Advanced Bionics CPI-3 User manual

029-M512-89 Rev A
© 2015 Advanced Bionics AG. All Rights Reserved. instructions for use
2013
Manufactured by:
Advanced Bionics LLC
California, U.S.A.
[phone]
AdvancedBionics.com
Advanced Bionics AG
Laubisrütistrasse 28
8712 Stäfa, Switzerland
[phone]
029-M512-89
English, Français, Deutsch, , Italiano
CPI-3
Clinical Programming Interface
CI-6101

1
CPI-3
Clinical Programming Interface
Instructions for Use
Cochlear implants are highly specialized devices that
must be adjusted to suit each individual patient. To
create individualized programs for each patient, a
clinician needs a Clinical Programming Interface
(CPI-3), connected to a computer running SoundWave™
Professional Suite software, and a sound processor(s).
Programming Kits
CPI-3 and its accessories are available as part of
programming kits and also as separate items. The kits
and their parts are as follows:
Unilateral Programming Kit (CI-6017)
Model No.* Description Kit
Qty
CI-6101 CPI-3 1
CI-6407 Harmony™& Auria™
Programming Cable 1
CI-6406 PSP Programming Cable 1
CI-6405 Naída CI Programming Cable 1
CI-6515 Neptune™Programming Cable 1

2
CI-6408-
002 USB Cable – 2m 1
CI-6201 Wearing Clip 1
CI-6202 Carry Case 1
Bilateral Programming Kit (CI-6018)
Model
No.* Description Kit Qty
CI-6101 CPI-3 1
CI-6407 Harmony & Auria Programming
Cable 2
CI-6406 PSP Programming Cable 1
CI-6405 Naída CI Programming Cable 2
CI-6515 Neptune Programming Cable 2
CI-6408-
002 USB Cable – 2m 1
CI-6201 Wearing Clip 1
CI-6202 Carry Case 1
* Items purchased separately by model number are
packaged in quantities of one (1).

3
Additional Accessories not included in kit:
Model No.* Description
CI-6203 CPI-3 Lanyard
CI-6408-
003 USB Cable – 3m
AB-653X* Programming Cable Lock
*The X denotes model number varients
Quick Start Guide
1. Start SoundWave software (version 2.2 or later) on
your computer
2. Connect the CPI-3 to a USB port on your PC using
the supplied USB cable
3. Connect the sound processor(s) to the CPI-3, using
the programming cable(s) appropriate to the sound
processor(s)
4. Choose placement of CPI-3 for programming session:
on the table, clipped onto the patient’s clothing or
worn on a lanyard around the patient’s neck

4
Programming Connections
f
CI Patient
USB Cable
Programming
Cables

5
CPI-3 Overview
Front view
Back view
Figure 1: Front & back views of the CPI-3
* Functionality not available with current software release.
CPI-3 power
indicator
Sound processor indicator
Trigger*
Audio*
USB
Serial
Number Manufacture
date

6
Top view Bottom view
Trigger*
(blue rim) Audio*
(black
rim)
Micro-USB
Sound processor
programming
cable
Figure 2: Top & bottom views of the CPI-3
* Functionality not available with current software release.
Programming Equipment
You will use the following tools when fitting a patient:
• Clinical Programming Interface (CPI-3) —
Provides a bridge between the computer’s USB port
and the sound processor. Additionally, the CPI-3
delivers power from the computer’s USB port to
the connected sound processor during the fitting
procedure.
• SoundWave software (version 2.2 and later) installed
and running on a PC. You will use SoundWave to
create, customize, and download programs to your
patient’s sound processor(s). Please refer to the
SoundWave manual for further instructions.

7
• Clinical Programming Interface USB Cable —The
CPI-3 USB cable is connected to a PC USB port and
to the micro-USB port of the CPI-3. The CPI-3 USB
cable should be plugged into a high powered USB
port found directly on the PC. To switch off the CPI-3,
unplug the unit from the computer.
• Sound processor — The patient’s own sound
processor(s) is used during device fitting.
Depending on the type of processor being
programmed, the battery or the removable control
header may need to be removed to connect the
programming cable.
• Programming Cable — Processor specific
programming cables are used to connect processors
to the CPI-3. A lock is available to help secure the
programming cable to the PSP. It slides onto the
sound processor like the battery. A cable lock is built
in to the Harmony & Auria programming cable.
Connecting the CPI-3 for Programming
1. Turn on your computer and have the SoundWave
software fully open and running.
2. Next, connect the CPI-3 to your computer. Do this by
connecting the USB cable1to the USB Port (micro-
USB) on the bottom of the CPI-3 (see Figure 2).
Connect the other end, into a USB port on your
computer.
1Use only the USB Cable supplied by Advanced Bionics. Other
USB Cables may not work properly.

