Cochlear Baha User manual

Cochlear™Baha®
and Vistafix®
Osscora Surgical Set
INSTRUCTIONS FOR USE
MODEL NO. 91053

2
Symbols
Warning
Risk of injury.
Attention
Important notes to prevent
damage occurring.
General explanations
Without risk to persons
or objects.
Sterilisable
Up to the stated temperature.
Thermo washer
Disinfectable.

3
Symbols on the control unit
Symbols
Do not dispose of with
domestic waste
Foot switch
On / Off
Data matrix code for product
identification e.g. for hygiene /
maintenance processes
Medical – General medical
equipment as to electrical shock,
fire and mechanical hazards only
in accordance with UL60601–1;
CAN/CSA C22.2 No. 601.1;
IEC60601–1; ANSI/AAMI
ES60601–1.
25UX (Control No.)
REF Catalogue number
SN
V
AC
VA
Serial number
Supply voltage of the unit
Alternating current
Electric power input
of the unit
ASupply current
Hz Frequency of the alternating
current
rpm Revolutions per minute
(rpm = min.-1 )
Follow instructions for use
Class II equipment
Date of manufacture
Electric fuse
Not suitable for
intracardiac application –
Type B appliance
Consult instructions for use
Separate disposal
of batteries

4
Symbols on the packaging
Symbols
This way up
Fragile, handle with care
Keep away from rain
Der Grüne Punkt
Identification mark of Duales
System Deutschland AG
General symbol for recovery/
recyclable
Temperature limit
Humidity limitation
R
E Y
Caution: Federal law restricts
this device to sale by or
on the order of a medical
practitioner.

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Symbols on the irrigation tubing
Symbols
Sterilisation with ethylene oxide
Not for re-use
Latex-free
Use by date
Batch ID
Consult instructions for use
Caution: Federal law restricts
this device to sale by or
on the order of a medical
practitioner.
STERILE
STERILE
EO
EO
Manufacturer:
ASSAmed GmbH
Münchweiser Str.4
D-66450 Bexbach
Germany

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Contents
Chapter Page
10. Factory settings 21
11. Control unit operation 23
12. Error messages 27
13. Reprocessing guidelines 29
14. Osscora contra-angle handpiece 37
15. Osscora accessories 47
16. Servicing 48
17. Technical data 50
Chapter Page
1. Introduction 7
2. Safety notes 8
3. Unpacking 12
4. Equipment supplied 13
5. Description of front panel 14
6. Description of rear panel 15
7. Description of motor with cable 16
8. Starting operation - General 17
9. Starting operation - Foot control 18

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1. Introduction
may use the surgical unit.We have based our development
and design of the Osscora surgial set on the “physician”
target group.
Responsibility of the manufacturer
Cochlear Bone Anchored Solutions AB can only accept
responsibility for the safety, reliability and performance
of the Osscora surgical set when there is compliance with
the following directions:
• The Osscora surgical set must be used in accordance
with these Instructions for Use.
• The Osscora surgical set has no components which
can be repaired by the user. Assembly, modifications
or repairs must be undertaken by authorised personnel
only.
• The electrical installation at the premises must comply
with the regulations applicable in your country.
• Unauthorised opening of the equipment invalidates all
claims under warranty and any other claims.
For your safety and the safety of your patients
These Instructions for Use explain how to use your Cochlear
product. However, we must also warn against possible
hazardous situations. Your safety, the safety of your team,
and of course, the safety of your patients is of paramount
importance to us.
It is therefore essential to read the safety notes on pages
8 to 11.
Intended use
Osscora surgical set with contra-angle handpiece is intended to
be used for Baha®and/or Vistafix®surgery including:
• Dermatome use
• Drilling
• Thread cutting
• Implant placement and removal
Qualification of the user
Osscora surgical set with contra-angle handpiece is intended to be
used in operating rooms and to be used by trained surgeons and
operating room staff.
Only suitable qualified medical, technical and specialist trained staff

