Cochlear Baha Manuel utilisateur
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.
5
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
6
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
English
7
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
English
8
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.
English
9
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.
English
10
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.
Autres manuels pour Baha
26
Ce manuel convient aux modèles suivants
2
Table des matières
Autres manuels Cochlear Équipement médical
