Universal and powerful battery ... - …

1 INSTRUCTIONS FOR USEU niversal and powerful battery system for a variety of applicationsCOLIBRI IIThis publication is not intended for distribution in the and implants approved by the AO II Instructions for Use DePuy synthes 1 INTRODUCTION General Information 3 COLIBRI II Handpiece 7 Use 9AT TACHMENTS General Information 14 Drill Attachments 16 Screw Attachments 17 Ream Attachments 18 Other Rotating Attachments 20 Saw Attachments 25 Other Attachments 29 CARE AND MAINTENANCE General Information 30 Preparation Prior to Cleaning 31 Manual Cleaning Instruction 32 Mechanical / Automated Cleaning Instruction with Manual Pre-Cleaning 35 Maintenance and Lubrication 39 Function Control 43 Packaging, Sterilization and Storage 44 Repairs and technical service 46 Disposal 47 TABLE OF CONTENTS2 DePuy synthes Colibri II Instructions for UseTable of ContentsWar ningThis description alone does not provide sufficient background for the direct use of the product.

2 Instruction by a surgeon experienced in handling this product is highly 48 SYSTEM SPECIFICATIONS 50 ELECTROMAGNETIC COMPATIBILITY Accompanying Documents According to IEC 60601-1-2, 2007, Clause 6 56 ADDITIONAL INFORMATION 60 ORDERING INFORMATION 61 Colibri II Instructions for Use DePuy synthes 3 Efficiently working cutting tools are the basis for success-ful surgery. Therefore, it is mandatory to check used cut-ting tools after every use for wear and / or damage and to replace them if necessary.

3 We recommend using new Syn-thes cutting tools for every surgery. Cutting tools must be cooled with irrigation liquid to prevent heat user of the product is responsible for proper use of the equipment during the Colibri II is used in conjunction with an implant system, make sure to consult the corresponding Tech-nique Guide .For important information regarding electromagnetic compatibility (EMC), please refer to the chapter Electro-magnetic Compatibility in this tool is classified as type BF against electrical shock and leakage current. The tool is suitable for use on pa-tients in accordance with IEC system requires regular maintenance service, at least once a year, in order to maintain its functionality.

4 This service has to be performed by the original manufacturer or an authorized manufacturer assumes no responsibility for damage resulting from neglected or unauthorized Transmissible Pathogens: Surgical patients iden-tified as at risk for Creutzfeldt-Jakob disease (CJD) and related infections should be treated with single-use in-struments. Dispose of the instruments used or suspected of use on a patient with CJD after surgery and/or follow the current national useThe Colibri II is designed for the use in traumatology and orthopedic surgery of the skeleton, drilling, reaming or cutting instructionsThe surgeon has to evaluate if the machine is suitable for an application, based on power limitation of the machine, attachment and cutting tool regarding bone strength/anatomical situation as well as handling of the machine, attachment and cutting tool regarding bone size.

5 In addition, the contraindications of the implant have to be respected. Please refer to the corresponding Technique Guides of the implant system used. The Colibri II is only to be used for surgery after careful consultation of the instructions for use. It is recom-mended that an alternative system is available to use during application, as technical problems can never be completely ruled Colibri II is designed for use by physicians and trained medical NOT use any component if damage is NOT use any component if the packaging is NOT use this equipment in the presence of oxygen, nitrous oxide or a mixture consisting of flammable anes-thetics and ensure the proper operation of the tool, only use Syn-thes original the first and every subsequent use, power tools and their accessories / attachments have to run through the complete reprocessing procedure.

6 Protective covers and foils must be fully removed before the tool to function properly, synthes recommends cleaning and servicing it after each use in accordance with the process recommended in the chapter Care and Maintenance . Compliance with these specifications can considerably extend the service life of the tool. Only use synthes oil ( ) to lubricate the INFORMATION4 DePuy synthes Colibri II Instructions for UsePrecautions: To avoid injuries, the locking mechanism of the tool has to be activated before every manipulation and before placing the tool back down, the mode switch has to be in OFF position. The tool may only be operated with a fully charged battery .

7 To do this, ensure that the battery is charged in good time. We recommend that the bat-tery is replaced into the charger immediately after s u r ger y. The batteries must not be sterilized, washed or im-mersed. This would destroy the battery with possi-ble secondary damage. When storing or transporting batteries, ensure that they are separately packed and do not store them with materials that conduct electricity in order to prevent short-circuit. This could damage the bat-tery and generate heat which can cause burns. Should the machine drop on the floor and have visible defects, do not use it anymore and send it to the synthes service center.

8 If a product drops on the floor, fragments may split off. This represents a danger for the patient and user as: these fragments may be sharp. unsterile fragments may enter the sterile field or hit the patient. Should the system have corroded parts, do not use it anymore and send it to the synthes service of deliveryThe Colibri II consists of a handpiece, one or several bat-tery casings and batteries and a range of attachments and accessories designed for the the system to operate properly, only synthes cutting tools should be auxiliaries such as cleaning brushes and synthes oil are available for cleaning and servicing the system. No oils from other manufacturers must be used.

9 Only synthes oil ( ) must be with other compositions can cause jamming, can have a toxic effect or can have a negative impact on the sterilization results. Only lubricate the power tool and the attachments when recommends the use of the specifically designed synthes Vario Case ( ) and of the specifically designed Washing Basket ( ) to sterilize and store the following components are essential to ensure proper operation: Handpiece ( ) battery Casing ( ) battery ( ) Sterile Cover ( ) Universal battery Charger II ( ) At least one attachment of the systemPlease refer to the end of these Instructions for Use for an overview of the components of the of the instrument or fragments of instrumentsSynthes instruments are designed and manufactured to perform within the scope of their intended use.

10 How-ever, if a Power Tool or accessory/attachment breaks during use, a visual inspection or a medical imaging de-vice (e. g. CT, Radiation Devices, etc.) can aid in locating the fragments and/or components of the and transportPlease use the original packaging for dispatch and trans-port. If this is no longer available, please contact the synthes / LiabilityThe warranty for the tools and accessories does not cover damage of any kind resulting from improper use, damaged seals or improper storage and transport. The manufacturer excludes liability for damage resulting from repairs or maintenance carried out by unauthorized manufacturer assumes no responsibility for damage resulting from neglected or unauthorized InformationColibri II Instructions for Use DePuy synthes 52Do not reuseProducts intended for single use must not be or reprocessing ( cleaning and resteril-ization)