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2. Safety notes
– Never touch the patient and the connection for
the foot control simultaneously.
– Check the parameter settings every time the
device is restarted.
Use only suitable and serviceable tools
Ensure that you comply with the manufacturer’s
instructions for surgical contra-angle handpieces
with respect to maximum speed, maximum torque,
forward and reverse movement.
Inappropriate use
Improper use, in addition to incorrect assembly,
installation, modification or repairs of the Osscora
surgical set or non-compliance with our instructions
invalidates all claims under warranty and any other
claims.
Please ensure that you carry out the following
instructions:
– Before using the Osscora surgical set for the first time,
store it at room temperature for 24 hours.
– Only fit the contra-angle handpiece when the motor is at
a complete standstill.
– Never touch rotary instruments that are
still rotating.
– Never touch the chuck mechanism of the
contra-angle handpiece while it is still running.
– Always ensure correct operating conditions and
that adequate cooling is delivered.
– Avoid overheating at the treatment site.
– Check the Osscora surgical set, the contra-angle
handpiece and the motor with cable for damage and
loose parts each time before use. Correct any faults or
refer to your local Cochlear office. Do not operate the
Osscora surgical set if it is damaged.
– When changing the fuse, disconnect the unit
from the power supply and only use original fuses.
– Perform a test run prior to each treatment.

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2. Safety notes
Risks due to electromagnetic fields
The functionality of implantable systems, such
as cardiac pacemakers and ICD (implantable
cardioverter defibrillator) can be affected by
electric, magnetic and electromagnetic fields.
– Find out if patients and users have an implanted
device before using the product and consider the
applications.
– Weigh the risks and benefits.
– Keep the product away from implanted devices.
– Make appropriate emergency provisions and take
immediate action on any signs of ill-health.
– Symptoms such as raised heartbeat, irregular
pulse and dizziness can be signs of a problem with
a cardiac pacemaker or ICD (implantable
cardioverter defibrillator).
Danger zones M and G
In accordance with IEC 60601-1 /ANSI/AAMI ES 60601-1,
the control unit and the motor with cable are not suitable
for use in potentially explosive atmospheres or with
potentially explosive mixtures of anaesthetic substances
containing oxygen or nitrous oxide.
Control unit
The control unit is classed as “conventional equipment”
(closed equipment without protection against the ingress
of water).
The Osscora surgical set control unit is designed only to
be used with the Osscora contra-angle handpiece. Use of
other contra-angle handpieces may result in deviation from
the indicated torques and is the user’s responsibility.
The motor, motorcable and contra-angle handpiece are
applied parts.
Foot control
The foot control is approved for use in zone M (AP).
Please note that at low speeds, it is more difficult to
determine that the motor is running.

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2. Safety notes
Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to particular
precautions with regards to EMC and must be installed
and put into operation in accordance with the EMC
notes included.
Cochlear guarantees the compliance of the device with
the EMC requirements only when used with original
Cochlear accessories and spare parts. The use of
other accessories/spare parts can lead to an increased
emission of electromagnetic interference or to a
reduced resistance against electromagnetic interference.
You can find the current EMC manufacturer’s
declaration on our website at
http://www.cochlear.com/files/assets/baha/pdf/
OsscoraEMC.pdf
HF communication equipment
Do not use any portable and mobile HF communication
equipment (e.g. mobile telephones) during operation.
These may affect medical electrical equipment.

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2. Safety notes
Coolant
The Osscora surgical set is designed for use with
physiological saline solution. Use only suitable irrigation
fluids and comply with the medical data and instructions
from the manufacturer. Use the supplied irrigation tubing
set or accessories supplied by Cochlear. Coolant bottle or
coolant bag can be obtained from a pharmacist.
Sterility of irrigation tubing set
Sterile irrigation tubing sets are supplied with the
equipment. These irrigation tubings are disposable articles
and must be thrown away after each treatment! Please
note the expiry date and the relevant regulations for
disposal of irrigation tubing. Only use disposable irrigation
tubing with undamaged packaging.
Rotational energy
Fast deceleration of the bur can, at times, cause the
selected torque to be overloaded as a result of the
rotational energy stored in the drive system.
Perform a test run prior to thread cutting and implant
placement to check if motor stops correctly after
releasing the foot control.
Mains cable
Only use the mains cable supplied.
Only connect to an earthed socket outlet.
Set up the device so that the power switch is easily
accessible. In dangerous situations, the device can be
disconnected from the power supply using the power
switch or power cable. The power switch can also be used
to safely stop the device.
Power failure
In the event of a power failure, if the control unit is
switched off, or when alternating between programs, the
last values set are saved and reactivated on power-up.
System failure
A total system failure of the Osscora surgical set does not
constitute a critical fault. Simply switch the unit off and
then on again.
Intermittent operating mode S3 (3min/10min)
If the operating mode specified is observed no overheating
of the system and therefore no injury to the patient, user or
third persons arises.
The responsibility for the use and timely shutdown of the
system lies with the user.