8
The CPI-3 Power Indicator (see front view in Figure 1)
light should illuminate blue, indicating that the CPI-3 is
correctly powered up.
3. The sound processor can then be connected to the
CPI-3 via a programming cable. The programming
cable is installed by first connecting to one of the
Sound Processor Ports (micro-HDMI) on the side of
the CPI-3 (see Figure 2). The other end is connected
to the sound processor in place of the battery,
PowerCel or control header. The patient is
connected to the system when his/her headpiece
cable is plugged into the sound processor and the
headpiece is locked with the implant. The corre-
sponding Sound Processor indicator light, on the front
of the CPI-3, will start to flash green indicating power
is flowing to the sound processor. The green light will
stop flashing and turn steady green, signaling the unit
is ready for use.
For bilateral programming, two sound processors can
be connected to CPI-3 using two separate programming
cables, each connecting to one of the sound
processor ports (see Figure 2). Please note that due to
power requirements, only one PSP sound processor can
be programmed at a time; simultaneous bilateral
programming is not possible with the PSP sound
processor.

9
Intraoperative Testing
The basic setup for intraoperative testing is the same as
that for programming, please refer to previous section.
For convenience in the operating theater, the longer
(3m ) USB Cable may be used.
Wearing Options
As well as placing the CPI-3 directly on the table, the
unit may also be placed in a wearing clip and attached
to a patient’s clothing or worn around the patient’s neck
using a lanyard.
Minimum Hardware and Software
Requirements
Operating
System Windows™7, Windows 8, Windows Vista and Windows XP
Home (SP-3 and later) and Windows
XP Professional (SP-3 and later)
USB Port USB 1.1 and later
Please refer to your SoundWave documentation for
additional software and hardware requirements.

10
Troubleshooting
If you are experiencing problems with your CPI-3,
please try these troubleshooting steps. After making
any change, give the system a few seconds to respond,
before trying another step. If these steps do not resolve
the issue, please contact your AB field representative or
technical support representative.
Symptom Troubleshooting Steps
Blue LED light
is off 1. Check the connection of the USB cable to the computer
2. Make sure the USB cable is
correctly connected to the CPI-3.
If the cable is connected correctly,
disconnect and reconnect the
cable.
3. Check that you are using the USB
cable supplied by AB, as other
USB cables may not work
4. Try connecting to other USB ports
on the computer
5. Unplug peripheral devices that
are using other USB ports on the
computer
6. Request a USB Hub from your AB
field representative

11
Symptom Troubleshooting Steps
Green LED lights
will not come on
or Green LED
lights do come
on, but continue
to flash and do
not go steady
1. Check the connection of the pro-
gramming cable from the sound
processor to the CPI-3
2. If using the Harmony & Auria
programming cable, make sure
that the pins are fully engaged
3. If using the Neptune program-
ming cable, make sure that the
programming header portion is
fully seated on the Neptune sound
processor
4. If using the PSP programming
cable, make sure that the pins are
fully inserted and that the black
cable lock is securely holding the
connector onto the PSP
The software
does not
recognize the
CPI-3 as
connected
1. Is the blue light on? If not, please
refer to troubleshooting steps
above
2. Reboot SoundWave software
3. Refer to the SoundWave manual
for instructions on checking and
setting up ports

12
Warnings & Precautions
• Only use the USB cable that is provided with the
CPI-3 to connect to a computer. Failure to do so may
cause damage to the CPI-3.
• Only use the programming cables provided with the
CPI-3 to connect to sound processors. Failure to do
so may cause damage to the sound processor and
to the CPI-3.
• Only connect AB sound processors to the CPI-3.
Connecting other devices to the CPI-3 may cause
damage to those devices and to the CPI-3.
• Care must be taken as cables may pose a
strangulation hazard, especially in young children.
• Clinician should inform the patient that they may
remove the device in the event of the CPI-3 heating
to an uncomfortable temperature.
• Discontinue use of the device if any of the
hazardous conditions specified above are
encountered.
• The programming computer and the USB port are
required to be IEC 60950 compliant.
• Not suitable for use in the presence of a flammable
anaesthetic mixture with air or with oxygen or nitrous
oxide.

13
Guidance & Manufacturer’s Declaration
Per IEC 60601-1-2
Electromagnetic emissions
Emissions test Compliance Electromagnetic
environment - guidance
RF
emissions
CISPR 11
Group 1 The CPI-3 uses RF
energy only for its internal
function. Therefore, its RF
emissions are very low
and are not likely to cause
any interference in nearby
electronic equipment.
RF
emissions
CISPR 11
Class B The CPI-3 is designed
and suitable for use in
clinical environments. It
should be connected to a
personal computer via a
standard USB connection
and receive power from
it only
Harmonic
emissions
IEC 61000-
3-2
Not
applicable
Voltage
fluctuations/
flicker emis-
sions IEC
61000-3-3
Not
applicable

14
Electromagnetic immunity
The CPI-3 is intended for use in the electromagnetic
environment specified below. The customer or the user
of the CPI-3 should assure that it is used in such an
environment.
Immunity IEC
60601
test level
Compliance
level Electromagnetic environment -
guidance
Electrostatic
discharge
(ESD)aIEC
61000-4-2
± 6 kV
contact ±
8 kV air
± 6 kV
contact
± 8 kV air
Floors should be
wood, concrete
or ceramic tile. If
floors are covered
with synthetic
material, the
relative humidity
should be at least
30 %. As with the
operation of other
electronic devices,
precaution should
be taken to not
generate ESD.
Power
frequency
(50/60 Hz)
Magnetic
Field
IEC 61000-
4-8
3 A/m 3 A/m Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in
a typical
commercial or
hospital
environment.

