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XO Osseo in XO 4 Unit User Guide

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1. angle If you need to control the maximum torque we recommend our software solution XO Smart Link 3 2 Set up for general bone surgery The following instructions will prepare the XO Osseo for bone surgery A Appropriate sterile handling procedures must be observed to ensure and maintain sterile conditions 3 2 1 Handmotor and Cord a Remove the sterilized handmotor and cord from the autoclave bag or wrapping just prior to surgery Regarding sterilization see chapter 5 Cleaning and sterilization b Connect the hand motor cord to the matching connector at the rear of the instrument bridge The suspension shall be configured as OSSEO in the unit menu and peristaltic pump shall be selected to operate with this suspension Place the handmotor on the sterile field O 3 2 2 Contra angle handpiece a Remove the sterilized handpiece from the autoclave bag just prior to surgery Regarding sterilization see chapter Error Reference source not found 5 Cleaning and sterilization b Slide the handpiece or contra angle firmly in place on the handmotor shaft and place the handmotor with handpiece on the sterile field 3 2 3 XO Peristaltic pump Connect the irrigation tubing according to the instructions in the User Guide for XO Peristaltic Pump N The tubing s are for one time use only Do not re sterilize NOTE If your XO 4 Unit is running with XO Smart Link please refer to XO Smart Link Quick Guide for further
2. details Your XO Osseo is now ready for general bone surgery 3 3 Implant surgery Implant surgery demands our software solution XO Smart Link With XO Smart Link you can set up instrument programs and configure all relevant parameters XO OSSEO User Guide YB 624 Version 1 01 4 Operation controls 4 Operation controls All functions are controlled from XO Foot control Please refer to XO 4 Quick Guide section XO Osseo for details Figure 1 XO Foot control XO OSSEO User Guide YB 624 Version 1 01 5 Cleaning and sterilization 5 Cleaning and sterilization 5 1 Irrigation tubing The irrigation tubing kit is for one time use only Discard after use Cannot be re sterilized 5 2 Handpiece contra angle Handpieces and contra angels must be cleaned maintained and sterilized strictly in accordance with the handpiece manufacturers specifications and recommendations Failure to do so may result in reduced torque performance and shortened lifetime of the handpiece 5 3 Handmotor with cord The handmotor is supplied with a sealing plug which has an O ring at the end Prior to autoclaving push the end of the sealing plug into the open center of the handmotor shaft N Failure to autoclave the handmotor with the sealing plug in place may cause damages to the handmotor The recommended infection control procedure is to autoclave the handmotor with cord between patients The handmotor with cord can be
3. you will find that XO Osseo will be a major adjunct to your daily practice We thank you for choosing XO Osseo XO CARE A S XO OSSEO User Guide YB 624 Version 1 01 1 XO 4 documentation 1 XO 4 documentation This document describes how XO Osseo in XO 4 Unit functions in general More details can be found in XO 4 2 XO 4 6 Quick Guide XO 4 2 XO 4 6 Configuration Guide e XO Smart Link Quick Guide XO OSSEO User Guide YB 624 Version 1 01 2 XO Osseo features 2 XO Osseo features XO Osseo is a build in micro motor unit intended for bone surgery in general and for dental implantology in particular XO Osseo is delivered with a low speed high torque brushless micro motor The micro motor is maintenance free and runs from 300RPM to 40 000RPM XO Osseo is intended for use together with XO Peristaltic Pump which supplies irrigation XO OSSEO User Guide YB 624 Version 1 01 3 Preparation and set up 3 Preparation and set up 3 1 General preparation Connect the peristaltic pump to XO 4 Unit as explained in the User Guide for XO Peristaltic Pump XO Peristaltic Pump is automatically detected by XO 4 unit and controlled by XO Osseo motor The parameters speed RPM and irrigation flow rate can be configured in 3 different levels Please refer to XO 4 Configuration Guide for details A The handmotor and contra angle will operate at maximum torque value depending on the used contra
