Cochlear Osscora 91051 Instructions For Use Manual
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Cochlear Osscora 91051 Instructions For Use Manual

Cochlear Osscora 91051 Instructions For Use Manual

Baha, vistafix surgical set
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Osscora
Surgical Set
™
Instructions for Use
Model no. 91051 / 91052 / 91053

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Summary of Contents for Cochlear Osscora 91051

  • Page 1 Osscora Surgical Set ™ Instructions for Use Model no. 91051 / 91052 / 91053...
  • Page 2 Symbols Warning Attention General explanations Risk of injury. Important notes to prevent Without risk to damage occurring. persons or objects. Thermo washer Sterilisable Disinfectable. Up to the stated temperature. Only for USA Caution: Federal law (USA) restricts this device to sale by or on the order of a medical practitioner.

  • Page 3: Table Of Contents

    Contents Chapter Page Chapter Page 1. Introduction 10. Factory settings 2. Safety notes 11. Control unit operation 3. Unpacking 12. Error messages 4. Equipment supplied 13. Disinfection, cleaning, sterilisation 5. Description of front panel 14. Osscora contra-angle handpiece 6. Description of rear panel 15.

  • Page 4: Introduction

    For your safety and the safety of your patients Responsibility of the manufacturer These Instructions for Use explain how to use your Cochlear Bone Anchored Solutions AB can only Cochlear product. However, we must also warn accept responsibility for the safety, reliability and against possible hazardous situations.

  • Page 5: Safety Notes

    English 2. Safety notes Please ensure that you carry out the following Cardiac pacemaker function instructions: Use of the Osscora surgical set involves the generation of magnetic fields, which are below the – Only fit the contra-angle handpiece when the interference threshold limit according to EN 50061 motor is at a complete standstill.
  • Page 6 English 2. Safety notes Danger zones M and G Motor and foot control In accordance with IEC 60601-1 /UL 60601-1, the The motor and foot control are approved for control unit is not suitable for use in potentially use in zone M (AP). explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen Please note that at low speeds, it is more difficult to...
  • Page 7 Cochlear. Coolant bottle or coolant bag can be saved and reactivated on power-up. obtained from a pharmacist. System failure...

  • Page 8: Unpacking

    English 3. Unpacking x Remove irrigation tubing set. u Lift out insert with stand. v Remove foot control and insert. y Remove carton containing motor, mains cable, handle and contra-angle handpiece. The packaging is environmentally friendly and can be disposed w Lift out insert with control unit.

  • Page 9: Equipment Supplied

    English 4. Equipment supplied 91051 Osscora surgical set 91052 Osscora surgical set 91053 Osscora surgical set 230 V (Europe) 230 V (Asia Pacific) 115 V Control unit, 230 V Control unit, 230 V Control unit, 115 V Foot control S-N1 Foot control S-N1 Foot control S-N1 Motor with 3,5 m cable incl.

  • Page 10: Description Of Front Panel

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

  • Page 11: Description Of Rear Panel

    English 6. Description of rear panel Stand holder Connecting socket Power switch for foot control ON/OFF Power socket Fuse holder with 2 fuses (250 V–1.25A slow-blow)

  • Page 12: Description Of Motor With Cable

    (see illustration). Test run – Start the motor. – If you observe dysfunctions (e.g. vibrations, unusual noise, overheating, coolant supply failure or leakage) contact your service agent. For details, please contact your local Cochlear office.

  • Page 13: Starting Operation-General

    English 8. Starting operation–General u Connect the mains cable x Fit the irrigation tubing set. and foot control. y Close pump arm. v Connect the motor cable. Note the positioning. w Insert the stand. Note the positioning.

  • Page 14: Starting Operation-Foot Control

    English 9. Starting operation–Foot control ORANGE Change program Program 1 to 3 GREEN YELLOW Pump Change motor direction ON/OFF forward /reverse drive GREY Start motor VARIABLE or ON/OFF (Factory setting = variable)
  • Page 15 English 9. Starting operation – Foot control Changing program Reverse operation The programs 1–3 can be selected in ascending sequence by You can switch between forward and reverse operation by operating the ORANGE button. pressing the YELLOW button. On selecting reverse operation, an audible signal can be heard and the selected program button When changing from program 3 to program 1, a longer flashes.
  • Page 16 English 9. Starting operation–Foot control To change from VARIABLE to ON / OFF w Keep P3 depressed and carry out adjustment. Keep program button P3 depressed throughout this procedure! 01 = VARIABLE (factory setting)–Press PLUS button. u Press P3 for approx. 4 seconds. 00 = ON/OFF–Press MINUS button.

  • Page 17: Factory Settings

    English 10. Factory settings Factory settings P1– P3 Forward Reverse Factory setting rpm 2000 2000 Adjustable range rpm 15–2000 15–2000 – – Motor direction Forward Forward Forward Reverse Pump Factory setting Max. Max. Adjustable range – – 5–50 5–50 Intermediate stage –...
  • Page 18 English 10. Factory settings Reset factory settings Factory setting always starts with program 1 ( P1). u Switch off the control unit. v Keep P1 depressed and simultaneously switch on the control unit. w Keep P1 depressed as long as on the display the adjustment “DE FAU”...

