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Cochlear Osscora 91051, Инструкция по эксплуатации, Страница: 56 / 56

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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. 

Manufacturer: 

Cochlear Bone Anchored Solutions AB  

Konstruktionsvägen 14, SE-435 33 Mölnlycke,  Sweden. 

Tel +46 31 792 44 00,  Fax: +46 31 792 46 95

Regional offices:

Cochlear Americas  

400 Inverness Parkway, Suite 400, Englewood CO 80112,  USA  

Tel: +1 303 790 9010  Fax: +1 303 792 9025

Cochlear AG  

European Headquarters, Margarethenstrasse 47, CH - 4053  Basel, Switzerland   

Tel: +41 61 205 0404  Fax: +41 61 205 0405

Cochlear Ltd  

(ABN 96 002 618 073) 14 Mars Road, Lane Cove NSW 2066,  Australia  

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

www.cochlear.com 

50628 AEN Rev. 000 / 15.10.2007

Содержание Osscora 91051

Страница 1: ...Osscora Surgical Set Instructions for Use Model no 91051 91052 91053...

Страница 2: ...revent damage occurring General explanations Without risk to persons or objects Sterilisable Up to the stated temperature Thermo washer Disinfectable Only for USA Caution Federal law USA restricts thi...

Страница 3: ...ra contra angle handpiece 28 15 Osscora accessories 44 16 Servicing 45 17 Technical data 47 Chapter Page 1 Introduction 4 2 Safety notes 5 3 Unpacking 8 4 Equipment supplied 9 5 Description of front p...

Страница 4: ...lidates 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 aga...

Страница 5: ...ease ensure that you carry out the following instructions Only fit the contra angle handpiece when the motor is at a complete standstill Never touch rotary instruments which are still rotating Never t...

Страница 6: ...IEC 60601 1 UL 60601 1 the control unit is not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxid...

Страница 7: ...the relevant regulations for disposal of irrigation tubing Rotational energy Fast deceleration of the bur can at times cause the selected torque to be overloaded as a result of the rotational energy s...

Страница 8: ...ustrial recycling companies However we recommend that you keep the original packaging u Lift out insert with stand v Remove foot control and insert w Lift out insert with control unit x Remove irrigat...

Страница 9: ...ocking pins 2 pcs and clips 10 pcs Motor with 3 5 m cable incl motor protective cover locking pins 2 pcs and clips 10 pcs Motor with 3 5 m cable incl motor protective cover locking pins 2 pcs and clip...

Страница 10: ...English 10 5 Description of front panel Motor connection socket Display OPEN Pump arm Program buttons Pump arm Stand holder P1 P2 P3...

Страница 11: ...English 11 6 Description of rear panel Connecting socket for foot control Fuse holder with 2 fuses 250 V 1 25A slow blow Power socket Power switch ON OFF Stand holder...

Страница 12: ...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 see illustration Test run Start the motor If you o...

Страница 13: ...Starting operation General u Connect the mains cable and foot control v Connect the motor cable Note the positioning w Insert the stand Note the positioning x Fit the irrigation tubing set y Close pum...

Страница 14: ...h 14 9 Starting operation Foot control GREEN Pump ON OFF GREY Start motor VARIABLE or ON OFF Factory setting variable ORANGE Change program Program 1 to 3 YELLOW Change motor direction forward reverse...

Страница 15: ...ble 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 sig...

Страница 16: ...sed throughout this procedure u Press P3 for approx 4 seconds v Keep P3 depressed and simultaneously press PLUS and MINUS w Keep P3 depressed and carry out adjustment 01 VARIABLE factory setting Press...

Страница 17: ...2 P3 Forward P3 Reverse Factory setting rpm 2000 2000 15 30 Adjustable range rpm 15 2000 15 2000 Motor direction Forward Forward Forward Reverse Pump Off On Off Off Factory setting Ncm Max Max 20 20 A...

Страница 18: ...y 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 D...

Страница 19: ...ble signal can be heard and the program button is illuminated On the display the selected program appears with the adjusted range in rpm Display adjustments P1 P2 speed P3 torque Pump operation ON OFF...

Страница 20: ...ontrol unit operation Keeping PLUS MINUS depressed activates the repeat function and the values are continuously increased decreased Press program button P1 P2 Increase speed Decrease speed Changing t...

Страница 21: ...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 When the adjustable torque in the forward reverse dri...

