tel: +32 15 79 55 11 Fax: +32 15 79 55 70

113-0033 2-3-7

Tel: +81 3 3817 0241 Fax: +81 3 3817 0245

FR Cochlear France S.A.S.

135 Route de Saint-Simon, 31035 Toulouse, France

AE Cochlear Middle East FZ-LLC

Tel: +33 5 34 63 85 85 (International) or 0805 200 016 (National) Dubai Healthcare City, Al Razi Building 64, Block A, Ground Floor,

Fax: +33 5 34 63 85 80

Offices IR1 and IR2, Dubai, United Arab Emirates

Tel: +971 4 818 4400 Fax: +971 4 361 8925

IT Cochlear Italia S.r.l.

Via Trattati Comunitari Europei 1957-2007 n.17,

PA Cochlear Latinoamérica S.A.

40127 Bologna (BO), Italy

International Business Park, Building 3835, Office 403,

Tel: +39 051 601 53 11 Fax: +39 051 39 20 62

Panama Pacifico, Panama

Tel: +507 830 6220 Fax: +507 830 6218

SE Cochlear Nordic AB

Konstruktionsvägen 14, 435 33 Mölnlycke, Sweden

NZ Cochlear NZ Limited

Tel +46 31 335 14 61 Fax +46 31 335 14 60

Level 4, Takapuna Towers, 19-21 Como St, Takapuna,

Auckland 0622, New Zealand

www.cochlear.com

Tel: + 64 9 914 1983 Fax: 0800 886 036

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Documents / Resources

Cochlear CP1110S Surgical Processor [pdf] Instruction Manual
WTO-CP1110S, WTOCP1110S, CP1110S Surgical Processor, CP1110S, Surgical Processor, Processor

References

User Manual

Cochlear CP1110S Surgical Processor Instruction Manual

CP1110S Surgical Processor

Product Information

Specifications:

Product Usage Instructions

Warnings and Precautions:

Batteries:

Frequently Asked Questions (FAQ)

Q: Can I use non-rechargeable batteries with the Cochlear
Surgical Processor?

Q: How far should I keep the surgical processor from
life-supporting devices?

Q: What should I do if the batteries become dirty?

Documents / Resources

References

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