  • Page 19: Control Unit Operation

    English 11. Control unit operation Changing the program (P1–P3) Activate the required program (P1–P3) by pressing the corresponding program button. During selection an audible signal can be heard and the program button is illuminated. On the display the selected program appears with the adjusted range in rpm: Pump operation ON/OFF...
  • Page 20 English 11. Control unit operation Changing the speed (P1–P2) Keeping PLUS / MINUS depressed activates the repeat function and the values are continuously increased / decreased. Press program button (P1– P2). Increase speed Decrease speed...
  • Page 21 English 11. Control unit operation Changing the torque (P3) Adjustable range from 5 up to 50 Ncm, intermediate stage 32 Ncm. Keeping PLUS /MINUS depressed activates the repeat function and the values are continuously increased /decreased. When changing from 5 to 50 Ncm and 50 to 5 Ncm, a longer confirmation signal is heard.
  • Page 22 English 11. Control unit operation Changing the coolant flow (P1–P3) Factory setting 80%. Adjustable range 65%, 80% and 100%. Depressing PLUS /MINUS the values are continuously increased / decreased. Keep program button P2 depressed throughout this procedure! Keep P2 depressed for approximately 4 seconds (the adjusted coolant flow rate appears).

  • Page 23: Error Messages

    English 12. Error messages Error No. Description Remedy Electronics overheating–safety shutdown Switch off the equipment, allow to cool for at least 10 minutes, then restart Electronics overloaded Switch off the equipment and then restart Foot control error–initialising Switch off the equipment, restart, do not actuate foot control when switching on Foot control error Switch off the equipment, check connection of the...
  • Page 24 Osscora surgical set and then switching it on again, the equipment must be checked by a service agent. For contact details, please contact your local Cochlear office. If a total failure of the equipment occurs caused by external circumstances, the equipment must be switched off and then on again.

  • Page 25: Disinfection, Cleaning, Sterilisation

    English 13. Disinfection, cleaning, sterilisation Manual cleaning and disinfection Follow your country-specific directives, standards and guidelines for cleaning, disinfection and sterilisation. The front panel of the control unit and the foot control are sealed and may be wiped clean. – Wear protective clothing. –...
  • Page 26 English 13. Disinfection, cleaning, sterilisation Motor with cable Pre-disinfection – If heavily soiled: Clean first with disinfectant cloths. Do not twist and kink the motor cable! Do not coil Only use disinfectants that have no protein-fixing effects. it too tightly! This instruction is not necessary when a sterilisation cassette is utilised (optional accessory).
  • Page 27 13. Disinfection, cleaning, sterilisation Sterilisation and storage Approved sterilisation procedures Follow your country-specific directives, standards Cochlear recommends sterilisation according to and guidelines. EN 13060 and EN 285, class B. Sterilisation and storage – Steam sterilisation with sterilisers in accordance with –...