Страница 22: ...program button P2 depressed throughout this procedure Keep P2 depressed for approximately 4 seconds the adjusted coolant flow rate appears Keep P2 depressed and press PLUS button to increase flow rat...

Страница 23: ...ff the equipment restart do not actuate foot control when switching on 09 Foot control error Switch off the equipment check connection of the foot control then restart 19 Run limiting control Switch o...

Страница 24: ...ing off the 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...

Страница 25: ...ly soiled Clean first with disinfectant cloths Only use disinfectants that have no protein fixing effects Manual cleaning and disinfection The front panel of the control unit and the foot control are...

Страница 26: ...oths Only use disinfectants that have no protein fixing effects Manual cleaning Rinse under demineralised water 38 C with the aid of a brush brush is not recommended in U K Then remove any liquid resi...

Страница 27: ...ust free and dry Approved sterilisation procedures Follow your country specific directives standards and guidelines Steam sterilisation with sterilisers in accordance with EN 13060 or EN 285 class B S...

Страница 28: ...a 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 cl...

Страница 29: ...stafix surgery Prior to initial use Please read the section on hygienic maintenance page 34 43 Lubricate the contra angle handpiece Sterilise the contra angle handpiece nozzle cleaner and spray clip C...

Страница 30: ...e 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 attac...

Страница 31: ...ra angle handpiece during operation This leads to detachment of the rotary instrument and makes the head of the contra angle handpiece hot To change rotary instrument in the Osscora contra angle handp...

Страница 32: ...e rotary instrument into the contra angle handpiece until back stop a and turn until it engages b v Check secure location by applying slight axial tension w Remove the rotary instrument by pushing the...

Страница 33: ...nsert 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 detai...

Страница 34: ...instrument Remove the contra angle handpiece from the motor Clean and disinfect the disassembled contra angle handpiece immediately after every treatment to flush out any liquid residues such as blood...

Страница 35: ...ora 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 Remov...

Страница 36: ...g 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 han...

Страница 37: ...with the air syringe 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...

Страница 38: ...ot contain chlorine and which are certified by officially recognised institutes For USA Use EPA registered surface disinfectants Note the manufacturer s specifications for the use of the surface disin...

Страница 39: ...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 processi...

Страница 40: ...ible onto the contra angle head until it engages w Put the shaft in the knee and mind the position of the rotational lock b Check free running rotation c x Press the sheath firmly against the knee and...

Страница 41: ...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 Recommen...

Страница 42: ...d 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 Repeat the complete hygiene and m...

Страница 43: ...nly remove dry sterile goods Store sterile goods dust free and dry Approved sterilisation procedures Follow your country specific directives standards and guidelines Steam sterilisation with sterilise...

Страница 44: ...English 44 15 Osscora accessories 91102 Sterilisation cassette 91054 Osscora motor with 3 5 m cable 91061 Irrigation tubing set 3 8 m 6 pcs 91050 Osscora contra angle handpiece Disposable article...

Страница 45: ...by a qualified organisation and needs to include the following procedures Visual inspection for outside damage Measurement of enclosure leakage current Measurement of patient leakage current Visual i...

Страница 46: ...ervicing after 500 sterilisation cycles or one year Repairs If a defect occurs always return all the equipment due to the fact that with motor malfunctions an inspection of the electronic controls is...

Страница 47: ...otective Class II type of protection against electric shock Type BF appliance not suitable for intracardiac application 91051 91052 91053 Supply voltage 220 240 V 100 130 V Rated current 0 1 0 8 A 0 2...

Страница 48: ...order to ensure that the warranty is maintained When having a torque higher that 30 Ncm on the rotary instrument you have to use hardened shafts 50 HRC 520 HV risk of deformation When using a longer...

Страница 49: ...set in accordance with current Instructions for Use Particular attention was shown to Safety notes Disinfection cleaning sterilisation and Servicing Osscora surgical set Type Serial Number Name of the...

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Страница 51: ...accordance with current Instructions for Use Particular attention was shown to Safety notes Disinfection cleaning sterilisation and Servicing Copy for the Medical Device Consultant Osscora surgical s...

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Страница 56: ...33 M lnlycke Sweden Tel 46 31 792 44 00 Fax 46 31 792 46 95 Regional offices Cochlear Americas 400 Inverness Parkway Suite 400 Englewood CO 80112 USA Tel 1 303 790 9010 Fax 1 303 792 9025 Cochlear AG...

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