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3. Unpacking
The packaging is environmentally friendly and can be
disposed of by industrial recycling companies. However, we
recommend that you keep the original packaging.
uLift out insert with stand.
vRemove foot control and insert.
wLift out insert with control unit.
xRemove irrigation tubing set.
yRemove carton containing
motor, mains cable, handle
and contra-angle handpiece.

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4. Equipment supplied
91053 Osscora surgical set
115 V
Control unit, 115 V
Foot control S-N1
Motor with 3,5 m cable incl. motor protective cover, locking pins (2 pcs) and clips (10 pcs)
Osscora contra-angle handpiece
Irrigation tubing set (6 pcs)
Mains cable (1 pcs)
(USA, CAN, JAP)
Stand

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5. Description of front panel
Motor connection socket
Display
OPEN
Pump arm
Program buttons Pump arm
Stand holder
P1 P2 P3

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6. Description of rear panel
Connecting socket
for foot control
Fuse holder with 2 fuses (250 V–T1.25AH)Power socket
Power switch
ON/OFF
Stand holder

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7. Description of motor with cable
The motor may not be dismantled!
The motor bearings are lubricated for life. No oil
lubrication or other maintenance is necessary.
To prevent the instrument on the motor attachment
from turning during the transmission, the locking
pin supplied can be pushed into one of the two
holes of the motor (see illustration).
Test run
– Start the motor.
– If you observe dysfunctions (e.g. vibrations,
unusual noise, overheating, coolant supply failure
or leakage) stop the motor immediately and
contact your service agent. For details, please
contact your local Cochlear office.

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8. Starting operation–General
uConnect the mains cable
and foot control.
vConnect the motor cable.
Note the positioning.
wInsert the stand.
Note the positioning.
(maximum load
capacity 1.5 kg)
xFit the irrigation tubing set.
a) Open the pump arm
b) Insert the tube in the rear
holder. Note the position of
the flange on the tube
c) Pull the tube towards the
front
d) Insert the tube in the front
holder. Note the position of
the flange on the tube
yClose pump arm.
d
a
b
c
Always place the Osscora on a flat level surface.
Ensure that the Osscora can be disconnected easily from the power supply.

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9. Starting operation–Foot control
GREEN
Pump
ON/OFF
GREY
Start motor
VARIABLE or FIXED speed
(Factory setting = variable)
ORANGE
Change program
Program 1 to 3
YELLOW
Change motor direction
forward/reverse drive

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ORANGE
Change program
Program 1 to 3
YELLOW
Change motor direction
forward/reverse drive
9. Starting operation–Foot control
Reverse operation
You can switch between forward and reverse operation by
pressing the YELLOW button. On selecting reverse operation,
an audible signal can be heard and the selected program button
flashes. Before the motor starts in reverse operation, there is a
delay while 3 audible warning signals are given.
Changing program
The programs 1–3 can be selected in ascending sequence by
operating the ORANGE button.
When changing from program 3 to program 1, a longer
confirmation signal is heard.
With each program change, the motor direction is
automatically set to forward operation.
Pump ON/OFF
Only when the motor is stationary the pump can be switched
on or off by operating the GREEN button of the foot control.
When pump operation is active, the pump symbol appears on
the display.

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9. Starting operation–Foot control
To change motor speed from VARIABLE speed to
FIXED speed (variable speed is only available for program 1 and 2.)
Keep program button P3 depressed throughout
this procedure!
uPress P3 for approx. 4 seconds.
vKeep P3 depressed and simultaneously
press PLUS and MINUS.
wKeep P3 depressed and carry out adjustment.
01 = VARIABLE speed (factory setting) – Press
PLUS button.
00 = FIXED speed – Press MINUS button.
After changeover the program button P3 illuminates
and is active!