4. CARE A S 5 Do not attempt to disassemble the handmotor and cord 6 XO Osseo should be checked in connection with general unit check up at least every two years 11 XO OSSEO User Guide YB 624 Version 1 01 8 Important Notes and Warnings 8 Important Notes and Warnings The Medical Device Vigilance System imposes on manufacturers the duty to promptly report to Competent Authorities in case a medical device made by the manufacturer has caused an incident that led to a serious deterioration of the state of health of a patient or user In the improbable event that your XO Osseo should be involved in such an incident it is therefore very important that you 1 Promptly inform XO CARE A S 2 Immediately stop using the Osseo unit and 3 Immediately store the Osseo unit separately and exactly in the condition it was in i e without any kind of cleaning or disassembling XO OSSEO User Guide YB 624 Version 1 01 9 Technical specifications 9 Technical specifications Product name XO Osseo Classification Class 1 type B IEC 601 1 Class lla M D D 93 42 EEC Max output power 125 W Max torque handmotor without contra angle 5 6 Necm Manufacturer XO CARE A S Usser d M lle H ndv rkersvinget 6 DK 2970 H rsholm Denmark Tel 45 7020 55 11 Fax 45 7020 5510 E mail sales O xo care com www xo care com C 0470 13 XO OSSEO User Guide YB 624 Version 1 01 XO is
5. XO Osseo in XO 4 Unit User Guide XO CARE A S Usser d M lle H ndv rkersvinget 6 DK 2970 H rsholm Denmark YB 624 Version 1 01 45 70 20 55 11 info O xo care com WWW XO Care com XO OSSEO User Guide YB 624 Version 1 01 List of contents oe ele Ifo ER el 5 E ON 4 1 04 OMEGN V ren 5 2 es Mer 6 3 Preparation and GR AR ER N EE OE ER EE 7 MES Ee GAAN LE IE RE BEN EE AE AE EL 7 32 Setup torgeneral bone SUE soos Re nee Re ee gee Ee RE Oe NEE ee 7 321 Handmotor and Gerdie ee EE Ee GE ee i E Ee ER is Ge 7 322 ee TiN ICS cat AE ER OE OE AE 7 323 AD PERSO UN EE EE OE EE EE EE OE N EE OE 7 39 A SE NE a NE ETR 7 da NN 8 5 Cleaning TAN Jer 9 ST T Ne 9 5 2 Handpiece contra angle Az E AA 9 53 Handmotor Ge estat A ERE 9 RS 10 TREN 11 8 eee renerne 12 9 Technical specications A td 13 XO OSSEO User Guide YB 624 Version 1 01 List of figures A PP EE OE EE EE OR 8 XO OSSEO User Guide YB 624 Version 1 01 Introduction Introduction Your new XO Osseo is a build in micro motor unit intended for bone surgery in general and for dental implantology in particular In your own interest we kindly ask and recommend that you take the time to carefully study this manual in order to familiarize yourself with XO Osseo and its operation By doing so you will be able to take full advantage of the qualities of XO Osseo and to operate without problems in actual practice We are confident that
6. a registered trademark Printing errors if any are subject to reservations and XO CARE A S reserves the right at any time to alter specifications without further notice O 2008 All rights reserved XO CARE
7. sterilized by steam autoclaving maximum temperature 135 C 275 F and with a holdtime of at least 4 min N Higher autoclave temperatures flash autoclaving and other sterilization methods may damage the equipment beyond repair Instrument suspensions can be washed in a thermo disinfector 90 C A Double wrapping is recommended A Do not leave the handmotor and cord over night in the autoclave A Do not lubricate through the open front end of the handmotor A Do not wash handmotor amp cord in a thermo disinfector XO OSSEO User Guide YB 624 Version 1 01 6 Accessories 6 Accessories Delivered with XO Osseo Ref No Part AO 187 Handmotor with cord complete 160095 Handmotor sealing plug Extras XO 055 Pre sterilized disposable surgical tubing kit 50 pcs IT 100 XO Smart Link XO OSSEO User Guide YB 624 Version 1 01 7 Maintenance and safety 7 Maintenance and safety Please observe the following instructions at all times 1 XO Osseo must be operated in accordance with this Manual 2 XO Osseo and its accessories must not be taken into use if signs of operational electrical or mechanical defects are found 3 XO Osseo is engineered to meet the general safety requirements of IEC 60601 1 IEC 60601 1 2 and particular requirements of 4 Technical changes including repairs adjustments calibrations and modifications may only be made by XO CARE A S or specialists approved by XO

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