15
Portable and mobile RF
communications equipment
should be used no closer to
any part of the CPI-3 system,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
d = 1.2√P < 800 MHz
d = 2.3√P ≥800 MHz
where Pis the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and dis the
recommended separation
distance in metres (m). Field
strengths from fixed RF
transmitters, as determined
by an electromagnetic site
survey,bshould be less than
the compliance level in each
frequency range.cInterference
may occur in the vicinity of
equipment marked with the
following symbol:
Radiated
RF IEC
61000-
4-3
3 V/m
80 MHz
to 2.5
GHz 3
3 V/m
Note 1: These guidelines
may not apply in all
situations. Electromag-
netic propagation is
affected by absorption
and reflection from
structures, objects, and
people.
a. Equipment can be
sensitive to ES. Handle
with care.
b. Field strengths from
fixed transmitters, such
as base stations for
radio (cellular/cordless)
telephones and land
mobile radios, amateur
radio, AM and FM radio
broadcast, and TV
broadcast cannot be
predicted theoretically
with accuracy. To assess
the electromagnetic
environment due to fixed
RF transmitters, an

16
electromagnetic site survey should be considered. If the
measured field strength in the location in which the CPI-3
is used exceeds the applicable RF compliance level above,
the CPI-3 should be observed to verify normal operation.
c. Over the frequency range 150 kHz to 80 MHz, field
strengths should be less than 3 V/m.
Separation distances between RF
communications equipment and CPI-3
The CPI-3 is intended for use in an electromagnetic
environment in which radiated RF disturbances are
controlled. The customer or the user of the CPI-3 can
help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF
communications equipment (transmitters) and the CPI-3
as recommended below, according to the maximum
output power of the communications equipment.
Rated
maximum
output power of
transmitter (W)
Separation distance according to
frequency of transmitter (m)
d = 1.2√P < 800
MHz d = 2.3√P ≥800 MHz
0.01 0.12 0.23
0.1 0.38 0.73
11.2 2.3
10 3.8 7.3
100 12 23
For transmitters rated at a maximum output power not
listed above, the recommended separation distance d in
meters (m) can be estimated using the equation

17
applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
Note 1: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Compatibility Tables
Table 1
Implant Type
Processor Type
C1 CII HiRes
90K HiRes 90K Advantage
Naída CI Q90 -✓6✓6✓6
Naída CI Q70 -✓5✓5✓5
Naída CI Q30 -✓6✓6✓6
Neptune -✓ 1✓1✓1
Harmony ✓2✓3✓3✓1
Auria -✓3✓3✓1
Platinum Sound
Processor (PSP) ✓4✓ ✓ ✓1
1Requires SoundWave 2.1 or later
2Requires SoundWave 2.0 or later
3Requires SoundWave 1.4 or later
4Requires SClin2000 and CPI-II
5Requires SoundWave 2.2 or later and CPI-3
6 Requires SoundWave 2.3 or later and CPI-3

18
Table 2
Implant Type
Software Type/Version
C1 CII HiRes
90K HiRes 90K Advantage
SClin2000 ✓ ✓ - -
SoundWave™1.6
(or earlier) -✓ ✓ -
SoundWave 2.0 ✓1✓ ✓ -
SoundWave 2.1 ✓1✓ ✓ ✓
SoundWave 2.2 ✓1✓ ✓ ✓
SoundWave 2.3 ✓1✓ ✓ ✓
1Only on Harmony
Table 3
Headpiece Type
Processor Type
Universal
Head-
piece
Aqua-
Mic Auria Head-
piece
Platinum
Head-
piece
Naída CI ✓ ✓1- -
Neptune ✓ ✓ - -
Harmony ✓-✓ ✓
Auria ✓-✓ ✓
PSP ✓- - ✓
1Requires AquaCase™ Container

19
Table 4
Implant Type
Programming
Interface
C1 CII HiRes 90K HiRes 90K
Advantage
CPI-II ✓ ✓ ✓ ✓
CPI-3 ✓1✓ ✓ ✓
1Only on Harmony
Cleaning & Maintenance
• Clean with a soft cloth. Do not immerse.
• Do not attempt to service or modify the Naida CI or
its accessories. Doing so may compromise system
performance and will void the manufacturer’s
warranty. Products should be serviced only at
Advanced Bionics.
Recommended Operating Conditions:
Temperature: 15°C (59°F) - 30°C (86°F)
Humidity: up to 95% relative humidity
Altitude: 380m below sea level to 3000m above sea level