  • Page 28: Osscora Contra-Angle Handpiece

    English 14. Osscora contra-angle handpiece Product description Osscora contra-angle handpiece u press-button v head w hexagon chucking system x spray clip y middle gear U knee V lower shaft W locking pin X sheath at nozzle cleaner...
  • Page 29 English 14. Osscora contra-angle handpiece Before use–safety notes CAUTION: • If using a Dermatome, please note the Osscora contra-angle handpiece is designed for use with the Baha Dermatome for Osscora only. It must not be used with any other Dermatome model. • This contra-angle handpiece is only intended for use with Osscora surgical set for Baha and Vistafix surgery.
  • Page 30 English 14. Osscora contra-angle handpiece Operation Assembly and removal Do not assemble/remove the contra-angle handpiece during the operation! u Push the contra-angle handpiece onto the motor. – Use a rotational lock between motor and instrument: see page 12. v Check that the motor and handpiece are securely attached. w Remove the contra-angle handpiece from the motor by pulling in an axial direction.
  • Page 31 English 14. Osscora contra-angle handpiece Operation Rotary instruments – Use only rotary instruments that are in perfect condition and be careful when the rotary instrument is rotating. – Insert rotary instruments only when the contra- angle handpiece is stationary. – Do not activate the press-button of the contra- angle handpiece during operation.
  • Page 32 (a) and turn until it engages (b). v Check secure location by applying slight axial tension. w Remove the rotary instrument by pushing the press-button. Please contact your local Cochlear office for how to get an applicable rotary instrument with hexagon.
  • Page 33 Operation Test run – Insert rotary instrument. – Start the contra-angle handpiece. – If you observe problems (e.g. vibrations, unusual noise, overheating, coolant supply failure or leakage) contact your service agent. For contact details, please contact your local Cochlear office.
  • Page 34 English 14. Osscora contra-angle handpiece Hygienic maintenance Follow your country-specific directives, standards and guidelines for cleaning, disinfection and sterilisation. – You can process the contra-angle handpiece manually or automatically. – Wear protective clothing. – Remove the rotary instrument. – Remove the contra-angle handpiece from the motor. –...
  • Page 35 English 14. Osscora contra-angle handpiece Disassemble Osscora contra-angle handpiece u Remove the spray clip. v Hold the head firmly with one hand. w Press sheath gently against knee. At the same time turn off the sheath from the knee. x Remove the shaft. y Remove the knee.
  • Page 36 English 14. Osscora contra-angle handpiece Manual cleaning u Rinse under demineralised water (< 38 °C) with the aid of a brush (not recommended in U.K.). v Then remove any liquid residues (absorbent cloth, blow dry with compressed air). Do not place the contra-angle handpiece in liquid disinfectant or in an ultrasonic bath.
  • Page 37 In the case of a clogged up spray nozzle or coolant tube contact your service agent. For details, please contact your local Cochlear office. The removable spray clip can be cleaned in an ultrasonic bath. Reassemble the contra-angle handpiece (serial numbers on individual parts must be identical).
  • Page 38 English 14. Osscora contra-angle handpiece Manual disinfection – Disinfect with surface disinfectants. u Wiping disinfection is recommended. – Use only surface disinfectants which do not contain chlorine and which are certified by officially recognised institutes. For USA: Use EPA registered surface disinfectants. –...
  • Page 39 Lubricate the contra-angle handpiece immediately after thermo washer disinfection. A contra-angle handpiece with this symbol can be cleaned and disinfected in a thermo washer disinfector. – Cochlear recommends processing with a thermo washer disinfector. – Note the manufacturer’s specifications on equipment, cleaning agents and detergents.
  • Page 40 English 14. Osscora contra-angle handpiece Reassemble Osscora contra-angle handpiece u Insert the middle gear into the contra-angle head. Check free running of the chucking system (a). v Insert the knee (4 positions are possible) onto the contra- angle head until it engages. w Put the shaft in the knee and mind the position of the rotational lock (b).
  • Page 41 Daily oil service only with W&H Service Oil F1, MD-400. For oil service, W&H Service Oil F1, MD-400 is recommended. For details on how to purchase this, contact your local Cochlear office. – Follow the Instructions for Use of the oil spray can. Recommended lubrication cycles –...
  • Page 42 English 14. Osscora contra-angle handpiece Test run following oil service u Place the contra-angle handpiece with the head, downwards. v Start the contra-angle handpiece for 30 seconds to remove excess oil. Start at the minimum speed and increase to the maximum speed within 5 to 10 seconds.
  • Page 43 English 14. Osscora contra-angle handpiece Approved sterilisation procedures Sterilisation and storage Cochlear recommends sterilisation according to EN Follow your country-specific directives, standards and 13060 or EN 285, class B. guidelines. – Note the instructions of the steriliser manufacturer. – Clean, disinfect, reassemble and lubricate before sterilising.

  • Page 44: Osscora Accessories

    English 15. Osscora accessories 91102 Disposable article 91061 Sterilisation cassette. Irrigation tubing set 3,8 m (6 pcs). 91054 91050 Osscora motor Osscora contra-angle with 3,5 m cable. handpiece.

  • Page 45: Servicing

    (electronic) components. We recommend that only authorised personnel undertake this servicing and checking. For details, please contact your local Cochlear office.
  • Page 46 The standard ISO 11498 stipulates a durability of at least 250 sterilisation cycles. In the case of the motor with cable from Cochlear we recommend that you carry out a regular servicing after 500 sterilisation cycles, or one year. Repairs...

  • Page 47: Technical Data

    English 17. Technical data 91051 / 91052 91053 Supply voltage: 220–240 V 100–130 V Rated current: 0.1–0.8 A 0.2–1.6 A Permitted voltage fluctuation: ± 10 % ± 10 % Frequency: 50–60 Hz 50–60 Hz Max. mechanical output power: 70 W 70 W Max.
  • Page 48 Only Cochlear Technical data Osscora contra-angle handpiece products and accessories, or products and accessories approved by Cochlear, should be used with each other in order to ensure Transmission ratio 20:1 that the warranty is maintained.
  • Page 49 Copy for the user / customer Certification of training Essential for EU user / customer The user has been trained in all functions of the Osscora surgical set in accordance with current Instructions for Use. Particular attention was shown to Safety notes, Disinfection, cleaning, sterilisation and Servicing.
  • Page 51 Copy for the Medical Device Consultant Certification of training Essential for EU user / customer The user has been trained in all functions of the Osscora surgical set in accordance with current Instructions for Use. Particular attention was shown to Safety notes, Disinfection, cleaning, sterilisation and Servicing.
  • Page 56 Tel: +61 2 9428 6555 Fax: +61 2 9428 6352 www.cochlear.com Baha and Vistafix are registered trademarks, and Osscora is a trademark of Cochlear Bone Anchored Solutions AB. Cochlear and the elliptical logo are trademarks of Cochlear Limited. E81005 JAN08.

This manual is also suitable for:

Osscora 91052Osscora 91053

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